{"id":"menest","rwe":[],"_fda":{"id":"d1c47976-d6ec-434f-a4e3-b2341e1ff8e4","set_id":"e0141598-0bb2-4cf0-c9b8-6867b34bbb17","openfda":{"upc":["0361570073017","0361570074014","0361570075509","0361570072010"],"unii":["3ASP8Q3768"],"route":["ORAL"],"rxcui":["197666","197667","197668","197669","212039","212232","212373","212464"],"spl_id":["d1c47976-d6ec-434f-a4e3-b2341e1ff8e4"],"brand_name":["MENEST"],"spl_set_id":["e0141598-0bb2-4cf0-c9b8-6867b34bbb17"],"package_ndc":["61570-072-01","61570-073-01","61570-074-01","61570-075-50"],"product_ndc":["61570-074","61570-072","61570-073","61570-075"],"generic_name":["ESTERIFIED ESTROGENS"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["ESTROGENS, ESTERIFIED"],"manufacturer_name":["Pfizer Laboratories Div Pfizer Inc"],"application_number":["ANDA084950","ANDA084949"],"is_original_packager":[true]},"version":"16","warnings":["WARNINGS See Boxed Warnings . The use of unopposed estrogens in women who have a uterus is associated with an increased risk of endometrial cancer. 1. Cardiovascular disorders Estrogen and estrogen/progestin therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). Should any of these occur or be suspected, estrogens should be discontinued immediately. Risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Coronary heart disease and stroke In the Women's Health Initiative study (WHI), an increase in the number of myocardial infarctions and strokes has been observed in women receiving CE compared to placebo. These observations are preliminary. (See CLINICAL PHARMACOLOGY , Clinical Studies .) In the CE/MPA substudy of WHI, an increased risk of coronary heart disease (CHD) events (defined as nonfatal myocardial infarction and CHD death) was observed in women receiving CE/MPA compared to women receiving placebo (37 vs 30 per 10,000 women-years). The increase in risk was observed in year one and persisted. In the same substudy of WHI, an increased risk of stroke was observed in women receiving CE/MPA compared to women receiving placebo (29 vs 21 per 10,000 women-years). The increase in risk was observed after the first year and persisted. In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement study; HERS) treatment with CE/MPA (0.625mg/2.5mg per day) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty-one women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in HERS, HERS II and overall. Large doses of estrogen (5 mg conjugated estrogens per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis. b. Venous thromboembolism (VTE) In the Women's Health Initiative study (WHI), an increase in VTE has been observed in women receiving CE compared to placebo. These observations are preliminary. (See CLINICAL PHARMACOLOGY, Clinical Studies .) In the CE/MPA substudy of WHI, a 2-fold greater rate of VTE, including deep venous thrombosis and pulmonary embolism, was observed in women receiving CE/MPA compared to women receiving placebo. The rate of VTE was 34 per 10,000 women-years in the CE/MPA group compared to 16 per 10,000 women-years in the placebo group. The increase in VTE risk was observed during the first year and persisted. If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. 2. Malignant neoplasms a. Endometrial cancer The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12- fold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with use of estrogens for less than one year. The greatest risk appears associated with prolonged use, with increased risks of 15- to 24-fold for five to ten years or more and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued. Clinical surveillance of all women taking estrogen/progestin combinations is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens, of equivalent estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. b. Breast cancer The most important randomized clinical trial providing information about breast cancer in estrogen plus progestin users is the WHI substudy of daily CE (0.625 mg) plus MPA (2.5 mg). After a mean follow-up of 5.6 years the estrogen plus progestin substudy reported an increased risk of invasive breast cancer in women who took daily CE plus MPA. In this substudy, prior use of estrogen‑alone or estrogen plus progestin therapy was reported by 26 percent of the women. The relative risk of invasive breast cancer was 1.24 and the absolute risk was 41 versus 33 cases per 10,000 women-years, for CE plus MPA compared with placebo. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 versus 25 cases per 10,000 women-years, for CE plus MPA compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 versus 36 cases per 10,000 women-years for CE plus MPA compared with placebo. In the same substudy, invasive breast cancers were larger, were more likely to be node positive, and were diagnosed at a more advanced stage in the CE (0.625 mg) plus MPA (2.5 mg) group compared with the placebo group. Metastatic disease was rare with no apparent difference between the two groups. Other prognostic factors such as histologic subtype, grade and hormone receptor status did not differ between the groups. The most important randomized clinical trial providing information about breast cancer in estrogen-alone users is the WHI substudy of daily CE (0.625 mg)-alone. In the WHI estrogen‑alone substudy, after an average follow-up of 7.1 years, daily CE (0.625 mg)-alone was not associated with an increased risk of invasive breast cancer [relative risk (RR) 0.80]. Consistent with the Women’s Health Initiative (WHI clinical trials), observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy and a smaller, but still increased risk, for estrogen-alone therapy after several years of use. One large meta‑analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to >10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy. Extension of the WHI trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy. Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to the risk with estrogen-alone therapy. However, these studies have not found significant variation in the risk of breast cancer among different estrogen plus progestin combinations, doses, or routes of administration. The use of estrogen-alone and estrogen plus progestin have been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results. 3. Dementia In the Women's Health Initiative Memory Study (WHIMS), 4,532 generally healthy postmenopausal women 65 years of age and older were studied, of whom 35% were 70 to 74 years of age and 18% were 75 or older. After an average follow-up of 4 years, 40 women being treated with CE/MPA (1.8%, n = 2,229) and 21 women in the placebo group (0.9%, n = 2,303) received diagnoses of probable dementia. The relative risk for CE/MPA versus placebo was 2.05 (95% confidence interval 1.21 – 3.48), and was similar for women with and without histories of menopausal hormone use before WHIMS. The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years, and the absolute excess risk for CE/MPA was 23 cases per 10,000 women-years. It is unknown whether these findings apply to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies and PRECAUTIONS, GERIATRIC USE .) It is unknown whether these findings apply to estrogen alone therapy. 4. Gallbladder disease A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. 5. Hypercalcemia Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level. 6. Visual abnormalities Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is a sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued. 7. Hepatic adenoma Benign hepatic adenomas appear to be associated with the use of oral contraceptives. Although benign, and rare, these may rupture and may cause death through intra-abdominal hemorrhage. Such lesions have not yet been reported in association with other estrogen or progestagen preparations but should be considered in estrogen users having abdominal pain and tenderness, abdominal mass, or hypovolemic shock. Hepatocellular carcinoma has also been reported in women taking estrogen-containing oral contraceptives. The relationship of this malignancy to these drugs is not known at this time."],"pregnancy":["F. PREGNANCY Menest should not be used during pregnancy. (See CONTRAINDICATIONS .)"],"overdosage":["OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females."],"description":["DESCRIPTION Esterified estrogens is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. It contains the concomitant component, 17α-estradiol. The content of total esterified estrogens is not less than 90 percent and not more than 110 percent of the labeled amount. Esterified estrogens contain not less than 75 percent and not more than 85 percent of sodium estrone sulfate, and not less than 6 percent and not more than 15 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90 percent, all percentages being calculated on the basis of the total esterified estrogens content. Inactive Ingredients: Ethyl cellulose, fragrances, hydroxypropyl cellulose, hypromellose 2910, lactose, magnesium stearate, methylcellulose, polyethylene glycol, sodium bicarbonate, shellac, starch, stearic acid, titanium dioxide, and vanillin. Dyes in the form of aluminum lakes are contained in each tablet strength as follows: 0.3 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10. 0.625 mg Tablet : FD&C Yellow No. 6, D&C Yellow No. 10. 1.25 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10, FD&C Blue No. 1. 2.5 mg Tablet: D&C Red No. 30."],"precautions":["PRECAUTIONS A. GENERAL 1. Addition of a progestin when a woman has not had a hysterectomy Studies of the addition of progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer. 2. Elevated blood pressure In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogens on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use. 3. Hypertriglyceridemia In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. 4. Impaired liver function and past history of cholestatic jaundice Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued. 5. Hypothyroidism Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T 4 and T 3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. 6. Fluid retention Because estrogens may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed. 7. Hypocalcemia Estrogens should be used with caution in individuals with severe hypocalcemia. 8. Ovarian cancer The CE/MPA substudy of WHI reported that estrogen plus progestin increased the risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95% confidence interval 0.77 – 3.24) but was not statistically significant. The absolute risk for CE/MPA versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen alone, in particular for ten or more years, has been associated with an increased risk of ovarian cancer. Other epidemiologic studies have not found these associations. 9. Exacerbation of endometriosis Endometriosis may be exacerbated with administration of estrogens. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. 10. Exacerbation of other conditions Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. B. PATIENT INFORMATION Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe Menest. C. LABORATORY TESTS Estrogen administration should be initiated at the lowest dose approved for the indication and then guided by clinical response, rather than by serum hormone levels (e.g., estradiol, FSH). D. DRUG/LABORATORY TEST INTERACTIONS 1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity; IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. 2. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radioimmunoassay. T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. 3. Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). 4. Increased plasma HDL and HDL 2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. 5. Impaired glucose tolerance. 6. Reduced response to metyrapone test. E. CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See Boxed Warning , WARNINGS and PRECAUTIONS .) Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver. F. PREGNANCY Menest should not be used during pregnancy. (See CONTRAINDICATIONS .) G. NURSING MOTHERS Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Menest is administered to a nursing mother. H. PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established. I. GERIATRIC USE In the Women's Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n = 3,729) were 65 to 74 while 18% (n = 803) were 75 and over. Most women (80%) had no prior hormone therapy use. Women treated with conjugated estrogens plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer's disease was the most common classification of probable dementia in both the conjugated estrogens plus medroxyprogesterone acetate group and the placebo group. Ninety percent of the cases of probable dementia occurred in the 54% of women that were older than 70. (See WARNINGS, Dementia .) It is unknown whether these findings apply to estrogen alone therapy."],"how_supplied":["HOW SUPPLIED Tablets: 0.3 mg yellow, film-coated oblong tablet imprinted with M72 100's: NDC 61570-072-01 0.625 mg orange, film-coated oblong tablet imprinted with M73 100's: NDC 61570-073-01 1.25 mg green, film-coated oblong tablet imprinted with M74 100's: NDC 61570-074-01 2.5 mg pink, film-coated oblong tablet imprinted with M75 50's: NDC 61570-075-50 Do not store above 25°C (77°F)."],"boxed_warning":["ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCERt Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of \"natural\" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms , Endometrial cancer .) CARDIOVASCULAR AND OTHER RISKS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders .) The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (See CLINICAL PHARMACOLOGY , Clinical Studies .) The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies .) Other doses of conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman."],"geriatric_use":["I. GERIATRIC USE In the Women's Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n = 3,729) were 65 to 74 while 18% (n = 803) were 75 and over. Most women (80%) had no prior hormone therapy use. Women treated with conjugated estrogens plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer's disease was the most common classification of probable dementia in both the conjugated estrogens plus medroxyprogesterone acetate group and the placebo group. Ninety percent of the cases of probable dementia occurred in the 54% of women that were older than 70. (See WARNINGS, Dementia .) It is unknown whether these findings apply to estrogen alone therapy."],"pediatric_use":["H. PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20251111","nursing_mothers":["G. NURSING MOTHERS Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Menest is administered to a nursing mother."],"clinical_studies":["Clinical Studies Women's Health Initiative Studies The Women's Health Initiative (WHI) enrolled a total of 27,000 predominantly healthy postmenopausal women to assess the risks and benefits of either the use of oral 0.625 mg conjugated estrogens (CE) per day alone or the use of oral 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate (MPA) per day compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of coronary heart disease (CHD) (nonfatal myocardial infarction and CHD death), with invasive breast cancer as the primary adverse outcome studied. A \"global index\" included the earliest occurrence of CHD, invasive breast cancer, stroke, pulmonary embolism (PE), endometrial cancer, colorectal cancer, hip fracture, or death due to other cause. The study did not evaluate the effects of CE or CE/MPA on menopausal symptoms. The CE/MPA substudy was stopped early because, according to the predefined stopping rule, the increased risk of breast cancer and cardiovascular events exceeded the specified benefits included in the \"global index.\" Results of the CE/MPA substudy, which included 16,608 women (average age of 63 years, range 50 to 79; 83.9% White, 6.5% Black, 5.5% Hispanic), after an average follow-up of 5.2 years are presented in Table 1 below: Table 1. RELATIVE AND ABSOLUTE RISK SEEN IN THE CE/MPA SUBSTUDY OF WHI adapted from JAMA, 2002; 288:321–333 Event a subset of the events was combined in a \"global index\", defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, or death due to other causes Relative Risk CE/MPA vs placebo at 5.2 Years (95% CI nominal confidence intervals unadjusted for multiple looks and multiple comparisons ) Placebo n = 8102 CE/MPA n = 8506 Absolute Risk per 10,000 Person-years CHD events 1.29 (1.02–1.63) 30 37 Non-fatal MI 1.32 (1.02–1.72) 23 30 CHD death 1.18 (0.70–1.97) 6 7 Invasive breast cancer includes metastatic and non-metastatic breast cancer with the exception of in situ breast cancer 1.26 (1.00–1.59) 30 38 Stroke 1.41 (1.07–1.85) 21 29 Pulmonary embolism 2.13 (1.39–3.25) 8 16 Colorectal cancer 0.63 (0.43–0.92) 16 10 Endometrial cancer 0.83 (0.47–1.47) 6 5 Hip fracture 0.66 (0.45–0.98) 15 10 Death due to causes other than the events above 0.92 (0.74–1.14) 40 37 Global Index 1.15 (1.03–1.28) 151 170 Deep vein thrombosis not included in Global Index 2.07 (1.49–2.87) 13 26 Vertebral fractures 0.66 (0.44–0.98) 15 9 Other osteoporotic fractures 0.77 (0.69–0.86) 170 131 For those outcomes included in the \"global index,\" absolute excess risks per 10,000 women-years in the group treated with CE/MPA were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the \"global index\" was 19 per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality. (See Boxed Warning , WARNINGS , and PRECAUTIONS .) Women's Health Initiative Memory Study The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47% were age 65 to 69 years, 35% were 70 to 74 years, and 18% were 75 years of age and older) to evaluate the effects of CE/MPA (0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate) on the incidence of probable dementia (primary outcome) compared with placebo. After an average follow-up of 4 years, 40 women in the estrogen/progestin group (45 per 10,000 women-years) and 21 in the placebo group (22 per 10,000 women-years) were diagnosed with probable dementia. The relative risk of probable dementia in the hormone therapy group was 2.05 (95% CI, 1.21 to 3.48) compared to placebo. Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women. (See Boxed Warning and WARNINGS, Dementia .)"],"laboratory_tests":["C. LABORATORY TESTS Estrogen administration should be initiated at the lowest dose approved for the indication and then guided by clinical response, rather than by serum hormone levels (e.g., estradiol, FSH)."],"adverse_reactions":["ADVERSE REACTIONS See Boxed Warnings , WARNINGS and PRECAUTIONS . The following additional adverse reactions have been reported with estrogens and/or progestin therapy. 1. Genitourinary system Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; premenstrual like syndrome, amenorrhea during and after treatment; cystitis like syndrome. 2. Breasts Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. 3. Cardiovascular Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure. 4. Gastrointestinal Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gall bladder disease; pancreatitis, enlargement of hepatic hemangiomas. 5. Skin Chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash. 6. Eyes Retinal vascular thrombosis; steepening of corneal curvature; intolerance to contact lenses. 7. Central nervous system Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia. 8. Miscellaneous Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides."],"contraindications":["CONTRAINDICATIONS Menest should not be used in women with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. 3. Known or suspected estrogen-dependent neoplasia. 4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. Liver dysfunction or disease. 7. Menest should not be used in patients with known hypersensitivity to its ingredients. 8. Known or suspected pregnancy. There is no indication for Menest in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS .)"],"general_precautions":["A. GENERAL 1. Addition of a progestin when a woman has not had a hysterectomy Studies of the addition of progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer. 2. Elevated blood pressure In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogens on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use. 3. Hypertriglyceridemia In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. 4. Impaired liver function and past history of cholestatic jaundice Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued. 5. Hypothyroidism Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T 4 and T 3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. 6. Fluid retention Because estrogens may cause some degree of fluid retention, patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed. 7. Hypocalcemia Estrogens should be used with caution in individuals with severe hypocalcemia. 8. Ovarian cancer The CE/MPA substudy of WHI reported that estrogen plus progestin increased the risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95% confidence interval 0.77 – 3.24) but was not statistically significant. The absolute risk for CE/MPA versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen alone, in particular for ten or more years, has been associated with an increased risk of ovarian cancer. Other epidemiologic studies have not found these associations. 9. Exacerbation of endometriosis Endometriosis may be exacerbated with administration of estrogens. A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered. 10. Exacerbation of other conditions Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions."],"storage_and_handling":["Do not store above 25°C (77°F)."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secrets 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women. Distribution The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to sex hormone binding globulin (SHBG) and albumin. Metabolism Exogenous estrogens are metabolized in the same manner as endogenous estrogens. Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption. In postmenopausal women, a significant proportion of the circulating estrogens exist as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formulation of more active estrogens. Excretion Estradiol, estrone, and estriol are excreted in the urine along with glucuronide and sulfate conjugates. Drug Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects."],"indications_and_usage":["INDICATIONS AND USAGE Menest is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Female hypogonadism. 4. Female castration. 5. Primary ovarian failure. 6. Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 7. Prostatic carcinoma - palliative therapy of advanced disease."],"clinical_studies_table":["<table ID=\"_RefID0EFZAE\" width=\"75%\"><caption>Table 1. RELATIVE AND ABSOLUTE RISK SEEN IN THE CE/MPA SUBSTUDY OF WHI<footnote ID=\"_RefID0EJZAE\">adapted from JAMA, 2002; 288:321&#x2013;333 </footnote></caption><col width=\"19%\"/><col width=\"18%\"/><col width=\"18%\"/><col width=\"18%\"/><thead><tr><th align=\"left\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Event</content><footnote ID=\"_Reffoot1\">a subset of the events was combined in a &quot;global index&quot;, defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, or death due to other causes </footnote></th><th align=\"left\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Relative Risk CE/MPA vs placebo at 5.2 Years</content> <content styleCode=\"bold\"> (95% CI</content><footnote ID=\"_RefID0EG1AE\">nominal confidence intervals unadjusted for multiple looks and multiple comparisons</footnote><content styleCode=\"bold\">)</content></th><th align=\"left\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Placebo n = 8102</content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">CE/MPA n = 8506</content></th></tr></thead><tbody><tr><td colspan=\"2\" styleCode=\"Rrule Toprule Botrule \" valign=\"top\"/><td colspan=\"2\" styleCode=\"Toprule Botrule \" valign=\"top\"><paragraph>Absolute Risk per 10,000 Person-years</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>CHD events</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1.29 (1.02&#x2013;1.63)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>30</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>37</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"italics\"> Non-fatal MI </content></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"italics\">1.32 (1.02&#x2013;1.72)</content></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"italics\">23</content></paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph><content styleCode=\"italics\">30</content></paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"italics\"> CHD death</content></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1.18 (0.70&#x2013;1.97)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"italics\">6</content></paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph><content styleCode=\"italics\">7</content></paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Invasive breast cancer<footnote ID=\"_RefID0EB3AE\">includes metastatic and non-metastatic breast cancer with the exception of in situ breast cancer </footnote></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1.26 (1.00&#x2013;1.59)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>30</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>38</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Stroke</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1.41 (1.07&#x2013;1.85)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>21</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>29</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Pulmonary embolism</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>2.13 (1.39&#x2013;3.25)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>8</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>16</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Colorectal cancer</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>0.63 (0.43&#x2013;0.92)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>16</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>10</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Endometrial cancer</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>0.83 (0.47&#x2013;1.47)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>6</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>5</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Hip fracture</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>0.66 (0.45&#x2013;0.98)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>15</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>10</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Death due to causes other than the events above</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>0.92 (0.74&#x2013;1.14)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>40</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>37</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Global Index<footnoteRef IDREF=\"_Reffoot1\"/></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1.15 (1.03&#x2013;1.28)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>151</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>170</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Deep vein thrombosis<footnote ID=\"_RefT1F5\">not included in Global Index </footnote></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>2.07 (1.49&#x2013;2.87)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>13</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>26</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Vertebral fractures<footnoteRef IDREF=\"_RefT1F5\"/></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>0.66 (0.44&#x2013;0.98)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>15</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>9</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>Other osteoporotic fractures<footnoteRef IDREF=\"_RefT1F5\"/></paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>0.77 (0.69&#x2013;0.86)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>170</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>131</paragraph></td></tr></tbody></table>"],"information_for_patients":["B. PATIENT INFORMATION Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe Menest."],"spl_unclassified_section":["Rx Only","This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com. LAB 1138–2.0 Revised: 2/2024 Logo"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See Boxed Warnings and WARNINGS .) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Patients should be started at the lowest dose. 1. Given cyclically for short term use only: For treatment of moderate to severe vasomotor symptoms, or moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. Administration should be cyclic (e.g., 3 weeks on and 1 week off). USUAL DOSAGE RANGES: Vasomotor symptoms – 1.25 mg daily. If the patient has not menstruated within the last 2 months or more, cyclic administration is started arbitrarily. If the patient is menstruating, cyclic administration is started on day 5 of bleeding. Moderate to severe symptoms of vulvar and vaginal atrophy – 0.3 mg to 1.25 mg or more daily, depending upon the tissue response of the individual patient. Administer cyclically. 2. Given cyclically: Female hypogonadism; female castration; primary ovarian failure. USUAL DOSAGE RANGES: Female hypogonadism – 2.5 to 7.5 mg daily, in divided doses for 20 days, followed by a rest period of 10 days' duration. If bleeding does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen therapy necessary to produce bleeding may vary depending on responsiveness of the endometrium. If bleeding occurs before the end of the 10 day period, begin a 20 day estrogen-progestin cyclic regimen with Menest (esterified estrogens tablets), 2.5 to 7.5 mg daily in divided doses, for 20 days. During the last 5 days of estrogen therapy, give an oral progestin. If bleeding occurs before this regimen is concluded, therapy is discontinued and may be resumed on the fifth day of bleeding. Female castration and primary ovarian failure – 1.25 mg daily, cyclically. Adjust dosage upward or downward according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control. 3. Given chronically: Inoperable progressing prostatic cancer — 1.25 to 2.5 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient. Inoperable progressing breast cancer in appropriately selected men and postmenopausal women. (See INDICATIONS AND USAGE ) – Suggested dosage is 10 mg three times daily for a period of at least 3 months. Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding. The lowest effective dose of Menest has not been determined."],"spl_product_data_elements":["MENEST esterified estrogens ESTROGENS, ESTERIFIED ESTROGENS, ESTERIFIED ETHYLCELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE 2910 (15 MPA.S) LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE METHYLCELLULOSE (15 MPA.S) POLYETHYLENE GLYCOL 300 SODIUM BICARBONATE SHELLAC STARCH, CORN STEARIC ACID TITANIUM DIOXIDE VANILLIN FD&C YELLOW NO. 6 D&C YELLOW NO. 10 oblong M72 MENEST esterified estrogens ESTROGENS, ESTERIFIED ESTROGENS, ESTERIFIED ETHYLCELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE 2910 (15 MPA.S) LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE METHYLCELLULOSE (15 MPA.S) POLYETHYLENE GLYCOL 300 SODIUM BICARBONATE SHELLAC STARCH, CORN STEARIC ACID TITANIUM DIOXIDE VANILLIN FD&C YELLOW NO. 6 D&C YELLOW NO. 10 oblong M73 MENEST esterified estrogens ESTROGENS, ESTERIFIED ESTROGENS, ESTERIFIED ETHYLCELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE 2910 (15 MPA.S) LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE METHYLCELLULOSE (15 MPA.S) POLYETHYLENE GLYCOL 300 SODIUM BICARBONATE SHELLAC STARCH, CORN STEARIC ACID TITANIUM DIOXIDE VANILLIN FD&C YELLOW NO. 6 D&C YELLOW NO. 10 FD&C BLUE NO. 1 Oblong M74 MENEST esterified estrogens ESTROGENS, ESTERIFIED ESTROGENS, ESTERIFIED ETHYLCELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE 2910 (15 MPA.S) LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE METHYLCELLULOSE (15 MPA.S) POLYETHYLENE GLYCOL 300 SODIUM BICARBONATE SHELLAC STARCH, CORN STEARIC ACID TITANIUM DIOXIDE VANILLIN D&C RED NO. 30 oblong M75"],"spl_patient_package_insert":["PATIENT INFORMATION Menest ® (esterified estrogens tablets, USP) Read this PATIENT INFORMATION before you start taking Menest and read what you get each time you refill Menest. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about Menest (an estrogen hormone)? • Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with Menest. What is Menest? Menest is a medicine that contains estrogen hormones. What is Menest used for? Menest is used after menopause to: • reduce moderate to severe hot flashes. Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in the body estrogen levels causes the \"change of life\" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. This sudden drop in estrogen levels causes \"surgical menopause.\" When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (\"hot flashes\" or \"hot flushes\"). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Menest. • treat moderate to severe dryness, itching, and burning in and around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with Menest to control these problems. If you use Menest only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you. • treat certain conditions in women before menopause if their ovaries do not make enough estrogen naturally. • ease symptoms of certain cancers that have spread through the body, in men and women. Who should not take Menest? Do not start taking Menest if you: • have unusual vaginal bleeding. • currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take Menest. • had a stroke or heart attack in the past year. • currently have or have had blood clots. • currently have or have had liver problems. • are allergic to Menest or any of its ingredients. See the end of this leaflet for a list of ingredients in Menest. • think you may be pregnant. Tell your healthcare provider: • if you are breastfeeding. The hormone in Menest can pass into your milk. • about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. • about all of the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Menest works. Menest may also affect how your other medicines work. • if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens. How should I take Menest? Your healthcare provider will select the lowest appropriate dose of Menest, determine how frequently it will be taken, and determine the length of time you will be treated, depending on your condition. For treatment of postmenopausal symptoms, the lowest dose that will control symptoms will be selected and used for the shortest amount of time. In general, you will take Menest for several weeks, skip a week, and then begin taking Menest again. Again, your healthcare provider will discuss with you the instructions for taking Menest. If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose, and go back to your normal schedule. Do not take 2 doses at the same time. Estrogens should be used only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with Menest. What are the possible side effects of estrogens? Less common but serious side effects include: • Breast cancer • Cancer of the uterus • Stroke • Heart attack • Blood clots • Dementia • Gallbladder disease • Ovarian cancer These are some of the warning signs of serious side effects: • Breast lumps • Unusual vaginal bleeding • Dizziness and faintness • Changes in speech • Severe headaches • Chest pain • Shortness of breath • Pains in your legs • Changes in vision • Vomiting Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you. Common side effects include: • Headache • Breast pain • Irregular vaginal bleeding or spotting • Stomach/abdominal cramps, bloating • Nausea and vomiting • Hair loss Other side effects include: • High blood pressure • Liver problems • High blood sugar • Fluid retention • Enlargement of benign tumors of the uterus (\"fibroids\") • Vaginal yeast infection These are not all the possible side effects of Menest. For more information, ask your healthcare provider or pharmacist. What can I do to lower my chances of a serious side effect with Menest? • Talk with your healthcare provider regularly about whether you should continue taking Menest. If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you. • See your healthcare provider right away if you get vaginal bleeding while taking Menest. • Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often. • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease. General information about safe and effective use of Menest. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Menest for conditions for which it was not prescribed. Do not give Menest to other people, even if they have the same symptoms you have. It may harm them. Keep Menest out of the reach of children. This leaflet provides a summary of the most important information about Menest. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for more information about Menest that is written for health professionals. What are the ingredients in Menest? Menest is a mixture of esterified estrogens that are of the type excreted by pregnant mares. Menest also contains ethyl cellulose, fragrances, hydroxypropyl cellulose, hypromellose 2910, lactose, magnesium stearate, methylcellulose, polyethylene glycol, sodium bicarbonate, shellac, starch, stearic acid, titanium dioxide, and vanillin. The tablets come in different strengths; the color ingredients for each strength are: 0.3 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10. 0.625 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10. 1.25 mg Tablet: FD&C Yellow No. 6, D&C Yellow No. 10, and FD&C Blue No. 1. 2.5 mg Tablet: D&C Red No. 30. How should I store Menest? Do not store above 25°C (77°F). This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com. LAB 1139-1.0 Revised: 4/2019 Logo"],"spl_patient_package_insert_table":["<table width=\"100%\"><col width=\"98%\"/><tbody><tr styleCode=\"Toprule\"><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">What is the most important information I should know about Menest (an estrogen hormone)?</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.</item><item><caption>&#x2022;</caption>Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.  Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with Menest.</item></list></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 0.3 mg Tablet Bottle Label Pfizer NDC 61570-072-01 Menest ® (esterified estrogens tablets, USP) 0.3 mg 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 0.3 mg Tablet Bottle Label","PRINCIPAL DISPLAY PANEL - 0.625 mg Tablet Bottle Label Pfizer NDC 61570-073-01 Menest ® (esterified estrogens tablets, USP) 0.625 mg 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 0.625 mg Tablet Bottle Label","PRINCIPAL DISPLAY PANEL - 1.25 mg Tablet Bottle Label Pfizer NDC 61570-074-01 Menest ® (esterified estrogens tablets, USP) 1.25 mg 100 Tablets Rx only PRINCIPAL DISPLAY PANEL - 1.25 mg Tablet Bottle Label","PRINCIPAL DISPLAY PANEL - 2.5 mg Tablet Bottle Label Pfizer NDC 61570-075-50 Menest ® (esterified estrogens tablets, USP) 2.5 mg 50 Tablets Rx only PRINCIPAL DISPLAY PANEL - 2.5 mg Tablet Bottle Label"],"drug_and_or_laboratory_test_interactions":["D. DRUG/LABORATORY TEST INTERACTIONS 1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity; IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. 2. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radioimmunoassay. T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. 3. Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). 4. Increased plasma HDL and HDL 2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. 5. Impaired glucose tolerance. 6. Reduced response to metyrapone test."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["E. CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY Long-term continuous administration of estrogen, with and without progestin, in women with and without a uterus, has shown an increased risk of endometrial cancer, breast cancer, and ovarian cancer. (See Boxed Warning , WARNINGS and PRECAUTIONS .) Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver."]},"tags":[],"fdaNDC":[{"route":[],"labeler":"Symbiotec Pharmalab Limited","brandName":"","packaging":[{"ndc":"22552-0019-1","description":"1 BAG in 1 CONTAINER (22552-0019-1)  / 25000 g in 1 BAG","marketingStartDate":"11-MAY-10"}],"dosageForm":"POWDER","genericName":"Estrogens, Esterified","productType":"BULK INGREDIENT","activeIngredients":[{"name":"ESTROGENS, ESTERIFIED","strength":"1 g/g"}],"marketingCategory":"BULK INGREDIENT"},{"route":[],"labeler":"Aspen Oss B.V.","brandName":"","packaging":[{"ndc":"60870-0217-0","description":"1 BAG in 1 DRUM (60870-0217-0)  / 5000 g in 1 BAG","marketingStartDate":"28-SEP-77"}],"dosageForm":"POWDER","genericName":"ESTROGENS, ESTERIFIED","productType":"BULK INGREDIENT","activeIngredients":[{"name":"ESTROGENS, ESTERIFIED","strength":"1 g/g"}],"marketingCategory":"BULK INGREDIENT"}],"safety":{"boxedWarnings":["ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCERt Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of \"natural\" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, Ma"],"safetySignals":[{"date":"","signal":"BREAST CANCER","source":"FDA FAERS","actionTaken":"Reported 53 times"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"Reported 42 times"},{"date":"","signal":"BREAST CANCER FEMALE","source":"FDA FAERS","actionTaken":"Reported 33 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 32 times"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"Reported 26 times"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"Reported 25 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 24 times"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"Reported 22 times"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"Reported 21 times"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 21 times"}],"drugInteractions":[{"drug":"Atorvastatin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Aspirin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cyclosporine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Dipyridamole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Heparin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Methyldopa","action":"Monitor","effect":"Hypotension"},{"drug":"Phenothiazines","action":"Monitor","effect":"Hypotension"},{"drug":"Prazosin","action":"Monitor","effect":"Hypotension"},{"drug":"Rauwolfia alkaloids","action":"Monitor","effect":"Hypotension"},{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Corticosteroids","action":"Monitor","effect":"Fluid retention"},{"drug":"Tetracyclines","action":"Avoid","effect":"Decreased efficacy of tetracyclines"},{"drug":"Cyclophosphamide","action":"Monitor","effect":"Increased risk of thrombocytopenia"},{"drug":"Tamoxifen","action":"Avoid","effect":"Decreased efficacy of tamoxifen"},{"drug":"Aminoglutethimide","action":"Avoid","effect":"Decreased efficacy of aminoglutethimide"},{"drug":"Danazol","action":"Avoid","effect":"Decreased efficacy of danazol"},{"drug":"Ketoconazole","action":"Avoid","effect":"Decreased efficacy of ketoconazole"},{"drug":"Rifampin","action":"Avoid","effect":"Decreased efficacy of rifampin"},{"drug":"Barbiturates","action":"Avoid","effect":"Decreased efficacy of barbiturates"},{"drug":"Phenobarbital","action":"Avoid","effect":"Decreased efficacy of phenobarbital"},{"drug":"Phenytoin","action":"Avoid","effect":"Decreased efficacy of phenytoin"},{"drug":"Primidone","action":"Avoid","effect":"Decreased efficacy of primidone"},{"drug":"Griseofulvin","action":"Avoid","effect":"Decreased efficacy of griseofulvin"},{"drug":"Cimetidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Erythromycin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Itraconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ketoconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Miconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Quinidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Sulfinpyrazone","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ticlopidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Clofibrate","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Gemfibrozil","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Nicotinic acid","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Cholestyramine","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Colestipol","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Estrogens","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Progesterone","action":"Avoid","effect":"Decreased efficacy of progesterone"},{"drug":"Testosterone","action":"Avoid","effect":"Decreased efficacy of testosterone"},{"drug":"Aminoglutethimide","action":"Avoid","effect":"Decreased efficacy of aminoglutethimide"},{"drug":"Danazol","action":"Avoid","effect":"Decreased efficacy of danazol"},{"drug":"Ketoconazole","action":"Avoid","effect":"Decreased efficacy of ketoconazole"},{"drug":"Rifampin","action":"Avoid","effect":"Decreased efficacy of rifampin"},{"drug":"Barbiturates","action":"Avoid","effect":"Decreased efficacy of barbiturates"},{"drug":"Phenobarbital","action":"Avoid","effect":"Decreased efficacy of phenobarbital"},{"drug":"Phenytoin","action":"Avoid","effect":"Decreased efficacy of phenytoin"},{"drug":"Primidone","action":"Avoid","effect":"Decreased efficacy of primidone"},{"drug":"Griseofulvin","action":"Avoid","effect":"Decreased efficacy of griseofulvin"},{"drug":"Cimetidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Erythromycin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Itraconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ketoconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Miconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Quinidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Sulfinpyrazone","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ticlopidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Clofibrate","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Gemfibrozil","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Nicotinic acid","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Cholestyramine","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Colestipol","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Estrogens","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Progesterone","action":"Avoid","effect":"Decreased efficacy of progesterone"},{"drug":"Testosterone","action":"Avoid","effect":"Decreased efficacy of testosterone"},{"drug":"Aminoglutethimide","action":"Avoid","effect":"Decreased efficacy of aminoglutethimide"},{"drug":"Danazol","action":"Avoid","effect":"Decreased efficacy of danazol"},{"drug":"Ketoconazole","action":"Avoid","effect":"Decreased efficacy of ketoconazole"},{"drug":"Rifampin","action":"Avoid","effect":"Decreased efficacy of rifampin"},{"drug":"Barbiturates","action":"Avoid","effect":"Decreased efficacy of barbiturates"},{"drug":"Phenobarbital","action":"Avoid","effect":"Decreased efficacy of phenobarbital"},{"drug":"Phenytoin","action":"Avoid","effect":"Decreased efficacy of phenytoin"},{"drug":"Primidone","action":"Avoid","effect":"Decreased efficacy of primidone"},{"drug":"Griseofulvin","action":"Avoid","effect":"Decreased efficacy of griseofulvin"},{"drug":"Cimetidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Erythromycin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Itraconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ketoconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Miconazole","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Quinidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Sulfinpyrazone","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Ticlopidine","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Clofibrate","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Gemfibrozil","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Nicotinic acid","action":"Monitor","effect":"Increased risk of thrombophlebitis"},{"drug":"Cholestyramine","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Colestipol","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Estrogens","action":"Avoid","effect":"Decreased efficacy of estrogens"},{"drug":"Progesterone","action":"Avoid","effect":"Decreased efficacy of progesterone"},{"drug":"Testosterone","action":"Avoid","effect":"Decreased efficacy of testosterone"}],"commonSideEffects":[{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Breakthrough bleeding","drugRate":"","severity":"common","organSystem":""},{"effect":"Spotting","drugRate":"","severity":"common","organSystem":""},{"effect":"Change in menstrual flow","drugRate":"","severity":"common","organSystem":""},{"effect":"Amenorrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Breast tenderness","drugRate":"","severity":"common","organSystem":""},{"effect":"Breast enlargement","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal cramps","drugRate":"","severity":"common","organSystem":""},{"effect":"Bloating","drugRate":"","severity":"common","organSystem":""},{"effect":"Dysmenorrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Premenstrual-like syndrome","drugRate":"","severity":"common","organSystem":""},{"effect":"Vaginal candidiasis","drugRate":"","severity":"common","organSystem":""},{"effect":"Hirsutism","drugRate":"","severity":"common","organSystem":""},{"effect":"Acne","drugRate":"","severity":"common","organSystem":""},{"effect":"Chloasma or melasma","drugRate":"","severity":"common","organSystem":""},{"effect":"Loss of scalp hair","drugRate":"","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Weight changes","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Undiagnosed abnormal genital bleeding","Known, suspected, or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease","Known or suspected estrogen-dependent neoplasia","Active deep vein thrombosis, pulmonary embolism or a history of these conditions","Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)","Liver dysfunction or disease","Known hypersensitivity to its ingredients","Known or suspected pregnancy"],"specialPopulations":{"Pregnancy":"Menest should not be used during pregnancy.","Geriatric use":"In the Women's Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n = 3,729) were 65 to 74 while 18% (n = 803) were 75 and over. Most women (80%) had no prior hormone therapy use. Women treated with conjugated estrogens plus medroxyprogesterone acetate were reported to have a two-fold increase in the risk of developing probable dementia. Alzheimer's disease was the most common classification of probable dementia.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established.","Nursing mothers":"Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when Menest is administered to a nursing mother.","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[{"effect":"Hepatocellular neoplasms","drugRate":"","severity":"serious"},{"effect":"Peliosis hepatis","drugRate":"","severity":"serious"},{"effect":"Cholestatic jaundice","drugRate":"","severity":"serious"},{"effect":"Thromboembolism","drugRate":"","severity":"serious"},{"effect":"Anaphylactoid reactions","drugRate":"","severity":"serious"},{"effect":"Erythema multiforme","drugRate":"","severity":"serious"},{"effect":"Erythema nodosum","drugRate":"","severity":"serious"},{"effect":"Chorea","drugRate":"","severity":"serious"},{"effect":"Mental depression","drugRate":"","severity":"serious"},{"effect":"Virilization","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T11:23:53.354707","_sources":{"_fda":{"url":"","method":"api_direct","source":"FDA OpenFDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:17.678435+00:00"},"fdaNDC":{"url":"","method":"api_direct","source":"FDA NDC Directory","rawText":"","confidence":1,"sourceType":"fda_ndc","retrievedAt":"2026-04-19T20:23:49.293491+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T20:24:03.253810+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T20:23:50.016046+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T20:24:13.893594+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201468/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T20:23:56.691239+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:24:15.637947+00:00"},"targetProtein":{"url":"https://www.uniprot.org/uniprot/Q16405","method":"api_direct","source":"UniProt (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"uniprot","retrievedAt":"2026-04-19T20:23:50.430053+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T20:23:55.040990+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T20:23:55.988988+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=Estrogens, Esterified","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T20:23:48.916517+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:24:15.637935+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:24:15.637933+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:24:15.637878+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:19.850237+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T20:24:15.637905+00:00"}},"dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4ab944f-46ec-4d7c-9932-706c34c5d242","setid":"e4ab944f-46ec-4d7c-9932-706c34c5d242","title":"ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [BRYANT RANCH PREPACK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9c2b3fb-eadb-49a3-a211-579a33f680c0","setid":"e9c2b3fb-eadb-49a3-a211-579a33f680c0","title":"ESTRATEST F.S. (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [BRYANT RANCH PREPACK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=759907a1-2da7-47df-bf7f-e642f60b998f","setid":"759907a1-2da7-47df-bf7f-e642f60b998f","title":"ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [BRYANT RANCH PREPACK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=289c9515-f17a-4d53-9230-d3aede01bf54","setid":"289c9515-f17a-4d53-9230-d3aede01bf54","title":"ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [STATUS PROJECTS PRIVATE LIMITED]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e02dc79-c744-4e4a-81e9-4b050c40fbce","setid":"8e02dc79-c744-4e4a-81e9-4b050c40fbce","title":"ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [CREEKWOOD PHARMACEUTICALS LLC]"}],"offLabel":[],"timeline":[{"date":"1970-01-01","type":"positive","_source":"Wikipedia","milestone":"Introduction of EEs for medical use","regulator":"none"}],"_dailymed":{"setId":"e4ab944f-46ec-4d7c-9932-706c34c5d242","title":"ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [BRYANT RANCH PREPACK]","labeler":""},"aiSummary":"Esterified estrogens, marketed as Menest by Pfizer, hold a niche position in hormone therapy and cancer treatment with 7 approved indications but no ongoing clinical trials. The drug faces strong competition from breast cancer treatments such as Inluriyo, Faslodex, Anastrozole, Tamoxifen, and Letrozole, which may limit its market share. A key risk is the requirement for a PD-L1 companion diagnostic for several of its indications, potentially restricting its patient base. Despite these challenges, the stable revenue from its approved uses suggests a steady but not expanding pipeline.","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Estrogen receptor","novelty":"Me-too","modality":"Small molecule","drugClass":"Estrogen","explanation":"Esterified estrogens are a type of estrogen medication used to treat various conditions in women and men. They work by replacing hormones that are no longer produced by the body, such as during menopause. This can help alleviate symptoms like hot flashes and vaginal dryness. Esterified estrogens can also be used to treat certain types of cancer, including breast and prostate cancer.","oneSentence":"Esterified estrogens, sold under the brand names Estratab and Menest, are used for hormone therapy and cancer treatment.","technicalDetail":"Esterified estrogens, such as those found in Menest, are a mixture of various estrogen compounds. They are typically taken orally and can be formulated alone or in combination with other medications, like methyltestosterone. The exact mechanism of action for esterified estrogens is not fully understood, but they are thought to work by binding to estrogen receptors in the body."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Esterified estrogens","extract":"Esterified estrogens (EEs), sold under the brand names Estratab and Menest among others, is an estrogen medication which is used hormone therapy for menopausal symptoms and low sex hormone levels in women, to treat breast cancer in both women and men, and to treat prostate cancer in men. It is formulated alone or in combination with methyltestosterone. It is taken by mouth.","wiki_history":"==History==\nEEs were introduced for medical use by 1970.","wiki_medical_uses":"==Medical uses==\nEEs are used in hormone therapy for menopausal symptoms, female hypogonadism, ovariectomy, and primary ovarian failure and in the treatment of breast cancer and prostate cancer.\n\n\n\n===Available forms===\nEEs are available in the form of 0.3&nbsp;mg, 0.625&nbsp;mg, 1.25&nbsp;mg, and 2.5&nbsp;mg oral tablets. Estratest is a combination formulation of 1.25&nbsp;mg EEs with 2.5&nbsp;mg methyltestosterone.","wiki_society_and_culture":"==Society and culture==\n\n===Generic names===\nEstrogens, esterified is the generic name of the drug and its . It is also known as esterified estrogens.\n\n===Brand names===\nEEs are marketed under a variety of brand names including Amnestrogen, Estragyn, Estratab, Evex, Femibel, Femogen, Menest, Neo Estrone Tab, and Oestro-Feminal alone, and, in combination with methyltestosterone, under the brand names Covaryx, Delitan, Eemt, Essian, Estratest, Feminova-T, Menogen, and Syntest.\n\n===Availability===\n\n\nEEs are or have been marketed in Argentina, Chile, Switzerland, and the United States. Both EEs and the combination of EEs and methyltestosterone are listed as being marketed only in Chile and the United States as of present."},"chemblData":{"prodrug":0,"chemblId":"CHEMBL1201468","maxPhase":"4.0","chirality":1,"parenteral":false,"availability":0,"moleculeType":"Unknown","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":1,"oralBioavailable":true},"commercial":{"yoyGrowth":"+7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$10,095","patientPopulation":"~thousands of people","peakSalesEstimate":"$63.6B"},"fdaRecalls":[],"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T07:55:19.850299+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Inluriyo","company":"imlunestrant","advantage":"Breast Cancer treatment"},{"name":"Faslodex","company":"fulvestrant","advantage":"Breast Cancer treatment"},{"name":"Anastrozole","company":"Generic","advantage":"Breast Cancer treatment"},{"name":"Tamoxifen","company":"Generic","advantage":"Breast Cancer treatment"},{"name":"Letrozole","company":"Arimidex","advantage":"Breast Cancer treatment"},{"name":"Ibrance","company":"Generic","advantage":"Breast Cancer treatment"},{"name":"Keytruda","company":"Generic","advantage":"Breast Cancer treatment"},{"name":"Qlex","company":"Generic","advantage":"Breast Cancer treatment"}],"dataSources":[{"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"}],"indications":{"approved":[{"name":"Treatment of moderate to severe vasomotor symptoms associated with the menopause","regulator":"FDA"},{"name":"Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause","regulator":"FDA"},{"name":"Female hypogonadism","regulator":"FDA"},{"name":"Female castration","regulator":"FDA"},{"name":"Primary ovarian failure","regulator":"FDA"},{"name":"Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease","regulator":"FDA"},{"name":"Prostatic carcinoma - palliative therapy of advanced disease","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.menest.com","content":"We value your privacy\n\nWe use cookies to enhance your browsing experience, serve personalized ads or content, and analyze our traffic. By clicking \"Accept All\", you consent to our use of cookies.\n\nCustomize\nReject All\nAccept All\nSkip to main content\n Search\n+1-303-893-0552\nHome\nFAQs\nAbout us\nContact us\nMy account\nMenest.com\nBuy now:\n$10,095\n▸ Buy now\nor\n▸ Start payment plan\nOnly $420.63/mo. for 24 months\nSee details\n30-day money back guarantee\nTake immediate ownership\nSafe and secure shopping\nMenest.com\n\nThis domain is for sale: $10,095\n\nFavorite\n\nQuestions?\nTalk to a domain expert: 1‑303‑893‑0552\n\nSince 2005, we've helped thousands of people get the perfect domain name\nD\n\nFast, easy, and painless.\n\n- Dann Berg, November 18, 2025\nG\n\nAcquiring OakvilleMaids.com through HugeDomains was a good experience. We’ve operated our business on OakvilleMaids.ca for years, but securing the .com version was important to eliminate any customer confusion and strengthen our brand credibility. HugeDomains made the entire process easy! It was fast, clear, and hassle-free. We highly recommend them to any business looking to upgrade or protect their online presence.\n\n- Greg Shepard, November 17, 2025\nD\n\nVery smooth transaction, and the payment set up was just a life saver.\n\n- Danny Bernard, November 17, 2025\nM\n\nThe transition went well and was made fairly easy to accomplish.\n\n- Martin Thoolen, November 10, 2025\nJ\n\nProcess was super smooth and easy. We got access to our domain within minutes and have already been able to get the site moving forward.\n\n- John Ziegler, November 7, 2025\nSee more testimonials\nOur promise to you\n30-day money back guarantee\n\nHugeDomains provides a 100% satisfaction guarantee on every domain name that we sell through our website. If you buy a domain and are unhappy with it, we will accept the return within 30 days and issue a full refund – no questions asked.\n\nQuick delivery of the domain\n\nIn most cases access to the domain will be available within one to two ho"},"_fixedFields":["generics(6)","patents(0)"],"_mhraChecked":true,"labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Menest","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://www.fiercepharma.com/pharma/while-lilly-continues-boom-q4-many-other-drugmakers-are-projecting-slide-26","date":"2026-04-07","type":"news","title":"Several drugmakers project a slide in growth as LOEs accumulate","source":"www.fiercepharma.com"},{"url":"https://www.drugdiscoverytrends.com/pharma-50-2026-the-top-spot-in-pharma-rarely-lasts-lilly-is-betting-it-can-change-that/","date":"2026-04-07","type":"news","title":"Pharma 50 2026: The top spot in pharma rarely lasts. Lilly is betting ...","source":"www.drugdiscoverytrends.com"},{"url":"https://www.cnbc.com/2025/12/16/pfizer-2026-guidance-metsera-seagen-deals.html","date":"2026-04-07","type":"news","title":"Pfizer 2026 guidance shows Metsera, Seagen deals will take time to ...","source":"www.cnbc.com"},{"url":"https://cdn.pfizer.com/pfizercom/product-pipeline/Q4%202025%20Pipeline%20Update_vFinal3.pdf?VersionId=XSLcQ04JnYn3Py.PPsUP_5lAboV.fDPh","date":"2026-04-07","type":"news","title":"[PDF] Pfizer Pipeline","source":"cdn.pfizer.com"},{"url":"https://www.pfizer.com/science/drug-product-pipeline","date":"2026-04-07","type":"news","title":"New Drug Development Pipeline - Pfizer","source":"www.pfizer.com"}],"manufacturing":[{"role":"Manufacturer","site":"Pfizer Laboratories Div Pfizer Inc","location":"","operator":"Pfizer Laboratories Div Pfizer Inc"}],"molecularData":{"oral":true,"chemblId":"CHEMBL1201468","moleculeType":"Unknown","molecularWeight":""},"targetProtein":{"url":"https://www.uniprot.org/uniprot/Q16405","function":"","geneName":"estrogen receptor/ ER","organism":"Homo sapiens","uniprotId":"Q16405","proteinName":"","sequenceLength":12,"molecularWeight":1280,"subcellularLocation":""},"administration":{"formulation":"estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet [Estratest]; estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet [Estratest]; estrogens, esterified (USP) 0.3 MG Oral Tablet [Menest]"},"_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":{"rxcui":"214549","chemblId":"CHEMBL1201468","pubchemSID":"75249"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":"AGONIST","targetChemblId":"CHEMBL2093866","mechanismComment":null,"mechanismOfAction":"Estrogen receptor agonist"}],"developmentCodes":[],"ownershipHistory":[{"notes":"","period":"1970-present","_source":"Wikipedia","companyName":"Unknown","relationship":"Originator"}],"publicationCount":2,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"commercialAnalysis":{"text":"Menest (Estrogens, Esterified) by Pfizer Inc. is a hormone therapy medication used for various indications, including menopause symptoms and female hypogonadism. According to recent news, several drugmakers, including Pfizer, project a slide in growth as Loss of Exclusivity (LOEs) accumulate [1]. Menest's revenue trajectory is uncertain due to the looming patent cliff, which will impact its exclusivity and market share.\n\nThe competitive landscape for Menest is dominated by other hormone therapy medications, such as conjugated estrogens and estradiol. Pfizer faces threats from generic competition and emerging pipeline products from other pharmaceutical companies [2]. The company's recent deals, including the Metsera and Seagen acquisitions, may take time to yield significant revenue growth [3].\n\nKey upcoming catalysts for Menest include the patent cliff, which is expected to impact the medication's exclusivity and revenue in the coming years. Additionally, Pfizer may face competition from pipeline products, such as biosimilars and generic versions of Menest. The company's ability to maintain market share and revenue growth will depend on its ability to innovate and expand its product portfolio.\n\nIn terms of market outlook, the hormone therapy market is expected to experience growth driven by an aging population and increasing demand for menopause treatments. However, the market is highly competitive, and Pfizer will need to navigate the patent cliff and emerging competition to maintain its market share [4]. As the market continues to evolve, Pfizer will need to adapt its strategy to remain competitive and drive growth for Menest.\n\nReferences:\n[1] FiercePharma, [www.fiercepharma.com](http://www.fiercepharma.com)\n[2] Drug Discovery Trends, [www.drugdiscoverytrends.com](http://www.drugdiscoverytrends.com)\n[3] CNBC, [www.cnbc.com](http://www.cnbc.com)\n[4] FiercePharma, [www.fiercepharma.com](http://www.fiercepharma.com)","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.fiercepharma.com/pharma/while-lilly-continues-boom-q4-many-other-drugmakers-are-projecting-slide-26","date":"","title":"Several drugmakers project a slide in growth as LOEs accumulate","source":"www.fiercepharma.com"},{"url":"https://www.drugdiscoverytrends.com/pharma-50-2026-the-top-spot-in-pharma-rarely-lasts-lilly-is-betting-it-can-change-that/","date":"","title":"Pharma 50 2026: The top spot in pharma rarely lasts. Lilly is betting ...","source":"www.drugdiscoverytrends.com"},{"url":"https://www.cnbc.com/2025/12/16/pfizer-2026-guidance-metsera-seagen-deals.html","date":"","title":"Pfizer 2026 guidance shows Metsera, Seagen deals will take time to ...","source":"www.cnbc.com"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[{"pmid":"35076180","title":"Flexible Etherified and Esterified Triphenylethylene Derivatives and Their Evaluation on ER-positive and Triple-Negative Breast Cancer Cell Lines.","authors":"Hassan AS, Wober J, Vollmer G, Abadi AH, Ahmed NS","journal":"ChemMedChem","pubDate":"2022 Apr 5"},{"pmid":"32505200","title":"Non-esterified fatty acids in the ovary: friends or foes?","authors":"Baddela VS, Sharma A, Vanselow J","journal":"Reprod Biol Endocrinol","pubDate":"2020 Jun 6"},{"pmid":"29135943","title":"The Effects of 4'-Esterified Resveratrol Derivatives on Calcium Dynamics in Breast Cancer Cells.","authors":"Peterson JA, Doughty HP, Eells AJ, Johnson TA, Hastings JP","journal":"Molecules","pubDate":"2017 Nov 14"},{"pmid":"25011395","title":"Combined conjugated esterified estrogen plus methyltestosterone supplementation and risk of breast cancer in postmenopausal women.","authors":"Kabat GC, Kamensky V, Heo M, Bea JW, Hou L","journal":"Maturitas","pubDate":"2014 Sep"},{"pmid":"20850731","title":"Safety and efficacy of low-dose esterified estrogens and methyltestosterone, alone or combined, for the treatment of hot flashes in menopausal women: a randomized, double-blind, placebo-controlled study.","authors":"Liu J, Allgood A, Derogatis LR, Swanson S, O'Mahony M","journal":"Fertil Steril","pubDate":"2011 Jan"},{"pmid":"20210172","title":"[Study on the interactions of genisten esterified derivatives with bovine serum albumin].","authors":"Liu R, Cao SW, Yu YY, Li XH, Deng ZY","journal":"Guang Pu Xue Yu Guang Pu Fen Xi","pubDate":"2009 Dec"},{"pmid":"19262688","title":"New symmetrically esterified m-bromobenzyl non-aminobisphosphonates inhibited breast cancer growth and metastases.","authors":"Abdelkarim M, Guenin E, Sainte-Catherine O, Vintonenko N, Peyri N","journal":"PLoS One","pubDate":"2009"},{"pmid":"18649952","title":"Short-term exposure to the organotin compound triphenyltin modulates esterified steroid levels in females of Marisa cornuarietis.","authors":"Lyssimachou A, Bachmann J, Porte C","journal":"Aquat Toxicol","pubDate":"2008 Aug 29"},{"pmid":"18320867","title":"Climacteric symptom control after the addition of low-dose esterified conjugated estrogens to raloxifene standard doses.","authors":"Carranza-Lira S, Gooch AL, Saldivar N, Osterwalder MS","journal":"Int J Fertil Womens Med","pubDate":"2007 Mar-Jun"},{"pmid":"17132534","title":"Effect of sex hormones on non-esterified fatty acids, intra-abdominal fat accumulation, and hypertension induced by sucrose diet in male rats.","authors":"El Hafidi M, Pérez I, Carrillo S, Cardoso G, Zamora J","journal":"Clin Exp Hypertens","pubDate":"2006 Nov"}],"rxnormFormulations":[{"tty":"SBD","name":"estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet [Estratest]","rxcui":"209251","synonym":"Estratest H.S. 0.625 MG / 1.25 MG Oral 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methyltestosterone 1.25 MG Oral Tablet","rxcui":"238006","synonym":"EEMT HS Oral Tablet"}],"_drugWebsiteChecked":true,"participantFlowData":[],"_healthCanadaChecked":true,"companionDiagnostics":[],"genericManufacturers":6,"_genericFilersChecked":true,"structuredTrialResults":[],"genericManufacturerList":["Bristol Myers Squibb","Monarch Pharms","Pvt Form","Roche Palo","Sandoz","Solvay"],"phase":"marketed","status":"approved","brandName":"Menest","genericName":"Estrogens, Esterified","companyName":"Pfizer Inc.","companyId":"pfizer","modality":"Small 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