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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 of menopause.

Adult:

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

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.

Boxed Warning:

Endometrial cancer. Breast cancer. Cardiovascular disorders. Probable dementia.

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). Flammable. Reevaluate periodically. Nursing mothers: not recommended.

Pharmacological Class:

Estrogen.

Interactions:

May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). Concomitant thyroid replacement; may need to increase thyroid dose. Avoid applying sunscreen to application site (increases estradiol absorption). May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Adverse Reactions:

Breast tenderness, metrorrhagia, nasopharyngitis, upper respiratory tract infection; thromboembolism, neoplasms.

How Supplied:

Pump (35g)—1, 2


Data provided by MPR.

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