Monistat Vaginal Cream (Miconazole Nitrate Vaginal Cream)
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Monistat Vaginal Cream (Miconazole Nitrate Vaginal Cream)

DRUG DESCRIPTION

Contents (miconazole nitrate vaginal cream)

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.

What are the possible side effects of miconazole vaginal (Micon 7, Monistat 3, Monistat 5, Monistat 7, M-Zole Dual Pack)?

Stop using miconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report...

Read All Potential Side Effects and See Pictures of Monistat Vaginal Cream »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

No information provided.

HOW SUPPLIED

STORAGE:

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

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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.

Read the Monistat Vaginal Cream (miconazole nitrate vaginal cream) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

·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.

PRECAUTIONS

NOT SUPPLIED

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

No information provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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.

DIRECTIONS FOR USE:

Vaginal Application

To begin the treatment, wait until bedtime. Before going to bed:

1. To open the tube, unscrew the cap. Turn the cap upside down and place the cap on the end of the tube.

Push down firmly  until the seal is broken .

2. Attach the applicator to the tube by turning applicator clockwise.

3. Squeeze the tube from the bottom. This will force the cream into the applicator. Do this until the inside piece of the applicator is pushed out as far as it will go and the applicator is completely filled. Separate applicator from tube.

4. Hold the applicator containing the cream by the opposite end from where the cream is. Gently insert the applicator into the vagina as far as it will go comfortably. This can be done while standing with your feet spread a few inches apart and your knees bent. Or, you can lie on your back with your knees bent. Once you are ready, push the inside piece of the applicator in and place the cream as far back in the vagina as possible. Then remove the applicator from the vagina. You should go to bed as soon as possible after inserting the cream. This will reduce leakage. 

You may want to use deodorant-free mini-pads or pantyshields during the time that you are using miconazole nitrate vaginal cream. This is because the cream can leak and/or you may see some discharge.

DO NOT USE TAMPONS.

5. After each use, replace cap and roll tube from bottom. 

6. Be sure to clean the applicator after each use. Pull the two pieces apart. Wash them with soap and warm water. To rejoin, gently push the inside piece into the outside piece as far as it will go.

7. Repeat steps 2 through 6 before going to bed on each of the next six evenings.

External Vulvar Application

If needed, use the cream twice daily as follows:

1. Squeeze a small amount of cream onto your finger.

2. Gently apply the cream onto the skin (vulva) that itches and is irritated. 

3. Repeat steps 1 and 2 each morning and evening as needed.

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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.

DIRECTIONS FOR USE:

Vaginal Application

To begin the treatment, wait until bedtime. Before going to bed:

1. To open the tube, unscrew the cap. Turn the cap upside down and place the cap on the end of the tube.

Push down firmly  until the seal is broken .

2. Attach the applicator to the tube by turning applicator clockwise.

3. Squeeze the tube from the bottom. This will force the cream into the applicator. Do this until the inside piece of the applicator is pushed out as far as it will go and the applicator is completely filled. Separate applicator from tube.

4. Hold the applicator containing the cream by the opposite end from where the cream is. Gently insert the applicator into the vagina as far as it will go comfortably. This can be done while standing with your feet spread a few inches apart and your knees bent. Or, you can lie on your back with your knees bent. Once you are ready, push the inside piece of the applicator in and place the cream as far back in the vagina as possible. Then remove the applicator from the vagina. You should go to bed as soon as possible after inserting the cream. This will reduce leakage. 

You may want to use deodorant-free mini-pads or pantyshields during the time that you are using miconazole nitrate vaginal cream. This is because the cream can leak and/or you may see some discharge.

DO NOT USE TAMPONS.

5. After each use, replace cap and roll tube from bottom. 

6. Be sure to clean the applicator after each use. Pull the two pieces apart. Wash them with soap and warm water. To rejoin, gently push the inside piece into the outside piece as far as it will go.

7. Repeat steps 2 through 6 before going to bed on each of the next six evenings.

External Vulvar Application

If needed, use the cream twice daily as follows:

1. Squeeze a small amount of cream onto your finger.

2. Gently apply the cream onto the skin (vulva) that itches and is irritated. 

3. Repeat steps 1 and 2 each morning and evening as needed.

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

Contents (miconazole nitrate vaginal cream)

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

Contents (miconazole nitrate vaginal cream)

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

Contents (miconazole nitrate vaginal cream)

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.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Monistat Vaginal Cream Patient Information Including Side Effects

Brand Names: Micon 7, Monistat 3, Monistat 5, Monistat 7, M-Zole Dual Pack

Generic Name: miconazole vaginal (Pronunciation: my CAW nah zole)

What is miconazole vaginal (Monistat Vaginal Cream)?

Miconazole is an antifungal medication. It prevents fungus from growing.

Miconazole vaginal is used to treat vaginal candida (yeast) infections.

Miconazole vaginal may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of miconazole vaginal (Monistat Vaginal Cream)?

Stop using miconazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Monistat Vaginal Cream (miconazole nitrate vaginal cream) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about miconazole vaginal (Monistat Vaginal Cream)?

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in the eyes, nose, or mouth.

Side Effects Centers

Monistat Vaginal Cream Patient Information including How Should I Take

What should I discuss with my healthcare provider before using miconazole vaginal (Monistat Vaginal Cream)?

If this is the first time that you have ever had symptoms of a vaginal yeast infection, consult your doctor before using this medication.

Do not use miconazole vaginal if you have ever had an allergic reaction to it.

Before using miconazole vaginal, talk to your doctor if you have

  • a fever,
  • abdominal pain,
  • foul-smelling discharge,
  • diabetes, or
  • HIV or AIDS.

You may not be able to use miconazole vaginal, or you may require special monitoring during treatment if you have any of the conditions listed above.

Do not use miconazole vaginal without first talking to your doctor if you are pregnant.

Do not use miconazole vaginal without first talking to your doctor if you are breast-feeding a baby.

How should I use miconazole vaginal (Monistat Vaginal Cream)?

Use miconazole vaginal exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using the medication.

Insert the tablet, suppository, or cream into the vagina using the applicator as directed.

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. The symptoms may improve before the infection is completely healed.

Use this medication continuously, even during your menstrual period.

You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.

Avoid getting this medication in the eyes, nose, or mouth.

Store miconazole vaginal at room temperature away from moisture and heat.

Side Effects Centers

Monistat Vaginal Cream Patient Information including If I Miss a Dose

What happens if I miss a dose (Monistat Vaginal Cream)?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not use a double dose of this medication.

What happens if I overdose (Monistat Vaginal Cream)?

An overdose of miconazole vaginal is unlikely. If you do suspect that a much larger than normal dose has been used or that miconazole vaginal has been ingested, contact an emergency room or a poison control center.

What should I avoid while using miconazole vaginal (Monistat Vaginal Cream)?

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Miconazole may damage a condom or diaphragm. Use another form of birth control while using miconazole vaginal.

What other drugs will affect miconazole vaginal (Monistat Vaginal Cream)?

Do not use miconazole vaginal without first talking to your doctor if you are taking warfarin (Coumadin). Special monitoring or a dosage adjustment may be necessary.

Avoid using other vaginal creams or douches at the same time as miconazole vaginal unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with miconazole vaginal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist has additional information about miconazole vaginal written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.05. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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