"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. Revised: Feb 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/13/2015
Additional Osphena Information
Report Problems to the Food and Drug Administration
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