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Estradiol Transdermal Patch
Menopause and HRT
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Drug Name:

Estradiol Transdermal Patch Rx

Generic Name and Formulations:
Estradiol 0.05mg/day, 0.1mg/day; ext-rel transdermal film.

Company:
Mylan Inc.

Therapeutic Use:

Indications for Estradiol Transdermal Patch:

Moderate-to-severe vasomotor symptoms of menopause. Moderate-to-severe symptoms of vulvar and vaginal atrophy due to menopause. Hypoestrogenism. Prevention of postmenopausal osteoporosis.

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.

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.

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.

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).

Pharmacological Class:

Estrogen.

Adverse Reactions:

Local redness and irritation; thromboembolism, neoplasms; rare: rash, allergic reactions, angioedema (permanently discontinue if occurs).

Note:

Formerly known under the brand name Estraderm.

Metabolism:

Hepatic (CYP1A2, CYP3A4).

Elimination:

Renal.

Generic Availability:

YES

How Supplied:

Patch—8

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