Monograph Details
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Ob/Gyn
> Menopause and HRT
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FEMHRT 0.5/2.5 |
| Manufacturer |
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Warner Chilcott Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Progestin + estrogen. |
| Generic Name |
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Norethindrone acetate 0.5mg, ethinyl estradiol 2.5micrograms; tabs. |
| Also |
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• FEMHRT 1/5
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| Indications |
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In women with an intact uterus: moderate to severe vasomotor symptoms associated with menopause; osteoporosis prevention. |
| Children |
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Not applicable. |
| Adults |
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1 tab daily. Reevaluate periodically. |
| Contraindications |
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Breast or estrogen-dependent carcinoma. Undiagnosed abnormal genital bleeding. Thrombophlebitis. Thromboembolic disorders. Missed abortion. Pregnancy (Cat.X). |
| Precautions |
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Gallbladder disease. Hypercalcemia in breast cancer or bone metastases. Conditions aggravated by fluid retention. Hepatic impairment. Hypercoagulability. Familial hyperlipoproteinemia. Depression. Do initial complete physical exam and repeat at least yearly (include BP, PAP smear, mammogram). Discontinue if cardiovascular events, jaundice, visual abnormalities or migraine occurs and at least 2 weeks before surgery associated with increased risk of thromboembolism. Nursing mothers. |
| Interactions |
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May be antagonized by rifampin, troglitazone, anticonvulsants. May antagonize temazepam, morphine, clofibrate. May be potentiated by Vit. C, acetaminophen, atorvastatin. Monitor theophylline, cyclosporine. May interfere with lab tests; see literature. |
| Adverse Reactions |
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GI upset, constipation, headache, edema, depression, nervousness, mastodynia, intolerance to contact lenses, glucose intolerance, changes in serum lipids; others. |
| How Supplied |
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Tabs—28, 90 |
| Additional Resources |
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• Related Prescribing Note |
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