"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
DOSAGE AND ADMINISTRATION
When estrogen is prescribed for a postmenopausal woman with a 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 with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see BOXED WARNINGS and WARNINGS). For women who have a 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.
Divigel® (estradiol gel) 0.1%, at doses of 0.25, 0.5, and 1.0 g/day, is indicated for topical use in the treatment of moderate to severe vasomotor symptoms associated with menopause. Each gram of Divigel® contains 1 mg of estradiol.
Patients should be treated with the lowest effective dose of Divigel®. Generally, women should be started at 0.25 gram Divigel® daily. Subsequent dosage adjustments may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.
Divigel® should be applied once daily on the skin of either the right or left upper thigh. The application surface area should be about 5 by 7 inches (approximately the size of two palm prints). The entire contents of a unit dose packet should be applied each day. To avoid potential skin irritation, Divigel® should be applied to the right or left upper thigh on alternating days. Divigel® should not be applied on the face, breasts, or irritated skin or in or around the vagina. After application, the gel should be allowed to dry before dressing. The application site should not be washed within 1 hour after applying Divigel®. Contact of the gel with eyes should be avoided. Hands should be washed after application.
Divigel® (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 0.25, 0.5, and 1.0 g, corresponding to 0.25, 0.5, and 1.0 mg estradiol, respectively.
NDC 0245-0880-30, carton of 30 packets, 0.25 mg estradiol per single-dose foil packet
NDC 0245-0881-30, carton of 30 packets, 0.5 mg estradiol per single-dose foil packet
NDC 0245-0882-30, carton of 30 packets, 1.0 mg estradiol per single-dose foil packet
Keep out of the 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 by: Orion Corporation Orion Pharma, Tengströminkatu 8, FI-20360 Turku, Finland. Distributed by: Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, 1-800-654-2299, Product of Finland. Revised June 2007
Last reviewed on RxList: 6/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Divigel Information
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