Prasterone (dehydroepiandrosterone, DHEA) vaginal

Prasterone is a synthetic version of a hormone called dehydroepiandrosterone (DHEA). DHEA is usually made by your adrenal glands. DHEA does not have active effects by itself, but it can be turned into active sex hormones like estrogen and testosterone in the body.

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

Prasterone may also be used for other reasons not mentioned in this medication guide.

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 (dehydroepiandrosterone, DHEA) 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.

Follow the instructions on the product label and package. Inform all your healthcare providers about your medical conditions, allergies, and all medications you are taking.

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 woman who is pregnant or breast-feeding.

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

Get emergency medical help if you have signs of an allergic reaction: hives; trouble 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 happen. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Postmenopausal Symptoms:

Prasterone 6.5 mg vaginal insert: Administer 1 insert intravaginally once a day at bedtime Comments:-Administer this drug using the provided applicator. Use: For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

Take the missed dose as soon as you can. If it is nearly time for your next dose, skip the missed dose. Do not use extra medicine to cover the missed dose.

An overdose of prasterone (dehydroepiandrosterone, DHEA) vaginal is not expected to be dangerous. Get emergency medical help or call the Poison Help line at 1-800-222-1222 if someone has accidentally swallowed the medication.

Follow your doctor's instructions about any limits on food, drinks, or activities.

It is unlikely that other medications you take by mouth or inject will affect prasterone used in the vagina. However, many medications can interact with one another. Inform all your healthcare providers about all the medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.