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nafithromycin

J01FA17

Forms & Strengths

Oral tablets: 400 mg
Intravenous solution for injection: 400 mg/vial

Adult Dosing

Community-acquired pneumonia (CAP): 400 mg once daily orally or IV for 3 to 5 days
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily orally for 3 days

Pediatric Dosing

Safety and efficacy in pediatric patients under 18 years of age have not been established

Indications

Treatment of community-acquired pneumonia (CAP) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, and atypical pathogens
Treatment of acute bacterial exacerbations of chronic bronchitis (ABECB)

Mechanism of Action

Semisynthetic fluoroketolide antibacterial agent
Binds to domain II and V of 23S rRNA of the 50S ribosomal subunit, inhibiting bacterial protein synthesis
Exhibits potent bactericidal activity against macrolide-resistant strains due to dual-binding affinity

Contraindications

Known hypersensitivity to nafithromycin, erythromycin, or any macrolide/ketolide class antibacterial
History of jaundice or hepatic dysfunction associated with prior use of ketolide or macrolide antibiotics
Concomitant administration with cisapride, pimozide, or ergot alkaloids due to risk of serious arrhythmias

Adverse Reactions

Common: Diarrhea, nausea, headache, vomiting, elevated liver enzymes (ALT/AST)
Serious: QT prolongation, Clostridioides difficile-associated diarrhea, severe hypersensitivity reactions, hepatotoxicity

Drug Interactions

CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase plasma concentrations of nafithromycin
CYP3A4 inducers (e.g., rifampin, carbamazepine) may significantly decrease nafithromycin efficacy
Drugs known to prolong the QT interval (e.g., class IA/III antiarrhythmics, antipsychotics) increase risk of ventricular arrhythmias
May increase serum concentrations of statins, digoxin, or warfarin through CYP3A4 inhibition or P-gp interaction

Curated Content: Needs Vetting Before Put to Clinical Use