Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ESTROGENS, ESTERIFIED (UNII: 3ASP8Q3768) (ESTROGENS, ESTERIFIED - UNII:3ASP8Q3768), METHYLTESTOSTERONE (UNII: V9EFU16ZIF) (METHYLTESTOSTERONE - UNII:V9EFU16ZIF)
Seton Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets are indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) - Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus. Esterified Estrogens and Methyltestosterone Full and Hall-Strength Tablets should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast - Known or suspected estrogen-dependent neoplasia - Active deep vein thrombosis, pulmonary embolism or history of these conditions. - Active or recent (e.g., within the past year) ar
Esterified Estrogens and Methyltestosterone Tablets, a combination of Esterified Estrogens and Methyltestosterone. Each green, oval, aqueous film coated tablet debossed "IP 78" on obverse and plain on the reverse contains: 1.25 mg of Esterified Estrogens USP, and 2.5 mg of Methyltestosterone, USP. Available in bottles of 100: NDC 13925- 181-01 Esterified Estrogens and Methyltestosterone Half-Strength Tablets, a combination of Esterified Estrogens and Methyltestosterone. Each light blue, capsule-shaped, aqueous film coated tablet debossed "IP 77" on obverse and plain on the reverse contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Available in bottles of 100: NDC 13925-180-01
unapproved drug other
ESTERIFIED ESTROGEN AND METHYLTESTOSTERONE- ESTERIFIED ESTROGEN AND METHYLTESTOSTERONE TABLET SETON PHARMACEUTICALS _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 ESTROGEN AND METHYLTESTOSTERONE ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLETS R ONLY CONTROLLED SUBSTANCE III 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, CLINICAL STUDIES.) Other Soma hati kamili