Pronunciation:

re-te-PAM-ue-lin

Brand Names:

• Altabax

Dosage Forms:

• Ointment

Classifications:

Therapeutic—

Antibacterial

Chemical—

Pleuromutilin

Uses of This Medicine:

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

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of retapamulin in children below 9 months of age. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of retapamulin in the elderly .

Other 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Other interactions—

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:

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

If your skin infection does not improve within 3 to 4 days, or if it becomes worse, check with your doctor .

Side Effects of This Medicine:

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 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 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.