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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 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. Osteoporosis prevention.

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. Reevaluate periodically. Osteoporosis: supplement diet with calcium 1.5 g/day and Vitamin D 400–800IU/day.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal genital bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE, or a history of these conditions. Active arterial thromboembolic disease (eg, stroke, 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. Known or suspected pregnancy (Cat.X).

Warnings/Precautions:

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. Hepatic dysfunction. Conditions aggravated by fluid retention. Endometriosis. Gallbladder disease. Bone disease associated with hypercalcemia. Do initial complete physical and repeat annually (include BP, mammogram, and PAP smear). Discontinue if hypercalcemia or jaundice occurs. Hypertriglyceridemia. Hypothyroidism. Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangioma. Nursing mothers.

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. Increased risk of endometrial cancer or hyperplasia, gallbladder disease. Local irritation, fluid retention, breakthrough bleeding, weight or menstrual changes, mastodynia, nausea, abdominal cramps, headache, migraine, dizziness; anaphylactic reaction, angioedema (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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