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Retapamulin

Medically reviewed by Drugs.com. Last updated on Aug 11, 2020.

Pronunciation

(re te PAM ue lin)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Altabax: 1% (15 g, 30 g)

Brand Names: U.S.

  • Altabax

Pharmacologic Category

  • Antibiotic, Pleuromutilin
  • Antibiotic, Topical

Pharmacology

Primarily bacteriostatic; inhibits normal bacterial protein biosynthesis by binding at a unique site (protein L3) on the ribosomal 50S subunit; prevents formation of active 50S ribosomal subunits by inhibiting peptidyl transfer and blocking P-site interactions at this site

Absorption

Topical: Low; increased when applied to abraded skin; age dependent; absorption highest in younger patients.

Infants and Children 2 to 24 months: In patients receiving twice-daily retapamulin, 46% of subjects 2 to 24 months of age had a measurable serum concentration compared to 7% of those ≥2 years. A higher proportion of infants 2 to 9 months had measurable serum concentration as compared to infants and children 9 to 24 months (69% vs 32%).

Children ≥ 2 years, Adolescents, and Adults: Low; increased when applied to abraded skin.

Metabolism

Hepatic via CYP 3A4; extensively metabolized by mono-oxygenation and di-oxygenation to multiple metabolites

Protein Binding

~94%

Use: Labeled Indications

Impetigo: Treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in adults and pediatric patients 9 months and older.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Impetigo: Topical: Apply a thin layer to affected area twice daily for 5 days (maximum; total treatment area should not exceed 100 cm2 total body surface area).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Impetigo: Note: For patients with a limited number of lesions (IDSA [Stevens 2014]); total treatment area should not exceed 2% of total body surface area or 100 cm2 total body surface area, whichever is less.

Infants <9 months: Limited data available: Topical: Apply thin layer to lesions twice daily for 5 days (IDSA [Stevens 2014]); Note: In trials, infants 2 to 9 months of age had higher systemic exposure than older pediatric patients; monitor closely for systemic effects.

Infants ≥9 months, Children, and Adolescents: Topical: Apply thin layer to affected area (lesions) twice daily for 5 days (IDSA [Stevens 2014]; manufacturer's labeling).

Administration

Topical: For external use only; not for intranasal, intravaginal, ophthalmic, oral, or mucosal application. May cover treatment area with sterile bandage or gauze dressing if needed. Wash hands after application if the hands are not the area for treatment.

Storage

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Retapamulin. Management: Avoid this combination in patients less than 2 years old. No action is required in other populations. Monitor therapy

Adverse Reactions

1% to 10%:

Central nervous system: Headache (1% to 2%)

Dermatologic: Eczema (infants, children & adolescents: 1%)

Gastrointestinal: Diarrhea (1% to 2%), nausea (1%)

Local: Application site irritation (adults: 2%), application site pruritus (infants, children & adolescents: 2%)

Respiratory: Nasopharyngitis (1% to 2%)

<1%, postmarketing, and/or case reports: Angioedema, application site burning, application site pain, contact dermatitis, epistaxis, erythema, hypersensitivity reaction, increased creatine phosphokinase

Warnings/Precautions

Concerns related to adverse effects:

• Skin irritation: If sensitization or severe local skin irritation occurs, wipe ointment off and discontinue use.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Other warnings/precautions:

• Appropriate use: For external use only; not for intranasal, intravaginal, ophthalmic, oral, or mucosal application. Concomitant use with other topical products to the same treatment area has not been evaluated.

Pregnancy Considerations

Retapamulin has limited systemic absorption following topical administration. Use during pregnancy is not expected to result in significant exposure to the fetus.

Patient Education

What is this drug used for?

• It is used to treat impetigo.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Burning

• Redness

• Severe skin irritation

• Swelling

• Oozing

• Bleeding

• Skin sores

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.