Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

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.

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).

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.

OVERDOSE No information provided. CONTRAINDICATIONS No information provided.

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