"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 plus progestin 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 PREMPRO or PREMPHASE therapy with institution of appropriate symptomatic care.
PREMPRO or PREMPHASE therapy 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 a 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 PREMPRO/PREMPHASE
- Known liver dysfunction or disease
- Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
- Known or suspected pregnancy
Last reviewed on RxList: 2/21/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Prempro, Premphase Information
- Prempro, Premphase Drug Interactions Center: conj estrog-medroxyprogest ace oral
- Prempro, Premphase Side Effects Center
- Prempro, Premphase in detail including Side Effects and Drug Images
- Prempro, Premphase Overview including Precautions
- Prempro, Premphase FDA Approved Prescribing Information including Dosage
Prempro, Premphase - User Reviews
Prempro, Premphase User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Find out what women really need.