"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.
Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of ELESTRIN therapy with institution of appropriate symptomatic care.
ELESTRIN should not be used in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding
- Known, suspected, or history of breast cancer
- Known or suspected estrogen-dependent neoplasia
- Active DVT, PE, or history of these conditions.
- Active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions
- Known anaphylactic reaction or angioedema to ELESTRIN
- Known liver impairment or disease
- Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
- Known or suspected pregnancy.
Last reviewed on RxList: 3/17/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Elestrin Information
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