"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
OSPHENA is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin [see WARNINGS AND PRECAUTIONS].
Use of OSPHENA should be 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 Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause
Take one 60 mg tablet with food once daily.
Dosage Forms And Strengths
OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with “60” on one side.
OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with “60” on one side. They are available as follows:
NDC 59630-580-10 Bottle of 100
NDC 59630-580-30 Blister pack of 30 tablets containing 2 blister cards of 15 tablets each
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].
Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Penn Pharmaceutical Services Ltd. 23-24 Tafarnauback Industrial Estate Tredegar, Gwent, South Wales NP22 3AA, United Kingdom Made in UK. Approved: February 2013
Last reviewed on RxList: 3/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Osphena 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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