Elestrin

— THERAPEUTIC CATEGORIES —
  • Menopause and HRT

Elestrin Generic Name & Formulations

General Description

Estradiol 0.06%; gel; contains alcohol.

Pharmacological Class

Estrogen.

How Supplied

Pump (35g)—1, 2

Manufacturer

Generic Availability

NO

Elestrin Indications

Indications

Moderate to severe vasomotor symptoms due to menopause.

Elestrin Dosage and Administration

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.

Elestrin Contraindications

Contraindications

Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE, or history of these conditions. Active arterial thromboembolic disease (eg, stroke, MI) or a history of these conditions. Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. Hepatic impairment or disease. Known anaphylactic reaction or angioedema. Pregnancy.

Elestrin Boxed Warnings

Boxed Warning

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

Elestrin 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 disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. 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. Bone disease associated with hypercalcemia. Visual abnormalities. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, pancreatitis, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Hypocalcemia. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Flammable. Reevaluate periodically. Nursing mothers: not recommended.

Elestrin Pharmacokinetics

See Literature

Elestrin Interactions

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).

Elestrin Adverse Reactions

Adverse Reactions

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

Elestrin Clinical Trials

See Literature

Elestrin Note

Not Applicable

Elestrin Patient Counseling

See Literature