البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G) (MEDROXYPROGESTERONE - UNII:HSU1C9YRES)
REMEDYREPACK INC.
MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATE 10 mg
ORAL
PRESCRIPTION DRUG
Medroxyprogesterone acetate tablets 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. MPA tablets 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 MPA. - Known liver impairment or disease. - Known or suspected pregnancy.
Medroxyprogesterone acetate tablets are available in the following strengths and package sizes: 2.5 mg tablets Bottles of 100: NDC 59762-3740-1 (scored, round, orange, imprinted G3740) Bottles of 100: NDC 59762-0055-1 (scored, round, orange, imprinted PROVERA 2.5) Bottles of 1000: NDC 59762-3740-5 (scored, round, orange, imprinted G3740) Bottles of 1000: NDC 59762-0055-2 (scored, round, orange, imprinted PROVERA 2.5) 5 mg tablets Bottles of 100: NDC 59762-3741-1 (scored, hexagonal, white, imprinted G3741) Bottles of 100: NDC 59762-0058-1 (scored, round, blue, imprinted PROVERA 5) Bottles of 1000: NDC 59762-3741-4 (scored, hexagonal, white, imprinted G3741) Bottles of 1000: NDC 59762-0058-2 (scored, round, blue, imprinted PROVERA 5) 10 mg tablets Bottles of 100: NDC 59762-3742-2 (scored, round, white, imprinted G3742) Bottles of 100: NDC 59762-0056-1 (scored, round, white, imprinted PROVERA 10) Bottles of 1000: NDC 59762-3742-8 (scored, round, white, imprinted G3742) Bottles of 1000: NDC 59762-0056-2 (scored, round, white, imprinted PROVERA 10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. "Keep out of reach of children"
New Drug Application Authorized Generic
MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET REMEDYREPACK INC. ---------- MEDROXYPROGESTERONE ACETATE TABLETS, USP 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 contain medroxyprogesterone acetate, which is a derivative of progeste اقرأ الوثيقة كاملة