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Estradiol Transdermal Patch Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 0.05mg/day, 0.1mg/day; ext-rel transdermal film.
Pharmacological Class
Estrogen.
How Supplied
Patch—8
Manufacturer
Generic Availability
YES
Estradiol Transdermal Patch Indications
Indications
Moderate-to-severe vasomotor symptoms of menopause. Moderate-to-severe symptoms of vulvar and vaginal atrophy due to menopause. Hypoestrogenism. Prevention of postmenopausal osteoporosis.
Estradiol Transdermal Patch Dosage and Administration
Adult
Initially one 0.05mg/day patch twice per week applied to trunk (avoid breasts, waistline). May be given continuously if patient does not have an intact uterus or cyclically (3 weeks on, 1 week off) in patients with intact uterus. Rotate application sites. Osteoporosis: supplement diet with calcium 1.5 g/day and Vitamin D 400–800IU/day.
Children
Not applicable.
Estradiol Transdermal Patch Contraindications
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.
Estradiol Transdermal Patch Boxed Warnings
Boxed Warning
Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.
Estradiol Transdermal Patch Warnings/Precautions
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.
Estradiol Transdermal Patch Pharmacokinetics
See Literature
Estradiol Transdermal Patch Interactions
Interactions
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).
Estradiol Transdermal Patch Adverse Reactions
Adverse Reactions
Local redness and irritation; thromboembolism, neoplasms; rare: rash, allergic reactions, angioedema (permanently discontinue if occurs).
Estradiol Transdermal Patch Clinical Trials
See Literature
Estradiol Transdermal Patch Note
Notes
Formerly known under the brand name Estraderm.
Estradiol Transdermal Patch Patient Counseling
See Literature
