FEMHRT 1/5 Rx
Generic Name and Formulations:
Norethindrone acetate 1mg, ethinyl estradiol 5mcg; tabs.
Indications for FEMHRT 1/5:
In women with an intact uterus: moderate to severe vasomotor symptoms associated with menopause; osteoporosis prevention.
1 tab daily. Reevaluate periodically.
Breast or estrogen-dependent carcinoma. Undiagnosed abnormal genital bleeding. Thrombophlebitis. Thromboembolic disorders. Missed abortion. Pregnancy (Cat.X).
Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Breast cancer. Risk of probable dementia in women >65yrs of age. 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.
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 full labeling.
Progestin + estrogen.
GI upset, constipation, headache, edema, depression, nervousness, mastodynia, intolerance to contact lenses, glucose intolerance, changes in serum lipids; others.
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