Retapamulin topical (for the skin) is an antibiotic that is used to treat an infection called impetigo (im-pe-TYE-go). Impetigo usually affects the nose, lips, or other areas of the face, but it may also affect other areas of the body.

Retapamulin may be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Apply a thin layer of retapamulin topical to the affected area.

Wash your hands after applying this medicine, or after touching your skin lesions for any other reason. The bacteria that causes impetigo can infect any skin area that comes into contact with your lesions.

Take care not to wash the medicine off any skin on your hands that you are treating with this medicine.

You may cover the treated skin areas with a bandage or clean gauze after applying the medicine.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

Do not use retapamulin topical to treat any skin condition that has not been checked by your doctor.

Do not share this medicine with another person, even if they have the same symptoms you have. Each member of the household should be seen by a doctor if they start to show symptoms of impetigo.

Use the medicine for 5 days in a row. Call your doctor if your symptoms do not improve after 3 to 4 days.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Impetigo:

Apply a thin layer to the affected area (up to 100 cm2 in total area) twice a day for 5 days

Comments:
-Consider alternative therapy if there is no improvement or worsening in the affected area after 2 to 3 days of treatment.

Use: Topical treatment of impetigo due to methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes

Usual Pediatric Dose for Impetigo:

Apply a thin layer to the affected area (up to 2% total body surface area) twice a day for 5 days

Comments:
-For pediatric patients aged 9 months or older.
-Concomitant use with strong CYP450 3A4 inhibitors is not recommended in patients younger than 24 months of age due to the higher systemic exposure of the drug in this patient population.
-Consider alternative therapy if there is no improvement or worsening in the affected area after 2 to 3 days of treatment.

Use: Topical treatment of impetigo due to methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes

Retapamulin topical is not approved for use by anyone younger than 9 months old.

Tell your doctor if you are pregnant

It may not be safe to breast-feed while using retapamulin topical. Ask your doctor about any risk.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of retapamulin topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Impetigo is highly contagious and spreads easily from person to person. Avoid sharing personal items such as towels, washcloths, or razors with other people if you are infected with impetigo. Use a clean towel and washcloth each time you bathe to keep from reinfecting your own skin.

Avoid getting this medication in your eyes, nose, or mouth, or inside your vagina. If this does happen, rinse with water.

Avoid using other medications on the areas you treat with retapamulin topical unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wipe the ointment off your skin and call your doctor at once if you have:

• severe burning, itching, redness, swelling, blistering, oozing, or other skin irritation where the medicine was applied; or

• new or worsening signs of skin infection.

Common side effects of retapamulin topical may include:

• mild itching or skin irritation; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other.

Children younger than 2 years old can absorb larger amounts of retapamulin topical through the skin than adults. This could make it more likely that retapamulin topical could interact with other medications the child is using, especially antifungal or antiviral medicine, or other antibiotics.

Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.