Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (ESTROGENS, CONJUGATED - UNII:IU5QR144QX)
Physicians Total Care, Inc.
ESTROGENS, CONJUGATED
ESTROGENS, CONJUGATED 0.3 mg
ORAL
PRESCRIPTION DRUG
PREMARIN therapy is indicated in the: - Treatment of moderate to severe vasomotor symptoms due to menopause. - Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. - Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). - Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL STUDIES .) The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-b
PREMARIN® (conjugated estrogens tablets, USP) The appearance of these tablets is a trademark of Wyeth Pharmaceuticals. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP.
New Drug Application
PREMARIN - CONJUGATED ESTROGENS TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- RX ONLY WARNINGS ENDOMETRIAL CANCER 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. (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 daily oral conjugated estrogens (CE 0.625 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS.) The estrogen plus progestin substudy of WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), 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, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, DEMENTIA and PRECAUTIONS, GERIATRIC USE.) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosa Прочитајте комплетан документ