Contents

One tube of vaginal cream containing miconazole nitrate 2%. One plastic applicator.

Active Ingredient: Miconazole nitrate 2% (100 mg per dose).

Inactive Ingredients: Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water.

For the treatment of vaginal yeast infections and the relief of external vulvar itching and irritation associated with a yeast infection. If you have any or all of the symptoms of a yeast infection (vaginal itching, burning, discharge) and if at sometime in the past your doctor has told you that these symptoms are due to a yeast infection, then miconazole nitrate vaginal cream should work for you. If, however, you have never had these symptoms before, you should see your doctor before using miconazole nitrate vaginal cream. MICONAZOLE VAGINAL CREAM IS FOR THE TREATMENT OF VAGINAL YEAST INFECTIONS AND FOR THE RELIEF OF EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION. IT DOES NOT TREAT OTHER INFECTIONS OR EXTERNAL ITCHING AND IRRITATION DUE TO CAUSES OTHER THAN YEAST INFECTIONS. IT DOES NOT PREVENT PREGNANCY.

No information provided.

STORAGE:

Store at room temperature 59°-86°F (15°-30°C). Avoid heat (over 86°F or 30°C).

The following side effects have been reported with the use of miconazole nitrate vaginal cream; a temporary increase in burning, itching, and/or irritation when the cream is inserted. Abdominal cramping, headaches, hives, and skin rash have also been reported. If any of these occur, stop using miconazole nitrate vaginal cream and consult your doctor.

·This product is only effective in treating vaginal infection caused by yeast and in relieving vulvar itching and irritation associated with a yeast infection. Do not use in the eyes or take by mouth.

·Do not use miconazole nitrate vaginal cream if  you have any of  the following signs and symptoms. Also, if they occur while using miconazole nitrate vaginal cream, STOP using the product and contact your doctor right away. You may have a  more serious illness.

Fever (Above 100°F orally)

Pain in the lower abdomen, back or either shoulder.  A vaginal discharge that smells bad

· If  there is no improvement or if the infection worsens within 3 days, or complete relief is not felt within 7 days, or your symptoms return within two months, then you may have something other than a yeast infection. You should consult your doctor.

· If you may have been exposed to the human immunodeficiency virus (HIV, the virus that causes AIDS) and are now having recurrent vaginal infections, especially infections that don't clear up easily with proper treatment, see your doctor promptly to determine the cause of your symptoms and to receive proper medical care. 

· Mineral oil may weaken latex in condoms or in diaphragms. This cream contains mineral oil. Do not  rely on condoms or diaphragms to prevent sexually transmitted diseases or pregnancy while using miconazole nitrate vaginal cream.

· Do not use tampons while using this medication.

· Do not use in girls less than 12 years of age. 

· If you are pregnant or think you may be, do not use this product except under the advice and supervision of a doctor. 

· Keep this and all drugs out of the reach of children. 

· In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

IMPORTANT: DO NOT USE IF CARTON WAS OPENED. THE TUBE OPENING SHOULD BE SEALED. IF SEAL HAS BEEN PUNCTURED OR IS NOT VISIBLE, DO NOT USE. RETURN THE PRODUCT TO THE STORE WHERE YOU BOUGHT IT.

NOT SUPPLIED

No information provided.

No information provided.

No information provided.

WHAT ARE VAGINAL YEAST INFECTIONS (Candidiasis)?

A yeast infection is a common type of vaginal infection. Your doctor may call it candidiasis. This condition is caused by an organism called Candida, which is a type of yeast. Even healthy women usually have this yeast on the skin, in the mouth, in the digestive tract, and in the vagina. At times, the yeast can grow very quickly. In fact, the infection is sometimes called yeast (Candida) "overgrowth." Some women also experience a yeast infection on the external skin (vulva) associated with the internal vaginal infection.

A yeast infection can occur at almost any time of life. It is most common during the childbearing years. The infection tends to develop most often in some women who are pregnant, diabetic, taking antibiotics, taking birth control pills, or have a damaged immune system.

Various medical conditions can damage the body's normal defenses against infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV-the virus that causes AIDS). Infection with HIV causes the body to be more susceptible to infections, including vaginal yeast infections. Women with HIV infection may have frequent vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment. If you may have been exposed to HIV and are experiencing either frequently recurring vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment, you should see your doctor promptly. If you wish further information on risk factors for HIV infection or on the relationship between recurrent or persistent vaginal yeast infections and HIV infection, please contact your doctor or the CDC National AIDS HOTLINE at 1-800-342-AIDS (English), 1-800-344-7432 (Spanish), or 1-800-243-7889 (hearing impaired, TDD).

IF YOU EXPERIENCE VAGINAL YEAST INFECTIONS FREQUENTLY (THEY RECUR WITHIN A TWO MONTH PERIOD) OR IF YOU HAVE VAGINAL YEAST INFECTIONS THAT DO NOT CLEAR UP EASILY WITH PROPER TREATMENT, YOU SHOULD SEE YOUR DOCTOR PROMPTLY TO DETERMINE THE CAUSE AND TO RECEIVE PROPER MEDICAL CARE.

SYMPTOMS OF VAGINAL YEAST INFECTIONS

There are many signs and symptoms of a yeast infection. They can include:

· Vaginal itching (ranging from mild to intense);

· A clumpy vaginal discharge that may look like cottage cheese;

· Vaginal soreness, irritation or burning, especially during intercourse;

· Rash or redness around the vagina (vulvar irritation).

NOTE: Vaginal discharge that is different from above, for example, a yellow/green discharge or a discharge that smells "fishy," may indicate that you have something other than a yeast infection. If this is the case, you should consult your doctor before using miconazole nitrate vaginal cream.

FOR BEST RESULTS

1. Be sure to use all of the cream even if your symptoms go away before you have used all of the cream.

2. Use one applicatorful of cream at bedtime for seven nights in a row, even during your menstrual period.

3. Wear cotton underwear.

4. If your partner has any penile itching, redness, or discomfort, he should consult his doctor and mention that you are treating yourself for a vaginal yeast infection.

5. Dry the outside vaginal area thoroughly after a shower, bath, or swim. Change out of a wet bathing suit or damp workout clothes as soon as possible. A dry area is less likely to encourage the growth of yeast.

6. Wipe from front to rear (away from the vagina) after a bowel movement or urination.

7. Don't douche unless your doctor tells you to do so. Douching may disturb the vaginal bacterial balance.

8. Do not scratch if you can help it. Scratching can cause more irritation and can spread the infection.

9. Discuss with your doctor any medication you are now taking. Certain types of medication can make your vagina more prone to infection.

IF YOU HAVE A QUESTION

Questions of a medical nature should be taken up with your doctor.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

MICONAZOLE NITRATE CREAM - VAGINAL

(mye-KON-a-zole NYE-trate)

COMMON BRAND NAME(S): Monistat

USES: This medication is used to treat vaginal yeast infections. Miconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

HOW TO USE: Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

If you are pregnant, follow your doctor's instructions on how to use the applicator to insert this medication.

Use the medication once daily, usually at bedtime or as directed by your doctor. Wash your hands before using the medication. This medication comes with an applicator (either prefilled or disposable). Follow the package instructions on how to fill the disposable applicator with the cream. Lie on your back with your knees toward your chest. Insert one applicator full of cream into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator all the way down to apply the cream. If you have itching/burning around the outside of the vagina (vulva), you should also apply some cream to that area. After use, discard the applicator and wash your hands.

Continue to use this medication every day for the full time prescribed, even if symptoms disappear after a few days or if your menstrual period starts. Stopping the medication too soon may allow the yeast infection to return. Do not use tampons or douches while using this medication. Unscented sanitary napkins may be used for your menstrual period or to protect your clothing from leakage of the medication.

Inform your doctor if your condition persists or returns 1 week after completing the treatment.

SIDE EFFECTS: Headache, burning/itching/pain in the vagina or urinary opening, or lower abdominal cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fever, chills, flu-like symptoms, stomach/abdominal pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using miconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (e.g., clotrimazole, fluconazole); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems, 4 or more vaginal yeast infections per year.

Ask your doctor whether you can have sexual intercourse while using this product. Avoid using a diaphragm, cervical cap, or latex condoms for birth control while using this product and for 3 days after treatment is finished. Some ingredients in this cream may damage these products, possibly causing them to break. Use other forms of birth control such as polyurethane condoms.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: warfarin, oral antibiotics, corticosteroids (e.g., prednisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This product may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., KOH smear, culture) may be performed periodically to monitor your progress. Consult your doctor for more details.

Dry the genital area thoroughly after showering, bathing, or swimming. Avoid wearing tight jeans, nylon underwear, pantyhose, a wet bathing suit, or damp/sweaty exercise clothes for long periods. Wear cotton underwear, and change your underwear daily. This may help to prevent the growth of yeast.

If your sexual partner experiences symptoms, they should contact their doctor immediately.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the cream at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.