Prasterone

Class: Adrenals
Chemical Name: (3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-1,2,3,4,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-one
Molecular Formula: C₁₉H₂₈O₂
CAS Number: 105597-37-3
Brands: Intrarosa

Medically reviewed by Drugs.com on Nov 17, 2021. Written by ASHP.

Introduction

Inactive endogenous steroid converted intracellularly into active androgens and/or estrogens.

Uses for Prasterone

Dyspareunia

Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, associated with menopause.

Prasterone Dosage and Administration

Administration

Intravaginal

Administer intravaginally using the disposable applicator provided by manufacturer.

Dosage

Adults

Dyspareunia

Vaginal

6.5 mg (one insert) once daily at bedtime.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Prasterone

Contraindications

• Undiagnosed abnormal genital bleeding. Determine cause of undiagnosed, persistent, or recurrent genital bleeding in postmenopausal women prior to considering therapy.

Warnings/Precautions

Breast Cancer

Estrogen is a metabolite of prasterone. Use of exogenous estrogen contraindicated in women with known or suspected history of breast cancer. Not studied in women with history of breast cancer.

Specific Populations

Pregnancy

Not studied in pregnant women. Animal reproduction studies not conducted.

Manufacturer states that prasterone is labeled for use only in postmenopausal women.

Lactation

Not known if distributed into human milk. Effects of drug on breast-fed infant or milk production also unknown.

Pediatric Use

Safety and efficacy not established in pediatric patients; not indicated for use in children.

Geriatric Use

In placebo-controlled 12-week studies and open-label 52-week clinical trial, 19 and 11% of patients, respectively, were ≥65 years of age.

Hepatic Impairment

Effect of hepatic impairment on pharmacokinetics not studied.

Renal Impairment

Effect of renal impairment on pharmacokinetics not studied.

Common Adverse Effects

Vaginal discharge, abnormal Papanicolaou test (Pap smear).

Interactions for Prasterone

Drug interaction studies not performed.