Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)
Bryant Ranch Prepack
MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATE 5 mg
ORAL
PRESCRIPTION DRUG
Medroxyprogesterone Acetate Tablets USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets. Medroxyprogesterone acetate is contraindicated in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of breast cancer. - Known or suspected estrogen- or progesterone-dependent neoplasia. - Active DVT, PE, or a history of these conditions - Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. - Known anaphylactic reaction or angioedema to medroxyprogesterone acetate. - Known liver impairment or disease. - Known or suspected pregnancy.
Product: 63629-2614 NDC: 63629-2614-1 30 TABLET in a BOTTLE NDC: 63629-2614-2 100 TABLET in a BOTTLE NDC: 63629-2614-3 60 TABLET in a BOTTLE NDC: 63629-2614-4 7 TABLET in a BOTTLE NDC: 63629-2614-5 10 TABLET in a BOTTLE Product: 63629-6812
Abbreviated New Drug Application
MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET BRYANT RANCH PREPACK ---------- MEDROXYPROGESTERONE ACETATE TABLETS USP 0872 0873 0779 RX ONLY WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (SEE CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DISORDERS and PROBABLE DEMENTIA.) The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (SEE CLINICAL STUDIES and WARNINGS, CARDIOVASCULAR DIS ORDERS .) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older 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,PROBABLE DEMENTIA and PRECAUTIONS,GERIATRIC USE.) BREAST CANCER The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, MALIGNANT NEOPLASM,BREAST CANCER.) 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 dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. DESCRIPTION Medroxyprogesterone Acetate Tablets USP contain medroxyprogesterone acetate, USP whi Διαβάστε το πλήρες έγγραφο