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Osphena Generic Name & Formulations
Legal Class
Rx
General Description
Ospemifene 60mg; tabs.
Pharmacological Class
Estrogen (agonist/antagonist).
How Supplied
Tabs—90
Manufacturer
Generic Availability
NO
Osphena Indications
Indications
Treatment of moderate to severe dyspareunia or vaginal dryness due to menopause.
Osphena Dosage and Administration
Adult
60mg once daily with food.
Children
Not applicable.
Osphena Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Known or suspected estrogen-dependent neoplasia. Active DVT, pulmonary embolism, or history of. Active arterial thromboembolism (eg, stroke, MI, or history of). Known or suspected pregnancy.
Osphena Boxed Warnings
Boxed Warning
Endometrial cancer. Cardiovascular disorders.
Osphena Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial cancer in women with intact uterus (adding progestins has been shown to reduce endometrial hyperplasia risk). Evaluate if undiagnosed persistent or recurring abnormal genital bleeding occurs. Increased risk of cardiovascular disorders (eg, MI, stroke, VTE); discontinue if suspected or occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Use for shortest duration consistent with treatment goals and risks. Known, suspected, or history of breast cancer: do not use. Severe hepatic impairment: not recommended. Reevaluate periodically. Nursing mothers: not recommended.
Osphena Pharmacokinetics
See Literature
Osphena Interactions
Interactions
Avoid concomitant other estrogens or estrogen agonists/antagonists. Antagonized by rifampin. Potentiated by fluconazole (avoid), ketoconazole. May affect or be affected by highly protein-bound drugs. May increase risk of adverse reactions with concomitant CYP3A4 and CYP2C9 inhibitors.
Osphena Adverse Reactions
Adverse Reactions
Hot flush, vaginal discharge/hemorrhage, muscle spasms, headache, hyperhidrosis, night sweats.
Osphena Clinical Trials
See Literature
Osphena Note
Not Applicable
Osphena Patient Counseling
See Literature
