{"id":"rosuvastatin","rwe":[{"pmid":"41894269","year":"2026","title":"Association between craniosynostosis and phospholipid metabolism: Insights from single-cell and transcriptomic analysis.","finding":"","journal":"Medicine","studyType":"Clinical Study"},{"pmid":"41892527","year":"2026","title":"Pathologic, Laboratory, and Surgical Findings of Topical Statin Gels (Simvastatin, Atorvastatin, and Rosuvastatin) in a Rat Model of Peritoneal Endometriosis.","finding":"","journal":"Gels (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41892077","year":"2026","title":"A Case of Recurrent Chromoblastomycosis Treated with Multiple Surgical Management Options.","finding":"","journal":"Dermatopathology (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41884637","year":"2026","title":"Risk of new-onset diabetes across individual statins in secondary prevention: results from the Korean national health insurance service cohort.","finding":"","journal":"Frontiers in cardiovascular medicine","studyType":"Clinical Study"},{"pmid":"41883442","year":"2026","title":"Experimental beneficial effect of rosuvastatin on burn wound healing in a rat model.","finding":"","journal":"World journal of experimental medicine","studyType":"Clinical Study"}],"_fda":{"id":"447c034b-bd46-2a37-e063-6394a90a4feb","set_id":"02797697-300a-43db-92cf-9b78f08626be","openfda":{"upc":["0369367359092","0369367359108"],"unii":["83MVU38M7Q"],"route":["ORAL"],"rxcui":["859419","859424","859747","859751"],"spl_id":["447c034b-bd46-2a37-e063-6394a90a4feb"],"brand_name":["Rosuvastatin Calcium"],"spl_set_id":["02797697-300a-43db-92cf-9b78f08626be"],"package_ndc":["69367-359-05","69367-359-30","69367-359-09","69367-359-10","69367-359-01","69367-360-10","69367-360-30","69367-360-09","69367-360-05","69367-360-01","69367-361-09","69367-361-01","69367-361-05","69367-361-10","69367-361-30","69367-362-01","69367-362-05","69367-362-30","69367-362-09"],"product_ndc":["69367-359","69367-360","69367-361","69367-362"],"generic_name":["ROSUVASTATIN CALCIUM"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ROSUVASTATIN CALCIUM"],"manufacturer_name":["Westminster Pharmaceuticals, LLC"],"application_number":["ANDA207062"],"is_original_packager":[true]},"version":"6","pregnancy":["8.1 Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders - including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use - using propensity score‑based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC). In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area). Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. In rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18."],"overdosage":["10 OVERDOSAGE No specific antidotes for rosuvastatin are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations."],"description":["11 DESCRIPTION Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The empirical formula for rosuvastatin calcium is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white or almost white, hygroscopic powder that is slightly soluble in water, freely soluble in methylene chloride, practically insoluble in ethanol. Rosuvastatin calcium has a partition coefficient (octanol/water) of 2.20 at pH of 7.3. Rosuvastatin for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: anhydrous lactose, lactose monohydrate, anhydrous dibasic calcium phosphate, microcrystalline cellulose (101, 102), crospovidone, magnesium stearate, hypromellose 2910, titanium dioxide, triacetin, D&C yellow #10 aluminium lake, FD&C red #40/allura red AC aluminium lake, FD&C blue #2/ indigo carmine aluminium lake, FD&C yellow #6/ sunset yellow FCF aluminium lake. Image"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-359-30 69367-359-09 69367-359-01 69367-359-05 69367-359-10 Yellow colored, round, biconvex film coated tablets, debossed with \"RS\" on one side and plain on the other side. 10 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-360-30 69367-360-09 69367-360-01 69367-360-05 69367-360-10 Pink colored, round, biconvex film coated tablets, debossed with \"RS1\" on one side and plain on the other side. 20 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-361-30 69367-361-09 69367-361-01 69367-361-05 69367-361-10 Pink colored, round, biconvex film coated tablets, debossed with \"RS2\" on one side and plain on the other side. 40 mg bottles of 30, 90, 100 and 500 tablets 69367-362-30 69367-362-09 69367-362-01 69367-362-05 Pink colored, oval, biconvex film coated tablets, debossed with \"RS3\" on one side and plain on the other side. Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture."],"geriatric_use":["8.5 Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Advanced age (≥65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving rosuvastatin for the increased risk of myopathy [see Warnings and Precautions ( 5.1 )] ."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [see Clinical Studies ( 14 )] . In the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturation in patients aged 10 to 17 years. The safety and effectiveness of rosuvastatin as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established pediatric patients 7 years of age and older with HoFH. Use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with HoFH [see Clinical Studies ( 14 )] . The safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with HeFH, younger than 7 years of age with HoFH, or in pediatric patients with other types of hyperlipidemia (other than HeFH or HoFH)."],"effective_time":"20251126","clinical_studies":["14 CLINICAL STUDIES Primary Prevention of CV Disease In the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, the effect of rosuvastatin on the occurrence of major CV disease events was assessed in 17,802 males (≥50 years) and females (≥60 years) who had no clinically evident CV disease, LDL‑C levels <130 mg/dL and hsCRP levels ≥2 mg/L. The study population had an estimated baseline coronary heart disease risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL‑C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Patients had a median baseline LDL‑C of 108 mg/dL and hsCRP of 4.3 mg/L. Patients were randomly assigned to placebo (n=8901) or rosuvastatin 20 mg once daily (n=8901) and were followed for a mean duration of 2 years. The JUPITER study was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in rosuvastatin-treated subjects. The primary end point was a composite end point consisting of the time-to-first occurrence of any of the following major CV events: CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or an arterial revascularization procedure. Rosuvastatin significantly reduced the risk of major CV events (252 events in the placebo group vs. 142 events in the rosuvastatin group) with a statistically significant (p<0.001) relative risk reduction of 44% and absolute risk reduction of 1.2% (see Figure 1). The risk reduction for the primary end point was consistent across the following predefined subgroups: age, sex, race, smoking status, family history of premature CHD, body mass index, LDL‑C, HDL‑C, and hsCRP levels. Figure 1. Time to First Occurrence of Major CV Events in JUPITER The individual components of the primary end point are presented in Figure 3. Rosuvastatin significantly reduced the risk of nonfatal myocardial infarction, nonfatal stroke, and arterial revascularization procedures. There were no significant treatment differences between the rosuvastatin and placebo groups for death due to CV causes or hospitalizations for unstable angina. Rosuvastatin significantly reduced the risk of myocardial infarction (6 fatal events and 62 nonfatal events in placebo-treated subjects vs. 9 fatal events and 22 nonfatal events in rosuvastatin-treated subjects) and the risk of stroke (6 fatal events and 58 nonfatal events in placebo-treated subjects vs. 3 fatal events and 30 nonfatal events in rosuvastatin-treated subjects). In a post-hoc subgroup analysis of JUPITER subjects (rosuvastatin=725, placebo=680) with a hsCRP ≥2 mg/L and no other traditional risk factors (smoking, BP ≥140/90 or taking antihypertensives, low HDL‑C) other than age, after adjustment for high HDL‑C, there was no significant treatment benefit with rosuvastatin treatment. Figure 2. Major CV Events by Treatment Group in JUPITER At one year, rosuvastatin increased HDL‑C and reduced LDL‑C, hsCRP, total cholesterol and serum triglyceride levels (p<0.001 for all versus placebo). Primary Hyperlipidemia in Adults Rosuvastatin reduces Total‑C, LDL‑C, ApoB, non-HDL‑C, and TG, and increases HDL‑C, in adult patients with hyperlipidemia and mixed dyslipidemia. In a multicenter, double-blind, placebo-controlled study in patients with hyperlipidemia, rosuvastatin given as a single daily dose (5 to 40 mg) for 6 weeks significantly reduced Total‑C, LDL‑C, non-HDL‑C, and ApoB, across the dose range (Table 10). Table 10: Lipid-modifying Effect of Rosuvastatin in Adult Patients with Hyperlipidemia (Adjusted Mean % Change from Baseline at Week 6) Dose N Total ‑ C LDL ‑ C Non-HDL ‑ C ApoB TG HDL ‑ C Placebo 13 -5 -7 -7 -3 -3 3 Rosuvastatin 5 mg 17 -33 -45 -44 -38 -35 13 Rosuvastatin 10 mg 17 -36 -52 -48 -42 -10 14 Rosuvastatin 20 mg 17 -40 -55 -51 -46 -23 8 Rosuvastatin 40 mg 18 -46 -63 -60 -54 -28 10 Rosuvastatin was compared with the statins (atorvastatin, simvastatin, and pravastatin) in a multicenter, open-label, dose-ranging study of 2240 patients with hyperlipidemia or mixed dyslipidemia. After randomization, patients were treated for 6 weeks with a single daily dose of either rosuvastatin, atorvastatin, simvastatin, or pravastatin (Figure 3 and Table 11). Figure 3. Percent LDL ‑ C Change by Dose of Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin at Week 6 in Adult Patients with Hyperlipidemia or Mixed Dyslipidemia Box plots are a representation of the 25th, 50th, and 75th percentile values, with whiskers representing the 10th and 90th percentile values. Mean baseline LDL‑C: 189 mg/dL. Table 11: Percent Change in LDL-C by Dose of Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin From Baseline to Week 6 (LS Mean Corresponding standard errors are approximately 1.00. ) in Adult Patients with Hyperlipidemia or Mixed Dyslipidemia (Sample Sizes Ranging from 156–167 Patients Per Group) Treatment Daily Dose Treatment 10 mg 20 mg 40 mg 80 mg Rosuvastatin -46 Rosuvastatin 10 mg reduced LDL-C significantly more than atorvastatin 10 mg; pravastatin 10 mg, 20 mg, and 40 mg; simvastatin 10 mg, 20 mg, and 40 mg. (p<0.002) -52 Rosuvastatin 20 mg reduced LDL-C significantly more than atorvastatin 20 mg and 40 mg; pravastatin 20 mg and 40 mg; simvastatin 20 mg, 40 mg, and 80 mg. (p<0.002) -55 Rosuvastatin 40 mg reduced LDL-C significantly more than atorvastatin 40 mg; pravastatin 40 mg; simvastatin 40 mg, and 80 mg. (p<0.002) --- Atorvastatin -37 -43 -48 -51 Simvastatin -28 -35 -39 -46 Pravastatin -20 -24 -30 --- Slowing of the Progression of Atherosclerosis In the Measuring Effects on Intima Media Thickness: an Evaluation Of Rosuvastatin 40 mg (METEOR) study, the effect of therapy with rosuvastatin on carotid atherosclerosis was assessed by B-mode ultrasonography in patients with elevated LDL‑C, at low risk (Framingham risk <10% over ten years) for symptomatic coronary artery disease and with subclinical atherosclerosis as evidenced by carotid intimal-medial thickness (cIMT). In this double-blind, placebo-controlled clinical study 984 adult patients were randomized (of whom 876 were analyzed) in a 5:2 ratio to rosuvastatin 40 mg or placebo once daily. Ultrasonograms of the carotid walls were used to determine the annualized rate of change per patient from baseline to two years in mean maximum cIMT of 12 measured segments. The estimated difference in the rate of change in the maximum cIMT analyzed over all 12 carotid artery sites between patients treated with rosuvastatin and placebo-treated patients was -0.0145 mm/year (95% CI –0.0196, –0.0093; p<0.0001). The annualized rate of change from baseline for the placebo group was +0.0131 mm/year (p<0.0001). The annualized rate of change from baseline for the group treated with rosuvastatin was -0.0014 mm/year (p=0.32). At an individual patient level in the group treated with rosuvastatin, 52.1% of patients demonstrated an absence of disease progression (defined as a negative annualized rate of change), compared to 37.7% of patients in the placebo group. HeFH in Adults In a study of adult patients with HeFH (baseline mean LDL of 291 mg/dL), patients were randomized to rosuvastatin 20 mg or atorvastatin 20 mg. The dose was increased at 6-week intervals. Significant LDL-C reductions from baseline were seen at each dose in both treatment groups (Table 12). Table 12: LDL-C Percent Change from Baseline Rosuvastatin (n=435) LS Mean LS Means are least square means adjusted for baseline LDL-C (95% CI) Atorvastatin (n=187) LS Mean (95% CI) Week 6 20 mg -47% (-49%, -46%) -38% (-40%, -36%) Week 12 40 mg -55% (-57%, -54%) -47% (-49%, -45%) Week 18 80 mg NA -52% (-54%, -50%) HeFH in Pediatric Patients In a double-blind, randomized, multicenter, placebo-controlled, 12-week study, 176 (97 male and 79 female) pediatric patients with HeFH were randomized to rosuvastatin 5 mg, 10 mg or 20 mg or placebo daily. Patients ranged in age from 10 to 17 years (median age of 14 years) with approximately 30% of the patients 10 to 13 years and approximately 17%, 18%, 40%, and 25% at Tanner stages II, III, IV, and V, respectively. Females were at least 1 year postmenarche. Mean LDL-C at baseline was 233 mg/dL (range of 129 to 399). The 12‑week double-blind phase was followed by a 40 week open label dose-titration phase, where all patients (n=173) received 5 mg, 10 mg or 20 mg rosuvastatin daily. Rosuvastatin significantly reduced LDL-C (primary end point), total cholesterol and ApoB levels at each dose compared to placebo. Results are shown in Table 13 below. Table 13: Lipid-Modifying Effects of Rosuvastatin in Pediatric Patients 10 to 17 years of Age with HeFH (Least-Squares Mean Percent Change from Baseline To Week 12) Dose (mg) N LDL-C HDL-C Total-C TG Median percent change ApoB Placebo 46 -1% +7% 0% -7% -2% 5 42 -38% +4% Difference from placebo not statistically significant -30% -13% -32% 10 44 -45% +11% -34% -15% -38% 20 44 -50% +9% -39% 16% -41% Rosuvastatin was also studied in a two-year open‑label, uncontrolled, titration-to-goal trial that included 175 pediatric patients with HeFH who were 8 to 17 years old (79 males and 96 females). All patients had a documented genetic defect in the LDL receptor or in ApoB. Approximately 89% were White, 7% were Asian, 1% were Black or African American, and fewer than 1% were Hispanic or Latino ethnicity. Mean LDL-C at baseline was 236 mg/dL. Fifty-eight (33%) patients were prepubertal at baseline. The starting rosuvastatin dosage for all pediatric patients was 5 mg once daily. Pediatric patients aged 8 to less than 10 years of age (n=41 at baseline) could titrate to a maximum dosage of 10 mg once daily, and pediatric patients aged 10 to 17 years of age could titrate to a maximum dosage of 20 mg once daily. The reductions in LDL‑C from baseline were generally consistent across age groups within the trial as well as with previous experience in both adult and pediatric controlled trials. HoFH in Adult and Pediatric Patients In an open-label, forced-titration study, HoFH patients (n=40, 8‑63 years) were evaluated for their response to rosuvastatin 20 to 40 mg titrated at a 6‑week interval. In the overall population, the mean LDL‑C reduction from baseline was 22%. About one-third of the patients benefited from increasing their dose from 20 mg to 40 mg with further LDL-C lowering of greater than 6%. In the 27 patients with at least a 15% reduction in LDL‑C, the mean LDL-C reduction was 30% (median 28% reduction). Among 13 patients with an LDL‑C reduction of <15%, 3 had no change or an increase in LDL‑C. Reductions in LDL‑C of 15% or greater were observed in 3 of 5 patients with known receptor negative status. HoFH in Pediatric Patients Rosuvastatin was studied in a randomized, double-blind, placebo-controlled, multicenter, cross-over study in 14 pediatric patients with HoFH. The study included a 4‑week dietary lead‑in phase during which patients received rosuvastatin 10 mg daily, a cross‑over phase that included two 6‑week treatment periods with either rosuvastatin 20 mg or placebo in random order, followed by a 12‑week open‑label phase during which all patients received rosuvastatin 20 mg. Patients ranged in age from 7 to 15 years of age (median 11 years), 50% were male, 71% were White, 21% were Asian, 7% were Black or African American, and no patients were of Hispanic or Latino ethnicity. Fifty percent were on apheresis therapy and 57% were taking ezetimibe. Patients who entered the study on apheresis therapy or ezetimibe continued the treatment throughout the entire study. Mean LDL‑C at baseline was 416 mg/dL (range 152 to 716 mg/dL). A total of 13 patients completed both treatment periods of the randomized cross-over phase; one patient withdrew consent due to inability to have blood drawn during the cross-over phase. Rosuvastatin 20 mg significantly reduced LDL-C, total cholesterol, ApoB, and non-HDL-C compared to placebo (Table 14). Table 14: Lipid-modifying Effects of Rosuvastatin in Pediatric Patients 7 to 15 years of Age with HoFH After 6 Weeks Placebo (N=13) Rosuvastatin 20 mg (N=13) Percent difference (95% CI) LDL-C (mg/dL) 481 396 -22.3% (-33.5, -9.1) 1 Total-C (mg/dL) 539 448 -20.1% (-29.7, -9.1) 2 Non-HDL-C (mg/dL) 505 412 -22.9% (-33.7, ‑10.3) 2 ApoB (mg/dL) 268 235 -17.1% (-29.2, -2.9) 3 % Difference estimates are based on transformations of the estimated mean difference in log LDL measurements between rosuvastatin and placebo using a mixed model adjusted for study period. 1 p= 0.005, 2 p= 0.003, 3 p= 0.024 Primary Dysbetalipoproteinemia in Adults In a randomized, multicenter, double-blind crossover study, 32 adult patients (27 with є2/є2 and 4 with apo E mutation [Arg145Cys] with primary dysbetalipoproteinemia entered a 6‑week dietary lead-in period on the NCEP Therapeutic Lifestyle Change (TLC) diet. Following dietary lead-in, patients were randomized to a sequence of treatments for 6 weeks each: rosuvastatin 10 mg followed by rosuvastatin 20 mg or rosuvastatin 20 mg followed by rosuvastatin 10 mg. Rosuvastatin reduced non-HDL‑C (primary end point) and circulating remnant lipoprotein levels. Results are shown in the table below. Table 15: Lipid-modifying Effects of Rosuvastatin 10 mg and 20 mg in Adult Patients with Primary Dysbetalipoproteinemia (Type III hyperlipoproteinemia) After Six Weeks by Median Percent Change (95% CI) from Baseline (N=32) Median at Baseline (mg/dL) Median percent change from baseline (95% CI) Rosuvastatin 10 mg Median percent change from baseline (95% CI) Rosuvastatin 20 mg Total-C 342.5 -43.3 (-46.9, – 37.5) -47.6 (-51.6, -42.8) Triglycerides 503.5 -40.1 (-44.9, -33.6) -43.0 (-52.5, -33.1) Non‑HDL-C 294.5 -48.2 (-56.7, -45.6) -56.4 (-61.4, -48.5) VLDL-C + IDL-C 209.5 -46.8 (-53.7, -39.4) -56.2 (-67.7, -43.7) LDL-C 112.5 -54.4 (-59.1, -47.3) -57.3 (-59.4, -52.1) HDL-C 35.5 10.2 (1.9, 12.3) 11.2 (8.3, 20.5) RLP-C 82.0 -56.4 (-67.1, -49.0) -64.9 (-74.0, -56.6) Apo-E 16.0 -42.9 (-46.3, -33.3) -42.5 (-47.1, -35.6) Hypertriglyceridemia in Adults In a double-blind, placebo-controlled study in adult patients with baseline TG levels from 273 to 817 mg/dL, rosuvastatin given as a single daily dose (5 to 40 mg) over 6 weeks significantly reduced serum TG levels (Table 16). Table 16: Lipid-Modifying Effect of Rosuvastatin in Adult Patients with Primary Hypertriglyceridemia After Six Weeks by Median (Min, Max) Percent Change from Baseline to Week 6 Dose Placebo (n=26) Rosuvastatin 5 mg (n=25) Rosuvastatin 10 mg (n=23) Rosuvastatin 20 mg (n=27) Rosuvastatin 40 mg (n=25) Triglycerides 1 (-40, 72) -21 (-58, 38) -37 (-65, 5) -37 (-72, 11) -43 (-80, -7) Non-HDL-C 2 (-13, 19) -29 (-43, -8) -49 (-59, -20) -43 (-74, 12) -51 (-62, -6) Total-C 1 (-13, 17) -24 (-40, -4) -40 (-51, -14) -34 (-61, -11) -40 (-51, -4) LDL-C 5 (-30, 52) -28 (-71, 2) -45 (-59, 7) -31 (-66, 34) -43 (-61, -3) HDL-C -3 (-25, 18) 3 (-38, 33) 8 (-8, 24) 22 (-5, 50) 17 -14, 63) Image Image Image"],"pharmacodynamics":["12.2 Pharmacodynamics Inhibition of HMG-CoA reductase by rosuvastatin accelerates the expression of LDL-receptors, followed by the uptake of LDL-C from blood to the liver, leading to a decrease in plasma LDL-C and total cholesterol. Sustained inhibition of cholesterol synthesis in the liver also decreases levels of very-low-density lipoproteins. The maximum LDL-C reduction of rosuvastatin is usually achieved by 4 weeks and is maintained after that."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both C max and AUC increased in approximate proportion to rosuvastatin dose. The absolute bioavailability of rosuvastatin is approximately 20%. The AUC of rosuvastatin does not differ following evening or morning drug administration. Effect of food Administration of rosuvastatin with food did not affect the AUC of rosuvastatin. Distribution Mean volume of distribution at steady-state of rosuvastatin is approximately 134 liters. Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. Elimination Metabolism Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite. The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 \\ 2C9, and in vitro studies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one-half the HMG‑CoA reductase inhibitory activity of the parent compound. Overall, greater than 90% of active plasma HMG‑CoA reductase inhibitory activity is accounted for by the parent compound. Excretion Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%). After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. The elimination half-life of rosuvastatin is approximately 19 hours. Specific Populations Geriatric Patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years). Pediatric Patients In a population pharmacokinetic analysis of two pediatric trials involving patients with HeFH 10 to 17 years of age and 8 to 17 years of age, respectively, rosuvastatin exposure appeared comparable to or lower than rosuvastatin exposure in adult patients. Male and Female Patients There were no differences in plasma concentrations of rosuvastatin between males and females. Racial or Ethnic Groups A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among White, Hispanic or Latino ethnicity, and Black or Afro-Caribbean groups. However, pharmacokinetic studies, including one conducted in the US, have demonstrated an approximate 2‑fold elevation in median exposure (AUC and C max ) in Asian subjects when compared with a White control group. Patients with Renal Impairment Mild to moderate renal impairment (CL cr ≥30 mL/min/1.73 m 2 ) had no influence on plasma concentrations of rosuvastatin. However, plasma concentrations of rosuvastatin increased to a clinically significant extent (about 3‑fold) in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) not receiving hemodialysis compared with healthy subjects (CL cr >80 mL/min/1.73 m 2 ). Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Patients with Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. In patients with Child‑Pugh A disease, C max and AUC were increased by 60% and 5%, respectively, as compared with patients with normal liver function. In patients with Child‑Pugh B disease, C max and AUC were increased 100% and 21%, respectively, compared with patients with normal liver function. Drug Interaction Studies Rosuvastatin clearance is not dependent on metabolism by cytochrome P450 3A4 to a clinically significant extent. Rosuvastatin is a substrate for certain transporter proteins including the hepatic uptake transporter organic anion-transporting polyprotein 1B1 (OATP1B1) and efflux transporter breast cancer resistance protein (BCRP). Concomitant administration of rosuvastatin with medications that are inhibitors of these transporter proteins (e.g. cyclosporine, certain HIV protease inhibitors [see Dosage and Administration ( 2.6 ) and Drug Interactions ( 7.1 )] and ticagrelor [see Drug Interactions ( 7.1 )]) may result in increased rosuvastatin plasma concentrations. Table 8: Effect of Coadministered Drugs on Rosuvastatin Systemic Exposure Coadministered drug and dosing regimen Rosuvastatin Mean Ratio (ratio with/without coadministered drug) No Effect=1.0 Dose (mg) Single dose unless otherwise noted. Change in AUC Change in C max Sofosbuvir/velpatasvir/voxilaprevir (400 mg -100 mg-100 mg) + Voxilaprevir (100 mg) once daily for 15 days 10 mg, single dose 7.39 Clinically significant [see Dosage and Administration ( 2) and Warnings and Precautions ( 5)] (6.68-8.18) Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7 = 30% decrease, 11=11‑fold increase in exposure) 18.88 (16.23-21.96) Cyclosporine - stable dose required (75 mg - 200 mg BID) 10 mg, QD for 10 days 7.1 11 Darolutamide 600 mg BID, 5 days 5 mg, single dose 5.2 ~5 Regorafenib 160 mg QD, 14 days 5 mg, single dose 3.8 4.6 Atazanavir/ritonavir combination 300 mg/100 mg QD for 8 days 10 mg 3.1 7 Simeprevir 150 mg QD, 7 days 10 mg, single dose 2.8 (2.3-3.4) 3.2 (2.6-3.9) Velpatasvir 100 mg once daily 10 mg, single dose 2.69 (2.46-2.94) 2.61 (2.32-2.92) Ombitasvir 25 mg/paritaprevir 150 mg/ ritonavir 100 mg + dasabuvir 400 mg BID 5 mg, single dose 2.59 (2.09-3.21) 7.13 (5.11-9.96) Teriflunomide Not available 2.51 2 2.65 Enasidenib 100 mg QD, 28 days 10 mg, single dose 2.44 3.66 Elbasvir 50 mg/grazoprevir 200 mg once daily 10 mg, single dose 2.26 (1.89-2.69) 5.49 (4.29-7.04) Glecaprevir 400 mg/pibrentasvir 120 mg once daily 5 mg, once daily 2.15 (1.88-2.46) 5.62 (4.80-6.59) Lopinavir/ritonavir combination 400 mg/100 mg BID for 17 days 20 mg, QD for 7 days 2.1 (1.7-2.6) 5 (3.4-6.4) Capmatinib 400 mg BID 10 mg, single dose 2.08 (1.56-2.76) 3.04 (2.36-3.92) Fostamatinib 100 mg BID 20 mg, single dose 1.96 (1.77-2.15) 1.88 (1.69-2.09) Febuxostat 120 mg QD for 4 days 10 mg, single dose 1.9 (1.5-2.5) 2.1 (1.8-2.6) Gemfibrozil 600 mg BID for 7 days 80 mg 1.9 (1.6-2.2) 2.2 (1.8-2.7) Tafamidis 61 mg BID on Days 1 & 2, followed by QD on Days 3 to 9 10 mg 1.97 (1.68-2.31) 1.86 (1.59-2.16) Eltrombopag 75 mg QD, 5 days 10 mg 1.6 (1.4-1.7) 2 (1.8-2.3) Darunavir 600 mg/ritonavir 100 mg BID, 7 days 10 mg, QD for 7 days 1.5 (1.0-2.1) 2.4 (1.6-3.6) Tipranavir/ritonavir combination 500 mg/200 mg BID for 11 days 10 mg 1.4 (1.2-1.6) 2.2 (1.8-2.7) Dronedarone 400 mg BID 10 mg 1.4 Itraconazole 200 mg QD, 5 days 10 mg or 80 mg 1.4 (1.2-1.6) 1.3 (1.1-1.4) 1.4 (1.2-1.5) 1.2 (0.9-1.4) Ezetimibe 10 mg QD, 14 days 10 mg, QD for 14 days 1.2 (0.9-1.6) 1.2 (0.8-1.6) Fosamprenavir/ritonavir 700 mg/100 mg BID for 7 days 10 mg 1.1 1.5 Fenofibrate 67 mg TID for 7 days 10 mg ↔ 1.2 (1.1-1.3) Rifampicin 450 mg QD, 7 days 20 mg ↔ Aluminum & magnesium hydroxide combination antacidAdministered simultaneously. Administered 2 hours apart 40 mg. 40 mg 0.5 (0.4-0.5) 0.8 (0.7-0.9) 0.5 (0.4-0.6) 0.8 (0.7-1.0) Ketoconazole 200 mg BID for 7 days 80 mg 1.0 (0.8-1.2) 1.0 (0.7-1.3) Fluconazole 200 mg QD for 11 days 80 mg 1.1 (1.0-1.3) 1.1 (0.9-1.4) Erythromycin 500 mg QID for 7 days 80 mg 0.8 (0.7-0.9) 0.7 (0.5-0.9) QD= Once daily, BID= Twice daily, TID= Three times daily, QID= Four times daily Table 9: Effect of Rosuvastatin Coadministration on Systemic Exposure to Other Drugs Rosuvastatin Dosage Regimen Coadministered Drug Mean Ratio (ratio with/without coadministered drug) No Effect=1.0 Name and Dose Change in AUC Change in C max 40 mg QD for 10 days Warfarin Clinically significant pharmacodynamic effects [see Drug Interactions ( 7.3)] 25 mg single dose R- Warfarin 1.0 (1.0-1.1) Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7=30% decrease, 11=11-fold increase in exposure) S-Warfarin 1.1 (1.0-1.1) R-Warfarin 1.0 (0.9-1.0) S-Warfarin 1.0 (0.9-1.1) 40 mg QD for 12 days Digoxin 0.5 mg single dose 1.0 (0.9-1.2) 1.0 (0.9-1.2) 40 mg QD for 28 days Oral Contraceptive (ethinyl estradiol 0.035 mg & norgestrel 0.180, 0.215 and 0.250 mg) QD for 21 Days EE 1.3 (1.2-1.3) NG 1.3 (1.3-1.4) EE 1.3 (1.2-1.3) NG 1.2 (1.1-1.3) EE = ethinyl estradiol, NG = norgestrel, QD= Once daily"],"adverse_reactions":["6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Proteinuria and Hematuria [see Warnings and Precautions ( 5.4 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.5 )] Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of up to 12 weeks. Table 2: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials Adverse Reactions Placebo N=382 % Rosuvastatin 5 mg N=291 % Rosuvastatin 10 mg N=283 % Rosuvastatin 20 mg N=64 % Rosuvastatin 40 mg N=106 % Total Rosuvastatin 5 mg-40 mg N=744 % Headache 5.0 5.5 4.9 3.1 8.5 5.5 Nausea 3.1 3.8 3.5 6.3 0 3.4 Myalgia 1.3 3.1 2.1 6.3 1.9 2.8 Asthenia 2.6 2.4 3.2 4.7 0.9 2.7 Constipation 2.4 2.1 2.1 4.7 2.8 2.4 Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In the METEOR study, patients were treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years. Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3. Table 3: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the METEOR Trial Adverse Reactions Placebo N=281 % Rosuvastatin 40 mg N=700 % Myalgia 12.1 12.7 Arthralgia 7.1 10.1 Headache 5.3 6.4 Dizziness 2.8 4.0 Increased CPK 0.7 2.6 Abdominal pain 1.8 2.4 ALT greater than 3x ULN Frequency recorded as abnormal laboratory value. 0.7 2.2 In the JUPITER study, patients were treated with rosuvastatin 20 mg (n=8,901) or placebo (n=8,901) for a mean duration of 2 years. In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%). Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients [see Clinical Studies ( 14 )] . Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 4. Table 4: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the JUPITER Trial Adverse Reactions Placebo N=8,901 % Rosuvastatin 20 mg N=8,901 % Myalgia 6.6 7.6 Arthralgia 3.2 3.8 Constipation 3.0 3.3 Diabetes mellitus 2.3 2.8 Nausea 2.3 2.4 Pediatric Patients with HeFH In a 12‑week controlled study in pediatric patients 10 to 17 years of age with HeFH with rosuvastatin 5 to 20 mg daily [see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14 )] , elevations in serum CK greater than 10 x ULN were observed more frequently in rosuvastatin-treated patients compared with patients receiving placebo. Four of 130 (3%) patients treated with rosuvastatin (2 treated with 10 mg and 2 treated with 20 mg) had increased CK greater than 10 x ULN, compared to 0 of 46 patients on placebo. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of rosuvastatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood Disorders : thrombocytopenia Hepatobiliary Disorders : hepatitis, jaundice, fatal and non-fatal hepatic failure Musculoskeletal Disorders : arthralgia, rare reports of immune-mediated necrotizing myopathy associated with statin use Nervous System Disorders : peripheral neuropathy, rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, and confusion) associated with the use of all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). There have been rare reports of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered. Psychiatric Disorders : depression, sleep disorders (including insomnia and nightmares) Reproductive System and Breast Disorders : gynecomastia Respiratory Disorders : interstitial lung disease Skin and Subcutaneous Tissue Disorders : drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug eruption"],"contraindications":["4 CONTRAINDICATIONS Rosuvastatin tablets is contraindicated in the following conditions: Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3 )] . Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [see Adverse Reactions ( 6.1 )] . Acute liver failure or decompensated cirrhosis. ( 4 ) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. ( 7.1 ) Aluminum and Magnesium Hydroxide Combination Antacids : Administer rosuvastatin at least 2 hours before the antacid. ( 7.2 ) Warfarin : Obtain INR prior to starting rosuvastatin. Monitor INR frequently until stable upon initiation, dose titration or discontinuation. ( 7.3 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin and instructions for preventing or managing them [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] . Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Cyclosporine Clinical Impact: Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with rosuvastatin. Intervention: If used concomitantly, do not exceed a dose of rosuvastatin 5 mg once daily. Teriflunomide Clinical Impact: Teriflunomide increased rosuvastatin exposure more than 2.5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Intervention: In patients taking teriflunomide, do not exceed a dose of rosuvastatin 10 mg once daily. Enasidenib Clinical Impact: Enasidenib increased rosuvastatin exposure more than 2.4-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Intervention: In patients taking enasidenib, do not exceed a dose of rosuvastatin 10 mg once daily. Capmatinib Clinical Impact: Capmatinib increased rosuvastatin exposure more than 2.1-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Intervention: In patients taking capmatinib, do not exceed a dose of rosuvastatin 10 mg once daily. Fostamatinib Clinical Impact: Fostamatinib increased rosuvastatin exposure more than 2.0-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Intervention: In patients taking fostamatinib, do not exceed a dose of rosuvastatin 20 mg once daily. Febuxostat Clinical Impact: Febuxostat increased rosuvastatin exposure more than 1.9-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Intervention: In patients taking febuxostat, do not exceed a dose of rosuvastatin 20 mg once daily. Gemfibrozil Clinical Impact: Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with rosuvastatin. Intervention: Avoid concomitant use of gemfibrozil with rosuvastatin. If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 10 mg once daily. Tafamidis Clinical Impact: Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of tafamidis with rosuvastatin. Intervention: Avoid concomitant use of tafamidis with rosuvastatin. If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin. Anti-Viral Medications Clinical Impact: Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Intervention: Sofosbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Avoid concomitant use with rosuvastatin. Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and do not exceed a dose of rosuvastatin 10 mg once daily. Darolutamide Clinical Impact: Darolutamide increased rosuvastatin exposure more than 5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Intervention: In patients taking darolutamide, do not exceed a dose of rosuvastatin 5 mg once daily. Regorafenib Clinical Impact: Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy. Intervention: In patients taking regorafenib, do not exceed a dose of rosuvastatin 10 mg once daily. Fenofibrates (e.g., fenofibrate and fenofibric acid) Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with rosuvastatin. Intervention: Consider if the benefit of using fibrates concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have occurred with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with rosuvastatin. Intervention: Consider if the benefit of using lipid-modifying doses (≥1 g/day) of niacin concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with rosuvastatin. Intervention: Consider if the benefit of using colchicine concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug. Ticagrelor Clinical Impact: Concomitant use of rosuvastatin and ticagrelor has been shown to increase rosuvastatin concentrations, which may result in increased risk of myopathy. Cases of myopathy and rhabdomyolysis have been reported in patients using both products concomitantly. Cases have occurred more frequently in patients taking 40 mg of rosuvastatin. Intervention: In patients taking concomitant ticagrelor, especially those with additional risk factors for myopathy and rhabdomyolysis, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of rosuvastatin. 7.2 Drug Interactions that Decrease the Efficacy of Rosuvastatin Table 6 presents drug interactions that may decrease the efficacy of rosuvastatin and instructions for preventing or managing them. Table 6: Drug Interactions that Decrease the Efficacy of Rosuvastatin Antacids Clinical Impact: Concomitant aluminum and magnesium hydroxide combination antacid administration decreased the mean exposure of rosuvastatin 50% [see Clinical Pharmacology ( 12.3 )]. Intervention: In patients taking antacid, administer rosuvastatin at least 2 hours before the antacid. 7.3 Rosuvastatin Effects on Other Drugs Table 7 presents rosuvastatin's effect on other drugs and instructions for preventing or managing them. Table 7: Rosuvastatin Effects on Other Drugs Warfarin Clinical Impact: Rosuvastatin significantly increased the INR in patients receiving warfarin [see Clinical Pharmacology ( 12.3 )]. Intervention: In patients taking warfarin, obtain an INR before starting rosuvastatin and frequently enough after initiation, dose titration or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regularly recommended intervals."],"how_supplied_table":["<table ID=\"ID137\" width=\"100%\" styleCode=\"Noautorules\"><col width=\"11%\"/><col width=\"18%\"/><col width=\"17%\"/><col width=\"51%\"/><tbody><tr><td align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Strength</content> </td><td align=\"left\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">How Supplied</content> </td><td align=\"left\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">NDC</content> </td><td align=\"left\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Tablet Description</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">5 mg  </td><td align=\"left\" styleCode=\" Botrule Rrule\">bottles of 30, 90, 100, 500 and 1000 tablets  </td><td align=\"left\" styleCode=\" Botrule Rrule\">69367-359-30   69367-359-09   69367-359-01   69367-359-05   69367-359-10  </td><td align=\"left\" styleCode=\" Botrule Rrule\">Yellow colored, round, biconvex film coated tablets, debossed with &quot;RS&quot; on one side and plain on the other side.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">10 mg  </td><td align=\"left\" styleCode=\" Botrule Rrule\">bottles of 30, 90, 100, 500 and 1000 tablets  </td><td align=\"left\" styleCode=\" Botrule Rrule\">69367-360-30   69367-360-09   69367-360-01   69367-360-05   69367-360-10  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Pink colored, round, biconvex film coated tablets, debossed with &quot;RS1&quot; on one side and plain on the other side.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">20 mg  </td><td align=\"left\" styleCode=\" Botrule Rrule\">bottles of 30, 90, 100, 500 and 1000 tablets  </td><td align=\"left\" styleCode=\" Botrule Rrule\">69367-361-30   69367-361-09   69367-361-01   69367-361-05   69367-361-10  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Pink colored, round, biconvex film coated tablets, debossed with &quot;RS2&quot; on one side and plain on the other side.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">40 mg  </td><td align=\"left\" styleCode=\" Botrule Rrule\">bottles of 30, 90, 100 and 500 tablets  </td><td align=\"left\" styleCode=\" Botrule Rrule\">69367-362-30   69367-362-09   69367-362-01   69367-362-05  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Pink colored, oval, biconvex film coated tablets, debossed with &quot;RS3&quot; on one side and plain on the other side.  </td></tr></tbody></table>"],"mechanism_of_action":["12.1 Mechanism of Action Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol."],"recent_major_changes":["RECENT MAJOR CHANGES Indication and Usage ( 1 ) 07/2024"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. 12.2 Pharmacodynamics Inhibition of HMG-CoA reductase by rosuvastatin accelerates the expression of LDL-receptors, followed by the uptake of LDL-C from blood to the liver, leading to a decrease in plasma LDL-C and total cholesterol. Sustained inhibition of cholesterol synthesis in the liver also decreases levels of very-low-density lipoproteins. The maximum LDL-C reduction of rosuvastatin is usually achieved by 4 weeks and is maintained after that. 12.3 Pharmacokinetics Absorption In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both C max and AUC increased in approximate proportion to rosuvastatin dose. The absolute bioavailability of rosuvastatin is approximately 20%. The AUC of rosuvastatin does not differ following evening or morning drug administration. Effect of food Administration of rosuvastatin with food did not affect the AUC of rosuvastatin. Distribution Mean volume of distribution at steady-state of rosuvastatin is approximately 134 liters. Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. Elimination Metabolism Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite. The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 \\ 2C9, and in vitro studies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one-half the HMG‑CoA reductase inhibitory activity of the parent compound. Overall, greater than 90% of active plasma HMG‑CoA reductase inhibitory activity is accounted for by the parent compound. Excretion Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%). After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. The elimination half-life of rosuvastatin is approximately 19 hours. Specific Populations Geriatric Patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years). Pediatric Patients In a population pharmacokinetic analysis of two pediatric trials involving patients with HeFH 10 to 17 years of age and 8 to 17 years of age, respectively, rosuvastatin exposure appeared comparable to or lower than rosuvastatin exposure in adult patients. Male and Female Patients There were no differences in plasma concentrations of rosuvastatin between males and females. Racial or Ethnic Groups A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among White, Hispanic or Latino ethnicity, and Black or Afro-Caribbean groups. However, pharmacokinetic studies, including one conducted in the US, have demonstrated an approximate 2‑fold elevation in median exposure (AUC and C max ) in Asian subjects when compared with a White control group. Patients with Renal Impairment Mild to moderate renal impairment (CL cr ≥30 mL/min/1.73 m 2 ) had no influence on plasma concentrations of rosuvastatin. However, plasma concentrations of rosuvastatin increased to a clinically significant extent (about 3‑fold) in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) not receiving hemodialysis compared with healthy subjects (CL cr >80 mL/min/1.73 m 2 ). Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Patients with Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. In patients with Child‑Pugh A disease, C max and AUC were increased by 60% and 5%, respectively, as compared with patients with normal liver function. In patients with Child‑Pugh B disease, C max and AUC were increased 100% and 21%, respectively, compared with patients with normal liver function. Drug Interaction Studies Rosuvastatin clearance is not dependent on metabolism by cytochrome P450 3A4 to a clinically significant extent. Rosuvastatin is a substrate for certain transporter proteins including the hepatic uptake transporter organic anion-transporting polyprotein 1B1 (OATP1B1) and efflux transporter breast cancer resistance protein (BCRP). Concomitant administration of rosuvastatin with medications that are inhibitors of these transporter proteins (e.g. cyclosporine, certain HIV protease inhibitors [see Dosage and Administration ( 2.6 ) and Drug Interactions ( 7.1 )] and ticagrelor [see Drug Interactions ( 7.1 )]) may result in increased rosuvastatin plasma concentrations. Table 8: Effect of Coadministered Drugs on Rosuvastatin Systemic Exposure Coadministered drug and dosing regimen Rosuvastatin Mean Ratio (ratio with/without coadministered drug) No Effect=1.0 Dose (mg) Single dose unless otherwise noted. Change in AUC Change in C max Sofosbuvir/velpatasvir/voxilaprevir (400 mg -100 mg-100 mg) + Voxilaprevir (100 mg) once daily for 15 days 10 mg, single dose 7.39 Clinically significant [see Dosage and Administration ( 2) and Warnings and Precautions ( 5)] (6.68-8.18) Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7 = 30% decrease, 11=11‑fold increase in exposure) 18.88 (16.23-21.96) Cyclosporine - stable dose required (75 mg - 200 mg BID) 10 mg, QD for 10 days 7.1 11 Darolutamide 600 mg BID, 5 days 5 mg, single dose 5.2 ~5 Regorafenib 160 mg QD, 14 days 5 mg, single dose 3.8 4.6 Atazanavir/ritonavir combination 300 mg/100 mg QD for 8 days 10 mg 3.1 7 Simeprevir 150 mg QD, 7 days 10 mg, single dose 2.8 (2.3-3.4) 3.2 (2.6-3.9) Velpatasvir 100 mg once daily 10 mg, single dose 2.69 (2.46-2.94) 2.61 (2.32-2.92) Ombitasvir 25 mg/paritaprevir 150 mg/ ritonavir 100 mg + dasabuvir 400 mg BID 5 mg, single dose 2.59 (2.09-3.21) 7.13 (5.11-9.96) Teriflunomide Not available 2.51 2 2.65 Enasidenib 100 mg QD, 28 days 10 mg, single dose 2.44 3.66 Elbasvir 50 mg/grazoprevir 200 mg once daily 10 mg, single dose 2.26 (1.89-2.69) 5.49 (4.29-7.04) Glecaprevir 400 mg/pibrentasvir 120 mg once daily 5 mg, once daily 2.15 (1.88-2.46) 5.62 (4.80-6.59) Lopinavir/ritonavir combination 400 mg/100 mg BID for 17 days 20 mg, QD for 7 days 2.1 (1.7-2.6) 5 (3.4-6.4) Capmatinib 400 mg BID 10 mg, single dose 2.08 (1.56-2.76) 3.04 (2.36-3.92) Fostamatinib 100 mg BID 20 mg, single dose 1.96 (1.77-2.15) 1.88 (1.69-2.09) Febuxostat 120 mg QD for 4 days 10 mg, single dose 1.9 (1.5-2.5) 2.1 (1.8-2.6) Gemfibrozil 600 mg BID for 7 days 80 mg 1.9 (1.6-2.2) 2.2 (1.8-2.7) Tafamidis 61 mg BID on Days 1 & 2, followed by QD on Days 3 to 9 10 mg 1.97 (1.68-2.31) 1.86 (1.59-2.16) Eltrombopag 75 mg QD, 5 days 10 mg 1.6 (1.4-1.7) 2 (1.8-2.3) Darunavir 600 mg/ritonavir 100 mg BID, 7 days 10 mg, QD for 7 days 1.5 (1.0-2.1) 2.4 (1.6-3.6) Tipranavir/ritonavir combination 500 mg/200 mg BID for 11 days 10 mg 1.4 (1.2-1.6) 2.2 (1.8-2.7) Dronedarone 400 mg BID 10 mg 1.4 Itraconazole 200 mg QD, 5 days 10 mg or 80 mg 1.4 (1.2-1.6) 1.3 (1.1-1.4) 1.4 (1.2-1.5) 1.2 (0.9-1.4) Ezetimibe 10 mg QD, 14 days 10 mg, QD for 14 days 1.2 (0.9-1.6) 1.2 (0.8-1.6) Fosamprenavir/ritonavir 700 mg/100 mg BID for 7 days 10 mg 1.1 1.5 Fenofibrate 67 mg TID for 7 days 10 mg ↔ 1.2 (1.1-1.3) Rifampicin 450 mg QD, 7 days 20 mg ↔ Aluminum & magnesium hydroxide combination antacidAdministered simultaneously. Administered 2 hours apart 40 mg. 40 mg 0.5 (0.4-0.5) 0.8 (0.7-0.9) 0.5 (0.4-0.6) 0.8 (0.7-1.0) Ketoconazole 200 mg BID for 7 days 80 mg 1.0 (0.8-1.2) 1.0 (0.7-1.3) Fluconazole 200 mg QD for 11 days 80 mg 1.1 (1.0-1.3) 1.1 (0.9-1.4) Erythromycin 500 mg QID for 7 days 80 mg 0.8 (0.7-0.9) 0.7 (0.5-0.9) QD= Once daily, BID= Twice daily, TID= Three times daily, QID= Four times daily Table 9: Effect of Rosuvastatin Coadministration on Systemic Exposure to Other Drugs Rosuvastatin Dosage Regimen Coadministered Drug Mean Ratio (ratio with/without coadministered drug) No Effect=1.0 Name and Dose Change in AUC Change in C max 40 mg QD for 10 days Warfarin Clinically significant pharmacodynamic effects [see Drug Interactions ( 7.3)] 25 mg single dose R- Warfarin 1.0 (1.0-1.1) Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7=30% decrease, 11=11-fold increase in exposure) S-Warfarin 1.1 (1.0-1.1) R-Warfarin 1.0 (0.9-1.0) S-Warfarin 1.0 (0.9-1.1) 40 mg QD for 12 days Digoxin 0.5 mg single dose 1.0 (0.9-1.2) 1.0 (0.9-1.2) 40 mg QD for 28 days Oral Contraceptive (ethinyl estradiol 0.035 mg & norgestrel 0.180, 0.215 and 0.250 mg) QD for 21 Days EE 1.3 (1.2-1.3) NG 1.3 (1.3-1.4) EE 1.3 (1.2-1.3) NG 1.2 (1.1-1.3) EE = ethinyl estradiol, NG = norgestrel, QD= Once daily 12.5 Pharmacogenomics Disposition of rosuvastatin, involves OATP1B1 and other transporter proteins. Higher plasma concentrations of rosuvastatin have been reported in very small groups of patients (n=3 to 5) who have two reduced function alleles of the gene that encodes OATP1B1 ( SLCO1B1 521T > C). The frequency of this genotype (i.e., SLCO1B1 521 C/C) is generally lower than 5% in most racial/ethnic groups. The impact of this polymorphism on efficacy and/or safety of rosuvastatin has not been clearly established."],"indications_and_usage":["1 INDICATIONS AND USAGE Rosuvastatin tablets is indicated: To reduce the risk major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia. Rosuvastatin tablets is an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. to reduce LDL-C and slow the progression of atherosclerosis in adults. to reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis : Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher rosuvastatin dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing rosuvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. ( 5.1 ) Immune-Mediated Necrotizing Myopathy (IMNM) : Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin if IMNM is suspected. ( 5.2 ) Hepatic Dysfunction : Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin. ( 5.3 ) 5.1 Myopathy and Rhabdomyolysis Rosuvastatin may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher rosuvastatin dosage. Asian patients on rosuvastatin may be at higher risk for myopathy [see Drug Interactions ( 7.1 ) and Use in Specific Populations ( 8.8 )] . The myopathy risk is greater in patients taking rosuvastatin 40 mg daily compared with lower rosuvastatin dosages. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin with cyclosporine or gemfibrozil is not recommended. Rosuvastatin dosage modifications are recommended for patients taking certain antiviral medications, darolutamide, and regorafenib [see Dosage and Administration ( 2.6 )] . Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions ( 7.1 )] . Discontinue rosuvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if rosuvastatin is discontinued. Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the rosuvastatin dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. 5.2 Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue rosuvastatin if IMNM is suspected. 5.3 Hepatic Dysfunction Increases in serum transaminases have been reported with use of rosuvastatin [see Adverse Reactions ( 6.1 )] . In most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy. In a pooled analysis of placebo-controlled trials, increases in serum transaminases to more than three times the ULN occurred in 1.1% of patients taking rosuvastatin versus 0.5% of patients treated with placebo. Marked persistent increases of hepatic transaminases have also occurred with rosuvastatin. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Use in Specific Populations ( 8.7 )] . Consider liver enzyme testing before rosuvastatin initiation and when clinically indicated thereafter. Rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis [see Contraindications ( 4 )] . If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin. 5.4 Proteinuria and Hematuria In the rosuvastatin clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among rosuvastatin treated patients. These findings were more frequent in patients taking rosuvastatin 40 mg, when compared to lower doses of rosuvastatin or comparator statins, though it was generally transient and was not associated with worsening renal function. Although the clinical significance of this finding is unknown, consider a dose reduction for patients on rosuvastatin therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing. 5.5 Increases in HbA1c and Fasting Serum Glucose Levels Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin. Based on clinical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus [see Adverse Reactions ( 6.1 )] . Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices."],"clinical_studies_table":["<table ID=\"ID120\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 10: Lipid-modifying Effect of Rosuvastatin in Adult Patients with Hyperlipidemia (Adjusted Mean % Change from Baseline at Week 6)</caption><col width=\"20%\"/><col width=\"11%\"/><col width=\"12%\"/><col width=\"12%\"/><col width=\"14%\"/><col width=\"10%\"/><col width=\"7%\"/><col width=\"10%\"/><tbody><tr><td align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Dose</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">N</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Total</content>&#x2011; <content styleCode=\"bold\">C</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">LDL</content>&#x2011; <content styleCode=\"bold\">C</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Non-HDL</content>&#x2011; <content styleCode=\"bold\">C</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">ApoB</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">TG</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">HDL</content>&#x2011; <content styleCode=\"bold\">C</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Placebo  </td><td align=\"center\" styleCode=\" Botrule Rrule\">13  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-7  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-7  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Rosuvastatin 5 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">17  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-33  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-45  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-44  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-38  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-35  </td><td align=\"center\" styleCode=\" Botrule Rrule\">13  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Rosuvastatin 10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">17  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-36  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-52  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-48  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-42  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-10  </td><td align=\"center\" styleCode=\" Botrule Rrule\">14  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Rosuvastatin 20 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">17  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-40  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-55  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-51  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-46  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-23  </td><td align=\"center\" styleCode=\" Botrule Rrule\">8  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Rosuvastatin 40 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">18  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-46  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-63  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-60  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-54  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-28  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10  </td></tr></tbody></table>","<table ID=\"ID124\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 11: Percent Change in LDL-C by Dose of Rosuvastatin, Atorvastatin, Simvastatin, and Pravastatin From Baseline to Week 6 (LS Mean <footnote ID=\"ID124_0\"> Corresponding standard errors are approximately 1.00. </footnote>) in Adult Patients with Hyperlipidemia or Mixed Dyslipidemia (Sample Sizes Ranging from 156&#x2013;167 Patients Per Group) </caption><col width=\"27%\"/><col width=\"20%\"/><col width=\"17%\"/><col width=\"17%\"/><col width=\"17%\"/><tbody><tr><td styleCode=\"Lrule Toprule Botrule Rrule\"/><td colspan=\"4\" align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Treatment Daily Dose</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Treatment</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">10 mg</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">20 mg</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">40 mg</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">80 mg</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Rosuvastatin  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-46 <content styleCode=\"italics\"><footnote ID=\"ID124_1\"> Rosuvastatin 10 mg reduced LDL-C significantly more than atorvastatin 10 mg; pravastatin 10 mg, 20 mg, and 40 mg; simvastatin 10 mg, 20 mg, and 40 mg. (p&lt;0.002) </footnote></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-52 <content styleCode=\"italics\"><footnote ID=\"ID124_2\"> Rosuvastatin 20 mg reduced LDL-C significantly more than atorvastatin 20 mg and 40 mg; pravastatin 20 mg and 40 mg; simvastatin 20 mg, 40 mg, and 80 mg. (p&lt;0.002) </footnote></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-55 <content styleCode=\"italics\"><footnote ID=\"ID124_3\"> Rosuvastatin 40 mg reduced LDL-C significantly more than atorvastatin 40 mg; pravastatin 40 mg; simvastatin 40 mg, and 80 mg. (p&lt;0.002) </footnote></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">---  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Atorvastatin  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-37  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-43  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-48  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-51  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Simvastatin  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-28  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-35  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-39  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-46  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Pravastatin  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-20  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-24  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-30  </td><td align=\"center\" styleCode=\" Botrule Rrule\">---  </td></tr></tbody></table>","<table ID=\"ID126\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 12: LDL-C Percent Change from Baseline</caption><col width=\"12%\"/><col width=\"14%\"/><col width=\"36%\"/><col width=\"36%\"/><tbody><tr><td styleCode=\"Lrule Toprule Botrule Rrule\"/><td styleCode=\" Toprule Botrule Rrule\"/><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin (n=435)</content> <content styleCode=\"bold\">LS Mean</content><content styleCode=\"italics\"><footnote ID=\"ID126_0\"> LS Means are least square means adjusted for baseline LDL-C </footnote></content><content styleCode=\"bold\">(95% CI)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Atorvastatin</content><content styleCode=\"bold\">(n=187)</content> <content styleCode=\"bold\">LS Mean <content styleCode=\"italics\"><footnoteRef IDREF=\"ID126_0\"/></content></content><sup/><content styleCode=\"bold\">(95% CI)</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Week 6  </td><td align=\"left\" styleCode=\" Botrule Rrule\">20 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-47% (-49%, -46%)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-38% (-40%, -36%)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Week 12  </td><td align=\"left\" styleCode=\" Botrule Rrule\">40 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-55% (-57%, -54%)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-47% (-49%, -45%)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Week 18  </td><td align=\"left\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">NA  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-52% (-54%, -50%)  </td></tr></tbody></table>","<table ID=\"ID128\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 13: Lipid-Modifying Effects of Rosuvastatin in Pediatric Patients 10 to 17 years of Age with HeFH (Least-Squares Mean Percent Change from Baseline To Week 12)</caption><col width=\"14%\"/><col width=\"14%\"/><col width=\"14%\"/><col width=\"14%\"/><col width=\"14%\"/><col width=\"14%\"/><col width=\"14%\"/><tbody><tr><td align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Dose (mg)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">N</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">LDL-C</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">HDL-C</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Total-C</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">TG <content styleCode=\"italics\"><footnote ID=\"ID128_0\">Median percent change </footnote></content></content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">ApoB</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Placebo  </td><td align=\"center\" styleCode=\" Botrule Rrule\">46  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-1%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">+7%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-7%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-2%  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">42  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-38%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">+4% <content styleCode=\"italics\"><footnote ID=\"ID128_1\"> Difference from placebo not statistically significant </footnote></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-30%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-13% <content styleCode=\"italics\"><footnoteRef IDREF=\"ID128_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-32%  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">10  </td><td align=\"center\" styleCode=\" Botrule Rrule\">44  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-45%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">+11% <content styleCode=\"italics\"><footnoteRef IDREF=\"ID128_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-34%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-15% <content styleCode=\"italics\"><footnoteRef IDREF=\"ID128_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-38%  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">20  </td><td align=\"center\" styleCode=\" Botrule Rrule\">44  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-50%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">+9% <content styleCode=\"italics\"><footnoteRef IDREF=\"ID128_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-39%  </td><td align=\"center\" styleCode=\" Botrule Rrule\">16% <content styleCode=\"italics\"><footnoteRef IDREF=\"ID128_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">-41%  </td></tr></tbody></table>","<table ID=\"ID130\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 14: Lipid-modifying Effects of Rosuvastatin in Pediatric Patients 7 to 15 years of Age with HoFH After 6 Weeks</caption><col width=\"23%\"/><col width=\"18%\"/><col width=\"27%\"/><col width=\"30%\"/><tbody><tr><td styleCode=\"Lrule Toprule Botrule Rrule\"/><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Placebo</content> <content styleCode=\"bold\">(N=13)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin 20 mg</content> <content styleCode=\"bold\">(N=13)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Percent difference</content> <content styleCode=\"bold\">(95% CI)</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">LDL-C (mg/dL)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">481  </td><td align=\"center\" styleCode=\" Botrule Rrule\">396  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-22.3% (-33.5, -9.1) <content styleCode=\"italics\"><sup>1</sup></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Total-C (mg/dL)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">539  </td><td align=\"center\" styleCode=\" Botrule Rrule\">448  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-20.1% (-29.7, -9.1) <content styleCode=\"italics\"><sup>2</sup></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Non-HDL-C (mg/dL)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">505  </td><td align=\"center\" styleCode=\" Botrule Rrule\">412  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-22.9% (-33.7, &#x2011;10.3) <content styleCode=\"italics\"><sup>2</sup></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">ApoB (mg/dL)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">268  </td><td align=\"center\" styleCode=\" Botrule Rrule\">235  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-17.1% (-29.2, -2.9) <content styleCode=\"italics\"><sup>3</sup></content> </td></tr><tr><td colspan=\"4\" align=\"left\">% Difference estimates are based on transformations of the estimated mean difference in log LDL measurements between rosuvastatin and placebo using a mixed model adjusted for study period.  <content styleCode=\"italics\"><sup>1</sup></content>p= 0.005, <content styleCode=\"italics\"><sup>2</sup></content>p= 0.003, <content styleCode=\"italics\"><sup>3</sup></content>p= 0.024  </td></tr></tbody></table>","<table ID=\"ID132\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 15: Lipid-modifying Effects of Rosuvastatin 10 mg and 20 mg in Adult Patients with Primary Dysbetalipoproteinemia (Type III hyperlipoproteinemia) After Six Weeks by Median Percent Change (95% CI) from Baseline (N=32)</caption><col width=\"18%\"/><col width=\"20%\"/><col width=\"30%\"/><col width=\"30%\"/><tbody><tr><td styleCode=\"Lrule Toprule Botrule Rrule\"/><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Median at Baseline (mg/dL)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Median percent change from baseline (95% CI)</content> <content styleCode=\"bold\">Rosuvastatin 10 mg</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Median percent change from baseline (95% CI)</content> <content styleCode=\"bold\">Rosuvastatin 20 mg</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Total-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">342.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-43.3   (-46.9, &#x2013; 37.5)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-47.6   (-51.6, -42.8)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Triglycerides  </td><td align=\"center\" styleCode=\" Botrule Rrule\">503.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-40.1   (-44.9, -33.6)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-43.0   (-52.5, -33.1)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Non&#x2011;HDL-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">294.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-48.2   (-56.7, -45.6)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-56.4   (-61.4, -48.5)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">VLDL-C + IDL-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">209.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-46.8   (-53.7, -39.4)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-56.2   (-67.7, -43.7)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">LDL-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">112.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-54.4   (-59.1, -47.3)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-57.3   (-59.4, -52.1)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">HDL-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">35.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10.2   (1.9, 12.3)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">11.2   (8.3, 20.5)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">RLP-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">82.0  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-56.4   (-67.1, -49.0)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-64.9   (-74.0, -56.6)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Apo-E  </td><td align=\"center\" styleCode=\" Botrule Rrule\">16.0  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-42.9   (-46.3, -33.3)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-42.5   (-47.1, -35.6)  </td></tr></tbody></table>","<table ID=\"ID134\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 16: Lipid-Modifying Effect of Rosuvastatin in Adult Patients with Primary Hypertriglyceridemia After Six Weeks by Median (Min, Max) Percent Change from Baseline to Week 6</caption><col width=\"17%\"/><col width=\"15%\"/><col width=\"16%\"/><col width=\"17%\"/><col width=\"17%\"/><col width=\"16%\"/><tbody><tr><td align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">Dose</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Placebo</content> <content styleCode=\"bold\">(n=26)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">5 mg</content> <content styleCode=\"bold\">(n=25)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">10 mg</content> <content styleCode=\"bold\">(n=23)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">20 mg</content> <content styleCode=\"bold\">(n=27)</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">40 mg</content> <content styleCode=\"bold\">(n=25)</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Triglycerides  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1 (-40, 72)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-21 (-58, 38)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-37 (-65, 5)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-37 (-72, 11)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-43 (-80, -7)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Non-HDL-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2 (-13, 19)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-29 (-43, -8)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-49 (-59, -20)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-43 (-74, 12)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-51 (-62, -6)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Total-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1 (-13, 17)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-24 (-40, -4)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-40 (-51, -14)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-34 (-61, -11)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-40 (-51, -4)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">LDL-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 (-30, 52)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-28 (-71, 2)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-45 (-59, 7)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-31 (-66, 34)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-43 (-61, -3)  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">HDL-C  </td><td align=\"center\" styleCode=\" Botrule Rrule\">-3 (-25, 18)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3 (-38, 33)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">8 (-8, 24)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">22 (-5, 50)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">17 -14, 63)  </td></tr></tbody></table>"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in rats at dose levels of 2, 20, 60, or 80 mg/kg/day by oral gavage, the incidence of uterine stromal polyps was significantly increased in females at 80 mg/kg/day at systemic exposure 20 times the human exposure at 40 mg/day based on AUC. Increased incidence of polyps was not seen at lower doses. In a 107-week carcinogenicity study in mice given 10, 60, or 200 mg/kg/day by oral gavage, an increased incidence of hepatocellular adenoma/carcinoma was observed at 200 mg/kg/day at systemic exposures 20 times the human exposure at 40 mg/day based on AUC. An increased incidence of hepatocellular tumors was not seen at lower doses. Rosuvastatin was not mutagenic or clastogenic with or without metabolic activation in the Ames test with Salmonella typhimurium and Escherichia coli , the mouse lymphoma assay, and the chromosomal aberration assay in Chinese hamster lung cells. Rosuvastatin was negative in the in vivo mouse micronucleus test. In rat fertility studies with oral gavage doses of 5, 15, 50 mg/kg/day, males were treated for 9 weeks prior to and throughout mating and females were treated 2 weeks prior to mating and throughout mating until gestation day 7. No adverse effect on fertility was observed at 50 mg/kg/day (systemic exposures up to 10 times the human exposure at 40 mg/day based on AUC). In testicles of dogs treated with rosuvastatin at 30 mg/kg/day for one month, spermatidic giant cells were seen. Spermatidic giant cells were observed in monkeys after 6‑month treatment at 30 mg/kg/day in addition to vacuolation of seminiferous tubular epithelium. Exposures in the dog were 20 times and in the monkey 10 times the human exposure at 40 mg/day based on body surface area. Similar findings have been seen with other drugs in this class."],"pharmacokinetics_table":["<table ID=\"ID107\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 8: Effect of Coadministered Drugs on Rosuvastatin Systemic Exposure</caption><col width=\"50%\"/><col width=\"16%\"/><col width=\"17%\"/><col width=\"16%\"/><tbody><tr><td align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Coadministered drug and dosing regimen</content> </td><td colspan=\"3\" align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td styleCode=\" Botrule Rrule\"/><td colspan=\"2\" align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Mean Ratio</content> <content styleCode=\"bold\">(ratio with/without coadministered drug)</content> <content styleCode=\"bold\">No Effect=1.0</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Dose (mg) <content styleCode=\"italics\"><footnote ID=\"ID107_0\"> Single dose unless otherwise noted. </footnote></content></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in AUC</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in C <sub>max</sub></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Sofosbuvir/velpatasvir/voxilaprevir (400 mg -100 mg-100 mg) + Voxilaprevir (100 mg) once daily for 15 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.39 <content styleCode=\"italics\"><footnote ID=\"ID107_1\">Clinically significant [see Dosage and Administration ( 2) and Warnings and Precautions ( 5)] </footnote></content>  (6.68-8.18) <content styleCode=\"italics\"><footnote ID=\"ID107_2\"> Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7 = 30% decrease, 11=11&#x2011;fold increase in exposure) </footnote></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">18.88 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>   (16.23-21.96) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Cyclosporine - stable dose required (75 mg - 200 mg BID)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, QD for 10 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">11 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Darolutamide 600 mg BID, 5 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.2 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">~5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Regorafenib 160 mg QD, 14 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.8 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">4.6 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Atazanavir/ritonavir combination 300 mg/100 mg QD for 8 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">7 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Simeprevir 150 mg QD, 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.8 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.3-3.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.2 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.6-3.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Velpatasvir 100 mg once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.69 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.46-2.94) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.61 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.32-2.92) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Ombitasvir 25 mg/paritaprevir 150 mg/ ritonavir 100 mg + dasabuvir 400 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.59 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.09-3.21) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.13 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (5.11-9.96) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Teriflunomide  </td><td align=\"center\" styleCode=\" Botrule Rrule\">Not available  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.51 <content styleCode=\"italics\"><sup>2</sup></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.65 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Enasidenib 100 mg QD, 28 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.44  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.66  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Elbasvir 50 mg/grazoprevir 200 mg once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.26 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.89-2.69) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.49 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (4.29-7.04) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Glecaprevir 400 mg/pibrentasvir 120 mg once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.15 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.88-2.46) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.62 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (4.80-6.59) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Lopinavir/ritonavir combination 400 mg/100 mg BID for 17 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">20 mg, QD for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.7-2.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (3.4-6.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Capmatinib 400 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.08 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.56-2.76) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.04 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.36-3.92) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fostamatinib 100 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">20 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.96 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.77-2.15) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.88 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.69-2.09) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Febuxostat 120 mg QD for 4 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.9 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.5-2.5) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.8-2.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Gemfibrozil 600 mg BID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.9 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.6-2.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.2 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.8-2.7) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Tafamidis 61 mg BID on Days 1 &amp; 2, followed by QD on Days 3 to 9  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.97 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.68-2.31) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.86 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.59-2.16) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Eltrombopag 75 mg QD, 5 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.6   (1.4-1.7) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2   (1.8-2.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Darunavir 600 mg/ritonavir 100 mg BID, 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, QD for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.5   (1.0-2.1) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.4   (1.6-3.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Tipranavir/ritonavir combination 500 mg/200 mg BID for 11 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4   (1.2-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.2   (1.8-2.7) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Dronedarone 400 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4  </td><td styleCode=\" Botrule Rrule\"/></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Itraconazole 200 mg QD, 5 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg or 80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4   (1.2-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  1.3   (1.1-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4   (1.2-1.5) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  1.2   (0.9-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Ezetimibe 10 mg QD, 14 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, QD for 14 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.2   (0.9-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.2   (0.8-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fosamprenavir/ritonavir 700 mg/100 mg BID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.5  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fenofibrate 67 mg TID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">&#x2194;  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.2   (1.1-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Rifampicin 450 mg QD, 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">20 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">&#x2194;  </td><td styleCode=\" Botrule Rrule\"/></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Aluminum &amp; magnesium hydroxide combination antacidAdministered simultaneously.   Administered 2 hours apart  </td><td align=\"center\" styleCode=\" Botrule Rrule\">40 mg.   40 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (0.4-0.5) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  0.8   (0.7-0.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (0.4-0.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  0.8   (0.7-1.0) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Ketoconazole 200 mg BID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.8-1.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.7-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fluconazole 200 mg QD for 11 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.1   (1.0-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.1   (0.9-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Erythromycin 500 mg QID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.8   (0.7-0.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.7   (0.5-0.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td colspan=\"4\" align=\"left\" styleCode=\"Lrule Botrule Rrule\">QD= Once daily, BID= Twice daily, TID= Three times daily, QID= Four times daily  </td></tr></tbody></table>","<table ID=\"ID108\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 9: Effect of Rosuvastatin Coadministration on Systemic Exposure to Other Drugs</caption><col width=\"22%\"/><col width=\"25%\"/><col width=\"27%\"/><col width=\"24%\"/><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin Dosage Regimen</content> </td><td colspan=\"3\" align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Coadministered Drug</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td styleCode=\" Botrule Rrule\"/><td colspan=\"2\" align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Mean Ratio (ratio with/without coadministered drug)</content> <content styleCode=\"bold\">No Effect=1.0</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Name and Dose</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in AUC</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in C <sub>max</sub></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">40 mg QD for 10 days  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Warfarin <content styleCode=\"italics\"><footnote ID=\"ID108_0\"> Clinically significant pharmacodynamic effects [see Drug Interactions ( 7.3)] </footnote></content>  25 mg single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">R- Warfarin 1.0   (1.0-1.1) <content styleCode=\"italics\"><footnote ID=\"ID108_1\"> Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7=30% decrease, 11=11-fold increase in exposure) </footnote></content>  S-Warfarin 1.1   (1.0-1.1) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">R-Warfarin 1.0   (0.9-1.0) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content>  S-Warfarin 1.0   (0.9-1.1) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">40 mg QD for 12 days  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Digoxin   0.5 mg single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.9-1.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.9-1.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">40 mg QD for 28 days  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Oral Contraceptive (ethinyl estradiol 0.035 mg &amp; norgestrel 0.180, 0.215 and 0.250 mg) QD for 21 Days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">EE 1.3   (1.2-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content>  NG 1.3   (1.3-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">EE 1.3   (1.2-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content>  NG 1.2   (1.1-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td></tr><tr><td colspan=\"4\" align=\"left\" styleCode=\"Lrule Botrule Rrule\">EE = ethinyl estradiol, NG = norgestrel, QD= Once daily  </td></tr></tbody></table>"],"adverse_reactions_table":["<table ID=\"ID55\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 2: Adverse Reactions Reported in &#x2265;2% of Patients Treated with Rosuvastatin and &gt; Placebo in Placebo-Controlled Trials</caption><col width=\"13%\"/><col width=\"10%\"/><col width=\"15%\"/><col width=\"15%\"/><col width=\"15%\"/><col width=\"15%\"/><col width=\"15%\"/><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Adverse Reactions</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Placebo</content> <content styleCode=\"bold\">N=382</content> <content styleCode=\"bold\">%</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">5 mg</content> <content styleCode=\"bold\">N=291</content> <content styleCode=\"bold\">%</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">10 mg</content> <content styleCode=\"bold\">N=283</content> <content styleCode=\"bold\">%</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">20 mg</content> <content styleCode=\"bold\">N=64</content> <content styleCode=\"bold\">%</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> <content styleCode=\"bold\">40 mg</content> <content styleCode=\"bold\">N=106</content> <content styleCode=\"bold\">%</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Total Rosuvastatin</content> <content styleCode=\"bold\">5 mg-40 mg</content> <content styleCode=\"bold\">N=744</content> <content styleCode=\"bold\">%</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Headache  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.0  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">4.9  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">8.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.5  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Nausea  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.8  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.5  </td><td align=\"center\" styleCode=\" Botrule Rrule\">6.3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.4  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Myalgia  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">6.3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.9  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.8  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Asthenia  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.6  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.4  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.2  </td><td align=\"center\" styleCode=\" Botrule Rrule\">4.7  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.9  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.7  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Constipation  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.4  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">4.7  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.8  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.4  </td></tr></tbody></table>","<table ID=\"ID57\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 3: Adverse Reactions Reported in &#x2265;2% of Patients Treated with Rosuvastatin and &gt; Placebo in the METEOR Trial</caption><col width=\"46%\"/><col width=\"25%\"/><col width=\"27%\"/><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Adverse Reactions</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Placebo</content> <content styleCode=\"bold\">N=281</content> <content styleCode=\"bold\">%</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin 40 mg</content> <content styleCode=\"bold\">N=700</content> <content styleCode=\"bold\">%</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Myalgia  </td><td align=\"center\" styleCode=\" Botrule Rrule\">12.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">12.7  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Arthralgia  </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10.1  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Headache  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">6.4  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Dizziness  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.8  </td><td align=\"center\" styleCode=\" Botrule Rrule\">4.0  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Increased CPK  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.7  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.6  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Abdominal pain  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.8  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.4  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">ALT greater than 3x ULN <content styleCode=\"italics\"><footnote ID=\"ID57_0\"> Frequency recorded as abnormal laboratory value. </footnote></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.7  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.2  </td></tr></tbody></table>","<table ID=\"ID59\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 4: Adverse Reactions Reported in &#x2265;2% of Patients Treated with Rosuvastatin and &gt; Placebo in the JUPITER Trial</caption><col width=\"33%\"/><col width=\"29%\"/><col width=\"36%\"/><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Adverse Reactions</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Placebo</content> <content styleCode=\"bold\">N=8,901</content> <content styleCode=\"bold\">%</content> </td><td align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin 20 mg</content> <content styleCode=\"bold\">N=8,901</content> <content styleCode=\"bold\">%</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Myalgia  </td><td align=\"center\" styleCode=\" Botrule Rrule\">6.6  </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.6  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Arthralgia  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.2  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.8  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Constipation  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.0  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.3  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Diabetes mellitus  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.8  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Nausea  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.3  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.4  </td></tr></tbody></table>"],"drug_interactions_table":["<table ID=\"ID68\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin</caption><col width=\"17%\"/><col width=\"56%\"/><col width=\"26%\"/><tbody><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Cyclosporine</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with rosuvastatin.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">If used concomitantly, do not exceed a dose of rosuvastatin 5 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Teriflunomide</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Teriflunomide increased rosuvastatin exposure more than 2.5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking teriflunomide, do not exceed a dose of rosuvastatin 10 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Enasidenib</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Enasidenib increased rosuvastatin exposure more than 2.4-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking enasidenib, do not exceed a dose of rosuvastatin 10 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Capmatinib</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Capmatinib increased rosuvastatin exposure more than 2.1-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking capmatinib, do not exceed a dose of rosuvastatin 10 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Fostamatinib</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Fostamatinib increased rosuvastatin exposure more than 2.0-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking fostamatinib, do not exceed a dose of rosuvastatin 20 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Febuxostat</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Febuxostat increased rosuvastatin exposure more than 1.9-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking febuxostat, do not exceed a dose of rosuvastatin 20 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Gemfibrozil</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with rosuvastatin.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Avoid concomitant use of gemfibrozil with rosuvastatin. If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 10 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Tafamidis</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of tafamidis with rosuvastatin.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Avoid concomitant use of tafamidis with rosuvastatin. If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Anti-Viral Medications</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td styleCode=\" Botrule Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Sofosbuvir/velpatasvir/voxilaprevir</item><item>Ledipasvir/sofosbuvir</item></list></td><td align=\"left\" styleCode=\" Botrule Rrule\">Avoid concomitant use with rosuvastatin.  </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td styleCode=\" Botrule Rrule\"><list listType=\"unordered\" styleCode=\"Disc\"><item>Simeprevir</item><item>Dasabuvir/ombitasvir/paritaprevir/ritonavir</item><item>Elbasvir/grazoprevir</item><item>Sofosbuvir/velpatasvir</item><item>Glecaprevir/pibrentasvir</item><item>Atazanavir/ritonavir</item><item>Lopinavir/ritonavir</item></list></td><td align=\"left\" styleCode=\" Botrule Rrule\">Initiate with rosuvastatin 5 mg once daily, and do not exceed a dose of rosuvastatin 10 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Darolutamide</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\">Clinical Impact:  </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Darolutamide increased rosuvastatin exposure more than 5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\">Intervention:  </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking darolutamide, do not exceed a dose of rosuvastatin 5 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Regorafenib</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking regorafenib, do not exceed a dose of rosuvastatin 10 mg once daily.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Fenofibrates (e.g., fenofibrate and fenofibric acid)</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with rosuvastatin.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Consider if the benefit of using fibrates concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Niacin</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Cases of myopathy and rhabdomyolysis have occurred with concomitant use of lipid-modifying doses (&#x2265;1 g/day) of niacin with rosuvastatin.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Consider if the benefit of using lipid-modifying doses (&#x2265;1 g/day) of niacin concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Colchicine</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with rosuvastatin.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Consider if the benefit of using colchicine concomitantly with rosuvastatin outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of either drug.  </td></tr><tr><td colspan=\"3\" align=\"left\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"bold\">Ticagrelor</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">Concomitant use of rosuvastatin and ticagrelor has been shown to increase rosuvastatin concentrations, which may result in increased risk of myopathy. Cases of myopathy and rhabdomyolysis have been reported in patients using both products concomitantly. Cases have occurred more frequently in patients taking 40 mg of rosuvastatin.  </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td colspan=\"2\" align=\"left\" styleCode=\" Botrule Rrule\">In patients taking concomitant ticagrelor, especially those with additional risk factors for myopathy and rhabdomyolysis, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dose titration of rosuvastatin.  </td></tr></tbody></table>","<table ID=\"ID71\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 6: Drug Interactions that Decrease the Efficacy of Rosuvastatin</caption><col width=\"17%\"/><col width=\"82%\"/><tbody><tr><td colspan=\"2\" align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Antacids</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td align=\"left\" styleCode=\" Botrule Rrule\">Concomitant aluminum and magnesium hydroxide combination antacid administration decreased the mean exposure of rosuvastatin 50% <content styleCode=\"italics\">[see Clinical Pharmacology ( <linkHtml href=\"#ID105\">12.3</linkHtml>)]. </content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td align=\"left\" styleCode=\" Botrule Rrule\">In patients taking antacid, administer rosuvastatin at least 2 hours before the antacid.  </td></tr></tbody></table>","<table ID=\"ID74\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 7: Rosuvastatin Effects on Other Drugs</caption><col width=\"17%\"/><col width=\"82%\"/><tbody><tr><td colspan=\"2\" align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Warfarin</content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Clinical Impact:</content> </td><td align=\"left\" styleCode=\" Botrule Rrule\">Rosuvastatin significantly increased the INR in patients receiving warfarin <content styleCode=\"italics\">[see Clinical Pharmacology ( <linkHtml href=\"#ID105\">12.3</linkHtml>)]. </content> </td></tr><tr><td align=\"right\" styleCode=\"Lrule Botrule Rrule\"><content styleCode=\"italics\">Intervention:</content> </td><td align=\"left\" styleCode=\" Botrule Rrule\">In patients taking warfarin, obtain an INR before starting rosuvastatin and frequently enough after initiation, dose titration or discontinuation to ensure that no significant alteration in INR occurs. Once the INR is stable, monitor INR at regularly recommended intervals.  </td></tr></tbody></table>"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis Advise patients that rosuvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions ( 5.1 ), and Drug Interactions ( 7.1 )] . Hepatic Dysfunction Inform patients that rosuvastatin may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions ( 5.3 )] . Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions ( 5.5 )] . Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus. Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if rosuvastatin should be discontinued [see Use in Specific Populations ( 8.1 )] . Lactation Advise patients that breastfeeding during treatment with rosuvastatin is not recommended [see Use in Specific Populations ( 8.2 )] . Concomitant Use of Antacids When taking rosuvastatin with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin administration [see Drug Interactions ( 7.2 )]. Missed Doses If a dose is missed, advise patients not take an extra dose. Just resume the usual schedule [see Dosage and Administration ( 2.1 )] . Distributed by: Westminster Pharmaceuticals, LLC Nashville, TN 37217 Manufactured by: Renata PLC (General Plant-2) Noyapara, Bhawal Mirzapur Rajendrapur, Gazipur, 1700 Bangladesh PATIENT INFORMATION Rosuvastatin (roe-SOO-va-STAT-in) Tablets, USP (rosuvastatin) tablets, for oral use Read this Patient Information carefully before you start taking rosuvastatin tablets and each time you get a refill. If you have any questions about rosuvastatin tablets, ask your healthcare provider. Only your healthcare provider can determine if rosuvastatin tablets is right for you. What is rosuvastatin tablets? Rosuvastatin tablets is a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin. • Rosuvastatin tablets are used to: to reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke or the need for procedures to improve blood flow to the heart called arterial revascularization in adults who do not have known heart disease but do have certain additional risk factors. along with diet to: lower the level of low-density lipoprotein (LDL-C) cholesterol or \"bad\" cholesterol in adults with primary hyperlipidemia. slow the buildup of fatty deposits (plaque) in the walls of blood vessels. treat adults and children 8 years of age and older with high blood cholesterol due to heterozygous familial hypercholesterolemia (HeFH) (an inherited condition that causes high levels of LDL-C). along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children 7 years of age and older with homozygous familial hypercholesterolemia (HoFH) (an inherited condition that causes high levels of LDL-C). along with diet for the treatment of adults with: primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat). hypertriglyceridemia. It is not known if rosuvastatin tablets is safe and effective in children younger than 8 years of age with HeFH or children younger than 7 years of age with HoFH or in children with other types of hyperlipidemias (other than HeFH or HoFH). Do not take rosuvastatin tablets if you: • have liver problems. • are allergic to rosuvastatin or any of the ingredients in rosuvastatin tablets. See the end of this leaflet for a complete list of ingredients in rosuvastatin tablets. Symptoms of allergic reactions include rash, itching, hives, and swelling. Before you take rosuvastatin tablets, tell your healthcare provider about all of your medical conditions, including if you: • have unexplained muscle aches or weakness. • have or have had kidney problems. • have or have had liver problems. • drink more than 2 glasses of alcohol daily. • have thyroid problems. • are of Asian descent. • are pregnant or think you may be pregnant, or are planning to become pregnant. If you become pregnant while taking rosuvastatin tablets, call your healthcare provider right away to discuss your rosuvastatin tablets treatment. • are breastfeeding. Rosuvastatin can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take rosuvastatin tablets. Do not breastfeed while taking rosuvastatin tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider who prescribes rosuvastatin tablets if another healthcare provider increases the dose of another medicine you are taking. Rosuvastatin tablets may affect the way other medicines work, and other medicines may affect how rosuvastatin tablets works. Especially tell your healthcare provider if you take: • coumarin anticoagulants (medicines that prevent blood clots, such as warfarin) • antacids (medicines you take for heartburn that contain aluminum and magnesium hydroxide Taking rosuvastatin tablets with certain medicines may increase the risk of muscle problems. Especially tell your healthcare provider if you take: • cyclosporine (a medicine for your immune system) • teriflunomide (a medicine used to treat relapsing remitting multiple sclerosis) • enasidenib (a medicine used to treat acute myeloid leukemia) • capmatinib (a medicine for the treatment of non-small cell lung cancer) • fostamatinib (a medicine used to treat low platelet counts) • febuxostat (a medicine used to treat and prevent high blood levels of uric acid) • gemfibrozil (a fibric acid medicine for lowering cholesterol) • tafamidis [used to treat cardiomyopathy (enlarged and thickened heart muscle)] • anti-viral medicines including certain HIV or hepatitis C virus drugs such as: lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir combination of ▪ sofosbuvir/velpatasvir/voxilaprevir ▪ dasabuvir/ombitasvir/paritaprevir/ritonavir ▪ elbasvir/grazoprevir ▪ sofosbuvir/velpatasvir ▪ glecaprevir/pibrentasvir and all other combinations with ledipasvir including ledipasvir/sofosbuvir • darolutamide (a medicine for the treatment of prostate cancer) • regorafenib (a medicine used to treat cancer of the colon and rectum) • fibric acid derivatives (such as fenofibrate) • ticagrelor (helps reduce the chance of a blood clot formation that can block a blood vessel) • niacin or nicotinic acid • colchicine (a medicine used to treat gout) Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get new medicine. How should I take rosuvastatin tablets? • Take rosuvastatin tablets exactly as your healthcare provider tells you to take it. • Take rosuvastatin tablets, by mouth, 1 time each day. Swallow the tablet whole. • Rosuvastatin tablets can be taken at any time of day, with or without food. • Do not change your dose or stop rosuvastatin tablets without talking to your healthcare provider, even if you are feeling well. • Your healthcare provider may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin tablets. Your healthcare provider may change your dose of rosuvastatin tablets if needed. • While taking rosuvastatin tablets, continue to follow your cholesterol-lowering diet and to exercise as your healthcare provider told you to. • If you take a medicine called an antacid that contains a combination of aluminum and magnesium hydroxide, take rosuvastatin tablets at least 2 hours before you take the antacid. • If you miss a dose of rosuvastatin tablets, take your next dose at your normal scheduled time. Do not take an extra dose of rosuvastatin tablets. • In case of an overdose, get medical help or contact a live Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org. What are the possible side effects of rosuvastatin tablets? Rosuvastatin tablets may cause serious side effects, including: • Muscle pain, tenderness and weakness (myopathy) . Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your healthcare provider right away if: you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take rosuvastatin tablets. you have muscle problems that do not go away even after your healthcare provider has told you to stop taking rosuvastatin tablets. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. Your chances of getting muscle problems are higher if you: are taking certain other medicines while you take rosuvastatin tablets (see \"Especially tell your healthcare provider if you take\") are 65 years of age or older are of Asian descent have thyroid problems (hypothyroidism) that are not controlled have kidney problems are taking higher doses of rosuvastatin tablets • Liver problems. Your healthcare provider may do blood tests to check your liver before you start taking rosuvastatin tablets and if you have symptoms of liver problems while you take rosuvastatin tablets. Call your healthcare provider right away if you have any of the following symptoms of liver problems: feel unusually tired or weak loss of appetite upper belly pain dark urine yellowing of your skin or the whites of your eyes • Protein and blood in the urine . Rosuvastatin tablets may cause you to have protein and blood in your urine. If you develop protein or blood in your urine, your healthcare provider may decrease your dose of rosuvastatin tablets. • Increase in blood sugar (glucose) levels . Rosuvastatin tablets may cause an increase in your blood sugar levels. The most common side effects may include headache, nausea, muscle aches and pains, weakness, and constipation. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store rosuvastatin tablets? • Store rosuvastatin tablets at room temperature, between 68°F to 77°F (20°C to 25°C) and in a dry place. Keep rosuvastatin tablets and all medicines out of the reach of children. General Information about the safe and effective use of rosuvastatin tablets Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use rosuvastatin tablets for a condition for which it was not prescribed. Do not give rosuvastatin tablets to other people, even if they have the same medical condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about rosuvastatin tablets that is written for health professionals. What are the Ingredients in rosuvastatin tablets? Active Ingredient: rosuvastatin as rosuvastatin calcium Inactive Ingredients: anhydrous lactose, lactose monohydrate, anhydrous dibasic calcium phosphate, microcrystalline cellulose (101, 102), crospovidone, magnesium stearate, hypromellose 2910, titanium dioxide, triacetin, D&C yellow #10 aluminium lake, FD&C red #40/allura red AC aluminium lake, FD&C blue #2/ indigo carmine aluminium lake, FD&C yellow #6/ sunset yellow FCF aluminium lake. Distributed by: Westminster Pharmaceuticals, LLC Nashville, TN 37217 Manufactured by: Renata PLC (General Plant-2) Noyapara, Bhawal Mirzapur Rajendrapur, Gazipur, 1700 Bangladesh This Patient Information has been approved by the U.S. Food and Drug Administration Rev. 07/2025"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Take orally with or without food, at any time of day. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust dosage if necessary. ( 2.1 ) Adults : Recommended dosage range is 5 to 40 mg once daily. ( 2.1 ) Pediatric Patients with HeFH : Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. ( 2.2) Pediatric Patients with HoFH : Recommended dosage is 20 mg once daily for patients aged 7 years and older. ( 2.2 ) Asian Patients : Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at doses up to 20 mg once daily. ( 2.4 ) Patients with Severe Renal Impairment (not on hemodialysis) : Initiate at 5 mg once daily; do not exceed 10 mg once daily. ( 2.5 ) See full prescribing information for rosuvastatin tablets dosage and administration modifications due to drug interactions. ( 2.6 ) 2.1 General Dosage and Administration Information Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. Swallow the tablets whole. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust the dosage if necessary. If a dose is missed, advise patients not take an extra dose. Resume treatment with the next dose. When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [ see Drug Interactions ( 7.2 ) ]. 2.2 Recommended Dosage in Adult Patients The dosage range for rosuvastatin tablets is 5 to 40 mg orally once daily. The recommended dose of rosuvastatin tablets depends on a patient's indication for usage, LDL-C, and individual risk for CV events. 2.3 Recommended Dosage in Pediatric Patients Dosage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older. Dosage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily. 2.4 Dosing in Asian Patients Initiate rosuvastatin tablets at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin tablets when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.8 ), and Clinical Pharmacology ( 12.3 )]. 2.5 Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2 ) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.6 )]. There are no dosage adjustment recommendations for patients with mild and moderate renal impairment. 2.6 Dosage Modifications Due to Drug Interactions Rosuvastatin Tablets Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for rosuvastatin tablets due to drug interactions [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )]. Table 1: Rosuvastatin Tablets Dosage Modifications Due to Drug Interactions Concomitantly Used Drug Rosuvastatin Tablets Dosage Modifications Cyclosporine Do not exceed 5 mg once daily. Teriflunomide Do not exceed 10 mg once daily. Enasidenib Do not exceed 10 mg once daily. Capmatinib Do not exceed 10 mg once daily. Fostamatinib Do not exceed 20 mg once daily. Febuxostat Do not exceed 20 mg once daily. Gemfibrozil Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 10 mg once daily. Tafamidis Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily. Antiviral Medications Sofbuvir/velpatasvir/voxilaprevir Ledipasvir/sofosbuvir Concomitant use not recommended. o Simeprevir o Dasabuvir/ombitasvir/paritaprevir/ritonavir o Elbasvir/Grazoprevir o Sofosbuvir/Velpatasvir o Glecaprevir/Pibrentasvir o Atazanavir/Ritonavir o Lopinavir/Ritonavir Initiate at 5 mg once daily. Do not exceed 10 mg once daily. Darolutamide Do not exceed 5 mg once daily. Regorafenib Do not exceed 10 mg once daily. Rosuvastatin Tablets Administration Modifications Due to Drug Interactions When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions ( 7.2 )] ."],"spl_product_data_elements":["Rosuvastatin Calcium Rosuvastatin Calcium ANHYDROUS LACTOSE LACTOSE MONOHYDRATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE 101 CROSPOVIDONE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 HYPROMELLOSE 2910 (15 MPA.S) TITANIUM DIOXIDE TRIACETIN D&C YELLOW NO. 10 ALUMINUM LAKE FD&C RED NO. 40 FD&C BLUE NO. 2 ROSUVASTATIN CALCIUM ROSUVASTATIN biconvex RS Rosuvastatin Calcium Rosuvastatin Calcium ANHYDROUS LACTOSE LACTOSE MONOHYDRATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE 101 CROSPOVIDONE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 HYPROMELLOSE 2910 (15 MPA.S) TITANIUM DIOXIDE TRIACETIN FD&C RED NO. 40 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 ROSUVASTATIN CALCIUM ROSUVASTATIN biconvex RS1 Rosuvastatin Calcium Rosuvastatin Calcium ROSUVASTATIN CALCIUM ROSUVASTATIN ANHYDROUS LACTOSE LACTOSE MONOHYDRATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE 101 CROSPOVIDONE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 HYPROMELLOSE 2910 (15 MPA.S) TITANIUM DIOXIDE TRIACETIN FD&C RED NO. 40 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 biconvex RS2 Rosuvastatin Calcium Rosuvastatin Calcium ANHYDROUS LACTOSE LACTOSE MONOHYDRATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE 101 CROSPOVIDONE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 102 HYPROMELLOSE 2910 (15 MPA.S) TITANIUM DIOXIDE TRIACETIN FD&C RED NO. 40 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 ROSUVASTATIN CALCIUM ROSUVASTATIN biconvex RS3"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Rosuvastatin tablets: 5 mg of rosuvastatin: yellow colored, round, biconvex film coated tablets, debossed with \"RS\" on one side and plain on the other side. 10 mg of rosuvastatin: pink colored, round, biconvex film coated tablets, debossed with \"RS1\" on one side and plain on the other side. 20 mg of rosuvastatin: pink colored, round, biconvex film coated tablets, debossed with \"RS2\" on one side and plain on the other side. 40 mg of rosuvastatin: pink colored, oval, biconvex film coated tablets, debossed with \"RS3\" on one side and plain on the other side. Tablets: 5 mg, 10 mg, 20 mg and 40 mg of rosuvastatin. ( 3 )"],"clinical_pharmacology_table":["<table ID=\"ID107\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 8: Effect of Coadministered Drugs on Rosuvastatin Systemic Exposure</caption><col width=\"50%\"/><col width=\"16%\"/><col width=\"17%\"/><col width=\"16%\"/><tbody><tr><td align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Coadministered drug and dosing regimen</content> </td><td colspan=\"3\" align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td styleCode=\" Botrule Rrule\"/><td colspan=\"2\" align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Mean Ratio</content> <content styleCode=\"bold\">(ratio with/without coadministered drug)</content> <content styleCode=\"bold\">No Effect=1.0</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Dose (mg) <content styleCode=\"italics\"><footnote ID=\"ID107_0\"> Single dose unless otherwise noted. </footnote></content></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in AUC</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in C <sub>max</sub></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Sofosbuvir/velpatasvir/voxilaprevir (400 mg -100 mg-100 mg) + Voxilaprevir (100 mg) once daily for 15 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.39 <content styleCode=\"italics\"><footnote ID=\"ID107_1\">Clinically significant [see Dosage and Administration ( 2) and Warnings and Precautions ( 5)] </footnote></content>  (6.68-8.18) <content styleCode=\"italics\"><footnote ID=\"ID107_2\"> Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7 = 30% decrease, 11=11&#x2011;fold increase in exposure) </footnote></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">18.88 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>   (16.23-21.96) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Cyclosporine - stable dose required (75 mg - 200 mg BID)  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, QD for 10 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">11 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Darolutamide 600 mg BID, 5 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.2 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">~5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Regorafenib 160 mg QD, 14 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.8 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">4.6 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Atazanavir/ritonavir combination 300 mg/100 mg QD for 8 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">7 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Simeprevir 150 mg QD, 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.8 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.3-3.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.2 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.6-3.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Velpatasvir 100 mg once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.69 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.46-2.94) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.61 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.32-2.92) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Ombitasvir 25 mg/paritaprevir 150 mg/ ritonavir 100 mg + dasabuvir 400 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.59 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.09-3.21) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">7.13 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (5.11-9.96) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Teriflunomide  </td><td align=\"center\" styleCode=\" Botrule Rrule\">Not available  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.51 <content styleCode=\"italics\"><sup>2</sup></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.65 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Enasidenib 100 mg QD, 28 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.44  </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.66  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Elbasvir 50 mg/grazoprevir 200 mg once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.26 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.89-2.69) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.49 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (4.29-7.04) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Glecaprevir 400 mg/pibrentasvir 120 mg once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 mg, once daily  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.15 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.88-2.46) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">5.62 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (4.80-6.59) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Lopinavir/ritonavir combination 400 mg/100 mg BID for 17 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">20 mg, QD for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.7-2.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (3.4-6.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Capmatinib 400 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.08 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.56-2.76) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">3.04 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (2.36-3.92) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fostamatinib 100 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">20 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.96 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.77-2.15) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.88 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.69-2.09) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Febuxostat 120 mg QD for 4 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.9 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.5-2.5) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.1 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.8-2.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Gemfibrozil 600 mg BID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.9 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.6-2.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.2 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.8-2.7) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Tafamidis 61 mg BID on Days 1 &amp; 2, followed by QD on Days 3 to 9  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.97 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.68-2.31) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.86 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (1.59-2.16) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Eltrombopag 75 mg QD, 5 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.6   (1.4-1.7) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2   (1.8-2.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Darunavir 600 mg/ritonavir 100 mg BID, 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, QD for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.5   (1.0-2.1) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.4   (1.6-3.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Tipranavir/ritonavir combination 500 mg/200 mg BID for 11 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4   (1.2-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">2.2   (1.8-2.7) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Dronedarone 400 mg BID  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4  </td><td styleCode=\" Botrule Rrule\"/></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Itraconazole 200 mg QD, 5 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg or 80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4   (1.2-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  1.3   (1.1-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.4   (1.2-1.5) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  1.2   (0.9-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Ezetimibe 10 mg QD, 14 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg, QD for 14 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.2   (0.9-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.2   (0.8-1.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fosamprenavir/ritonavir 700 mg/100 mg BID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.1  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.5  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fenofibrate 67 mg TID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">10 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">&#x2194;  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.2   (1.1-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Rifampicin 450 mg QD, 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">20 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">&#x2194;  </td><td styleCode=\" Botrule Rrule\"/></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Aluminum &amp; magnesium hydroxide combination antacidAdministered simultaneously.   Administered 2 hours apart  </td><td align=\"center\" styleCode=\" Botrule Rrule\">40 mg.   40 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (0.4-0.5) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  0.8   (0.7-0.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.5 <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_1\"/></content>  (0.4-0.6) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content>  0.8   (0.7-1.0) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Ketoconazole 200 mg BID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.8-1.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.7-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Fluconazole 200 mg QD for 11 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.1   (1.0-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.1   (0.9-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\">Erythromycin 500 mg QID for 7 days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">80 mg  </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.8   (0.7-0.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">0.7   (0.5-0.9) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID107_2\"/></content> </td></tr><tr><td colspan=\"4\" align=\"left\" styleCode=\"Lrule Botrule Rrule\">QD= Once daily, BID= Twice daily, TID= Three times daily, QID= Four times daily  </td></tr></tbody></table>","<table ID=\"ID108\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 9: Effect of Rosuvastatin Coadministration on Systemic Exposure to Other Drugs</caption><col width=\"22%\"/><col width=\"25%\"/><col width=\"27%\"/><col width=\"24%\"/><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule Rrule\"><content styleCode=\"bold\">Rosuvastatin Dosage Regimen</content> </td><td colspan=\"3\" align=\"center\" styleCode=\" Toprule Botrule Rrule\"><content styleCode=\"bold\">Coadministered Drug</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td styleCode=\" Botrule Rrule\"/><td colspan=\"2\" align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Mean Ratio (ratio with/without coadministered drug)</content> <content styleCode=\"bold\">No Effect=1.0</content> </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\"/><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Name and Dose</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in AUC</content> </td><td align=\"center\" styleCode=\" Botrule Rrule\"><content styleCode=\"bold\">Change in C <sub>max</sub></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">40 mg QD for 10 days  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Warfarin <content styleCode=\"italics\"><footnote ID=\"ID108_0\"> Clinically significant pharmacodynamic effects [see Drug Interactions ( 7.3)] </footnote></content>  25 mg single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">R- Warfarin 1.0   (1.0-1.1) <content styleCode=\"italics\"><footnote ID=\"ID108_1\"> Mean ratio with 90% CI (with/without coadministered drug, e.g., 1= no change, 0.7=30% decrease, 11=11-fold increase in exposure) </footnote></content>  S-Warfarin 1.1   (1.0-1.1) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">R-Warfarin 1.0   (0.9-1.0) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content>  S-Warfarin 1.0   (0.9-1.1) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">40 mg QD for 12 days  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Digoxin   0.5 mg single dose  </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.9-1.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">1.0   (0.9-1.2) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">40 mg QD for 28 days  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Oral Contraceptive (ethinyl estradiol 0.035 mg &amp; norgestrel 0.180, 0.215 and 0.250 mg) QD for 21 Days  </td><td align=\"center\" styleCode=\" Botrule Rrule\">EE 1.3   (1.2-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content>  NG 1.3   (1.3-1.4) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td><td align=\"center\" styleCode=\" Botrule Rrule\">EE 1.3   (1.2-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content>  NG 1.2   (1.1-1.3) <content styleCode=\"italics\"><footnoteRef IDREF=\"ID108_1\"/></content> </td></tr><tr><td colspan=\"4\" align=\"left\" styleCode=\"Lrule Botrule Rrule\">EE = ethinyl estradiol, NG = norgestrel, QD= Once daily  </td></tr></tbody></table>"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Breastfeeding not recommended during treatment with rosuvastatin. ( 8.2 ) 8.1 Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders - including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use - using propensity score‑based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. Animal Data In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC). In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area). Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. In rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18. 8.2 Lactation Risk Summary Limited data from case reports in published literature indicate that rosuvastatin is present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Statins, including rosuvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with rosuvastatin [see Use in Specific Populations ( 8.1 ) and Clinical Pharmacology ( 12.1 )] . 8.4 Pediatric Use The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [see Clinical Studies ( 14 )] . In the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturation in patients aged 10 to 17 years. The safety and effectiveness of rosuvastatin as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established pediatric patients 7 years of age and older with HoFH. Use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with HoFH [see Clinical Studies ( 14 )] . The safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with HeFH, younger than 7 years of age with HoFH, or in pediatric patients with other types of hyperlipidemia (other than HeFH or HoFH). 8.5 Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Advanced age (≥65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving rosuvastatin for the increased risk of myopathy [see Warnings and Precautions ( 5.1 )] . 8.6 Renal Impairment Rosuvastatin exposure is not influenced by mild to moderate renal impairment (CL cr ≥30 mL/min/1.73 m 2 ). Exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) who are not receiving hemodialysis [see Clinical Pharmacology ( 12.3 )] . Renal impairment is a risk factor for myopathy and rhabdomyolysis. Monitor all patients with renal impairment for development of myopathy. In patients with severe renal impairment not on hemodialysis, the recommended starting dosage is 5 mg daily and should not exceed 10 mg daily [see Dosage and Administration ( 2.5 ) and Warnings and Precautions ( 5.1 )] . 8.7 Hepatic Impairment Rosuvastatin is contraindicated in patients with acute liver failure or decompensated cirrhosis. Chronic alcohol liver disease is known to increase rosuvastatin exposure. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see Contraindications ( 4 ) , Warning and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )] . 8.8 Asian Patients Pharmacokinetic studies have demonstrated an approximate 2‑fold increase in median exposure to rosuvastatin in Asian subjects when compared with White controls. Adjust the rosuvastatin dosage in Asian patients [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )] ."],"information_for_patients_table":["<table ID=\"ID141\" width=\"623\" styleCode=\"Noautorules\"><caption/><col width=\"623\"/><tbody><tr><td align=\"center\" styleCode=\"Lrule Toprule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">PATIENT INFORMATION</content>  Rosuvastatin (roe-SOO-va-STAT-in) Tablets, USP   (rosuvastatin)   tablets, for oral use  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Read this Patient Information carefully before you start taking rosuvastatin tablets and each time you get a refill. If you have any questions about rosuvastatin tablets, ask your healthcare provider. Only your healthcare provider can determine if rosuvastatin tablets is right for you.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">What is rosuvastatin tablets?</content>  Rosuvastatin tablets is a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin.   &#x2022; Rosuvastatin tablets are used to:  <list listType=\"unordered\" styleCode=\"Circle\"><item>to reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke or the need for procedures to improve blood flow to the heart called arterial revascularization in adults who do not have known heart disease but do have certain additional risk factors.</item><item>along with diet to: <list listType=\"unordered\" styleCode=\"Circle\"><item>lower the level of low-density lipoprotein (LDL-C) cholesterol or &quot;bad&quot; cholesterol in adults with primary hyperlipidemia.</item><item>slow the buildup of fatty deposits (plaque) in the walls of blood vessels.</item><item>treat adults and children 8 years of age and older with high blood cholesterol due to heterozygous familial hypercholesterolemia (HeFH) (an inherited condition that causes high levels of LDL-C).</item></list></item><item>along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children 7 years of age and older with homozygous familial hypercholesterolemia (HoFH) (an inherited condition that causes high levels of LDL-C).</item><item>along with diet for the treatment of adults with: <list listType=\"unordered\" styleCode=\"Circle\"><item>primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat).</item><item>hypertriglyceridemia.</item></list></item></list>It is not known if rosuvastatin tablets is safe and effective in children younger than 8 years of age with HeFH or children younger than 7 years of age with HoFH or in children with other types of hyperlipidemias (other than HeFH or HoFH).  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">Do not take rosuvastatin tablets if you:</content>  &#x2022; have liver problems.   &#x2022; are allergic to rosuvastatin or any of the ingredients in rosuvastatin tablets. See the end of this leaflet for a complete list of ingredients in rosuvastatin tablets. Symptoms of allergic reactions include rash, itching, hives, and swelling.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">Before you take rosuvastatin tablets, tell your healthcare provider about all of your medical conditions, including if you:</content>  &#x2022; have unexplained muscle aches or weakness.   &#x2022; have or have had kidney problems.   &#x2022; have or have had liver problems.   &#x2022; drink more than 2 glasses of alcohol daily.   &#x2022; have thyroid problems.   &#x2022; are of Asian descent.   &#x2022; are pregnant or think you may be pregnant, or are planning to become pregnant. If you become pregnant while taking rosuvastatin tablets, call your healthcare provider right away to discuss your rosuvastatin tablets treatment.   &#x2022; are breastfeeding. Rosuvastatin can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take rosuvastatin tablets. Do not breastfeed while taking rosuvastatin tablets.  <content styleCode=\"bold\">Tell your healthcare provider about all the medicines you take,</content>including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider who prescribes rosuvastatin tablets if another healthcare provider increases the dose of another medicine you are taking. Rosuvastatin tablets may affect the way other medicines work, and other medicines may affect how rosuvastatin tablets works.     Especially tell your healthcare provider if you take:   &#x2022; coumarin anticoagulants (medicines that prevent blood clots, such as warfarin)   &#x2022; antacids (medicines you take for heartburn that contain aluminum and magnesium hydroxide   Taking rosuvastatin tablets with certain medicines may increase the risk of muscle problems.   Especially tell your healthcare provider if you take:   &#x2022; cyclosporine (a medicine for your immune system)   &#x2022; teriflunomide (a medicine used to treat relapsing remitting multiple sclerosis)   &#x2022; enasidenib (a medicine used to treat acute myeloid leukemia)   &#x2022; capmatinib (a medicine for the treatment of non-small cell lung cancer)   &#x2022; fostamatinib (a medicine used to treat low platelet counts)   &#x2022; febuxostat (a medicine used to treat and prevent high blood levels of uric acid)   &#x2022; gemfibrozil (a fibric acid medicine for lowering cholesterol)   &#x2022; tafamidis [used to treat cardiomyopathy (enlarged and thickened heart muscle)]   &#x2022; anti-viral medicines including certain HIV or hepatitis C virus drugs such as:  <list listType=\"unordered\" styleCode=\"Circle\"><item>lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir</item><item>combination of</item></list> &#x25AA; sofosbuvir/velpatasvir/voxilaprevir   &#x25AA; dasabuvir/ombitasvir/paritaprevir/ritonavir   &#x25AA; elbasvir/grazoprevir   &#x25AA; sofosbuvir/velpatasvir   &#x25AA; glecaprevir/pibrentasvir <content styleCode=\"bold\">and</content> <list listType=\"unordered\" styleCode=\"Circle\"><item>all other combinations with ledipasvir including ledipasvir/sofosbuvir</item></list>&#x2022; darolutamide (a medicine for the treatment of prostate cancer)   &#x2022; regorafenib (a medicine used to treat cancer of the colon and rectum)   &#x2022; fibric acid derivatives (such as fenofibrate)   &#x2022; ticagrelor (helps reduce the chance of a blood clot formation that can block a blood vessel)   &#x2022; niacin or nicotinic acid   &#x2022; colchicine (a medicine used to treat gout)   Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get new medicine.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">How should I take rosuvastatin tablets?</content>  &#x2022; Take rosuvastatin tablets exactly as your healthcare provider tells you to take it.   &#x2022; Take rosuvastatin tablets, by mouth, 1 time each day. Swallow the tablet whole.   &#x2022; Rosuvastatin tablets can be taken at any time of day, with or without food.   &#x2022; <content styleCode=\"bold\">Do not</content>change your dose or stop rosuvastatin tablets without talking to your healthcare provider, even if you are feeling well.   &#x2022; Your healthcare provider may do blood tests to check your cholesterol levels before and during your treatment with rosuvastatin tablets. Your healthcare provider may change your dose of rosuvastatin tablets if needed.   &#x2022; While taking rosuvastatin tablets, continue to follow your cholesterol-lowering diet and to exercise as your healthcare provider told you to.   &#x2022; If you take a medicine called an antacid that contains a combination of aluminum and magnesium hydroxide, take rosuvastatin tablets at least 2 hours before you take the antacid.   &#x2022; If you miss a dose of rosuvastatin tablets, take your next dose at your normal scheduled time. <content styleCode=\"bold\">Do not take</content>an extra dose of rosuvastatin tablets.   &#x2022; In case of an overdose, get medical help or contact a live Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">What are the possible side effects of rosuvastatin tablets?</content> <content styleCode=\"bold\">Rosuvastatin tablets may cause serious side effects, including:</content>  &#x2022; <content styleCode=\"bold\">Muscle pain, tenderness and weakness (myopathy)</content>. Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your healthcare provider right away if:  <list listType=\"unordered\" styleCode=\"Circle\"><item>you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take rosuvastatin tablets.</item><item>you have muscle problems that do not go away even after your healthcare provider has told you to stop taking rosuvastatin tablets. Your healthcare provider may do further tests to diagnose the cause of your muscle problems.</item></list>Your chances of getting muscle problems are higher if you:  <list listType=\"unordered\" styleCode=\"Circle\"><item>are taking certain other medicines while you take rosuvastatin tablets (see &quot;Especially tell your healthcare provider if you take&quot;)</item><item>are 65 years of age or older</item><item>are of Asian descent</item><item>have thyroid problems (hypothyroidism) that are not controlled</item><item>have kidney problems</item><item>are taking higher doses of rosuvastatin tablets</item></list>&#x2022; <content styleCode=\"bold\">Liver problems.</content>Your healthcare provider may do blood tests to check your liver before you start taking rosuvastatin tablets and if you have symptoms of liver problems while you take rosuvastatin tablets. Call your healthcare provider right away if you have any of the following symptoms of liver problems:  <list listType=\"unordered\" styleCode=\"Circle\"><item>feel unusually tired or weak</item><item>loss of appetite</item><item>upper belly pain</item><item>dark urine</item><item>yellowing of your skin or the whites of your eyes</item></list>&#x2022; <content styleCode=\"bold\">Protein and blood in the urine</content>. Rosuvastatin tablets may cause you to have protein and blood in your urine. If you develop protein or blood in your urine, your healthcare provider may decrease your dose of rosuvastatin tablets.   &#x2022; <content styleCode=\"bold\">Increase in blood sugar (glucose) levels</content>. Rosuvastatin tablets may cause an increase in your blood sugar levels.   The most common side effects may include headache, nausea, muscle aches and pains, weakness, and constipation.   Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">How should I store rosuvastatin tablets?</content>  &#x2022; Store rosuvastatin tablets at room temperature, between 68&#xB0;F to 77&#xB0;F (20&#xB0;C to 25&#xB0;C) and in a dry place.  <content styleCode=\"bold\">Keep rosuvastatin tablets and all medicines out of the reach of children.</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">General Information about the safe and effective use of rosuvastatin tablets</content>  Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use rosuvastatin tablets for a condition for which it was not prescribed. Do not give rosuvastatin tablets to other people, even if they have the same medical condition you have. It may harm them.   You can ask your pharmacist or healthcare provider for information about rosuvastatin tablets that is written for health professionals.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">What are the Ingredients in rosuvastatin tablets?</content> <content styleCode=\"bold\">Active Ingredient:</content>rosuvastatin as rosuvastatin calcium  <content styleCode=\"bold\">Inactive Ingredients:</content>anhydrous lactose, lactose monohydrate, anhydrous dibasic calcium phosphate, microcrystalline cellulose (101, 102), crospovidone, magnesium stearate, hypromellose 2910, titanium dioxide, triacetin, D&amp;C yellow #10 aluminium lake, FD&amp;C red #40/allura red AC aluminium lake, FD&amp;C blue #2/ indigo carmine aluminium lake, FD&amp;C yellow #6/ sunset yellow FCF aluminium lake.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">Distributed by:</content>  Westminster Pharmaceuticals, LLC   Nashville, TN 37217   <content styleCode=\"bold\">Manufactured by:</content>  Renata PLC (General Plant-2)   Noyapara, Bhawal Mirzapur   Rajendrapur, Gazipur, 1700   Bangladesh  </td></tr></tbody></table>"],"dosage_and_administration_table":["<table ID=\"ID24\" width=\"100%\" styleCode=\"Noautorules\"><caption>Table 1: Rosuvastatin Tablets Dosage Modifications Due to Drug Interactions</caption><col width=\"44%\"/><col width=\"55%\"/><tbody><tr><td align=\"left\" styleCode=\"Lrule Toprule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">Concomitantly Used Drug</content> </td><td align=\"left\" styleCode=\" Toprule Botrule Rrule\" valign=\"top\"><content styleCode=\"bold\">Rosuvastatin Tablets Dosage Modifications</content> </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Cyclosporine  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 5 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Teriflunomide  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 10 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Enasidenib  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 10 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Capmatinib  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 10 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Fostamatinib  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 20 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Febuxostat  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 20 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Gemfibrozil  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 10 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Tafamidis  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily.  </td></tr><tr><td colspan=\"2\" align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Antiviral Medications  </td></tr><tr><td styleCode=\"Lrule Botrule Rrule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"Circle\"><item>Sofbuvir/velpatasvir/voxilaprevir</item><item>Ledipasvir/sofosbuvir</item></list></td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Concomitant use not recommended.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">o Simeprevir   o Dasabuvir/ombitasvir/paritaprevir/ritonavir   o Elbasvir/Grazoprevir   o Sofosbuvir/Velpatasvir   o Glecaprevir/Pibrentasvir   o Atazanavir/Ritonavir   o Lopinavir/Ritonavir  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Initiate at 5 mg once daily. Do not exceed 10 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Darolutamide  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 5 mg once daily.  </td></tr><tr><td align=\"left\" styleCode=\"Lrule Botrule Rrule\" valign=\"top\">Regorafenib  </td><td align=\"left\" styleCode=\" Botrule Rrule\" valign=\"top\">Do not exceed 10 mg once daily.  </td></tr></tbody></table>"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rosuvastatin Tablets, USP 5 mg NDC 69367-359-30 30's Bottle Label Rosuvastatin Tablets, USP 5 mg NDC 69367-359-09 90's Bottle Label Rosuvastatin Tablets, USP 5 mg NDC 69367-359-01 100's Bottle Label Rosuvastatin Tablets, USP 5 mg NDC 69367-359-05 500's Bottle Label Rosuvastatin Tablets, USP 5 mg NDC 69367-359-10 1000's Bottle Label Rosuvastatin Tablets, USP 10 mg NDC 69367-360-30 30's Bottle Label Rosuvastatin Tablets, USP 10 mg NDC 69367-360-09 90's Bottle Label Rosuvastatin Tablets, USP 10 mg NDC 69367-360-01 100's Bottle Label Rosuvastatin Tablets, USP 10 mg NDC 69367-360-05 500's Bottle Label Rosuvastatin Tablets, USP 10 mg NDC 69367-360-10 1000's Bottle Label Rosuvastatin Tablets, USP 20 mg NDC 69367-361-30 30's Bottle Label Rosuvastatin Tablets, USP 20 mg NDC 69367-361-09 90's Bottle Label Rosuvastatin Tablets, USP 20 mg NDC 69367-361-01 100's Bottle Label Rosuvastatin Tablets, USP 20 mg NDC 69367-361-05 500's Bottle Label Rosuvastatin Tablets, USP 20 mg NDC 69367-361-10 1000's Bottle Label Rosuvastatin Tablets, USP 40 mg NDC 69367-362-30 30's Bottle Label Rosuvastatin Tablets, USP 40 mg NDC 69367-362-09 90's Bottle Label Rosuvastatin Tablets, USP 40 mg NDC 69367-362-01 100's Bottle Label Rosuvastatin Tablets, USP 40 mg NDC 69367-362-05 500's Bottle Label Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image Image"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in rats at dose levels of 2, 20, 60, or 80 mg/kg/day by oral gavage, the incidence of uterine stromal polyps was significantly increased in females at 80 mg/kg/day at systemic exposure 20 times the human exposure at 40 mg/day based on AUC. Increased incidence of polyps was not seen at lower doses. In a 107-week carcinogenicity study in mice given 10, 60, or 200 mg/kg/day by oral gavage, an increased incidence of hepatocellular adenoma/carcinoma was observed at 200 mg/kg/day at systemic exposures 20 times the human exposure at 40 mg/day based on AUC. An increased incidence of hepatocellular tumors was not seen at lower doses. Rosuvastatin was not mutagenic or clastogenic with or without metabolic activation in the Ames test with Salmonella typhimurium and Escherichia coli , the mouse lymphoma assay, and the chromosomal aberration assay in Chinese hamster lung cells. Rosuvastatin was negative in the in vivo mouse micronucleus test. In rat fertility studies with oral gavage doses of 5, 15, 50 mg/kg/day, males were treated for 9 weeks prior to and throughout mating and females were treated 2 weeks prior to mating and throughout mating until gestation day 7. No adverse effect on fertility was observed at 50 mg/kg/day (systemic exposures up to 10 times the human exposure at 40 mg/day based on AUC). In testicles of dogs treated with rosuvastatin at 30 mg/kg/day for one month, spermatidic giant cells were seen. Spermatidic giant cells were observed in monkeys after 6‑month treatment at 30 mg/kg/day in addition to vacuolation of seminiferous tubular epithelium. Exposures in the dog were 20 times and in the monkey 10 times the human exposure at 40 mg/day based on body surface area. Similar findings have been seen with other drugs in this class."]},"tags":[{"label":"HMG-CoA Reductase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"3-hydroxy-3-methylglutaryl-coenzyme A reductase","category":"target"},{"label":"HMGCR","category":"gene"},{"label":"PDE6D","category":"gene"},{"label":"A10BH52","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Arteriosclerotic vascular disease","category":"indication"},{"label":"Cerebrovascular accident","category":"indication"},{"label":"Familial hypercholesterolemia - heterozygous","category":"indication"},{"label":"Familial hypercholesterolemia - homozygous","category":"indication"},{"label":"Familial type 3 hyperlipoproteinemia","category":"indication"},{"label":"Hypercholesterolemia","category":"indication"},{"label":"Astrazeneca","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anticholesteremic Agents","category":"pharmacology"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Hydroxymethylglutaryl-CoA Reductase Inhibitors","category":"pharmacology"},{"label":"Hypolipidemic Agents","category":"pharmacology"},{"label":"Lipid Regulating Agents","category":"pharmacology"}],"phase":"marketed","fdaNDC":[{"route":["ORAL"],"labeler":"TORRENT PHARMACEUTICALS LIMITED","brandName":"Rosuvastatin Calcium","packaging":[{"ndc":"13668-723-05","description":"500 TABLET in 1 BOTTLE (13668-723-05)","marketingStartDate":"20230801"},{"ndc":"13668-723-10","description":"1000 TABLET in 1 BOTTLE (13668-723-10)","marketingStartDate":"20241220"},{"ndc":"13668-723-30","description":"30 TABLET in 1 BOTTLE 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Monitor INR frequently until stable upon initiation, dose titration or discontinuation.","clinicalEffect":""}],"commonSideEffects":[{"effect":"Headache","drugRate":"7.6%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":79,"totalAffected":6,"trialsReporting":4},{"effect":"Cough","drugRate":"10.0%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":2,"trialsReporting":1},{"effect":"Nasal congestion","drugRate":"1.9%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":52,"totalAffected":1,"trialsReporting":2},{"effect":"Diarrhoea","drugRate":"1.3%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":79,"totalAffected":1,"trialsReporting":4},{"effect":"Abdominal pain lower","drugRate":"5.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":1,"trialsReporting":1},{"effect":"Nausea","drugRate":"2.8%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":36,"totalAffected":1,"trialsReporting":2},{"effect":"Ligament sprain","drugRate":"5.0%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":20,"totalAffected":1,"trialsReporting":1},{"effect":"Decreased appetite","drugRate":"5.0%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":20,"totalAffected":1,"trialsReporting":1},{"effect":"Oropharyngeal pain","drugRate":"2.8%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":36,"totalAffected":1,"trialsReporting":2},{"effect":"Dizziness","drugRate":"2.8%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":36,"totalAffected":1,"trialsReporting":2},{"effect":"Haematoma","drugRate":"6.2%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":16,"totalAffected":1,"trialsReporting":1},{"effect":"Phlebitis","drugRate":"6.2%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":16,"totalAffected":1,"trialsReporting":1},{"effect":"Nasopharyngitis","drugRate":"9.1%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":11,"totalAffected":1,"trialsReporting":1},{"effect":"Anaemia","drugRate":"0.0%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":32,"totalAffected":0,"trialsReporting":1},{"effect":"Abnormal sensation in eye","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":32,"totalAffected":0,"trialsReporting":1},{"effect":"Palpitations","drugRate":"0.0%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":32,"totalAffected":0,"trialsReporting":1},{"effect":"Alanine aminotransferase increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":52,"totalAffected":0,"trialsReporting":2},{"effect":"Aspartate aminotransferase increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":52,"totalAffected":0,"trialsReporting":2},{"effect":"Blood creatine phosphokinase increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":32,"totalAffected":0,"trialsReporting":1},{"effect":"Blood lactate dehydrogenase increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":52,"totalAffected":0,"trialsReporting":2},{"effect":"Ocular hyperaemia","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Abdominal distension","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Abdominal pain","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":36,"totalAffected":0,"trialsReporting":2},{"effect":"Abnormal faeces","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Faeces soft","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Flatulence","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":36,"totalAffected":0,"trialsReporting":2},{"effect":"Periorbital haematoma","drugRate":"0.0%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Blood alkaline phosphatase increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Gamma-glutamyltransferase increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Lipase increased","drugRate":"0.0%","organSystem":"Investigations","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Dysmenorrhoea","drugRate":"0.0%","organSystem":"Reproductive system and breast disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Polymenorrhoea","drugRate":"0.0%","organSystem":"Reproductive system and breast disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Dry throat","drugRate":"0.0%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Erythema","drugRate":"0.0%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":36,"totalAffected":0,"trialsReporting":2},{"effect":"Ear discomfort","drugRate":"0.0%","organSystem":"Ear and labyrinth disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Vertigo","drugRate":"0.0%","organSystem":"Ear and labyrinth disorders","placeboRate":"","totalAtRisk":36,"totalAffected":0,"trialsReporting":2},{"effect":"Blepharospasm","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Dry eye","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Eye irritation","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Eye pain","drugRate":"0.0%","organSystem":"Eye disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Abdominal pain upper","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Dry mouth","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Fatigue","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Mucosal dryness","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Musculoskeletal pain","drugRate":"0.0%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Neck pain","drugRate":"0.0%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Burning sensation","drugRate":"0.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Hypoaesthesia","drugRate":"0.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Paraesthesia","drugRate":"0.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1},{"effect":"Vulvovaginal dryness","drugRate":"0.0%","organSystem":"Reproductive system and breast disorders","placeboRate":"","totalAtRisk":20,"totalAffected":0,"trialsReporting":1}],"contraindications":["Acute liver failure or decompensated cirrhosis","Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets"],"specialPopulations":{"Geriatric":"8.5 Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin, 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Advanced age (≥65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis. Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac fun","Pediatric":"8.4 Pediatric Use The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [see Clinical Studies ( 14","Pregnancy":"8.1 Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1 )] . In addition, treatment of hyperlipidemia is not generally","Specific Populations":"8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Breastfeeding not recommended during treatment with rosuvastatin. ( 8.2 ) 8.1 Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when admin"},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"AstraZeneca","patents":[],"pricing":[],"_fixedAt":"2026-03-30T11:28:09.923299","_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T20:49:27.444158+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T20:49:41.341665+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T20:49:28.187737+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:55:02.556633+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:27:52.125090+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1744447/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T20:49:34.998668+00:00"},"fdaRecalls":{"url":"","method":"api_direct","source":"FDA Enforcement/Recalls","rawText":"","confidence":1,"sourceType":"fda_enforcement","retrievedAt":"2026-04-19T20:49:33.359910+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T20:46:08.511699+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-359-30 69367-359-09 69367-359-01 69367-359-05 69367-359-10 Yellow colored, round, biconvex film coated tablets, debossed with \"RS\" on one side and plain on the other side. 10 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-360-30 69367-360-09 69367-360-01 69367-360-05 69367-360-10 Pink colored, round, biconvex film c","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T20:45:49.285076+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:49:54.808749+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"11 DESCRIPTION Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The empirical formula for rosuvastatin calcium is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white or almost white, hygros","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T20:46:08.511608+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:27:52.125122+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T20:49:33.480254+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T20:49:32.970686+00:00"},"fdaClinicalStudies":{"url":"","method":"ai_extraction","source":"FDA Label (clinical_studies, 15,102 chars)","aiModel":"featherless","rawText":"14 CLINICAL STUDIES Primary Prevention of CV Disease In the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, the effect of rosuvastatin on the occurrence of major CV disease events was assessed in 17,802 males (≥50 years) and females (≥60 years) who had no clinically evident CV disease, LDL‑C levels <130 mg/dL and hsCRP levels ≥2 mg/L. The study population had an estimated baseline coronary heart disease risk of 11.6% over","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-19T20:46:55.171257+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T20:49:34.436822+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=rosuvastatin","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T20:49:26.965927+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:49:54.808679+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T20:49:29.015681+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku extraction","aiModel":"claude-haiku-4-5","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:02.556586+00:00"},"nonclinicalToxicology":{"url":"","method":"deterministic","source":"FDA Label (nonclinical_toxicology)","rawText":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in rats at dose levels of 2, 20, 60, or 80 mg/kg/day by oral gavage, the incidence of uterine stromal polyps was significantly increased in females at 80 mg/kg/day at systemic exposure 20 times the human exposure at 40 mg/day based on AUC. Increased incidence of polyps was not seen at lower doses. In a 107-week carcinogenicity study in mice given 10, 60, or 200 mg/kg/day by ora","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T20:46:08.511693+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:54:52.626075+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:02.556630+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (5 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T08:27:52.546712+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:02.556623+00:00"},"safety.specialPopulations":{"url":"","method":"deterministic","source":"FDA Label (special populations)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T20:49:11.581406+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:49:54.808613+00:00"}},"allNames":"crestor","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d9b83920-26ae-462a-ac10-33fd1ed7738f","setid":"d9b83920-26ae-462a-ac10-33fd1ed7738f","title":"ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e6b86b67-62c7-43cc-8174-b2b8e0a60711","setid":"e6b86b67-62c7-43cc-8174-b2b8e0a60711","title":"ROSUVASTATIN (ROSUVASTATIN) TABLET, FILM COATED [BRYANT RANCH PREPACK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c2d9a04e-8c72-d487-e053-2a95a90a0fcd","setid":"c2d9a04e-8c72-d487-e053-2a95a90a0fcd","title":"ROSUVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=11fad602-16c2-4c1f-bdf1-867d95f063ca","setid":"11fad602-16c2-4c1f-bdf1-867d95f063ca","title":"ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94245f53-2892-4209-8c94-c32c87d5b106","setid":"94245f53-2892-4209-8c94-c32c87d5b106","title":"ROSUVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]"}],"offLabel":[],"synonyms":["rosuvastatin","rosuvastatin calcium","crestor","rosuvastatin zinc","ZD4522"],"timeline":[{"date":"2003-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from IPR to Astrazeneca"},{"date":"2003-08-12","type":"positive","source":"DrugCentral","milestone":"FDA approval (IPR)"},{"date":"2005-01-19","type":"positive","source":"DrugCentral","milestone":"PMDA approval (AstraZeneca K.K.)"},{"date":"2018-12-18","type":"positive","source":"FDA Orange Book","milestone":"Ezallor Sprinkle approved — EQ 5MG BASE"},{"date":"2020-04-01","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 26 manufacturers approved"}],"aiSummary":"Rosuvastatin is an HMG-CoA reductase inhibitor indicated for reducing cardiovascular events and LDL-C across multiple patient populations including primary hyperlipidemia, atherosclerosis, and familial hypercholesterolemia. It demonstrates approximately 20% bioavailability with a 19-hour half-life and is primarily hepatically cleared (72%) with minimal renal excretion. Significant drug interactions exist with CYP2C9 and transporter inhibitors (cyclosporine, teriflunomide, enasidenib) requiring dose reductions to mitigate myopathy and rhabdomyolysis risk. Rosuvastatin is contraindicated in acute liver failure, decompensated cirrhosis, and hypersensitivity reactions, with careful monitoring required in severe renal impairment and Asian populations showing 2-fold higher exposure.","brandName":"Crestor","ecosystem":[{"indication":"Arteriosclerotic vascular disease","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"fluvastatin","slug":"fluvastatin","company":"Novartis"},{"name":"lovastatin","slug":"lovastatin","company":"Merck"},{"name":"pravastatin","slug":"pravastatin","company":"Bristol Myers Squibb"}],"globalPrevalence":523000000},{"indication":"Cerebrovascular accident","otherDrugs":[{"name":"amlodipine","slug":"amlodipine","company":"Pfizer"},{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"pravastatin","slug":"pravastatin","company":"Bristol Myers Squibb"},{"name":"ramipril","slug":"ramipril","company":"King Pharms"}],"globalPrevalence":101000000},{"indication":"Familial hypercholesterolemia - heterozygous","otherDrugs":[{"name":"alirocumab","slug":"alirocumab","company":"Sanofi Aventis"},{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"bempedoic acid","slug":"bempedoic-acid","company":"Esperion Theraps Inc"},{"name":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"}],"globalPrevalence":390000000},{"indication":"Familial hypercholesterolemia - homozygous","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"evolocumab","slug":"evolocumab","company":"Repatha"},{"name":"ezetimibe","slug":"ezetimibe","company":"Msd Intl Gmbh"},{"name":"lomitapide","slug":"lomitapide","company":"Aegerion"}],"globalPrevalence":390000000},{"indication":"Familial type 3 hyperlipoproteinemia","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"pravastatin","slug":"pravastatin","company":"Bristol Myers Squibb"},{"name":"simvastatin","slug":"simvastatin","company":"Merck"}],"globalPrevalence":4000000},{"indication":"Hypercholesterolemia","otherDrugs":[{"name":"alirocumab","slug":"alirocumab","company":"Sanofi Aventis"},{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"cerivastatin","slug":"cerivastatin","company":"Bayer Pharms"},{"name":"cholestyramine","slug":"cholestyramine","company":"Bristol Myers"}],"globalPrevalence":390000000},{"indication":"Hypertriglyceridemia","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"},{"name":"fenofibrate","slug":"fenofibrate","company":"Abbvie"},{"name":"gemfibrozil","slug":"gemfibrozil","company":"Pfizer Pharms"}],"globalPrevalence":1680000000},{"indication":"Mixed hyperlipidemia","otherDrugs":[{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"cerivastatin","slug":"cerivastatin","company":"Bayer Pharms"},{"name":"choline fenofibrate","slug":"choline-fenofibrate","company":"Abbvie"},{"name":"ezetimibe","slug":"ezetimibe","company":"Msd Intl Gmbh"}],"globalPrevalence":390000000}],"mechanism":{"target":"HMG-CoA reductase","novelty":"Follow-on","targets":[{"gene":"HMGCR","source":"DrugCentral","target":"3-hydroxy-3-methylglutaryl-coenzyme A reductase","protein":"3-hydroxy-3-methylglutaryl-coenzyme A reductase","isPrimary":true,"activityType":"Ki","activityValue":9.05},{"gene":"PDE6D","source":"DrugCentral","target":"Phosphodiesterase 6D","protein":"Retinal rod rhodopsin-sensitive cGMP 3',5'-cyclic phosphodiesterase subunit delta"}],"moaClass":"Hydroxymethylglutaryl-CoA Reductase Inhibitors","modality":"Enzyme inhibitor","drugClass":"HMG-CoA reductase inhibitor (statin)","explanation":"Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. By inhibiting this enzyme, rosuvastatin reduces cholesterol synthesis in the liver. Greater than 90% of active plasma HMG-CoA reductase inhibitory activity is accounted for by the parent compound, with the major metabolite N-desmethyl rosuvastatin having approximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound.","oneSentence":"Rosuvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme converting HMG-CoA to mevalonate, a cholesterol precursor.","technicalDetail":"Rosuvastatin specifically targets and inhibits 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, the rate-limiting enzyme in the mevalonate pathway, which is essential for cholesterol biosynthesis."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Rosuvastatin","title":"Rosuvastatin","extract":"Rosuvastatin, sold under the brand name Crestor among others, is a statin medication, used to prevent cardiovascular disease in those at high risk and treat abnormal lipids. It is recommended to be used with dietary changes, exercise, and weight loss. It is taken orally.","wiki_society_and_culture":"==Society and culture==\nRosuvastatin is the international nonproprietary name (INN).\n\n===Economics===\nBecause low- to moderate dose statins are strongly recommended by the United States Preventive Services Task Force (USPSTF) for primary prevention of cardiovascular disease in adults aged 40–75 years who are at risk, the Patient Protection and Affordable Care Act (PPACA) in the United States requires most health insurance plans to cover the costs of these drugs without charging the insured patient a copayment or coinsurance, even if he or she has not yet reached his or her annual deductible. Rosuvastatin 5&nbsp;mg and 10&nbsp;mg are examples of regimens meeting the USPSTF guideline; and some only cover other statins.\n\nThe drug was billed as a \"super-statin\" during its clinical development; the claim was that it offered high potency and improved cholesterol reduction compared to rivals in the class. The main competitors to rosuvastatin are atorvastatin and simvastatin. However, people can also combine ezetimibe with either simvastatin or atorvastatin and other agents on their own, for somewhat similar augmented response rates.  some published information for comparing rosuvastatin, atorvastatin, and ezetimibe/simvastatin results are available, but many of the relevant studies are still in progress.\n\nIn 2013, it was the fourth-highest-selling drug in the United States, accounting for approximately $5.2billion in sales. In 2021, it was the thirteenth most commonly prescribed medication in the United States, with more than 32million prescriptions.\n\n===Legal status===\nRosuvastatin is approved in the United States for the treatment of high LDL cholesterol (dyslipidemia), total cholesterol (hypercholesterolemia), and/or triglycerides (hypertriglyceridemia). In February 2010, rosuvastatin was approved by the FDA for the primary prevention of cardiovascular events.\n\n, rosuvastatin had been approved in 154 countries and launched in 56. Approval in the United States by the Foo"},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1744447","maxPhase":"4.0","chirality":1,"parenteral":false,"availability":1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":true},"commercial":{"launchDate":"2003","_launchSource":"DrugCentral (FDA 2003-08-12, IPR)"},"fdaRecalls":[{"date":"20230207","reason":"CGMP Deviations: recalling drug products following an FDA inspection.","status":"Terminated","distribution":"United States including Puerto Rico and Canada","classification":"Class II"},{"date":"20250313","reason":"CGMP Deviations","status":"Ongoing","distribution":"U.S. Nationwide","classification":"Class II"},{"date":"20230207","reason":"CGMP Deviations: recalling drug products following an FDA inspection.","status":"Terminated","distribution":"United States including Puerto Rico and Canada","classification":"Class II"},{"date":"20251231","reason":"Out of specification for dissolution.","status":"Ongoing","distribution":"Nationwide in the USA","classification":"Class II"},{"date":"20230207","reason":"CGMP Deviations: recalling drug products following an FDA inspection.","status":"Terminated","distribution":"United States including Puerto Rico and Canada","classification":"Class II"},{"date":"20230207","reason":"CGMP Deviations: recalling drug products following an FDA inspection.","status":"Terminated","distribution":"United States including Puerto Rico and Canada","classification":"Class II"},{"date":"20230323","reason":"cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.","status":"Ongoing","distribution":"USA Nationwide","classification":"Class II"}],"overdosage":"10 OVERDOSAGE No specific antidotes for rosuvastatin are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. In the event of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.","references":[{"id":1,"url":"https://drugcentral.org/drugcard/2406","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=rosuvastatin","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rosuvastatin","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Rosuvastatin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T01:51:04.612162","_validation":{"fieldsValidated":8,"lastValidatedAt":"2026-04-20T08:27:54.543007+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"sitagliptin","drugSlug":"sitagliptin","fdaApproval":"2006-10-16","patentExpiry":"Feb 25, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"saxagliptin","drugSlug":"saxagliptin","fdaApproval":"2009-07-31","patentExpiry":"Nov 30, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"alogliptin","drugSlug":"alogliptin","fdaApproval":"2013-01-25","patentExpiry":"Jun 27, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"linagliptin","drugSlug":"linagliptin","fdaApproval":"2011-05-02","patentExpiry":"Sep 5, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"simvastatin","drugSlug":"simvastatin","fdaApproval":"1991-12-23","patentExpiry":"Feb 23, 2030","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"rosuvastatin","howSupplied":"16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets are supplied as: Strength How Supplied NDC Tablet Description 5 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-359-30 69367-359-09 69367-359-01 69367-359-05 69367-359-10 Yellow colored, round, biconvex film coated tablets, debossed with \"RS\" on one side and plain on the other side. 10 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-360-30 69367-360-09 69367-360-01 69367-360-05 69367-360-10 Pink colored, round, biconvex film coated tablets, debossed with \"RS1\" on one side and plain on the other side. 20 mg bottles of 30, 90, 100, 500 and 1000 tablets 69367-361-30 69367-361-09 69367-361-01 69367-361-05 69367-361-10 Pink colored, round, biconvex film coated tablets, debossed with \"RS2\" on one side and plain on the other side. 40 mg bottles of 30, 90, 100 and 500 tablets 69367-362-30 69367-362-09 69367-362-01 69367-362-05 Pink colored, oval, biconvex film coated tablets, debossed with \"RS3\" on one side and plain on the other side. Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.","indications":{"approved":[{"name":"Arteriosclerotic vascular disease","source":"DrugCentral","snomedId":72092001,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":523000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet, 2023"},{"name":"Cerebrovascular accident","source":"DrugCentral","snomedId":230690007,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":101000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Familial hypercholesterolemia - heterozygous","source":"DrugCentral","snomedId":238079002,"regulator":"FDA","eligibility":null,"usPrevalence":86000000,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO Global Health Estimates, 2023"},{"name":"Familial hypercholesterolemia - homozygous","source":"DrugCentral","snomedId":238078005,"regulator":"FDA","eligibility":"adult patients with homozygous familial hypercholesterolemia","usPrevalence":86000000,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO Global Health Estimates, 2023"},{"name":"Familial type 3 hyperlipoproteinemia","source":"DrugCentral","snomedId":398796005,"regulator":"FDA","eligibility":"adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia)","usPrevalence":null,"globalPrevalence":4000000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet, 2023"},{"name":"Hypercholesterolemia","source":"DrugCentral","snomedId":13644009,"regulator":"FDA","eligibility":null,"usPrevalence":86000000,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO Global Health Estimates, 2023"},{"name":"Hypertriglyceridemia","source":"DrugCentral","snomedId":302870006,"regulator":"FDA","eligibility":"adult patients with hypertriglyceridemia","globalPrevalence":1680000000,"prevalenceMethod":"ai-extracted","prevalenceSource":"J Health Popul Nutr, 2025 (PMID:40859400)"},{"name":"Mixed hyperlipidemia","source":"DrugCentral","snomedId":267434003,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":390000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Myocardial Infarction Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":523000000,"prevalenceMethod":"curated","prevalenceSource":"WHO CVD Factsheet, 2023"},{"name":"Prevention of Transient Ischemic Attacks","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Primary Prevention of Coronary Heart Disease","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_fixedFields":["primaryTarget"],"currentOwner":"Astrazeneca","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"sitagliptin","brandName":"sitagliptin","genericName":"sitagliptin","approvalYear":"2006","relationship":"same-class"},{"drugId":"saxagliptin","brandName":"saxagliptin","genericName":"saxagliptin","approvalYear":"2009","relationship":"same-class"},{"drugId":"alogliptin","brandName":"alogliptin","genericName":"alogliptin","approvalYear":"2013","relationship":"same-class"},{"drugId":"linagliptin","brandName":"linagliptin","genericName":"linagliptin","approvalYear":"2011","relationship":"same-class"},{"drugId":"simvastatin","brandName":"simvastatin","genericName":"simvastatin","approvalYear":"1991","relationship":"same-class"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Capsule, Tablet","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"EZALLOR SPRINKLE"},{"form":"TABLET","route":"ORAL","productName":"ROSUVASTATIN"},{"form":"TABLET","route":"ORAL","productName":"ROSUVASTATIN CALCIUM"},{"form":"TABLET","route":"ORAL","productName":"Rosuvastatin Calcium"},{"form":"TABLET","route":"ORAL","productName":"ROSZET"},{"form":"TABLET","route":"ORAL","productName":"ROSUVASTATIN AND EZETIMIBE"},{"form":"TABLET, COATED","route":"ORAL","productName":"Rosuvastatin Calcium"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"ROSUVASTATIN"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"ROSUVASTATIN CALCIUM"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Rosuvastatin"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Rosuvastatin Calcium"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Rosuvastatin calcium"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"CRESTOR"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Crestor"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000148821","MMSL":"107656","NDDF":"009902","UNII":"413KH5ZJ73","VUID":"4021405","CHEBI":"CHEBI:38545","VANDF":"4021405","INN_ID":"8021","RXNORM":"301542","UMLSCUI":"C0965129","chemblId":"CHEMBL1744447","ChEMBL_ID":"CHEMBL1496","KEGG_DRUG":"D01915","DRUGBANK_ID":"DB01098","PDB_CHEM_ID":" FBI","PUBCHEM_CID":"446157","SNOMEDCT_US":"1217216007","IUPHAR_LIGAND_ID":"2954","SECONDARY_CAS_RN":"147098-20-2","MESH_DESCRIPTOR_UI":"D000068718"},"drugDescription":{"pH":"2.20 at pH of 7.3 (partition coefficient octanol/water)","structure":"bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt","appearance":"white or almost white, hygroscopic powder","composition":"Rosuvastatin for oral use contains rosuvastatin 5 mg, 10 mg, 20 mg or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: anhydrous lactose, lactose monohydrate, anhydrous dibasic calcium phosphate, microcrystalline cellulose (101, 102), crospovidone, magnesium stearate, hypromellose 2910, titanium dioxide, triacetin, D&C yellow #10 aluminium lake, FD&C red #40/allura red AC aluminium lake, FD&C blue #2/indigo carmine aluminium lake, FD&C yellow #6/sunset yellow FCF aluminium lake.","molecularWeight":"1,001.14","molecularFormula":"(C22H27FN3O6S)2Ca"},"formularyStatus":[],"_enricherVersion":"v2","chemblMechanisms":[{"actionType":"INHIBITOR","targetChemblId":"CHEMBL402","mechanismComment":null,"mechanismOfAction":"HMG-CoA reductase inhibitor"}],"developmentCodes":[],"ownershipHistory":[{"period":"2003-","companyName":"Ipr","relationship":"Original Developer"},{"period":"present","companyName":"Astrazeneca","relationship":"Current Owner"},{"period":"2005","companyName":"AstraZeneca K.K.","relationship":"PMDA Licensee"}],"pharmacokinetics":{"tmax":"3 to 5 hours following oral dosing","halfLife":"approximately 19 hours","clearance":"After intravenous dose: approximately 28% via renal route, 72% via hepatic route","excretion":"Rosuvastatin and metabolites primarily excreted in feces (90%)","metabolism":"Not extensively metabolized; approximately 10% of radiolabeled dose recovered as metabolite. 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8"}],"rxnormFormulations":[{"tty":"SBD","name":"rosuvastatin 10 MG Oral Capsule [Ezallor]","rxcui":"2167563","synonym":"Ezallor 10 MG Oral Capsule"},{"tty":"SBD","name":"rosuvastatin 20 MG Oral Capsule [Ezallor]","rxcui":"2167567","synonym":"Ezallor 20 MG Oral Capsule"},{"tty":"SBD","name":"rosuvastatin 40 MG Oral Capsule [Ezallor]","rxcui":"2167571","synonym":"Ezallor 40 MG Oral Capsule"},{"tty":"SBD","name":"rosuvastatin 5 MG Oral Capsule [Ezallor]","rxcui":"2167575","synonym":"Ezallor 5 MG Oral Capsule"},{"tty":"SBD","name":"ezetimibe 10 MG / rosuvastatin 10 MG Oral Tablet [Roszet]","rxcui":"2536060","synonym":"Roszet (ezetimibe 10 MG / rosuvastatin 10 MG) Oral Tablet"},{"tty":"SBD","name":"ezetimibe 10 MG / rosuvastatin 20 MG Oral Tablet [Roszet]","rxcui":"2536062","synonym":"Roszet (ezetimibe 10 MG / rosuvastatin 20 MG) Oral Tablet"},{"tty":"SBD","name":"ezetimibe 10 MG / rosuvastatin 40 MG Oral Tablet [Roszet]","rxcui":"2536064","synonym":"Roszet (ezetimibe 10 MG / rosuvastatin 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(as rosuvastatin calcium 10.4 MG) Oral Tablet"},{"tty":"SCD","name":"rosuvastatin calcium 40 MG Oral Tablet","rxcui":"859419","synonym":""},{"tty":"SCD","name":"rosuvastatin calcium 5 MG Oral Tablet","rxcui":"859424","synonym":""},{"tty":"SCD","name":"rosuvastatin calcium 10 MG Oral Tablet","rxcui":"859747","synonym":""},{"tty":"SCD","name":"rosuvastatin calcium 20 MG Oral Tablet","rxcui":"859751","synonym":""}],"storageAndHandling":"","participantFlowData":[],"companionDiagnostics":[{"biomarker":"high-sensitivity C-reactive protein (hsCRP)","requirement":"required","diagnosticId":"cdx-0","diagnosticName":"FDA-approved test"}],"faersSexDistribution":[{"term":2,"count":107207},{"term":1,"count":94864},{"term":0,"count":764}],"genericManufacturers":29,"_genericFilersChecked":true,"nonclinicalToxicology":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in rats at dose levels of 2, 20, 60, or 80 mg/kg/day by oral gavage, the incidence of uterine stromal polyps was significantly increased in females at 80 mg/kg/day at systemic exposure 20 times the human exposure at 40 mg/day based on AUC. Increased incidence of polyps was not seen at lower doses. In a 107-week carcinogenicity study in mice given 10, 60, or 200 mg/kg/day by oral gavage, an increased incidence of hepatocellular adenoma/carcinoma was observed at 200 mg/kg/day at systemic exposures 20 times the human exposure at 40 mg/day based on AUC. An increased incidence of hepatocellular tumors was not seen at lower doses. Rosuvastatin was not mutagenic or clastogenic with or without metabolic activation in the Ames test with Salmonella typhimurium and Escherichia coli , the mouse lymphoma assay, and the chromosomal aberration assay in Chinese hamster lung cells. Rosuvastatin was negative in the in vivo mouse micronucleus test. In rat fertility studies with oral gavage doses of 5, 15, 50 mg/kg/day, males were treated for 9 weeks prior to and throughout mating and females were treated 2 weeks prior to mating and throughout mating until gestation day 7. No adverse effect on fertility was observed at 50 mg/kg/day (systemic exposures up to 10 times the human exposure at 40 mg/day based on AUC). In testicles of dogs treated with rosuvastatin at 30 mg/kg/day for one month, spermatidic giant cells were seen. Spermatidic giant cells were observed in monkeys after 6‑month treatment at 30 mg/kg/day in addition to vacuolation of seminiferous tubular epithelium. Exposures in the dog were 20 times and in the monkey 10 times the human exposure at 40 mg/day based on body surface area. Similar findings have been seen with other drugs in this class.\n13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in rats at dose level","structuredTrialResults":[{"hr":"1.02","nctId":"NCT04481789","phase":"PHASE1","pValue":"","ciLower":"0.97","ciUpper":"1.08","endpoint":"Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Rosuvastatin, Sildenafil and Furosemide.","enrollment":84},{"hr":"118.49","nctId":"NCT05064488","phase":"PHASE1","pValue":"","ciLower":"111.89","ciUpper":"125.47","endpoint":"Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Digoxin","enrollment":40},{"hr":"133.98","nctId":"NCT06504862","phase":"PHASE1","pValue":"","ciLower":"105.52","ciUpper":"170.11","endpoint":"Part 1: Area Under the Concentration-time Curve of Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","enrollment":32},{"hr":"127.2","nctId":"NCT05741372","phase":"NA","pValue":"","ciLower":"85.4","ciUpper":"189.6","endpoint":"Area Under the Concentration Time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24)","enrollment":28}],"genericManufacturerList":["Accord Hlthcare","Alkem Labs Ltd","Amneal Pharms Co","Apotex","Aurobindo Pharma Ltd","Biocon Pharma","Cadila Pharms Ltd","Changzhou Pharm","Chartwell Rx","Glenmark Speclt","Hetero Labs Ltd V","Inventia","Lupin","Macleods Pharms Ltd","Mankind Pharma","Msn","Renata","Sandoz","Sciegen Pharms","Shandong","Strides Pharma","Sun Pharm","Sunshine","Teva Pharms Usa","Torrent","Umedica","Watson Labs Inc","Zhejiang Jingxin","Zhejiang Yongtai"],"faersSeriousnessBreakdown":[{"term":1,"count":149258},{"term":2,"count":69196}],"status":"active","companyName":"Astrazeneca","companyId":"astrazeneca","modality":"Small molecule","firstApprovalDate":"2003","enrichmentLevel":5,"visitCount":10,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":66,"withResults":9},"validation":{"fieldsValidated":8,"lastValidatedAt":"2026-04-20T08:27:54.543007+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}