DIVIGEL Rx

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DIVIGEL

Menopause and HRT
Only 4 drugs may be compared at once

Generic Name and Formulations:

Estradiol 0.25mg, 0.5mg, 1mg; per packet; topical gel.

Select 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:

Patients with intact uterus should receive a progestin to avoid endometrial hyperplasia. 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

DIVIGEL 30 packets of 1mg gel cartons (Qty:1)

appx. price $126.00