Prasterone is a manmade form of a hormone called dehydroepiandrosterone (DHEA). DHEA is normally produced by your adrenal glands. DHEA is inactive by itself, but in the body DHEA can be converted into active sex hormones including estrogen and testosterone.

Prasterone vaginal (for use in the vagina) is used in women to treat painful sexual intercourse that is related to vaginal changes caused by menopause.

Prasterone may also be used for purposes not listed in this medication guide.

Follow all directions on the product label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

The usual dose of this medicine is one insert placed into the vagina every day at bedtime.

Use only the applicator supplied with this medicine to insert a prasterone vaginal insert.

Store this medicine at room temperature away from moisture and heat.

You may also store the medicine in a refrigerator. Do not freeze.

You should not use prasterone if you are allergic to it, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor.

To make sure prasterone vaginal is safe for you, tell your doctor if you have ever had breast cancer.

Although prasterone (dehydroepiandrosterone, DHEA) vaginal is for use only in postmenopausal women, prasterone should not be used by a women who is pregnant or breast-feeding.

Prasterone vaginal is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

An overdose of prasterone vaginal is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of prasterone (dehydroepiandrosterone, DHEA) vaginal may include:

• vaginal discharge; or

• changes in your Pap smear results.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on prasterone used in the vagina. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.