(mi kon' a zole)

Brand Name(s): Monistat^® 1 Combination Pack Dual-Pak^®, Monistat^® 3 Combination Pack^®, Monistat^® 3 Suppositories, Monistat^® 7 Cream, Monistat^® 7 Combination Pack^®, Monistat^® 7 Suppositories; also available generically

WHY is this medicine prescribed?

Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Vaginal miconazole comes as a cream or suppository to be inserted into the vagina. The cream may also be applied to the skin around the outside of the vagina. The suppositories are used as a one-time dose (Monistat 1) or once a day at bedtime for 3 days in a row (Monistat 3). The vaginal cream is used once a day at bedtime for 7 days in a row (Monistat 7). The cream is used twice a day for up to 7 days, on the skin around the outside of the vagina.Follow the directions on the package or as directed by your doctor carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use miconazole exactly as directed. Do not use more or less of it or use it more often than directed on the package or prescribed by your doctor.

Vaginal miconazole is available without a prescription (over the counter). If this is the first time you have had vaginal itching and discomfort, talk to a doctor before using miconazole. If a doctor has told you before that you had a yeast infection and you have the same symptoms again, use the vaginal cream or suppositories as directed on the package.

Do not have vaginal intercourse or use other vaginal products (such as tampons, douches, or spermicides) during your treatment.

You should begin to feel better during the first three days of treatment with miconazole. If your symptoms do not improve or get worse, call your doctor.

To apply the external miconazole cream, use your finger to apply a small amount of cream to the affected area of skin on the outside of the vagina.

To use the miconazole vaginal cream or suppositories, read the instructions provided with the medication and follow these steps:

1. Fill the special applicator that comes with the cream to the level indicated, or unwrap a suppository and place it on the applicator as shown in the instructions.
2. Lie on your back with your knees drawn upward and spread apart or standing with your feet far apart and knees bent.
3. Gently insert the applicator into the vagina, and push the plunger to release the medication.
4. Withdraw the applicator.
5. Discard the applicator if it is disposable. If the applicator is reusable, pull it apart and clean it with soap and warm water after each use.
6. Wash your hands promptly to avoid spreading the infection.

The dose should be applied when you lie down to go to bed. It works best if you do not get up after applying it except to wash your hands. You may wish to wear a sanitary napkin while using the suppositories or vaginal cream to protect your clothing against stains. Continue using miconazole vaginal cream or suppositories even if you get your period during treatment.

What SPECIAL PRECAUTIONS should I follow?

Before using vaginal miconazole,

• tell your doctor and pharmacist if you are allergic to miconazole, any other medications, or any of the ingredients in miconazole external cream, vaginal cream, or suppositories. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have lower stomach, back or shoulder pain. fever, chills, nausea, vomiting, or foul-smelling vaginal discharge; been exposed to or have human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or have had frequent vaginal yeast infections (once a month or 3 or more infections in 6 months).

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using miconazole, call your doctor.

• you should know that condoms and diaphragms may be weakened if they are used during your treatment with vaginal miconazole. Because of this, these devices may not be effective at preventing pregnancy or sexually transmitted diseases if you use them during your treatment.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Miconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• increased burning, itching, or irritation of the vagina

Some side effects can be serious. If you experience any of the following symptoms, stop using miconazole and call your doctor immediately:

• hives
• rash

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

If someone swallows miconazole vaginal, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about miconazole.

If you still have symptoms of infection 7 days after starting treatment with miconazole, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2018.