"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.
The gel is applied onto the skin in a thin layer. The recommended area of application is the upper arm to shoulder (approximately 320 cm²).
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 (0.52 mg estradiol) per actuation (1 pump).
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) 0.06% is available in a metered dose pump which delivers 0.52 mg of estradiol in 0.87 g of gel per pump actuation
Elestrin® (estradiol gel) 0.06% is 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 pump container holds 35 g of gel and is capable of delivering 26 g of gel as 30 metered doses. Each metered dose delivers 0.87 g of gel which contains 0.52 mg of estradiol.
NDC 18860-480-01….. 35 g of pump container. This pump
container is packaged individually or as two pump containers together in
Cartons (18860-480-30 and 18860-480-60).
NDC 18860-480-30.....Carton containing one ELESTRIN 35 g pump container.
NDC 18860-480-60.....Carton containing two ELESTRIN 35 g pump containers.
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: Meda Pharmaceuticals Commercial Corp., 1818 Market Street, Suite 2350, Philadelphia, PA 19103. Manufactured by: DPT Laboratories, Ltd. 318 McCullough San Antonio, TX 78215. Revised: Feb 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/17/2014
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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