Monograph Details
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Ob/Gyn
> Menopause and HRT
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PREFEST |
| Manufacturer |
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Duramed Pharmaceuticals, Inc. |
| 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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Estradiol 1mg tabs; estradiol 1mg + norgestimate 0.09mg tabs; in an alternating sequence of 3 tabs each. |
| Indications |
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In women with an intact uterus: treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis. |
| Children |
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Not applicable. |
| Adults |
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1 tab daily in correct sequence; repeat without interruption. Reevaluate periodically. |
| Contraindications |
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Breast or estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Thrombophlebitis. Thromboembolic disorders. Pregnancy (Cat.X). |
| Precautions |
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Not for prevention of cardiovascular disease. Use for shortest duration consistent with treatment goals and risks. Discontinue if cardiovascular events occur or are suspected; if jaundice occurs; and during immobilization or at least 2 weeks before surgery associated with thromboembolism. Hepatic dysfunction. Conditions aggravated by fluid retention. Gallbladder disease. Hypercalcemia in breast cancer or bone metastases. Hypercoagulability. Depression. Do initial complete physical and repeat at least yearly (include BP, PAP smear, mammogram). Familial hyperlipoproteinemia. Discontinue if visual disturbances occur. May interfere with lab tests. See literature. Nursing mothers. |
| Adverse Reactions |
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See literature. Headache, abdominal or back pain, arthralgia, vaginitis, nausea, fatigue, dizziness, depression, myalgia, mastodynia, chloasma, visual changes, intolerance to contact lenses, serum lipid changes. |
| How Supplied |
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Tabs—30 (blister pack) |
| Additional Resources |
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• Related Prescribing Note |
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