Elestrin Generic Name & Formulations
Estradiol 0.06%; gel; contains alcohol.
Pump (35g)—1, 2
Moderate to severe vasomotor symptoms due to menopause.
Elestrin Dosage and Administration
Prime pump before 1st use. Use lowest effective dose. Initially: apply 1 pump (0.87g) once daily to clean, dry, unbroken skin of upper arm.
Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (eg, stroke, MI) or a history of these conditions. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Hepatic impairment or disease. Known anaphylactic reaction or angioedema. Pregnancy.
Elestrin Boxed Warnings
Endometrial cancer. Cardiovascular disorders. Probable dementia. Breast cancer.
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 disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. 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. Bone disease associated with hypercalcemia. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypocalcemia. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Flammable. 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. Avoid applying sunscreen to application site (increases estradiol absorption). May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Elestrin Adverse Reactions
Breast tenderness, metrorrhagia, nasopharyngitis, upper respiratory tract infection; thromboembolism, neoplasms.
Elestrin Clinical Trials
Elestrin Patient Counseling