Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)
NuCare Pharmaceuticals, Inc.
MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATE 10 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.
Medroxyprogesterone Acetate Tablets USP are available as: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. A 5/2015
Abbreviated New Drug Application
MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET NUCARE PHARMACEUTICALS, INC. ---------- 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 ac Citiți documentul complet