Version May 2024
Skin and soft tissue infection:
Impetigo (limited number of lesions): Topical: Apply a thin layer to affected area twice daily for 5 days (total treatment area should not exceed 100 cm2 total BSA) (Ref).
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
(For additional information see "Retapamulin: Pediatric drug information")
Impetigo: Note: For patients with a limited number of lesions (Ref); 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 (Ref); 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 (Ref).
There are no dosage adjustments provided in manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults and pediatrics, unless otherwise indicated.
1% to 10%:
Dermatologic: Eczema (infants, children, and adolescents: 1%)
Gastrointestinal: Diarrhea (1% to 2%), nausea (adults: 1%)
Local: Application-site irritation (adults: 2%), application-site pruritus (infants, children, and adolescents: 2%)
Nervous system: Headache (1% to 2%)
Respiratory: Nasopharyngitis (1% to 2%)
<1%:
Dermatologic: Contact dermatitis, erythema of skin
Local: Application-site pain
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen
Postmarketing:
Hypersensitivity: Hypersensitivity reaction (including angioedema)
Local: Application-site burning
There are no contraindications listed in the manufacturer's labeling.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, External:
Altabax: 1% (15 g, 30 g)
No
Ointment (Altabax External)
1% (per gram): $28.89
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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.
Topical: For external use only; not for intranasal, intravaginal, ophthalmic, oral, or mucosal application. Following application, may cover treatment area with sterile bandage or gauze dressing if desired. Wash hands after application if hands are not the area for treatment.
Impetigo: Treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in adults and pediatric patients 9 months and older.
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Retapamulin. Management: The use of retapamulin with strong CYP3A4 inhibitors is not recommended in patients less than 2 years old. No action is required in other populations. Risk C: Monitor therapy
Retapamulin has limited systemic absorption following topical administration. Use during pregnancy is not expected to result in significant exposure to the fetus.
It is not known if retapamulin is present in breast milk.
Retapamulin has limited systemic absorption following topical administration. Use in lactating women is not expected to result in significant exposure to a breastfed infant. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
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.
Protein binding: ~94%.
Metabolism: Hepatic via CYP 3A4; extensively metabolized by mono-oxygenation and di-oxygenation to multiple metabolites.
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