Brand Names:

• 3 Day Vaginal Cream
• Femizol-M
• Gynazole-1
• Gyne-Lotrimin
• Monistat 1
• Mycelex-3
• Mycelex-7
• Terazol 3
• Terazol 7
• Tioconazole 1
• Vagistat-1
• Zazole
• Canesten 2
• Canesten 3
• Canesten 6 Day
• Canesten Combi-Pak 1 Day
• Canesten Combi-Pak 3 Day
• Canesten External Cream
• Clotrimaderm
• Gyne Cure
• Gyno-Trosyd
• Miconazole 3 Day Ovule Treatment
• Miconazole Nitrate
• Monistat 1 Combination Pack Vaginal Ovule

Dosage Forms:

• Cream
• Suppository
• Ointment

Uses of This Medicine:

Vaginal azoles are used to treat yeast (fungus) infections of the vagina.

For first-time users, make sure your doctor has checked and confirmed that you have a vaginal yeast infection before you use the vaginal azole antifungal medicines that do not require a prescription. Vaginal yeast infections can reoccur over time and, when the same symptoms occur again, self-treating with these medicines is recommended. However, you should see your doctor if the symptoms occur again within 2 months.

Vaginal antifungal azoles are available both over-the-counter (OTC) and with your doctor's prescription.

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.

Children—

Studies on these medicines have been done only in adult patients, and there is no specific information comparing use of vaginal azoles in children with use in other age groups. It is recommended that these medicines not be used in children up to 12 years of age.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of vaginal azoles in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy—

Studies have not been done in humans for use of all azole antifungals during the first trimester of pregnancy. These medicines are safe and effective when used for at least 7 days during the second and third trimesters of pregnancy. However, check with your doctor before using this medicine during the first trimester of pregnancy. Also, use of 1- and 3-day treatments may not be effective during pregnancy.

Breast-feeding—

It is not known whether vaginal azoles pass into the breast milk. However, these medicines have not been shown to cause problems in nursing babies.

Other 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. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Tacrolimus
• Warfarin

Other interactions—

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.

Proper Use of This Medicine:

Vaginal azoles usually come with patient directions. Read them carefully before using this medicine.

Use this medicine at bedtime, unless otherwise directed by your doctor. The vaginal tampon form of miconazole should be left in the vagina overnight and removed the next morning.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator.

Some of the vaginal suppositories or tablets come packaged with a small tube of cream. This cream can be applied outside of the vagina in the genital area to treat itching. The packages are called combination, dual, or twin packs.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, do not stop using this medicine if your menstrual period starts during the time of treatment.

Dosing—

The dose medicines in this class 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 these medicines. 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 yeast infection:
  • For vaginal cream dosage form:
    • Adults and teenagers—
      • Women who are not pregnant: 100 milligrams (mg) (one full applicator) of 2% cream inserted into the vagina at bedtime for three nights in a row.
      • Pregnant women, after the third month: 100 mg (one full applicator) of 2% cream inserted into the vagina at bedtime for six nights in a row.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For vaginal suppository dosage form:
    • Adults and teenagers—
      • Women who are not pregnant: 100 mg (one suppository) inserted into the vagina at bedtime for three nights in a row.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

• For yeast infection:
  • For vaginal cream dosage form:
    • Adults and teenagers—The dose depends on the strength of the cream.
      • 1% cream: 50 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for six to fourteen nights in a row.
      • 2% cream: 100 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row.
      • 10% cream: 500 mg (one full applicator) inserted into the vagina at bedtime for one night only.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For vaginal tablet dosage form:
    • Adults and teenagers—The dose depends on the strength of the vaginal tablet.
      • Women who are not pregnant:
        • 100-mg tablet: Insert one tablet into the vagina at bedtime for six or seven nights in a row.
        • 200-mg tablet: Insert one tablet into the vagina at bedtime for three nights in a row.
        • 500-mg tablet: Insert one tablet into the vagina at bedtime for one night only.
      • Pregnant women: 100 mg (one vaginal tablet) inserted into the vagina at bedtime for seven nights in a row.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

• For yeast infection:
  • For vaginal suppository dosage form:
    • Adults and teenagers—150 milligrams (mg) (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

• For yeast infection:
  • For vaginal cream dosage form:
    • Adults and teenagers—20 milligrams (one full applicator) inserted into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For vaginal suppository dosage form:
    • Adults and teenagers—The dose depends on the strength of the suppository.
      • 100-milligram (mg) suppository: Insert one vaginal suppository into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed.
      • 200-mg suppository or
      • 400-mg suppository: Insert one vaginal suppository into the vagina at bedtime for three nights in a row. Treatment may be repeated if needed.
      • 1200-mg suppository: Insert one vaginal suppository into the vagina at bedtime for one night.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For tampon dosage form:
    • Adults and teenagers—100 mg (one tampon) inserted into the vagina at bedtime and then removed the next morning. This is repeated every night for five nights in a row.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

• For yeast infection:
  • For vaginal cream dosage form:
    • Adults and teenagers—The dose depends on the strength of the cream.
      • 0.4% cream: 20 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for seven nights in a row.
      • 0.8% cream: 40 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For vaginal suppository dosage form:
    • Adults and teenagers—80 mg (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

• For yeast infection:
  • For vaginal ointment dosage form:
    • Adults and teenagers—300 milligrams (mg) (one full applicator) of 6.5% ointment inserted into the vagina at bedtime for one night only.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For vaginal suppository dosage form:
    • Adults and teenagers—300 mg (one vaginal suppository) inserted into the vagina at bedtime for one night only.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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.

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

Do not keep outdated medicine or medicine no longer needed.

Keep the vaginal cream, ointment, and suppository forms of this medicine from freezing.

Precautions While Using This Medicine:

If your symptoms do not improve within 3 days or have not disappeared in 7 days, or if they become worse, check with your doctor. The 1- or 3-day treatments may take up to 7 days to completely clear up your infection. However, not all vaginal infections are caused by yeast. If symptoms occur again within 2 months, check with your doctor.

Vaginal medicines usually will come out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. The use of nonmedicated tampons (like those used for menstrual periods) is not recommended since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

• Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties.
• Wear only clean panties.

If you have any questions about this, check with your health care professional.

Vaginal yeast infections are not usually spread by having sex and your sex partner does not need to be treated. However, if the sex partner has symptoms of local itching or skin irritation of the penis, he may benefit by being treated also.

If you use latex or rubber birth control devices (condoms, diaphragms, or cervical caps), you should wait 3 days after treatment with azole antifungal agents before using them again. Many brands of vaginal azoles contain oils in the product that can weaken these devices. This increases the chances of a condom breaking during sexual intercourse. The rubber in cervical caps or diaphragms may break down faster and wear out sooner. Check with your health care professional to make sure the vaginal azole product you are using can be used with latex rubber birth control devices.

Check with your doctor before douching to obtain advice about whether you may douche and, if allowed, the proper method.

Side Effects of This Medicine:

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.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Vaginal burning, itching, discharge, or other irritation not present before use of this medicine

Rare

Skin rash or hives

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

Abdominal or stomach cramps or pain

burning or irritation of penis of sexual partner

headache

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.