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Retapamulin

Pronunciation

(re te PAM ue lin)

Dosage Forms

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

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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

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.

Dosage

Impetigo: Topical:

Infants ≥9 months, Children, and Adolescents: Apply a thin layer to affected area twice daily for 5 days (maximum: total treatment area should not exceed 2% of total body surface area).

Adults: 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).

Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

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, and adolescents 1%)

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

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

Respiratory: Nasopharyngitis (1% to 2%)

<1% (Limited to important or life-threatening): Contact dermatitis, creatine phosphokinase increased, epistaxis, hypersensitivity

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 Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe skin irritation, edema, oozing, hemorrhaging, or skin sores (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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