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DIVIGEL
Menopause and HRT
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Drug Name:

DIVIGEL Rx

Generic Name and Formulations:
Estradiol 0.25mg, 0.5mg, 1mg; per packet; topical gel.

Company:
Vertical Pharmaceuticals

Therapeutic Use:

Indications for DIVIGEL:

Moderate-to-severe vasomotor menopausal symptoms.

Adult:

Apply contents of 1 packet once daily to 5" x 7" area of dry skin on upper thigh; alternate thighs daily. Initially 0.25g/day; individualize. Allow gel to dry before dressing; do not wash area for at least 1 hr after application; wash hands after use.

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, MI) or history of these conditions. Known liver impairment or disease. Known protein C, protein S, or antithormbin deficiency, or other known thromboembolic 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. Do initial complete physical and repeat annually (include BP, mammogram, Pap smear). Reevaluate periodically; use lowest effective dose. Endometriosis. Severe hypocalcemia. Bone disease associated with hypercalcemia. Discontinue if jaundice or hypercalcemia occurs, and during immobilization or at least 4–6weeks before surgery associated with increased risk of thromboembolism. Hypertriglyceridemia. Hypothyroidism. Asthma. Diabetes. Epilepsy. Migraines. Porphyria. Hepatic hemangioma. SLE. Discontinue if sudden visual changes occur pending evaluation. Hereditary angioedema. Product is flammable. Nursing mothers.

Interactions:

May be potentiated by CYP3A4 inhibitors (eg, St. John's wort, phenobarbital, carbamazepine, rifampin). May be antagonized CYP3A4 inducers (eg, erythromycin. clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be affected by application of sunscreen or topical lotions. May need to increase dose of thyorid replacement therapy; monitor free thyroid function.

Pharmacological Class:

Estrogen.

Adverse Reactions:

Breast tenderness, metrorrhagia, vaginal mycosis, nasopharyngitis, upper respiratory tract infection; hypertension, edema, headache, glucose intolerance, weight changes, nasopharyngitis, upper respiratory tract infection, increased risk of gallbladder disease, thromboembolic events, malignant neoplasms.

Metabolism:

Hepatic.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Packets—30

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