Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Estradiol (UNII: 4TI98Z838E) (Estradiol - UNII:4TI98Z838E), Norethindrone Acetate (UNII: 9S44LIC7OJ) (Norethindrone - UNII:T18F433X4S)
Physicians Total Care, Inc.
Estradiol
Estradiol 1 mg
ORAL
PRESCRIPTION DRUG
Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the: - Treatment of moderate to severe vasomotor symptoms associated with menopause. - 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 non-estrogen medications should be carefully considered. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg is also in
Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg are white, convex, coated tablets debossed with "B" on one side and "474" on the other side (NDC 54868-4677-0). Estradiol/Norethindrone Acetate Tablets are supplied as: 28 tablets in a calendar blister pack dispenser. Store in a dry place protected from light. Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
ESTRADIOL / NORETHINDRONE ACETATE - ESTRADIOL AND NORETHINDRONE ACETATE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- ESTRADIOL/NORETHINDRONE ACETATE TABLETS 1.0 mg/0.5 mg 0.5 mg/0.1 mg RX ONLY 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 plus progestin substudy of the Women's Health Initiative (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 estrogen-alone substudy of the 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) per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS.) The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg and during 5.2 years of treatment with CE 0.625 mg alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES, WARNINGS, DEMENTIA and PRECAUTIONS, GERIATRIC USE.) Other doses of oral 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. Baca dokumen lengkapnya