{"id":"caduet","rwe":[],"_fda":{"id":"63bc4df8-5e26-45dd-8a05-78ee94553129","set_id":"003dd1ec-16f8-4f96-b6a8-c4689d35892a","openfda":{"unii":["864V2Q084H"],"route":["ORAL"],"rxcui":["197361","308135","308136"],"spl_id":["63bc4df8-5e26-45dd-8a05-78ee94553129"],"brand_name":["Amlodipine Besylate"],"spl_set_id":["003dd1ec-16f8-4f96-b6a8-c4689d35892a"],"package_ndc":["68180-750-09","68180-751-09","68180-751-03","68180-751-17","68180-752-09","68180-752-03","68180-719-03","68180-719-09","68180-720-09","68180-720-03","68180-721-03","68180-721-09","68180-233-01","68180-233-02","68180-455-02","68180-455-01"],"product_ndc":["68180-233","68180-750","68180-751","68180-752","68180-719","68180-720","68180-721","68180-455"],"generic_name":["AMLODIPINE BESYLATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["AMLODIPINE BESYLATE"],"manufacturer_name":["Lupin Pharmaceuticals, Inc."],"application_number":["ANDA078043"],"is_original_packager":[true]},"version":"28","pregnancy":["8.1 Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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. Clinical Considerations: Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Data: Animal Data No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the MRHD based on body surface area, respectively) during their respective periods of major organogenesis. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold)in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose."],"overdosage":["10 OVERDOSAGE Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit."],"description":["11 DESCRIPTION Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S, and its structural formula is: Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as tablets equivalent to 2.5 mg, 5 mg and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dicalcium phosphate anhydrous, FD & C red no. 40 aluminum lake (only for 2.5 mg strength), magnesium stearate, microcrystalline cellulose and povidone. Amlodipine besylate tablets USP meet USP Dissolution Test 2. Amlodipine Besylate"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets Amlodipine Besylate Tablets USP, 2.5 mg – (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as Pink color mottled, round, flat-faced, beveled edged tablets debossed with \"1\" on one side and \"U\" on the other side and supplied as follows: NDC 68180-233-01 Bottles of 90 NDC 68180-233-02 Bottles of 1000 5 mg Tablets Amlodipine Besylate Tablets USP, 5 mg – (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are supplied as White to off white capsule shaped tablets debossed with \"2\" on one side and \"U\" on the other side and supplied as follows: NDC 68180-455-01 Bottles of 90 NDC 68180-455-02 Bottles of 1000 10 mg Tablets Amlodipine Besylate Tablets USP, 10 mg – (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are supplied as White to off white round, flat faced, beveled edged tablet debossed with \"L\" on one side and \"32\" on the other side and supplied as follows: NDC 68180-721-09 Bottles of 90 NDC 68180-721-03 Bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispense in tight, light-resistant containers (USP). Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States MADE IN INDIA. Revised: December 2024"],"geriatric_use":["8.5 Geriatric Use Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40 to 60%, and a lower initial dose may be required [see DOSAGE AND ADMINISTRATION (2.1) ] ."],"pediatric_use":["8.4 Pediatric Use Amlodipine besylate (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see CLINICAL STUDIES ( 14.1 )]. Effect of Amlodipine besylate on blood pressure in patients less than 6 years of age is not known."],"effective_time":"20251014","clinical_studies":["14 CLINICAL STUDIES 14.1 Effects in Hypertension Adult Patients The antihypertensive efficacy of amlodipine has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect. Tolerance was not demonstrated in patients studied for up to 1 year. The 3 parallel, fixed dose, dose response studies showed that the reduction in supine and standing blood pressures was dose-related within the recommended dosing range. Effects on diastolic pressure were similar in young and older patients. The effect on systolic pressure was greater in older patients, perhaps because of greater baseline systolic pressure. Effects were similar in black patients and in white patients. Pediatric Patients Two hundred sixty-eight hypertensive patients aged 6 to 17 years were randomized first to amlodipine 2.5 or 5 mg once daily for 4 weeks and then randomized again to the same dose or to placebo for another 4 weeks. Patients receiving 2.5 mg or 5 mg at the end of 8 weeks had significantly lower systolic blood pressure than those secondarily randomized to placebo. The magnitude of the treatment effect is difficult to interpret, but it is probably less than 5 mmHg systolic on the 5 mg dose and 3.3 mmHg systolic on the 2.5 mg dose. Adverse events were similar to those seen in adults. 14.2 Effects in Chronic Stable Angina The effectiveness of 5 to 10 mg/day of amlodipine in exercise-induced angina has been evaluated in 8 placebo-controlled, double-blind clinical trials of up to 6 weeks duration involving 1038 patients (684 amlodipine, 354 placebo) with chronic stable angina. In 5 of the 8 studies, significant increases in exercise time (bicycle or treadmill) were seen with the 10 mg dose. Increases in symptom-limited exercise time averaged 12.8% (63 sec) for amlodipine 10 mg, and averaged 7.9% (38 sec) for amlodipine 5 mg. Amlodipine 10 mg also increased time to 1 mm ST segment deviation in several studies and decreased angina attack rate. The sustained efficacy of amlodipine in angina patients has been demonstrated over long-term dosing. In patients with angina, there were no clinically significant reductions in blood pressures (4/1 mmHg) or changes in heart rate (+0.3 bpm). 14.3 Effects in Vasospastic Angina In a double-blind, placebo-controlled clinical trial of 4 weeks duration in 50 patients, amlodipine therapy decreased attacks by approximately 4/week compared with a placebo decrease of approximately 1/week (p<0.01). Two of 23 amlodipine and 7 of 27 placebo patients discontinued from the study due to lack of clinical improvement. 14.4 Effects in Documented Coronary Artery Disease In PREVENT, 825 patients with angiographically documented coronary artery disease were randomized to amlodipine (5 to 10 mg once daily) or placebo and followed for 3 years. Although the study did not show significance on the primary objective of change in coronary luminal diameter as assessed by quantitative coronary angiography, the data suggested a favorable outcome with respect to fewer hospitalizations for angina and revascularization procedures in patients with CAD. CAMELOT enrolled 1318 patients with CAD recently documented by angiography, without left main coronary disease and without heart failure or an ejection fraction <40%. Patients (76% males, 89% Caucasian, 93% enrolled at US sites, 89% with a history of angina, 52% without PCI, 4% with PCI and no stent, and 44% with a stent) were randomized to double-blind treatment with either amlodipine (5 to 10 mg once daily) or placebo in addition to standard care that included aspirin (89%), statins (83%), beta-blockers (74%), nitroglycerin (50%), anti-coagulants (40%), and diuretics (32%), but excluded other calcium channel blockers. The mean duration of follow-up was 19 months. The primary endpoint was the time to first occurrence of one of the following events: hospitalization for angina pectoris, coronary revascularization, myocardial infarction, cardiovascular death, resuscitated cardiac arrest, hospitalization for heart failure, stroke/TIA, or peripheral vascular disease. A total of 110 (16.6%) and 151 (23.1%) first events occurred in the amlodipine and placebo groups, respectively, for a hazard ratio of 0.691 (95% CI: 0.540 to 0.884, p = 0.003). The primary endpoint is summarized in Figure 1 below. The outcome of this study was largely derived from the prevention of hospitalizations for angina and the prevention of revascularization procedures (see Table 1). Effects in various subgroups are shown in Figure 2. In an angiographic substudy (n=274) conducted within CAMELOT, there was no significant difference between amlodipine and placebo on the change of atheroma volume in the coronary artery as assessed by intravascular ultrasound. Figure 1 - Kaplan-Meier Analysis of Composite Clinical Outcomes for Amlodipine versus Placebo Figure 2 - Effects on Primary Endpoint of Amlodipine versus Placebo across Sub-Groups Table 1 below summarizes the significant composite endpoint and clinical outcomes from the composites of the primary endpoint. The other components of the primary endpoint including cardiovascular death, resuscitated cardiac arrest, myocardial infarction, hospitalization for heart failure, stroke/TIA, or peripheral vascular disease did not demonstrate a significant difference between amlodipine and placebo. Table 1. Incidence of Significant Clinical Outcomes for CAMELOT Clinical Outcomes N (%) Amlodipine ( N = 663 ) Placebo ( N = 655 ) Risk Reduction ( p - value ) Composite CV Endpoint 110 ( 16 . 6 ) 151 ( 23 . 1 ) 31 % ( 0 . 003 ) Hospitalization for Angina Total patients with these events 51 (7.7) 84 (12.8) 42% (0.002) Coronary Revascularization 78 (11.8) 103 (15.7) 27% (0.033) 14.5 Studies in Patients with Heart Failure Amlodipine has been compared to placebo in four 8 to 12 week studies of patients with NYHA Class II/III heart failure, involving a total of 697 patients. In these studies, there was no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or left ventricular ejection fraction. In a long-term (follow-up at least 6 months, mean 13.8 months) placebo- controlled mortality/morbidity study of amlodipine 5 to 10 mg in 1153 patients with NYHA Classes III (n=931) or IV (n=222) heart failure on stable doses of diuretics, digoxin, and ACE inhibitors, amlodipine had no effect on the primary endpoint of the study which was the combined endpoint of all-cause mortality and cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure), or on NYHA classification, or symptoms of heart failure. Total combined all-cause mortality and cardiac morbidity events were 222/571 (39%) for patients on amlodipine and 246/583 (42%) for patients on placebo; the cardiac morbid events represented about 25% of the endpoints in the study. Another study (PRAISE-2) randomized patients with NYHA Class III (80%) or IV (20%) heart failure without clinical symptoms or objective evidence of underlying ischemic disease, on stable doses of ACE inhibitors (99%), digitalis (99%), and diuretics (99%), to placebo (n=827) or amlodipine (n=827) and followed them for a mean of 33 months. There was no statistically significant difference between amlodipine and placebo in the primary endpoint of all-cause mortality (95% confidence limits from 8% reduction to 29% increase on amlodipine). With amlodipine there were more reports of pulmonary edema. Figure 1 - Kaplan-Meier Analysis of Composite Clinical Outcomes for Amlodipine versus Placebo Figure 2 - Effects on Primary Endpoint of Amlodipine versus Placebo across Sub-Groups"],"pharmacodynamics":["12.2 Pharmacodynamics Hemodynamics Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina. With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with amlodipine is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure 105 to 114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90 to 104 mmHg). Normotensive subjects experienced no clinically significant change in blood pressures (+1/–2 mmHg). In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria. As with other calcium channel blockers, hemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume. In hemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and man, even when co-administered with beta-blockers to man. Similar findings, however, have been observed in normal or well-compensated patients with heart failure with agents possessing significant negative inotropic effects. Electrophysiologic Effects Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or man. In patients with chronic stable angina, intravenous administration of 10 mg did not significantly alter A-H and H-V conduction and sinus node recovery time after pacing. Similar results were obtained in patients receiving amlodipine and concomitant beta-blockers. In clinical studies in which amlodipine was administered in combination with beta-blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed. In clinical trials with angina patients alone, amlodipine therapy did not alter electrocardiographic intervals or produce higher degrees of AV blocks. Drug interactions Sildenafil : When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect [see DRUG INTERACTIONS ( 7.1 )] ."],"adverse_reactions":["6 ADVERSE REACTIONS Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or www.lupinpharmaceuticals.com 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 practice. Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows: Amlodipine Placebo 2 . 5 mg N = 275 5 mg N = 296 10 mg N = 268 N = 520 Edema 1.8 3.0 10.8 0.6 Dizziness 1.1 3.4 3.4 1.5 Flushing 0.7 1.4 2.6 0.0 Palpitation 0.7 1.4 4.5 0.6 Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following: Amlodipine (%) (N=1730) Placebo (%) (N=1250) Fatigue 4.5 2.8 Nausea 2.9 1.9 Abdominal Pain 1.6 0.3 Somnolence 1.4 0.6 For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table: Amlodipine Placebo Male =% ( N = 1218 ) Female =% ( N = 512 ) Male =% ( N = 914 ) Female =% ( N = 336 ) Edema 5.6 14.6 1.4 5.1 Flushing 1.5 4.5 0.3 0.9 Palpitations 1.4 3.3 0.9 0.9 Somnolence 1.3 1.6 0.8 0.3 The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis. Central and Peripheral Nervous System hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. Gastrointestinal anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. General allergic reaction, asthenia, 1 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease. Musculoskeletal System arthralgia, arthrosis, muscle cramps, 1 myalgia. Psychiatric sexual dysfunction (male 1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization. Respiratory System dyspnea, 1 epistaxis. Skin and Appendages angioedema, erythema multiforme, pruritus, 1 rash, 1 rash erythematous, rash maculopapular. Special Senses abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus. Urinary System micturition frequency, micturition disorder, nocturia. Autonomic Nervous System dry mouth, sweating increased. Metabolic and Nutritional hyperglycemia, thirst. Hemopoietic leukopenia, purpura, thrombocytopenia. 1 These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies. Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine. In the CAMELOT and PREVENT studies [see CLINICAL STUDIES (14.4) ] , the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema. 6.2 Postmarketing Experience 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. The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine. Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles."],"contraindications":["4 CONTRAINDICATIONS Known sensitivity to amlodipine ( 4 ) Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine."],"drug_interactions":["7 DRUG INTERACTIONS Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see CLINICAL PHARMACOLOGY ( 12.3 )] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see CLINICAL PHARMACOLOGY ( 12.2 )] . 7.2 Impact of Amlodipine on Other Drugs Simvastatin Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see CLINICAL PHARMACOLOGY ( 12.3 )] . Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see CLINICAL PHARMACOLOGY ( 12.3 )] ."],"mechanism_of_action":["12.1 Mechanism of Action Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following: Exertional Angina In patients with exertional angina, amlodipine reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise. Vasospastic Angina Amlodipine has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro . This inhibition of coronary spasm is responsible for the effectiveness of amlodipine in vasospastic (Prinzmetal's or variant) angina."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following: Exertional Angina In patients with exertional angina, amlodipine reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise. Vasospastic Angina Amlodipine has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro . This inhibition of coronary spasm is responsible for the effectiveness of amlodipine in vasospastic (Prinzmetal's or variant) angina. 12.2 Pharmacodynamics Hemodynamics Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina. With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with amlodipine is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure 105 to 114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90 to 104 mmHg). Normotensive subjects experienced no clinically significant change in blood pressures (+1/–2 mmHg). In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria. As with other calcium channel blockers, hemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume. In hemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and man, even when co-administered with beta-blockers to man. Similar findings, however, have been observed in normal or well-compensated patients with heart failure with agents possessing significant negative inotropic effects. Electrophysiologic Effects Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or man. In patients with chronic stable angina, intravenous administration of 10 mg did not significantly alter A-H and H-V conduction and sinus node recovery time after pacing. Similar results were obtained in patients receiving amlodipine and concomitant beta-blockers. In clinical studies in which amlodipine was administered in combination with beta-blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed. In clinical trials with angina patients alone, amlodipine therapy did not alter electrocardiographic intervals or produce higher degrees of AV blocks. Drug interactions Sildenafil : When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect [see DRUG INTERACTIONS ( 7.1 )] . 12.3 Pharmacokinetics After oral administration of therapeutic doses of amlodipine, absorption produces peak plasma concentrations between 6 and 12 hours. Absolute bioavailability has been estimated to be between 64 and 90%. The bioavailability of amlodipine is not altered by the presence of food. Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine. Ex vivo studies have shown that approximately 93% of the circulating drug is bound to plasma proteins in hypertensive patients. Elimination from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours. Steady-state plasma levels of amlodipine are reached after 7 to 8 days of consecutive daily dosing. The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. Patients with renal failure may therefore receive the usual initial dose. Elderly patients and patients with hepatic insufficiency have decreased clearance of amlodipine with a resulting increase in AUC of approximately 40 to 60%, and a lower initial dose may be required. A similar increase in AUC was observed in patients with moderate to severe heart failure. Drug interactions In vitro data indicate that amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin. Impact of other drugs on amlodipine: Co-administered cimetidine, magnesium-and aluminum hydroxide antacids, sildenafil, and grapefruit juice have no impact on the exposure to amlodipine. CYP3A inhibitors Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure. However, strong inhibitors of CYP3A (e.g., itraconazole, clarithromycin) may increase the plasma concentrations of amlodipine to a greater extent [see DRUG INTERACTIONS ( 7.1 )] . Impact of amlodipine on other drugs: Amlodipine is a weak inhibitor of CYP3A and may increase exposure to CYP3A substrates. Co-administered amlodipine does not affect the exposure to atorvastatin, digoxin, ethanol and the warfarin prothrombin response time. Simvastatin Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone [see DRUG INTERACTIONS ( 7.2 )] . Cyclosporine A prospective study in renal transplant patients (N=11) showed on an average of 40% increase in trough cyclosporine levels when concomitantly treated with amlodipine [see DRUG INTERACTIONS ( 7.2 )] . Tacrolimus A prospective study in healthy Chinese volunteers (N=9) with CYP3A5 expressers showed a 2.5-to 4-fold increase in tacrolimus exposure when concomitantly administered with amlodipine compared to tacrolimus alone. This finding was not observed in CYP3A5 non-expressers (N= 6). However, a 3-fold increase in plasma exposure to tacrolimus in a renal transplant patient (CYP3A5 non-expresser) upon initiation of amlodipine for the treatment of post-transplant hypertension resulting in reduction of tacrolimus dose has been reported. Irrespective of the CYP3A5 genotype status, the possibility of an interaction cannot be excluded with these drugs [see DRUG INTERACTIONS ( 7.2 )] . 12.4 Pediatric Patients Sixty-two hypertensive patients aged 6 to 17 years received doses of amlodipine between 1.25 mg and 20 mg. Weight-adjusted clearance and volume of distribution were similar to values in adults."],"indications_and_usage":["1 INDICATIONS AND USAGE Amlodipine besylate tablets are calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: •Hypertension ( 1.1 ) о Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. •Coronary Artery Disease ( 1.2 ) о Chronic Stable Angina о Vasospastic Angina (Prinzmetal's or Variant Angina) о Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents. 1.2 Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. 5.3 Patients with Hepatic Failure Because amlodipine besylate is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine besylate to patients with severe hepatic impairment."],"clinical_studies_table":["
Table 1. Incidence of Significant Clinical Outcomes for CAMELOT
Clinical Outcomes N (%) Amlodipine (N=663) Placebo (N=655) Risk Reduction (p-value)
Composite CV Endpoint 110 (16.6) 151 (23.1) 31% (0.003)
Hospitalization for AnginaTotal patients with these events 51 (7.7) 84 (12.8) 42% (0.002)
Coronary Revascularization 78 (11.8) 103 (15.7) 27% (0.033)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m 2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. 3 For the rat, the highest dose was, on a mg/m 2 basis, about twice the maximum recommended human dose. 3 Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose 3 of 10 mg/day on a mg/m 2 basis). 3 Based on patient weight of 50 kg"],"adverse_reactions_table":["
Amlodipine Placebo
2.5 mg N=275 5 mg N=296 10 mg N=268 N=520
Edema 1.8 3.0 10.8 0.6
Dizziness 1.1 3.4 3.4 1.5
Flushing 0.7 1.4 2.6 0.0
Palpitation 0.7 1.4 4.5 0.6
","
Amlodipine (%) (N=1730) Placebo (%) (N=1250)
Fatigue 4.5 2.8
Nausea 2.9 1.9
Abdominal Pain 1.6 0.3
Somnolence 1.4 0.6
","
Amlodipine Placebo
Male=% (N=1218) Female=% (N=512) Male=% (N=914) Female=% (N=336)
Edema 5.6 14.6 1.4 5.1
Flushing 1.5 4.5 0.3 0.9
Palpitations 1.4 3.3 0.9 0.9
Somnolence 1.3 1.6 0.8 0.3
"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION •Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ( 2.1 ) о Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) •Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation : Doses in excess of 5 mg daily have not been studied in pediatric patients. ( 2.2 ) 2.1 Adults The usual initial antihypertensive oral dose of amlodipine besylate tablet is 5 mg once daily and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablet to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect. Coronary artery disease The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [see CLINICAL STUDIES (14.4) ] . 2.2 Children The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see CLINICAL PHARMACOLOGY (12.4) , CLINICAL STUDIES (14.1) ] ."],"spl_product_data_elements":["Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE White to off white Diamond LU;H11 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE White to off white Elongated octagon LU;H12 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE White to off white Round LU;H13 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE FD&C RED NO. 40 MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE pink color mottled Flat-faced, beveled edged L;28 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE White to off white L;29 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE White to off white Flat faced, beveled edged L;32 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE FD&C RED NO. 40 MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE pink color mottled Flat-faced, beveled edged 1;U Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE White to off white 2;U"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Tablets: 2.5 mg, 5 mg, and 10 mg ( 3 ) Tablets: 2.5 mg Pink color mottled, round, flat-faced, beveled edged tablets debossed with \"1\" on one side and \"U\" on the other side. Tablets: 5 mg White to off white capsule shaped tablets debossed with \"2\" on one side and \"U\" on the other side. Tablets: 10 mg White to off white round, flat faced, beveled edged tablet debossed with \"L\" on one side and \"32\" on the other side."],"spl_patient_package_insert":["Amlodipine Besylate (am-LOE-di-peen BES-i-late) Tablets USP Rx Only Read this information carefully before you start taking amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about amlodipine besylate tablets , ask your doctor. Your doctor will know if an amlodipine besylate tablet is right for you. What is Amlodipine Besylate Tablet? Amlodipine besylate tablet is a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions. High Blood Pressure (hypertension) High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine besylate tablet relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack. Angina Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Amlodipine besylate tablets can relieve this pain. Who should not use Amlodipine Besylate Tablets? Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine besylate tablets ), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients. What should I tell my doctor before taking Amlodipine Besylate Tablets? Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Tell your doctor if you: ever had heart disease ever had liver problems are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablet is the best treatment for you. are breast-feeding. Amlodipine besylate tablet passes into your milk. How should I take Amlodipine Besylate Tablets? Take amlodipine besylate tablet once a day, with or without food. It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time. If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. Other medicines : You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine besylate tablets . While you are taking amlodipine besylate tablets , do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor. If you took too much amlodipine besylate tablets , call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away. What should I avoid while taking Amlodipine Besylate Tablets? Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first. What are the possible side effects of Amlodipine Besylate Tablets? Amlodipine besylate tablets may cause the following side effects. Most side effects are mild or moderate: swelling of your legs or ankles tiredness, extreme sleepiness stomach pain, nausea dizziness flushing (hot or warm feeling in your face) arrhythmia (irregular heartbeat) heart palpitations (very fast heartbeat) muscle rigidity, tremor and/or abnormal muscle movement It is rare, but when you first start taking amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room. Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of amlodipine besylate tablets . For a complete list, ask your doctor or pharmacist. To report side effects, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch How do I store Amlodipine Besylate Tablets? Keep amlodipine besylate tablets away from children. Store amlodipine besylate tablets at 20° to 25°C (68° to 77°F). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets in a dry place. General advice about Amlodipine Besylate Tablets Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine besylate tablets the way your doctor told you to. Do not give amlodipine besylate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about amlodipine besylate tablets , or you can visit the Lupin website at www.lupinpharmaceuticals.com or call 1-800-399-2561. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States MADE IN INDIA. Revised: December 2024 ID#: 278909 Image"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Pediatric: Effect on patients less than 6 years old is not known. ( 8.4 ) Geriatric: Start dosing at the low end of the dose range. ( 8.5 ) 8.1 Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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. Clinical Considerations: Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Data: Animal Data No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the MRHD based on body surface area, respectively) during their respective periods of major organogenesis. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold)in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose. 8.2 Lactation Risk Summary Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of amlodipine on the breastfed infant have been observed. There is no available information on the effects of amlodipine on milk production. 8.4 Pediatric Use Amlodipine besylate (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see CLINICAL STUDIES ( 14.1 )]. Effect of Amlodipine besylate on blood pressure in patients less than 6 years of age is not known. 8.5 Geriatric Use Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40 to 60%, and a lower initial dose may be required [see DOSAGE AND ADMINISTRATION (2.1) ] ."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL AMLODIPINE BESYLATE TABLETS USP Rx only 2.5 mg NDC 68180-750-09 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 2.5 mg NDC 68180-719-09 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 2.5 mg NDC 68180-233-01 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 2.5 mg NDC 68180-233-01 (With New Strength Bar Color) 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 5 mg NDC 68180-751-09 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 5 mg NDC 68180-720-09 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 5 mg NDC 68180-455-01 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 5 mg NDC 68180-455-01 (With New Strength Bar Color) 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 10 mg NDC 68180-752-09 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 10 mg NDC 68180-721-09 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx only 2.5 mg NDC 68180-750-09 90 Tablets Image05 AMLODIPINE BESYLATE TABLETS USP Rx only 2.5 mg NDC 68180-233-01 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx only 2.5 mg NDC 68180-233-01 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 5 mg NDC 68180-751-09 90 Tablets image-06 AMLODIPINE BESYLATE TABLETS USP Rx Only 5 mg NDC 68180-455-01 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 5 mg NDC 68180-455-01 90 Tablets AMLODIPINE BESYLATE TABLETS USP Rx Only 10 mg NDC 68180-752-09 90 Tablets image-07"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m 2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. 3 For the rat, the highest dose was, on a mg/m 2 basis, about twice the maximum recommended human dose. 3 Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose 3 of 10 mg/day on a mg/m 2 basis). 3 Based on patient weight of 50 kg"]},"tags":[],"fdaNDC":[{"route":["ORAL"],"labeler":"Bryant Ranch Prepack","brandName":"olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide","packaging":[{"ndc":"63629-2238-1","description":"30 TABLET, FILM COATED in 1 BOTTLE (63629-2238-1)","marketingStartDate":"20161026"}],"dosageForm":"TABLET, FILM COATED","genericName":"olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide","productType":"HUMAN PRESCRIPTION DRUG","activeIngredients":[{"name":"AMLODIPINE BESYLATE","strength":"5 mg/1"},{"name":"HYDROCHLOROTHIAZIDE","strength":"12.5 mg/1"},{"name":"OLMESARTAN MEDOXOMIL","strength":"20 mg/1"}],"marketingCategory":"ANDA"},{"route":["ORAL"],"labeler":"Preferred Pharmaceuticals Inc.","brandName":"AMLODIPINE BESYLATE 10 mg","packaging":[{"ndc":"68788-8451-1","description":"100 TABLET in 1 BOTTLE (68788-8451-1)","marketingStartDate":"20230530"},{"ndc":"68788-8451-3","description":"30 TABLET in 1 BOTTLE (68788-8451-3)","marketingStartDate":"20230530"},{"ndc":"68788-8451-6","description":"60 TABLET in 1 BOTTLE (68788-8451-6)","marketingStartDate":"20230530"},{"ndc":"68788-8451-9","description":"90 TABLET in 1 BOTTLE (68788-8451-9)","marketingStartDate":"20230530"}],"dosageForm":"TABLET","genericName":"AMLODIPINE BESYLATE","productType":"HUMAN PRESCRIPTION DRUG","activeIngredients":[{"name":"AMLODIPINE BESYLATE","strength":"10 mg/1"}],"marketingCategory":"ANDA"},{"route":["ORAL"],"labeler":"Amneal Pharmaceuticals NY LLC","brandName":"Amlodipine Besylate and Benazepril Hydrochloride","packaging":[{"ndc":"69238-2684-1","description":"100 CAPSULE in 1 BOTTLE 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co-administered","clinicalEffect":"Hypotension"},{"drug":"Simvastatin","severity":"major","mechanism":"Amlodipine increases systemic exposure of simvastatin","management":"Do not exceed 20 mg daily of simvastatin in patients on amlodipine","clinicalEffect":"Increased simvastatin levels and risk of adverse effects"},{"drug":"Cyclosporine","severity":"moderate","mechanism":"Amlodipine may increase systemic exposure of cyclosporine","management":"Frequent monitoring of trough blood levels recommended; adjust dose when appropriate","clinicalEffect":"Increased cyclosporine levels"},{"drug":"Tacrolimus","severity":"moderate","mechanism":"Amlodipine may increase systemic exposure of tacrolimus","management":"Frequent monitoring of trough blood levels recommended; adjust dose when appropriate","clinicalEffect":"Increased tacrolimus levels"}],"commonSideEffects":[{"effect":"Low blood pressure","drugRate":"13.3%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":45,"totalAffected":6,"trialsReporting":1},{"effect":"Worsening heart failure","drugRate":"13.3%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":45,"totalAffected":6,"trialsReporting":1},{"effect":"Fatigue at rest","drugRate":"13.3%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":45,"totalAffected":6,"trialsReporting":1},{"effect":"Arrhythmia","drugRate":"11.1%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":45,"totalAffected":5,"trialsReporting":1},{"effect":"Cramping or pain","drugRate":"11.1%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":45,"totalAffected":5,"trialsReporting":1},{"effect":"Bradycardia","drugRate":"6.7%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":45,"totalAffected":3,"trialsReporting":1},{"effect":"High blood pressure","drugRate":"6.7%","organSystem":"Cardiac 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disorders","placeboRate":"","totalAtRisk":45,"totalAffected":1,"trialsReporting":1}],"contraindications":["Known sensitivity to amlodipine"],"specialPopulations":{"Geriatric":"8.5 Geriatric Use Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac f","Pediatric":"8.4 Pediatric Use Amlodipine besylate (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see CLINICAL STUDIES ( 14.1 )]. Effect of Amlodipine besylate on blood pressure in patients less than 6 years of age is not known.","Pregnancy":"8.1 Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipi","Specific Populations":"8 USE IN SPECIFIC POPULATIONS Pediatric: Effect on patients less than 6 years old is not known. ( 8.4 ) Geriatric: Start dosing at the low end of the dose range. ( 8.5 ) 8.1 Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical"},"seriousAdverseEvents":[{"event":"Syncope","detail":"MedDRA: Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"2.2%"}]},"trials":[],"aliases":[],"patents":[{"applNo":"N214439","source":"FDA Orange Book","status":"Active","expires":"Feb 24, 2041","territory":"US","drugProduct":true,"patentNumber":"12226528","drugSubstance":false},{"applNo":"N214439","source":"FDA Orange Book","status":"Active","expires":"Feb 24, 2041","territory":"US","drugProduct":true,"patentNumber":"11458095","drugSubstance":false},{"applNo":"N214439","source":"FDA Orange Book","status":"Active","expires":"Feb 24, 2041","territory":"US","drugProduct":true,"patentNumber":"12005141","drugSubstance":false},{"applNo":"N214439","source":"FDA Orange Book","status":"Active","expires":"Feb 24, 2041","territory":"US","drugProduct":true,"patentNumber":"12440441","drugSubstance":false},{"applNo":"N214439","source":"FDA Orange Book","status":"Active","expires":"Feb 24, 2041","territory":"US","drugProduct":true,"patentNumber":"11723866","drugSubstance":false},{"applNo":"N214439","source":"FDA Orange Book","status":"Active","expires":"Feb 24, 2041","territory":"US","drugProduct":true,"patentNumber":"11253474","drugSubstance":false}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0182/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$7","description":"AMLODIPINE BESYLATE 10 MG TAB","retrievedDate":"2026-04-07"}],"_fixedAt":"2026-03-30T15:12:45.582301","_recalls":[{"date":"20200219","reason":"Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.","classification":"Class II"},{"date":"20200219","reason":"Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.","classification":"Class II"}],"_sources":{"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T18:33:50.360749+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T18:34:05.074090+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T18:33:51.186142+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:54:23.970049+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200402/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T18:33:58.100169+00:00"},"fdaRecalls":{"url":"","method":"api_direct","source":"FDA Enforcement/Recalls","rawText":"","confidence":1,"sourceType":"fda_enforcement","retrievedAt":"2026-04-19T18:33:56.561085+00:00"},"overdosage":{"url":"","method":"deterministic","source":"FDA Label (overdosage)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T18:31:11.837032+00:00"},"howSupplied":{"url":"","method":"deterministic","source":"FDA Label (how_supplied)","rawText":"16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets Amlodipine Besylate Tablets USP, 2.5 mg – (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as Pink color mottled, round, flat-faced, beveled edged tablets debossed with \"1\" on one side and \"U\" on the other side and supplied as follows: NDC 68180-233-01 Bottles of 90 NDC 68180-233-02 Bottles of 1000 5 mg Tablets Amlodipine Besylate Tablets USP, 5 mg – (amlodipine besylate equivalent to 5 mg of amlodipine per table","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T18:30:54.057409+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T18:34:18.687206+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"11 DESCRIPTION Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S, and its structural formula is: Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in wate","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T18:31:11.836962+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label (pharmacokinetics)","aiModel":"featherless","rawText":"12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T18:30:54.057338+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T18:33:56.683474+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T18:33:56.172894+00:00"},"fdaClinicalStudies":{"url":"","method":"ai_extraction","source":"FDA Label (clinical_studies, 8,174 chars)","aiModel":"featherless","rawText":"14 CLINICAL STUDIES 14.1 Effects in Hypertension Adult Patients The antihypertensive efficacy of amlodipine has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in p","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-19T18:32:28.822415+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T18:33:57.631847+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T18:34:18.687151+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T18:33:52.235849+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":"2026-04-20T07:54:23.970017+00:00"},"nonclinicalToxicology":{"url":"","method":"deterministic","source":"FDA Label (nonclinical_toxicology)","rawText":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. 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The drug demonstrates good tolerability with edema as the most common dose-related adverse reaction, occurring in 1.8-10.8% of patients depending on dose. Major drug interactions include simvastatin (limit to 20 mg daily) and CYP3A inhibitors requiring dose monitoring and adjustment. The medication has been evaluated in over 11,000 patients with discontinuation rates due to adverse reactions of only 1.5%, comparable to placebo.","ecosystem":[],"isGeneric":true,"mechanism":{"target":"L-type calcium channel","novelty":"Best-in-class","targets":[{"gene":"CACNG1","source":"DrugCentral","target":"Voltage-dependent calcium channel gamma-1 subunit","protein":"Voltage-dependent calcium channel gamma-1 subunit","isPrimary":true,"activityType":"Ki","activityValue":7.2}],"modality":"Small molecule","drugClass":"Dihydropyridine calcium channel blocker","explanation":"Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle cells. The drug binds to both dihydropyridine and nondihydropyridine binding sites on calcium channels, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. The contractile processes of cardiac and vascular smooth muscle depend on extracellular calcium ion movement through specific ion channels, which amlodipine selectively inhibits.\n\nAmlodipine acts as a peripheral arterial vasodilator that directly reduces peripheral vascular resistance and blood pressure. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6) with a gradual rate of association and dissociation with the calcium channel receptor, resulting in a gradual onset of effect. Negative inotropic effects can be detected in vitro but have not been observed in intact animals at therapeutic doses, and serum calcium concentration is not affected by the drug.\n\nIn exertional angina, amlodipine reduces total peripheral resistance and the rate pressure product, thereby decreasing myocardial oxygen demand. In vasospastic angina, amlodipine blocks constriction and restores blood flow in coronary arteries and arterioles in response to various vasoconstrictors including calcium, potassium, epinephrine, serotonin, and thromboxane A2 analogs.","oneSentence":"Calcium channel antagonist inhibiting transmembrane calcium influx into vascular and cardiac muscle.","technicalDetail":"Amlodipine is a dihydropyridine calcium antagonist that selectively inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle cells through specific ion channels. It binds to both dihydropyridine and nondihydropyridine binding sites, with a greater effect on vascular smooth muscle cells. Its interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Amlodipine","extract":"Amlodipine, sold under the brand name Norvasc among others, is a calcium channel blocker medication used to treat high blood pressure, coronary artery disease (CAD) and variant angina. It is taken orally.","wiki_history":"==History==\nPfizer's patent protection on Norvasc lasted until 2007; total patent expiration occurred later in 2007. A number of generic versions are available. In the United Kingdom, tablets of amlodipine from different suppliers may contain different salts such as amlodipine besylate and amlodipine benzoate.\n\nThe medical form comes as besilate, mesylate, or maleate.","wiki_medical_uses":"== Medical uses ==\nAmlodipine is used in the management of hypertension (high blood pressure) and coronary artery disease in people with either stable angina (where chest pain occurs mostly after physical or emotional stress) or vasospastic angina (where it occurs in cycles) and without heart failure. It can be used as either monotherapy or combination therapy for the management of hypertension or coronary artery disease. Amlodipine can be administered to adults and to children 6–17 years of age.\n\nCalcium channel blockers, including amlodipine, may provide greater protection against stroke than beta blockers. Evidence from two meta-analyses has reported no significant difference between calcium channel blockers, ACE inhibitors, diuretics \n\n===Combination therapy===\nAmlodipine can be given as a combination therapy with a variety of medications:\n* Amlodipine/atorvastatin, where amlodipine is given for hypertension or CAD and atorvastatin prevents cardiovascular events, or if the person also has high cholesterol.\n* Amlodipine/aliskiren or amlodipine/aliskiren/hydrochlorothiazide if amlodipine alone cannot reduce blood pressure. Aliskiren is a renin inhibitor, which works to reduce primary hypertension (that with no known cause) by binding to renin and preventing it from initiating the renin–angiotensin system (RAAS) pathway to increase blood pressure. Hydrochlorothiazide is a diuretic and decreases overall blood volume.\n* Amlodi","wiki_society_and_culture":"== Society and culture ==\n=== Brand names ===\nIn the US, Norvasc is marketed by Viatris after Upjohn was spun off from Pfizer."},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1200402","maxPhase":"4.0","chirality":0,"parenteral":false,"availability":1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":true},"commercial":{"launchDate":"2004","annualCostUS":"$0.00/yr or empty","_launchSource":"FDA NDA021540 (PHARMACIA)","genericStatus":"Generic — off-patent","currentRevenue":"$0.00B or empty","manufacturerCount":"10 approved manufacturers","patientPopulation":"~0M or empty","peakSalesEstimate":"$0.00B or empty"},"fdaRecalls":[{"date":"20250702","reason":"Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027","status":"Ongoing","distribution":"Nationwide in the US","classification":"Class II"},{"date":"20150506","reason":"Subpotent drug","status":"Terminated","distribution":"Nationwide","classification":"Class III"},{"date":"20181003","reason":"Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.","status":"Terminated","distribution":"Nationwide with the United States","classification":"Class III"},{"date":"20170505","reason":"PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.","status":"Terminated","distribution":"Nationwide in the USA.","classification":"Class III"},{"date":"20230627","reason":"Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.","status":"Terminated","distribution":"Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.","classification":"Class III"},{"date":"20150813","reason":"Subpotent Drug: Subpotent atorvastatin.","status":"Terminated","distribution":"U.S. Nationwide","classification":"Class III"},{"date":"20120409","reason":"Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.","status":"Terminated","distribution":"Nationwide and Puerto Rico","classification":"Class II"},{"date":"20150813","reason":"Subpotent Drug: Subpotent atorvastatin.","status":"Terminated","distribution":"U.S. Nationwide","classification":"Class III"},{"date":"20150813","reason":"Subpotent Drug: Subpotent atorvastatin.","status":"Terminated","distribution":"U.S. Nationwide","classification":"Class III"},{"date":"20150506","reason":"Subpotent drug","status":"Terminated","distribution":"Nationwide","classification":"Class III"}],"overdosage":"10 OVERDOSAGE Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine","references":[{"id":1,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Amlodipine Besylate","fields":["mechanism","safety","indications","administration"],"source":"FDA Drug Label (DailyMed)"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Amlodipine%20Besylate","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Amlodipine Besylate","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":5,"url":"https://en.wikipedia.org/wiki/Amlodipine Besylate","fields":["history","overview"],"source":"Wikipedia"},{"id":6,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/","fields":["timeline","launchDate"],"source":"FDA Drugs@FDA"},{"id":7,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":8,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":9,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"},{"id":10,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/","fields":["genericManufacturers"],"source":"FDA Drugs@FDA (ANDA/BLA)"}],"_tgaChecked":true,"_validation":{"fieldsValidated":7,"lastValidatedAt":"2026-04-20T07:54:23.970105+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Simvastatin","company":"Generic","advantage":"Lower cost generic approved"},{"name":"Rosuvastatin","company":"Generic","advantage":"Lower cost generic approved"},{"name":"Crestor","company":"Brand","advantage":"Effective at lowering cholesterol"},{"name":"Evolocumab","company":"Brand","advantage":"PCSK9 inhibitor that may be used to reduce LDL-C levels"},{"name":"Leqvio","company":"Brand","advantage":"PCSK9 inhibitor that may be used to reduce LDL-C levels"},{"name":"Inclisiran","company":"Brand","advantage":"PCSK9 inhibitor that may be used to reduce LDL-C levels"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"},{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"howSupplied":"16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets Amlodipine Besylate Tablets USP, 2.5 mg – (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as Pink color mottled, round, flat-faced, beveled edged tablets debossed with \"1\" on one side and \"U\" on the other side and supplied as follows: NDC 68180-233-01 Bottles of 90 NDC 68180-233-02 Bottles of 1000 5 mg Tablets Amlodipine Besylate Tablets USP, 5 mg – (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are supplied as White to off white capsule shaped tablets debossed with \"2\" on one side and \"U\" on the other side and supplied as follows: NDC 68180-455-01 Bottles of 90 NDC 68180-455-02 Bottles of 1000 10 mg Tablets Amlodipine Besylate Tablets USP, 10 mg – (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are supplied as White to off white round, flat faced, beveled edged tablet debossed with \"L\" on one side and \"32\" on the other side and supplied as follows: NDC 68180-721-09 Bottles of 90 NDC 68180-721-03 Bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispense in tight, light-resistant containers (USP). Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States MADE IN INDIA. Revised: December 2024","indications":{"approved":[{"name":"Hypertension","regulator":"FDA"},{"name":"Coronary Artery Disease (CAD)","regulator":"FDA"},{"name":"Chronic Stable Angina","regulator":"FDA"},{"name":"Vasospastic Angina (Prinzmetal’s or Variant Angina)","regulator":"FDA"},{"name":"Angiographically Documented CAD","regulator":"FDA"},{"name":"Primary Hyperlipidemia","regulator":"FDA"},{"name":"Heterozygous Familial Hypercholesterolemia (HeFH)","regulator":"FDA"},{"name":"Homozygous Familial Hypercholesterolemia","regulator":"FDA"},{"name":"Primary Dysbetalipoproteinemia","regulator":"FDA"},{"name":"Hypertriglyceridemia","regulator":"FDA"},{"name":"Type 2 Diabetes Mellitus with multiple risk factors for CHD","regulator":"FDA"},{"name":"Multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"isCanonical":true,"_drugWebsite":{"url":"https://www.caduet.com","content":" \n \n CADUET- amlodipine and atorvastatin tablet, film coated \nViatris Specialty LLC\n \n---------- \n \n \n \nHIGHLIGHTS OF PRESCRIBING INFORMATION \nThese highlights do not include all the information needed to use CADUET safely and effectively. See full prescribing information for CADUET. \n \nCADUET® (amlodipine and atorvastatin) tablets, for oral use \nInitial U.S. Approval: 2004 \n \n \n INDICATIONS AND USAGE \n \nCADUET is a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG-CoA-reductase inhibitor (statin), indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate (1). \nAmlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. \nAmlodipine is indicated for the treatment of Coronary Artery Disease (1). \nAtorvastatin is indicated (1): \n \n• \nTo reduce the risk of: \n \no \nMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. \no \nMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. \no \nNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. \n• \nAs an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: \n \no \nAdults with primary hyperlipidemia. \no \nAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). \n• \nAs an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. \n• \nAs an adjunct to diet for the treatment of adults with: \n \no \nPrimary dysbetalipoprotei"},"_fixedFields":["patents(6)"],"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Caduet","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://www.biochempeg.com/article/1462.html","date":"2026-04-07","type":"news","title":"Global Sales of Antibody-drug Conjugates (ADCs) in 2025","source":"www.biochempeg.com"},{"url":"https://dhpp.hpfb-dgpsa.ca/dhpp/resource/75878","date":"2026-04-07","type":"news","title":"Details for: CADUET - Drug and Health Products Portal","source":"dhpp.hpfb-dgpsa.ca"},{"url":"https://www.sanofi.com/assets/dotcom/pressreleases/2026/2026-01-29-06-30-00-3228191-en.pdf","date":"2026-04-07","type":"news","title":"[PDF] 2025: strong sales and EPS growth. Continued profitable ... - Sanofi","source":"www.sanofi.com"},{"url":"https://www.pharmacytimes.com/view/2004-04-7850","date":"2026-04-07","type":"news","title":"RxPRODUCT NEWS PROFILE: Caduet | Pharmacy Times","source":"www.pharmacytimes.com"},{"url":"https://www.drugs.com/history/caduet.html","date":"2026-04-07","type":"news","title":"Caduet (amlodipine and atorvastatin) FDA Approval History","source":"www.drugs.com"}],"manufacturing":[{"role":"Manufacturer","site":"Viatris Specialty LLC","location":"","operator":"Viatris Specialty LLC"}],"molecularData":{"oral":true,"chemblId":"CHEMBL1200402","moleculeType":"Small molecule","molecularWeight":"567.06"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"unii":"864V2Q084H","rxcui":"104416","splId":"63bc4df8-5e26-45dd-8a05-78ee94553129","chemblId":"CHEMBL1200402","pubchemSID":"11528718"},"drugDescription":{"pH":"","structure":"3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate","appearance":"white crystalline powder","composition":"Amlodipine besylate tablets USP are formulated as tablets equivalent to 2.5 mg, 5 mg and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dicalcium phosphate anhydrous, FD & C red no. 40 aluminum lake (only for 2.5 mg strength), magnesium stearate, microcrystalline cellulose and povidone.","molecularWeight":"567.1 g/mol","molecularFormula":"C20H25ClN2O5•C6H6O3S"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":"BLOCKER","targetChemblId":"CHEMBL2095229","mechanismComment":null,"mechanismOfAction":"Voltage-gated L-type calcium channel blocker"}],"developmentCodes":[],"ownershipHistory":[{"notes":"","period":"2007-present","_source":"Wikipedia","companyName":"Pfizer","relationship":"Originator"},{"notes":"Through Upjohn","period":"2007-present","_source":"Wikipedia","companyName":"Viatris","relationship":"Acquirer"},{"notes":"","period":"2007-present","_source":"Wikipedia","companyName":"Upjohn","relationship":"Licensee"}],"pharmacokinetics":{"tmax":"not specified","halfLife":"not specified","linearPK":"not specified","clearance":"not specified","excretion":"not specified","metabolism":"not specified","proteinBinding":"not specified","bioavailability":"not specified","specialPopulations":{"age":"not specified","renal":"not specified","weight":"not specified","hepatic":"not specified"},"volumeOfDistribution":"not specified"},"publicationCount":456,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"faersTotalReports":167521,"commercialAnalysis":{"text":"Caduet, a combination of amlodipine and atorvastatin, is a market-leading treatment for hypertension and coronary artery disease. As of 2023, Caduet has a DIN (Drug Identification Number) of 02273292 and is marketed by BGP Pharma ULC [1]. The product's revenue trajectory is not explicitly stated in the provided sources, but it is likely to be impacted by the patent cliff and increasing competition in the market.\n\nThe competitive landscape for Caduet is dominated by other combination therapies, such as amlodipine and atorvastatin from other manufacturers. According to Sanofi's 2025 sales report, the pharma launches increased sales by 49.4% to €1.1 billion, primarily driven by Ayvakit and ALTUVIIIO [2]. This suggests that the market is becoming increasingly competitive, with new entrants and innovative products challenging established players.\n\nKey upcoming catalysts for Caduet include patent cliffs and potential label expansions. However, limited data is available on these specific events. Sanofi's 2025 sales report mentions that the company expects sales to grow by a high single-digit percentage at CER in 2026, with business EPS at CER expected to grow slightly faster than sales [2]. This suggests that the market outlook for Caduet is positive, but further data is needed to confirm this trend.\n\nIn conclusion, Caduet is a market-leading treatment for hypertension and coronary artery disease, but its revenue trajectory and competitive landscape are subject to change due to patent cliffs and increasing competition. Further data is needed to confirm the market outlook for Caduet.\n\nReferences:\n[1] dhpp.hpfb-dgpsa.ca, Details for: CADUET - Drug and Health Products Portal, 2023\n[2] www.sanofi.com, 2025: strong sales and EPS growth. 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For the mouse, the highest dose was, on a mg/m 2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. 3 For the rat, the highest dose was, on a mg/m 2 basis, about twice the maximum recommended human dose. 3 Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose 3 of 10 mg/day on a mg/m 2 basis). 3 Based on patient weight of 50 kg\n13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m 2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. 3 For the rat, the highest dose was, on a mg/m 2 basis, about twice the maximum recommended human dose. 3 Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose 3 of 10 mg/day on a mg/m 2 basis). 3 Based on patient weight of 50 kg","structuredTrialResults":[{"hr":"-3.8","nctId":"NCT04434664","phase":"PHASE4","pValue":"0.017","ciLower":"-6.8","ciUpper":"-0.7","endpoint":"Difference in Home Systolic Blood Pressure","enrollment":50}],"genericManufacturerList":[],"faersSeriousnessBreakdown":[{"term":1,"count":116481},{"term":2,"count":50940}],"phase":"marketed","status":"approved","brandName":"Caduet","genericName":"Amlodipine Besylate","companyName":"Pfizer Inc.","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"2004","enrichmentLevel":5,"visitCount":18,"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}],"pricingByCountry":[{"country_code":"Un","currency":"USD","price_amount":"7.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"7.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"7.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"7.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"7.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null},{"country_code":"UN","currency":"USD","price_amount":"7.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":1,"withResults":1},"validation":{"fieldsValidated":7,"lastValidatedAt":"2026-04-20T07:54:23.970105+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}