Can faropenem be used in pediatric patients older than 3 months weighing ≥10 kg, and what are the recommended dosage, treatment duration, and safety considerations?

Faropenem for Pediatric Use

Faropenem is approved for pediatric use in children older than 3 months weighing ≥10 kg in certain countries (notably India and Japan), but it is NOT approved by the FDA in the United States, and its use raises significant concerns about promoting carbapenem resistance. 1, 2

Regulatory Status and Availability

• Faropenem medoxomil received a non-approvable letter from the FDA in October 2006 for adult respiratory indications, and development has not progressed to approval in the United States. 3
• The drug is available as an oral dry syrup formulation in some countries (India, Japan) for pediatric bacterial infections, but this does not reflect FDA endorsement or approval. 1, 4
• No FDA-approved pediatric formulation exists in the United States, making any use off-label and unsupported by U.S. regulatory standards. 3

Dosing Recommendations (Where Approved)

In countries where faropenem is approved for pediatric use:

• Standard dose: 15 mg/kg/day divided into three doses (5 mg/kg per dose every 8 hours). 1
• Some studies have used 15-30 mg/kg/day divided three times daily, though 15 mg/kg/day is the established clinical dose. 4
• Treatment duration: 3-8 days for most infections (5-14 days for Group A streptococcal infections). 4
• The formulation is administered orally as a dry syrup three times daily. 1, 4

Approved Indications (Where Available)

Faropenem has been studied and used for:

• Upper respiratory tract infections (pharyngitis, tonsillitis) with 90% clinical efficacy in studies. 4
• Acute otitis media with 94.1% clinical efficacy. 4
• Acute bronchitis and urinary tract infections. 1, 4
• Dermatological infections and bacterial periodontal infections. 1

Safety Profile

• Diarrhea is the primary adverse effect, occurring in 12.5% of patients, similar to other oral β-lactam antibiotics. 4
• No serious adverse drug reactions were observed in the Japanese pediatric study of 113 patients. 4
• Compliance was reported as very good due to the oral formulation. 4

Critical Concerns About Antimicrobial Resistance

The use of faropenem in pediatrics poses a significant threat to carbapenem stewardship:

• Cross-resistance with parenteral carbapenems (meropenem, imipenem, ertapenem) is a major concern, as overuse of oral faropenem may render these critical last-line agents ineffective. 2
• The convenience of oral administration increases the risk of inappropriate overuse, particularly in outpatient settings where parenteral carbapenems would not typically be used. 2
• Faropenem is stable against β-lactamases and has activity against penicillin-resistant Streptococcus pneumoniae (PRSP), but this broad spectrum increases selection pressure for resistant organisms. 1, 4

Clinical Context and Alternatives

For pediatric community-acquired pneumonia and respiratory infections in the United States:

• Standard therapy remains amoxicillin or amoxicillin-clavulanate for outpatient bacterial pneumonia, with treatment courses of 10 days (though shorter courses may be effective for mild disease). 5
• Macrolides (azithromycin, clarithromycin) are appropriate for atypical pneumonia coverage. 5
• Cephalosporins (cefdinir, cefuroxime) provide alternatives when β-lactam allergy is not present. 5

Common Pitfalls to Avoid

• Do not use faropenem as first-line therapy for common pediatric infections where narrower-spectrum agents are effective—this violates antimicrobial stewardship principles. 2
• Avoid off-label use of adult formulations in children, as excipients in adult preparations can cause toxicity in pediatric patients due to immature organ function and altered pharmacokinetics. 6
• Reserve carbapenems (including faropenem where available) for documented multidrug-resistant organisms or treatment failures with standard agents. 5, 2

Practical Recommendation

In the United States, faropenem should not be used in pediatric patients as it lacks FDA approval and suitable alternatives exist. In countries where it is approved, use should be strictly limited to documented infections with resistant organisms where narrower-spectrum agents have failed, to preserve the efficacy of the entire carbapenem class. 2