"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
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. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
ELESTRIN is applied once daily to the upper arm for the treatment of moderate to severe vasomotor symptoms due to menopause using a metered-dose pump which delivers 0.87 gram of estradiol gel per actuation.
Patients should be started with the lowest effective dose of ELESTRIN, which is one pump per day (0.87 g per day, which contains 0.52 mg of estradiol).
Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.
Dosage Forms And Strengths
ELESTRIN (estradiol gel) contains 0.06 percent estradiol in a hydroalcoholic gel base.
Storage And Handling
ELESTRIN is estradiol 0.06 percent in a colorless, non-staining hydroalcoholic gel supplied in a non-aerosol, metered-dose pump container constructed of polypropylene. The drug product is contained within a collapsible inner liner/bag consisting of an inner and outer layer of low density polyethylene with a resealable polypropylene cap. Each 144 g individually packaged pump container is capable of delivering 87 g of gel in 100 metered doses. Each metered dose contains 0.87 g of gel.
Storage and Handling
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].
Distributed by: Azur Pharma, 1818 Market Street, Suite 2350, Philadelphia, PA 19103. www.azurpharma.com. Manufactured by: DPT Laboratories, Ltd. 318 McCullough San Antonio, TX 78215. Revised: 02/2012
Last reviewed on RxList: 3/9/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Elestrin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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