Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)
AvKARE, Inc.
PROGESTERONE
PROGESTERONE 100 mg
ORAL
PRESCRIPTION DRUG
Progesterone 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 capsules should not be used in women with any of the following conditions: - Progesterone capsules should not be used in patients with known hypersensitivity to itsingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of breast cancer. - Active deep vein thrombosis, pulmonary embolism or history of these conditions. - Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. - Known liver dysfunction or disease. - Known or suspected pregnancy.
Progesterone, capsules 100 mg are available as an oval orange, opaque, capsule imprinted with P-1 in black ink. NDC 42291-690-01 (Bottle of 100). Progesterone, capsules 200 mg are available as an oval red, opaque, capsule imprinted with P-2 in black ink. NDC 42291-691-01 (Bottle of 100). Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature] Protect from excessive moisture Keep out of reach of children. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 AV 08/14 Manufactured by: Banner Pharmacaps Inc. High Point, NC 27265 July 2012
Abbreviated New Drug Application
PROGESTERONE- PROGESTERONE CAPSULE AVKARE, INC. ---------- PROGESTERONE CAPSULES BOXED WARNING 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 STUDIESand 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 weight of 314.47 and a molecular Lire le document complet