Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Obstetrics/Gynecology (Women’s Health)
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Monistat 3 (miconazole nitrate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Advanced Care Products
Approval Status: Approved February 2001
Treatment Area: Vaginal yeast infections
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.
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
- Abdominal cramping
- Skin rash
For additional information on the Monistat 3 Combination Pack,
please visit Monistat.