Monograph Details
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Ob/Gyn
> Menopause and HRT
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PROVERA |
| Manufacturer |
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Pfizer Labs |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Progestin. |
| Generic Name |
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Medroxyprogesterone acetate 2.5mg, 5mg, 10mg; scored tabs. |
| Indications |
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To prevent endometrial hyperplasia in postmenopausal women with an intact uterus receiving conjugated estrogens. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance without organic pathology. |
| Children |
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Not applicable. |
| Adults |
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Endometrial hyperplasia prophylaxis: 5–10mg daily for 12–14 days per month starting on Day 1 or Day 16. Amenorrhea: 5–10mg daily for 5–10 days; to induce optimum secretory transformation of primed endometrium: 10mg daily for 10 days; may start at any time. Abnormal bleeding: 5–10mg daily for 5–10 days starting on Day 16 or 21 of menstrual cycle; to induce optimum secretory transformation of primed endometrium: 10mg daily for 10 days starting on Day 16. |
| Contraindications |
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Thromboembolic disorders. Thrombophlebitis. Cerebral apoplexy. Hepatic dysfunction or disease. Undiagnosed vaginal bleeding. Breast or genital carcinoma. Missed abortion. As a diagnostic test for pregnancy. Pregnancy (Cat.X). |
| Precautions |
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Conditions aggravated by fluid retention. Diabetes. Depression. Pretreatment exam should include Pap smear. Discontinue if jaundice, visual disturbances, migraine, or thrombotic disorders occur. Nursing mothers. |
| Adverse Reactions |
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Thromboembolic events, edema, weight or menstrual or cervical changes, cholestatic jaundice, depression, pyrexia, insomnia, nausea, somnolence, mastodynia, galactorrhea, acne, hirsutism, alopecia, rash. |
| How Supplied |
Tabs 2.5mg, 5mg—30, 100
10mg—30, 100, 500 |
| Additional Resources |
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• Related Prescribing Note |
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