देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)
Virtus Pharmaceuticals
Progesterone
Progesterone 100 mg
ORAL
PRESCRIPTION DRUG
Progesterone, USP Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea. Progesterone, USP Capsules should not be used in women with any of the following conditions:
Progesterone, USP Capsules 100 mg are round, peach-colored capsules branded with black imprint "SV." NDC 69543-374-10 (Bottle of 100) Progesterone, USP Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint "SV2." NDC 69543-375-10 (Bottle of 100) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Keep out of reach of children.
New Drug Application
PROGESTERONE- PROGESTERONE CAPSULE VIRTUS PHARMACEUTICALS ---------- PROGESTERONE, USP CAPSULES 100 MG CAPSULES 200 MG RX ONLY WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA Estrogens 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 increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction 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 of the WHI 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 US E.) BREAST CANCER The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, MALIGNANT NEOPLASMS, 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 Progesterone, USP Capsules contain micronized progesterone for oral administration. Progesterone has a molecular w पूरा दस्तावेज़ पढ़ें