Minimum Age for Cefdinir Administration
Cefdinir is approved for use in pediatric patients 6 months of age and older. 1
FDA-Approved Age Indication
- The FDA drug label explicitly states that "safety and efficacy in neonates and infants less than 6 months of age have not been established" 1
- This 6-month minimum age applies to all approved indications for cefdinir, including respiratory tract infections, acute otitis media, pharyngitis/tonsillitis, and uncomplicated skin infections 1
Clinical Trial Evidence Supporting This Age Cutoff
- Multiple pediatric clinical trials have enrolled patients starting at 6 months of age, establishing safety and efficacy data from this age forward 2, 3
- A comparative study of cefdinir versus amoxicillin/clavulanate for acute otitis media specifically included children "ages 6 months to 12 years," with demonstrated clinical success rates of 80-83% 2
- A skin infection study in pediatric patients enrolled children "aged 6 months to 12 years," showing clinical cure rates of 98.3% with good tolerability 3
Dosing Considerations for Infants 6 Months and Older
- For infants and children 6 months through 12 years, the American Academy of Pediatrics recommends 7 mg/kg every 12 hours (twice daily) or 14 mg/kg every 24 hours (once daily) depending on the indication 4
- The twice-daily regimen (7 mg/kg every 12 hours) is preferred for more serious infections or when treating β-lactamase-producing Haemophilus influenzae 4
- The once-daily option (14 mg/kg every 24 hours) is effective for acute otitis media, sinusitis, and pharyngitis/tonsillitis 4
Clinical Context and Positioning
- Cefdinir serves as an alternative agent when first-line therapy (such as amoxicillin or amoxicillin-clavulanate) cannot be used 5, 4
- The Infectious Diseases Society of America positions cefdinir alongside cefixime, cefpodoxime, and ceftibuten as alternatives for treating β-lactamase-producing Haemophilus influenzae in community-acquired pneumonia 5, 4
Important Safety Considerations
- Do not use cefdinir in infants younger than 6 months due to lack of established safety and efficacy data 1
- Cefdinir can be administered with iron-fortified infant formula without significant pharmacokinetic interactions 1
- However, iron supplements should be taken at least 2 hours before or after cefdinir to avoid decreased absorption 1