国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ESTROGENS, CONJUGATED SYNTHETIC B (UNII: 8L6LAK9BTR) (ESTROGENS, CONJUGATED SYNTHETIC B - UNII:8L6LAK9BTR)
Physicians Total Care, Inc.
ESTROGENS, CONJUGATED SYNTHETIC B
ESTROGENS, CONJUGATED SYNTHETIC B 0.9 mg
ORAL
PRESCRIPTION DRUG
ENJUVIA tablets are indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with menopause. - Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. When prescribing solely for the treatment of moderate to severe vaginal dryness and pain with intercourse, topical vaginal products should be considered. ENJUVIA 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 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 the ingredients of ENJUVIA Tablets. - Known or suspected pregnancy. There is no indication for ENJUVIA in pregnancy
ENJUVIA® (synthetic conjugated estrogens, B) Tablets 0.3 mg: The tablets are oval, white, film-coated, and debossed with “E” on one side and “1” on the reverse and are available in bottles of: The tablets are oval, pink, film-coated, and debossed with “E” on one side and “3” on the reverse and are available in bottles of: 0.9 mg: The tablets are oval, light blue-green, film-coated, and debossed with “E” on one side and “5” on the reverse and are available in bottles of: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children. Dispense in a tight container with a child-resistant closure. Pharmacist: Include one “Patient Information” leaflet with each prescription. Iss. 3/2010
New Drug Application
ENJUVIA - SYNTHETIC CONJUGATED ESTROGENS, B TABLET PHYSICIANS TOTAL CARE, INC. ---------- ENJUVIA® (SYNTHETIC CONJUGATED ESTROGENS, B) TABLETS 11001651 RX ONLY 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 or dementia. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS and DEMENTIA.) The estrogen alone substudy of the Women’s Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) alone per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS.) The estrogen-plus-progestin substudy of the WHI 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 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. (See CLINICAL STUDIES, and WARNINGS, CARDIOVASCULAR DISORDERS and _MALIGNANT NEOPLASMS, BREAST CANCER_). The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and durin 完全なドキュメントを読む