Estradiol Transdermal Patch

— THERAPEUTIC DISORDERS TREATED —
  • Menopause and HRT

Estradiol Transdermal Patch Generic Name & Formulations

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