Divigel- Topical gel relieves menopausal flushes

Company:

Upsher-Smith

Pharmacologic class:

Estrogen

Active ingredient:

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

Indication:

Moderate-to-severe vasomotor menopausal symptoms.

Pharmacology:

The addition of exogenous estrogens helps to alleviate the vasomotor symptoms associated with declining estrogen levels.

Divigel (estradiol 0.1%) is a clear, colorless, alcohol-based gel that is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin.

Clinical trials:

The efficacy of this product in treating vasomotor symptoms in post-menopausal women was evaluated in a 12-week, double-blind, placebo-controlled trial involving 495 patients. Divigel 0.25 g, 0.5 g, or 1 g (corresponding to 0.25 mg, 0.5 mg, and 1 mg estradiol), applied once daily to the thigh, was compared with placebo. At Week 4, Divigel at doses of 0.5 g and 1 g/day led to significant reductions in the median daily frequency and the median daily severity of moderate-to-severe hot flushes compared with placebo; at Week 7, treatment with Divigel 0.25 g/day also reached statistical significance in improvements in these measurements.

The reductions in median daily frequency and severity of hot flushes were continued through Week 12 for all three Divigel doses compared with placebo.

Adults:

Apply entire contents of one packet once daily to 5-in x 7-in area of dry intact skin on upper thigh; alternate right and left thigh for daily application.

Initially 0.25 g (corresponding to 0.25 mg estradiol)/day; individualize. Allow gel to dry before dressing; do not wash area for at least one hour after application; wash hands after use.

Children:

Not applicable.

Contraindications:

Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasias. Hypercoagulability. Thrombophlebitis or thromboembolic disorders. Hepatic dysfunction or disease. Pregnancy.

Precautions:

Patients with intact uterus should receive a progestin to avoid endometrial hyperplasia. Do initial physical and repeat annually (include BP, mammogram, Pap smear). Re-evaluate 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 two weeks before surgery associated with increased risk of thromboembolism. Hypertriglyceridemia. Porphyria. Hepatic hemangioma. Systemic lupus erythematosus. Discontinue if sudden visual changes occur pending evaluation. Product is flammable. Nursing mothers.

Interactions:

May be potentiated by CYP3A4 inhibitors. May be antagonized by CYP3A4 inducers. May be affected by use of sunscreen.

Adverse reactions:

Hypertension, edema, chloasma, mastodynia, headache, glucose intolerance, vaginitis, changes in bleeding patterns, weight changes, intolerance to contact lenses, increased risk of gallbladder disease, thromboembolic events.

Additional patient info:

Do not allow other persons to contact the area of application for at least one hour. If someone else applies the gel, use disposable gloves. Avoid fire, flame, smoking until after gel has dried completely. Avoid eyes.

How supplied:

Packets—30

For more information, call 800.654.2299 or visit www.Divigelus.com.

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