Retapamulin

Retapamulin is a topical antibiotic used for the treatment of impetigo caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.

• Retapamulin is available under the following different brand names: Altabax

Common side effects of Retapamulin include:

• mild itching,
• skin irritation, and
• headache

Serious side effects of Retapamulin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe burning, itching, redness, swelling, blistering, oozing, or other skin irritation where the medicine was applied, and
• new or worsening signs of skin infection

Rare side effects of Retapamulin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Ointment

1. 1% (5, 10, 15 g tubes)

Impetigo

Adult dosage

• Apply a thin layer to the affected area (up to 100 cm²) twice daily for 5 days

Pediatric dosage

• Aged below 9 months: Safety and efficacy not established
• Aged 9 months and above: Apply a thin layer to the affected area (up to 2% BSA) twice daily for 5 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Retapamulin has no noted severe interactions with any other drugs.
• Retapamulin has no noted serious interactions with any other drugs.
• Retapamulin has no noted moderate interactions with any other drugs.
• Retapamulin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Retapamulin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Retapamulin?”

Cautions

• Not for oral, intranasal, ophthalmic or intravaginal use; efficacy and safety for mucosal surfaces not established
• Discontinue if sensitization or severe local irritation develops
• Epistaxis reported with use on the nasal mucosa
• Not evaluated on mucosal surfaces

Pregnancy and Lactation

• There are no available data on use in pregnant women to inform any drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes; the drug is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure.
• Lactation
  • There are no data available on the presence of drug in human milk, its effects on breastfed infant or on milk production; however, breastfeeding is not expected to result in the exposure of child to drug due to negligible systemic absorption in humans following topical administration of drug
  • Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from drug or from an underlying maternal condition