Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ESTROGENS, ESTERIFIED (UNII: 3ASP8Q3768) (ESTROGENS, ESTERIFIED - UNII:3ASP8Q3768), METHYLTESTOSTERONE (UNII: V9EFU16ZIF) (METHYLTESTOSTERONE - UNII:V9EFU16ZIF)
ANI Pharmaceuticals, Inc.
ESTROGENS, ESTERIFIED
ESTROGENS, ESTERIFIED 1.25 mg
ORAL
PRESCRIPTION DRUG
Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are indicated in the: Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets should not be used in women with any of the following conditions: Methyltestosterone should not be used in: Methyltestosterone is classified as a schedule III Controlled Substance under the Anabolic Steroids Act of 1990.
Esterified Estrogens and Methyltestosterone Tablets (Imprinted “1490”) Bottles of 100 ……………………………………………………..NDC 62559-149-01 Esterified Estrogens and Methyltestosterone Tablets (dark green, capsule shaped, sugar-coated oral tablets) contain: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. Esterified Estrogens and Methyltestosterone Half-Strength Tablets (Imprinted “1507”) Bottles of 100 ……………………………………………………..NDC 62559-150-01 Esterified Estrogens and Methyltestosterone Half-Strength Tablets (light green, capsule shaped, sugar-coated oral tablets) contain: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Keep Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Half-Strength Tablets out of reach of children . Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature] † This product has not obtained FDA pre-market approval applicable for new drugs.
unapproved drug other
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE- ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET ANI PHARMACEUTICALS, INC. _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS, 1.25 MG/2.5 MG ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS, 0.625 MG/1.25 MG (HALF-STRENGTH) CIII ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER 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 or 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, CLINI Citiți documentul complet