Monograph Details
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Ob/Gyn
> Menopause and HRT
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PREMPRO 0.625mg/2.5mg |
| Manufacturer |
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Wyeth Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Estrogen + progestin. |
| Generic Name |
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Conjugated estrogens 0.625mg, medroxyprogesterone acetate 2.5mg; tabs. |
| Also |
• PREMPRO 0.3mg/1.5mg
• PREMPRO 0.45mg/1.5mg
• PREMPRO 0.625mg/5mg
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| Indications |
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In women with an intact uterus: moderate to severe vasomotor symptoms associated with menopause; vulvar and vaginal atrophy; osteoporosis prevention (consider alternative treatments). |
| Children |
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Not applicable. |
| Adults |
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Initially 0.3mg/1.5mg once daily; consider dose increase if bleeding is problematic; periodically reassess need for higher dose. |
| Contraindications |
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Breast or estrogen-dependent carcinoma. Undiagnosed abnormal genital bleeding. Pulmonary embolism/DVT (active or history of). Arterial thromboembolism (eg, stroke, MI; active or recent). Hepatic impairment. Missed abortion. Pregnancy (Cat.X). |
| Precautions |
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Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Reevaluate periodically. Gallbladder disease. Hypercalcemia in breast cancer or bone metastases. Conditions aggravated by fluid retention. Familial hyperlipidemia. Hypercoagulation states. Do initial complete physical and repeat at least yearly (include BP, PAP smear, mammogram). Discontinue if cardiovascular events or visual abnormalities occur or are suspected. May interfere with lab tests; see literature. Nursing mothers: not recommended. |
| Adverse Reactions |
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See literature. Increased risk of cardiovascular events, breast cancer (in prolonged use). GI upset, pain, cramps, hepatic impairment, mastodynia, breakthrough bleeding, altered cervical secretion, vaginal infections, edema, worsening of porphyria, headache, migraine, dizziness, dementia, changes in vision, intolerance to contact lenses, muscle spasms, hair loss, weight or libido changes. |
| How Supplied |
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EZ-Dial dispensers—3 |
| Additional Resources |
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• Related Prescribing Note |
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