Bactroban Topical

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mupirocin topical in children. However, safety and effectiveness of mupirocin cream have not been established in children younger than 3 months of age, and mupirocin ointment in children younger than 2 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mupirocin topical cream in the elderly.

No information is available on the relationship of age to the effects of mupirocin topical ointment in the geriatric population. Safety and efficacy have not been established.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea—Use with caution. May make this condition worse.

This section provides information on the proper use of a number of products that contain mupirocin. It may not be specific to Bactroban. Please read with care.

It is very important that you 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. To do so may cause unwanted side effects or skin irritation.

This medicine should only be used on the skin. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin infection completely, keep using mupirocin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer to the affected area of the skin. Rub it in gently.
• After applying this medicine, the treated area may be covered with a gauze dressing if desired.

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 (cream):
  • For treatment of secondarily infected traumatic skin lesions:
    • Adults and children 3 months of age and older—Apply three times a day for 10 days.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
• For topical dosage form (ointment):
  • For treatment of impetigo:
    • Adults and children 2 months of age and older—Apply three times a day.
    • Children younger than 2 months of age—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.

If your skin infection does not improve within 3 to 5 days, or if it becomes worse, check with your doctor.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Check with your doctor right away if you have a severe itching, skin rash, burning, stinging, redness, swelling, or irritation on the skin.

Mupirocin is used to treat infected cuts or wounds. It is an antibiotic. It works by stopping the growth of certain bacteria.

How to use Bactroban Cream

Read the Patient Information Leaflet if available from your pharmacist before you start using mupirocin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication only on the skin. Clean and dry the affected area first. Then apply a small amount of cream to the area as directed by your doctor, usually 3 times a day. You may cover the treated area with a bandage.

Use this medication regularly to get the most benefit from it. Continue to use it for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Keep mupirocin away from your eyes, nose, or mouth unless otherwise directed by your doctor. If you accidentally get it in your eyes, nose, or mouth, rinse well with plenty of water.

Tell your doctor if your condition does not get better in 3 to 5 days.

Remember that your doctor has prescribed this medication because 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.

Although uncommon, mild burning or stinging after using this medication may occur. If you have severe burning, stinging, or irritation, stop using this medication and tell your doctor right away.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in a new skin infection caused by fungus or yeast. Tell your doctor right away if you notice signs of a new infection, or if your current infection does not get better or if it gets worse.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.