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Prasterone (Vaginal)

PRAS-ter-one

Medically reviewed on June 7, 2018

Commonly used brand name(s)

In the U.S.

  • Intrarosa

Available Dosage Forms:

  • Suppository

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Androgen

Uses For This Medicine

Prasterone is used to treat women with moderate to severe dyspareunia (painful intercourse) that is due to menopause. Low estrogen levels may cause changes in the vulvar and vaginal areas that lead to atrophy (a shrinking of tissues) and dryness. Prasterone is a steroid medicine.

Prasterone is available only with your doctor's prescription.

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For prasterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to prasterone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Intrarosa™ is not indicated for use in the pediatric population.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Intrarosa™ in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of prasterone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding or
  • Breast cancer, known or suspected, or a history of—Should not be used in patients with these conditions.

Proper Use of This Medicine

It is very important that you use prasterone exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

Prasterone comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

Prasterone comes with a disposable applicator. Place the vaginal insert in the applicator and then insert it into your vagina. Use each applicator only once, and then throw it away.

Dosing

The dose of prasterone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of prasterone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For vaginal dosage form (suppository):
    • For dyspareunia:
      • Adults—6.5 milligrams (mg) once a day, at bedtime.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of prasterone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may also store the medicine in the refrigerator.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

It is unlikely that a postmenopausal woman may become pregnant. But you should know that using prasterone while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Make sure any doctor or dentist who treats you knows that you are using prasterone. Prasterone may affect the results of certain medical tests (eg, Pap smear).

This Medicine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

  • White or brownish vaginal discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Further information

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

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