Retapamulin (Topical application)

Retapamulin is used to treat a bacterial skin infection known as impetigo. This medicine is a topical antibiotic.

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

If your skin infection does not get better in 3 to 4 days, or if it gets worse, contact your doctor.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it provides. Consider the following for this medicine:

Allergies

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

Pediatric

There haven't been any appropriate studies on the effects of retapamulin in children under 9 months of age. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of retapamulin.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there might be an interaction. In such cases, your doctor may adjust the dose or take other precautions. It's very important for your healthcare professional to know if you are taking any of the medicines listed below when you are on this medicine. The following interactions are significant and may not include all possibilities.

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

• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Conivaptan
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Alcohol or tobacco use with specific medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Skin infections (other than impetigo)—This medicine should not be used for other skin problems.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Less common

• Burning, itching, redness, skin rash, swelling, or soreness at the site
• Skin rash, encrusted, scaly, and oozing

Rare

• Blistering, burning, crusting, dryness, flaking of skin
• Flushing, redness of skin
• Itching, scaling, severe redness, soreness, swelling of skin
• Pain at the site of application
• Unusually warm skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Diarrhea
• Fever
• Headache
• Muscle aches
• Nausea
• Sore throat
• Stuffy or runny nose
• Unusual tiredness or weakness

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

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

In the U.S.

• Altabax

Available Dosage Forms:

• Ointment

Therapeutic Class: Antibacterial

Chemical Class: Pleuromutilin

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

Wash your hands with soap and water before using this medicine. Also wash your hands with soap and water after using this medicine if the hands are not the area for treatment.

Before applying this medicine, wash the affected area with soap and water, and dry thoroughly. Then apply a thin layer to the affected area and rub in gently.

After applying this medicine, the treated area may be covered with a sterile bandage or gauze dressing if desired.

Keep using this medicine for the full treatment time, even if your symptoms have improved after the first few doses. Your infection may not clear up if you stop using 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 impetigo: Adults and children 9 months of age and older—Apply to the affected area of the skin two times a day for 5 days. Children below 9 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

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.

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.