Norethindrone Acetate/ethinyl Estradiol Generic Name & Formulations
Norethindrone acetate, ethinyl estradiol; 0.5mg/2.5mcg, 1mg/5mcg; tabs.
Progestin + estrogen.
Norethindrone Acetate/ethinyl Estradiol Indications
Moderate to severe vasomotor symptoms of menopause. Prevention of postmenopausal osteoporosis.
Norethindrone Acetate/ethinyl Estradiol Dosage and Administration
1 tab once daily.
Norethindrone Acetate/ethinyl Estradiol Contraindications
Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasms. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Protein C, protein S, or antithrombin deficiency, or other thrombophilias. Hepatic impairment or disease. Pregnancy.
Norethindrone Acetate/ethinyl Estradiol Boxed Warnings
Cardiovascular disorders. Breast cancer. Endometrial cancer. Probable dementia.
Norethindrone Acetate/ethinyl Estradiol Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers: not recommended.
Norethindrone Acetate/ethinyl Estradiol Pharmacokinetics
Norethindrone Acetate/ethinyl Estradiol Interactions
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice), atorvastatin, ascorbic acid, acetaminophen. May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May antagonize lamotrigine; may need to adjust dose. Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Norethindrone Acetate/ethinyl Estradiol Adverse Reactions
Headache, abdominal pain, breast pain, generalized edema; thromboembolism, neoplasms.
Norethindrone Acetate/ethinyl Estradiol Clinical Trials
Norethindrone Acetate/ethinyl Estradiol Note
Formerly known under the brand name FemHRT.
Norethindrone Acetate/ethinyl Estradiol Patient Counseling