Prasterone Intravaginal

Prasterone, Intravaginal is a prescription medication used for the treatment of moderate-to-severe dyspareunia caused by postmenopausal vulvar/vaginal atrophy.

• Prasterone, Intravaginal is available under the following different brand names: Intrarosa, DHEA, Intravaginal, dehydroepiandrosterone, Intravaginal

Common side effects of Prasterone, Intravaginal include:

• Vaginal discharge, and
• Abnormal pap smear

Serious side effects of Prasterone, Intravaginal include:

• Rash,
• Itching,
• Swelling of the face, tongue, or throat,
• Severe dizziness, and
• Trouble breathing

Rare side effects of Prasterone, Intravaginal include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravaginal insert

• 6.5 mg

Dyspareunia

Adult dosage

• Administer 1 vaginal insert once a day at bedtime using the applicator provided

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Prasterone, Intravaginal has no noted severe interactions with any other drugs.
• Prasterone, Intravaginal has no noted serious interactions with any other drugs.
• Prasterone, Intravaginal has no noted moderate interactions with any other drugs.
• Prasterone, Intravaginal has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Undiagnosed abnormal genital bleeding; evaluate and determine the cause of bleeding before considering treating with intravaginal prasterone
• History of breast cancer

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Prasterone, Intravaginal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Prasterone, Intravaginal?”

Cautions

• Estrogen is a metabolite of prasterone; use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer (see Contraindications)

Pregnancy and Lactation

• No data are available on use in pregnant women since it is indicated only in postmenopausal women
• Lactation
  • Unknown if distributed in human breast milk
  • Indicated only in postmenopausal women; therefore, there is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production