Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)
Teva Pharmaceuticals USA, 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: 1. Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. 2. Undiagnosed abnormal genital bleeding. 3. Known, suspected, or history of breast cancer. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6. Known liver dysfunction or disease. 7. Known or suspected pregnancy.
Progesterone Capsules, 100 mg are available as oval, soft gelatin, peach opaque capsules filled with white to off-white suspension imprinted in black ink “TV” over “A18”, containing 100 mg of micronized progesterone USP, packaged in bottles of 100 capsules (NDC 0093-5353-01). Progesterone Capsules, 200 mg are available as oval, soft gelatin, pale yellow opaque capsules filled with white to off-white suspension imprinted in black ink “TV” over “A19”, containing 200 mg of micronized progesterone USP, packaged in bottles of 100 capsules (NDC 0093-5354-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured By: CATALENT PHARMA SOLUTIONS St. Petersburg, FL 33716 Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. B 5/2016
Abbreviated New Drug Application
PROGESTERONE- PROGESTERONE CAPSULE, LIQUID FILLED TEVA PHARMACEUTICALS USA, INC. ---------- PROGESTERONE CAPSULES 5353 5354 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 capsules contain micronized progesterone USP for oral administration. Progesterone (pregn-4-ene- Olvassa el a teljes dokumentumot