Miconazole, zinc oxide, and white petrolatum (Topical application)

Miconazole, zinc oxide, and white petrolatum combination is used to treat diaper rash (dermatitis) in infants 4 weeks of age and older who have a normal immune system and also have a yeast infection (candidiasis).

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your child's progress at regular visits to make sure this medicine is working properly and to check for side effects.

If the rash gets worse or does not improve after 7 days, call your doctor right away.

Do not use this medicine to prevent diaper rash.

Clean the diaper area and change your child’s diaper often to avoid worsening skin irritation.

Avoid using scented soaps, shampoos, or lotions in the diaper area while using this medicine.

Each antifungal medicine is made to treat a specific type of infection. Use only the medicine your doctor has prescribed. You should not use an over-the-counter product instead of what your doctor has told you to use.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some important points to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how miconazole, zinc oxide, and white petrolatum combination affects infants younger than 4 weeks old and very-low-birth-weight infants (less than 1500 grams). Safety and effectiveness have not been established for these groups.

Geriatric

There have not been appropriate studies on how miconazole, zinc oxide, and white petrolatum combination affects elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction is possible. In such cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been highlighted based on their potential significance and are not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Ethinyl Estradiol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Blistering, burning, crusting, dryness, flaking, itching, scaling, or severe redness, soreness, or swelling of the skin
• falling off of skin

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Vusion

Available Dosage Forms:

• Ointment

Therapeutic Class: Antifungal

Chemical Class: Miconazole

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only on your child's skin. Do not get any of it into your child's eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.

To use this medicine:

• Wash your hands with soap and water before and after you apply this medicine onto your child's diaper area.
• Change wet and soiled diapers right away. Clean the diaper area with lukewarm water and pat dry with a soft towel.
• Apply a thin layer of this medicine on your child's diaper area at each diaper change. Do not rub into your child's skin.

Keep using this medicine for the full 7 days, even if your child feels better after the first few doses. Your child's infection may not clear up if you stop the medicine too soon.

Dosing

The dose of this medicine 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 this medicine. 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 topical dosage form (ointment):For diaper rash with yeast infection: Infants 4 weeks of age and older and weighing 1500 grams (g) or more—Gently apply a thin layer to the diaper area with each diaper change for 7 days. Infants younger than 4 weeks of age and weighing less than 1500 g—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.