Estrogel (Estradiol Topical) - Indications and Dosage

INDICATIONS AND USAGE

EstroGel is indicated in the

1. Treatment of moderate to severe vasomotor symptoms associated with menopause.

2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

DOSAGE AND ADMINISTRATION

EstroGel 1.25 g is the single approved dose for the treatment of moderate to severe vasomotor symptoms and/or moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. The lowest effective dose of EstroGel for these indications has not been determined. When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

When estrogen is prescribed for a postmenopausal woman with an intact uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (eg, 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have an intact uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

HOW SUPPLIED

EstroGel is a clear, colorless, hydroalcoholic 0.06% estradiol gel supplied in a non-aerosol, metered-dose pump. The pump consists of an LDPE inner liner encased in rigid plastic with a resealable polypropylene cap. Three pump sizes are available, a 93-gram, a 50-gram, and a 25-gram. Each individually packaged pump contains 93 grams of gel and is capable of delivering 64 metered 1.25-g doses. Each individually packaged 50-gram pump contains 50 grams of gel and is capable of delivering 32 metered 1.25-g doses. Each individually packaged 25-gram pump contains 25 grams of gel and is capable of delivering 14 metered 1.25-g doses.

NDC: 0051-1028-58……………………...(93-gram pump)

NDC: 17139-617-40……………………...(50-gram pump)

NDC: 17139-617-20……………………...(25-gram sample pump)

NDC: 0051-1028-20……………………...(25-gram sample pump)

Keep out of reach of children.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured for:

Ascend Therapeutics, Inc.
Herndon, VA 20170
By Laboratoires Besins International
Montrouge, France

5000718
E01306 ARev2 01/2007

Utilizes EHG^™ Technology

©2007 Ascend Therapeutics, Inc.