What are the cefdinir dosing recommendations for acute otitis media in children ≥6 months and adults, including renal‑function adjustments and treatment duration?

Cefdinir Dosing for Acute Otitis Media

For acute otitis media, cefdinir should be dosed at 14 mg/kg/day (maximum 600 mg/day) administered either once daily or divided into two doses for 10 days in children ≥6 months, and 300 mg twice daily in adults. 1

Pediatric Dosing (≥6 Months Through 12 Years)

• Standard dose: 7 mg/kg every 12 hours OR 14 mg/kg once daily for 5-10 days 1
• Maximum daily dose: 600 mg/day regardless of weight 1
• Once-daily dosing for 10 days demonstrates equivalent efficacy to twice-daily dosing 1
• Cefdinir may be administered without regard to meals 1

Weight-Based Dosing Chart (Using 250 mg/5 mL Suspension)

• 18 kg (40 lbs): 2.5 mL every 12 hours OR 5 mL once daily 1
• 27 kg (60 lbs): 3.75 mL every 12 hours OR 7.5 mL once daily 1
• 36 kg (80 lbs): 5 mL every 12 hours OR 10 mL once daily 1
• ≥43 kg (95 lbs): 6 mL every 12 hours OR 12 mL once daily (maximum dose) 1

Adult Dosing

• Standard dose: 300 mg twice daily for 10 days 1
• Alternative: 600 mg once daily may be considered based on pharmacokinetic profile 2

When Cefdinir Is Appropriate

Cefdinir serves as a second-line agent, not first-line therapy for acute otitis media. 3

• Non-Type I penicillin allergy: Cefdinir is the preferred cephalosporin for patients with non-serious hypersensitivity reactions to penicillin (such as rash), as cross-reactivity risk is negligible at approximately 0.1% 3
• Treatment failure: Consider cefdinir when patients fail to respond to initial amoxicillin therapy within 48-72 hours 3
• DO NOT use for Type I hypersensitivity: Patients with anaphylaxis or angioedema to penicillins should receive macrolides or clindamycin instead 4

Renal Dose Adjustments

Pediatric Patients with Renal Insufficiency

• Creatinine clearance <30 mL/min/1.73 m²: 7 mg/kg (maximum 300 mg) once daily 1
• Hemodialysis: 7 mg/kg (maximum 300 mg) every other day, with an additional dose after each dialysis session 1

Adult Patients with Renal Insufficiency

• Creatinine clearance <30 mL/min: 300 mg once daily 1
• Hemodialysis: 300 mg every other day, with 300 mg administered after each dialysis session 1

Treatment Duration Considerations

• Standard duration: 10 days is recommended by the American Academy of Otolaryngology-Head and Neck Surgery 4
• 5-day regimen: While FDA-approved for 5-10 days 1, a head-to-head trial demonstrated that 5 days of cefdinir (14 mg/kg/day) resulted in significantly lower cure rates (71%) compared to 10 days of high-dose amoxicillin-clavulanate (86.5%, p=0.001) 5
• The cure rate with cefdinir decreased as children aged from 6-24 months, suggesting weight-based dosing may be inadequate in older/heavier children 5

Clinical Efficacy and Limitations

• Comparative effectiveness: Cefdinir at 14 mg/kg/day for 5 days was inferior to amoxicillin-clavulanate 80 mg/kg/day for 10 days in validated otoscopy studies 6, 5
• Pathogen coverage: Cefdinir demonstrates 97-99% susceptibility against H. influenzae including beta-lactamase producers, but lacks clinically significant activity against drug-resistant S. pneumoniae (DRSP) 3
• Recurrent AOM: Cefdinir showed 72% eradication rates for recurrent AOM caused by H. influenzae 3
• Higher doses ineffective: Even at 25 mg/kg/day, cefdinir fails to achieve adequate pharmacodynamic targets (<40% time above MIC) for penicillin-nonsusceptible S. pneumoniae, making it ineffective against resistant strains 7

Reassessment Algorithm After Treatment Failure

If no improvement occurs after 48-72 hours of cefdinir therapy: 3

1. Confirm diagnosis: Reassess to verify AOM and exclude alternative diagnoses 3
2. Switch antibiotics: Change to high-dose amoxicillin-clavulanate (90 mg/kg/day of amoxicillin with 6.4 mg/kg/day of clavulanate in 2 divided doses) 3
3. Consider parenteral therapy: Ceftriaxone 50 mg/kg IM or IV for 3 days is an alternative 3

Key Clinical Pitfalls

• Misclassifying penicillin allergy: Distinguish Type I reactions (anaphylaxis, angioedema) from non-serious reactions (rash)—cefdinir is safe only for the latter 3, 4
• Using as first-line therapy: High-dose amoxicillin (80-90 mg/kg/day) remains the gold standard initial treatment due to superior effectiveness, safety, cost, and narrow spectrum 3
• Inadequate duration: The 5-day regimen shows inferior outcomes; use 10-day courses for optimal efficacy 5
• Geographic resistance patterns: In areas with high DRSP prevalence, cefdinir provides insufficient coverage and should be avoided 3
• Palatability advantage: The oral suspension has superior taste compared to other antimicrobials, which may improve adherence in children 3, 8

Suspension Preparation

• Stability: After reconstitution, suspension remains stable for 10 days at room temperature (25°C/77°F) 1
• Storage: Keep container tightly closed and shake well before each administration 1
• Discard: Any unused portion must be discarded after 10 days 1