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Intrarosa Generic Name & Formulations
Legal Class
Rx
General Description
Prasterone 6.5mg; per vaginal insert.
Pharmacological Class
Steroid.
How Supplied
Blister pack—28 (w. applicatiors)
Manufacturer
Generic Availability
NO
Mechanism of Action
Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of Intrarosa in postmenopausal women with vulvar and vaginal atrophy is not fully established.
Intrarosa Indications
Indications
Moderate-to-severe dyspareunia due to menopause.
Intrarosa Dosage and Administration
Adult
Use 1 vaginal insert once daily at bedtime.
Children
Not established.
Intrarosa Contraindications
Contraindications
Undiagnosed abnormal genital bleeding.
Intrarosa Boxed Warnings
Not Applicable
Intrarosa Warnings/Precautions
Warnings/Precautions
Breast cancer or history of. Evaluate undiagnosed, persistent or recurrent genital bleeding prior to initiation. Premenopausal: not indicated. Pregnancy. Nursing mothers.
Intrarosa Pharmacokinetics
See Literature
Intrarosa Interactions
Not Applicable
Intrarosa Adverse Reactions
Adverse Reactions
Vaginal discharge, abnormal Pap smear.
Intrarosa Clinical Trials
See Literature
Intrarosa Note
Not Applicable
Intrarosa Patient Counseling
See Literature
