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Prasterone

Medically reviewed by Drugs.com. Last updated on June 28, 2020.

Pronunciation

(PRAS ter one)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Insert, Vaginal:

Intrarosa: 6.5 mg (28 ea)

Brand Names: U.S.

  • Intrarosa

Pharmacologic Category

  • Steroid, Synthetic

Pharmacology

An inactive steroid that is converted into active androgens and/or estrogens; the mechanism of action in postmenopausal women with vulvar and vaginal atrophy is unknown.

Metabolism

Metabolized via dehydrogenase, reductase, and aromatase to 2 active metabolites (estradiol and testosterone)

Use: Labeled Indications

Dyspareunia: Treatment of moderate to severe dyspareunia (a symptom of vulvar and vaginal atrophy due to menopause)

Contraindications

Undiagnosed abnormal genital bleeding

Dosing: Adult

Dyspareunia: Females: Intravaginal: 6.5 mg once daily at bedtime

Dosing: Geriatric

Refer to adult dosing.

Administration

Insert in vagina at bedtime using supplied applicator (for one time use only). Empty bladder and wash hands prior to insertion.

Storage

Store at 5°C to 30°C (41°F to 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Genitourinary: Vaginal discharge (6% to 14%)

1% to 10%: Genitourinary: Abnormal pap smear (2%)

Warnings/Precautions

Concerns related to adverse effects:

• Vaginal discharge: May occur with use.

Disease-related concerns:

• Breast cancer: Use caution in women with a history of known or suspected breast cancer; estrogen is a metabolite of prasterone.

• Vaginal bleeding: Prior to treatment, evaluate and determine cause of any postmenopausal woman with undiagnosed, persistent, or recurring genital bleeding.

Reproductive Considerations

Other formulations of prasterone (dehydroepiandrosterone [DHEA]) have been evaluated to improve pregnancy outcomes in women with diminished ovarian reserve (Gleicher 2011; Narkwichean 2013). This product is only approved for use in postmenopausal women.

Pregnancy Considerations

Animal reproduction studies have not been conducted with this preparation; this product is only approved for use in postmenopausal women.

Patient Education

What is this drug used for?

• It is used to treat vaginal pain during sex caused by changes that happen with menopause.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vaginal discharge

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.