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Home » Drug Information » Recently Approved Drugs » 2001
Medical Areas: Obstetrics/Gynecology

Drug Information

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Drug Name: Monistat 3 (miconazole nitrate)

Company: Advanced Care Products
Approval Status: Approved February 2001
Treatment Area: Vaginal yeast infections

General Information

Monistat 3 Combination Pack has been approved for treatment of vaginal yeast infections and relief of external itching and irritation due to the infection. The pack includes three vaginal suppositories, a plastic applicator, and one tube of cream for external vulvar use.

This quick three day treatment will be available over the counter, as are a number of other previously approved Monistat products. The Monistat 3 Combination Pack is the same strength as the three-day prescription treatment that has been available for over 15 years.

Vaginal yeast infections affect more than 13 million women in the United States each year. Three quarters of all women will experience at least one during their lifetime. Vaginal yeast infections are caused by overgrowth of Candida, a type of yeast found in the vagina. Symptoms include vaginal itching, discharge, irritation or burning, and a rash or redness around the vagina.

Side Effects

Adverse events associated with the use of miconazole nitrate may include (but are not limited to) the following:


  • Temporary increase in irritation when suppository is inserted
  • Abdominal cramping
  • Headaches
  • Skin rash

Literature References

For additional information on the Monistat 3 Combination Pack, please visit Monistat.


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