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ELESTRIN
Menopause and HRT
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Drug Name:

ELESTRIN Rx

Generic Name and Formulations:
Estradiol 0.06%; gel; contains alcohol.

Company:
Mylan Inc.

Therapeutic Use:

Indications for ELESTRIN:

Moderate-to-severe vasomotor symptoms associated with menopause.

Adult:

Prime pump before 1st use. Use lowest effective dose. Initially: Apply 1 pump (0.87g) daily to clean, dry, unbroken skin of upper arm. Reevaluate periodically.

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 history of these conditions. Active arterial thromboembolic disease (eg, stroke and 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. 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. Renal dysfunction. Gallbladder disease. Hypertriglyceridemia. Hypothyroidism. Conditions aggravated by fluid retention. Bone disease associated with hypercalcemia. Do initial complete physical; repeat annually (include BP, mammogram, PAP smear). Discontinue if jaundice occurs and during immobilization or 4–6 weeks before surgery associated with thromboembolism. Hereditary angioedema. Product is flammable. Nursing mothers.

Interactions:

May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors. Avoid applying sunscreen to application site (increases estradiol absorption).

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. Breast tenderness, metrorrhagia, vaginal discharge, nausea, nasopharyngitis, upper respiratory tract infection. Long-term use may increase risk of estrogen-dependent cancers (eg, breast and/or endometrial), dementia, others. Increased risk of thromboembolic disorders, gallbladder disease.

How Supplied:

Pump (35g)—1, 2

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