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ESTROGEL
Menopause and HRT
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Drug Name:

ESTROGEL Rx

Generic Name and Formulations:
Estradiol 0.75mg/1.25g; gel; contains alcohol.

Company:
Ascend Therapeutics

Therapeutic Use:

Indications for ESTROGEL:

Moderate-to-severe vasomotor symptoms of menopause. Vulvar and vaginal atrophy.

Adult:

Prime pump before 1st use. Apply 1 pump (1.25g) daily to clean, dry, intact skin over one arm; allow to dry for 5 minutes.

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. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Breast cancer. Risk of probable dementia in women >65yrs of age. 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. Hepatic dysfunction. Hypertriglyceridemia. Hypothyroidism. Hypoparathyroidism. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangioma. Product is flammable. Nursing mothers.

Interactions:

Plasma levels reduced by CYP3A4 inducers. Potentiated by CYP3A4 inhibitors.

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. Headache, flatulence, breast pain, application site reactions, rash, pruritus, fluid retention.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Metered-dose pump (25g, 50g, 93g)—1

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