Generic Name and Formulations:
Estradiol 0.06%; gel; contains alcohol.
Indications for ELESTRIN:
Moderate-to-severe vasomotor symptoms associated with menopause.
Prime pump before 1st use. Use lowest effective dose. Initially: Apply 1 pump (0.87g) daily to clean, dry, unbroken skin of upper arm. Reevaluate periodically.
Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (eg, stroke and MI), or a history of these conditions. Known liver impairment or disease. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Pregnancy (Cat X).
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Increased risk of cardiovascular events (eg, MI, stroke, VTE); discontinue if occurs. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Breast cancer. Risk of probable dementia in women >65yrs of age. Renal dysfunction. Gallbladder disease. Hypertriglyceridemia. Hypothyroidism. Conditions aggravated by fluid retention. Bone disease associated with hypercalcemia. Do initial complete physical; repeat annually (include BP, mammogram, PAP smear). Discontinue if jaundice occurs and during immobilization or 4–6 weeks before surgery associated with thromboembolism. Hereditary angioedema. Product is flammable. Nursing mothers.
May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors. Avoid applying sunscreen to application site (increases estradiol absorption).
See full labeling. Breast tenderness, metrorrhagia, vaginal discharge, nausea, nasopharyngitis, upper respiratory tract infection. Long-term use may increase risk of estrogen-dependent cancers (eg, breast and/or endometrial), dementia, others. Increased risk of thromboembolic disorders, gallbladder disease.
Pump (35g)—1, 2
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