Generic Name and Formulations:
Estradiol acetate 0.05mg/day, 0.1mg/day; vaginal ring.
Indications for FEMRING:
Moderate-to-severe vasomotor symptoms of menopause. Moderate-to-severe vulvar and vaginal atrophy due to menopause.
Use lowest effective dose for shortest duration consistent with treatment goals. Insert 1 ring vaginally once every 3 months; replace. Initially 0.05mg/day ring; may increase to 0.1mg/day ring if needed.
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.
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.
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. Narrow vagina, vaginal stenosis, vaginal infections, cervical prolapse, rectoceles and cystoceles increase risk of irritation or ulceration. May use ring while treating vaginal infections. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Reevaluate periodically. Nursing mothers: not recommended.
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). 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).
Vaginal bleeding, breast tenderness, vaginal candidiasis; thromboembolism, neoplasms.
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