Cefdinir Dosing for Pediatric Acute Otitis Media
For pediatric ear infections (acute otitis media), cefdinir should be dosed at 7 mg/kg every 12 hours OR 14 mg/kg once daily for 5-10 days, with the once-daily regimen studied specifically for 10 days. 1
FDA-Approved Dosing Regimens
The FDA label provides two equivalent dosing options for acute bacterial otitis media in children 6 months through 12 years 1:
- Twice-daily dosing: 7 mg/kg every 12 hours for 5-10 days 1
- Once-daily dosing: 14 mg/kg every 24 hours for 10 days 1
The total daily dose for all infections is 14 mg/kg, up to a maximum of 600 mg per day 1. Children weighing ≥43 kg should receive the maximum daily dose of 600 mg 1.
Practical Dosing Examples
Using the FDA dosage chart 1:
- 9 kg (20 lbs): 2.5 mL of 125 mg/5 mL suspension every 12 hours OR 5 mL once daily
- 18 kg (40 lbs): 5 mL of 125 mg/5 mL suspension every 12 hours OR 10 mL once daily
- 27 kg (60 lbs): 7.5 mL of 125 mg/5 mL suspension every 12 hours OR 15 mL once daily
- 36 kg (80 lbs): 10 mL of 125 mg/5 mL suspension every 12 hours OR 20 mL once daily
Duration of Therapy: Critical Consideration
A major caveat exists regarding the 5-day regimen: While the FDA label states 5-10 days for acute otitis media 1, and one study showed equivalence between 5-day cefdinir and 10-day cefprozil 2, more recent head-to-head data reveals important limitations:
- 10 days of high-dose amoxicillin/clavulanate (86.5% cure) significantly outperformed 5 days of cefdinir (71.0% cure) in children 6-24 months with AOM 3
- Cefdinir efficacy decreased with increasing age/weight, suggesting the standard dose may be inadequate in older/heavier children 3
- The once-daily 10-day regimen has been specifically studied and validated 1, whereas the 5-day regimen's efficacy appears questionable based on comparative data 3
Therefore, the 10-day once-daily regimen (14 mg/kg daily) is the safer choice to optimize clinical cure rates and minimize treatment failure.
Administration Details
- Cefdinir may be administered without regard to meals 1
- The suspension should be shaken well before each dose 1
- After reconstitution, store at room temperature (25°C/77°F) in a tightly closed container 1
- Discard any unused suspension after 10 days 1
Special Populations
For pediatric patients with renal insufficiency (creatinine clearance <30 mL/min/1.73 m²), reduce the dose to 7 mg/kg (up to 300 mg) once daily 1.
For patients on hemodialysis, give 7 mg/kg every other day, with an additional dose (7 mg/kg) at the conclusion of each hemodialysis session 1.
Clinical Context and Alternatives
While cefdinir is listed as an alternative for β-lactamase-producing Haemophilus influenzae in pneumonia guidelines 4, it is not a first-line agent for acute otitis media. The evidence suggests that when bacterial treatment is indicated for AOM, high-dose amoxicillin or amoxicillin/clavulanate remains superior 3. Cefdinir serves as a reasonable second-line option for penicillin-allergic patients or in cases of treatment failure with amoxicillin 5, but prescribers should be aware of its lower cure rates compared to first-line agents 3.
The drug's superior palatability compared to other oral antibiotics may improve adherence in children who have failed other therapies due to taste-related noncompliance 6, 7.