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retapamulin (Altabax)

 

Classes: Antibacterials, Topical

Dosing and uses of Altabax (retapamulin)

 

Adult dosage forms and strengths

ointment

  • 1% (5, 10, 15g tubes)

 

Impetigo

Indicated for impetigo caused by MSSA or Streptococcus pyogenes

Apply thin layer to affected area (up to 100 cm²) BID x5 days

 

Pediatric dosage forms and strengths

ointment

  • 1% (5, 10, 15g tubes)

 

Impetigo

Indicated for impetigo caused by MSSA or Streptococcus pyogenes

<9 months: Safety and efficacy not established

≥9 months: Apply thin layer to affected area (up to 2% BSA) BID x5 days

 

Altabax (retapamulin) adverse (side) effects

1-10%

Application site irritation (2%)

 

Warnings

Contraindications

None

 

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 nasal mucosa

Not evaluated on mucosal surfaces

 

Pregnancy and lactation

Pregnancy category: B

Lactation: use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Altabax (retapamulin)

Mechanism of action

Pleuromutilin antibacterial; binds to 50S ribosomal subunit and inhibits bacterial protein synthesis, bateriostatic at MIC; bactericidal at 1000x MIC

 

Pharmacokinetics

Absorption: Low

Protein Bound: 94%

Metabolism: in vitro by liver CYP3A4