What are the pediatric indications for cefdinir?

Pediatric Indications for Cefdinir

Cefdinir is FDA-approved for treating acute otitis media, pharyngitis/tonsillitis, acute maxillary sinusitis, and uncomplicated skin and skin structure infections in pediatric patients aged 6 months and older. 1

FDA-Approved Pediatric Indications

Cefdinir is indicated for the following conditions in children ≥6 months of age 1:

• Acute otitis media - Dosed at 14 mg/kg/day in 1 or 2 divided doses 2, 1
• Pharyngitis/tonsillitis (streptococcal) - Can be given for 5 or 10 days 2, 3
• Acute maxillary sinusitis - Supported by evidence from adult studies and similar pathophysiology in children 1
• Uncomplicated skin and skin structure infections - Demonstrated efficacy equivalent to cefalexin 3

Role in Treatment Algorithms

Acute Otitis Media

Cefdinir serves as a first-line alternative for penicillin-allergic children with acute otitis media. 2 The American Academy of Pediatrics recommends cefdinir at 14 mg/kg/day in 1 or 2 doses as an alternative when amoxicillin cannot be used 2. Importantly, cefdinir, cefuroxime, cefpodoxime, and ceftriaxone are highly unlikely to cross-react with penicillin allergy due to their distinct chemical structures, with cross-reactivity rates of only 0.1% 2.

Acute Bacterial Sinusitis

For acute sinusitis, cefdinir is considered a suitable agent with activity comparable to second-generation cephalosporins against Streptococcus pneumoniae and adequate coverage of Haemophilus influenzae. 2 The drug provides coverage against β-lactamase-producing strains of H. influenzae and Moraxella catarrhalis, which account for nearly 50% and 90-100% of isolates respectively in most geographic areas 2.

Pharyngitis/Tonsillitis

Cefdinir demonstrates efficacy equivalent to penicillin V when given for 5 or 10 days for streptococcal pharyngitis 2, 3. When phlegmonous tonsillitis fails to respond to cefdinir after 72 hours, switching to high-dose amoxicillin-clavulanate (90 mg/6.4 mg per kg per day) or parenteral ceftriaxone is recommended 4.

Microbiologic Activity

Cefdinir provides 2, 5, 3:

• Good activity against penicillin-susceptible S. pneumoniae (comparable to cefuroxime axetil and cefpodoxime)
• Moderate activity against H. influenzae (similar to cefuroxime axetil but lower than cefpodoxime)
• Stability against 13 common β-lactamases, maintaining activity against β-lactamase-producing strains 3, 6
• Limited activity against drug-resistant S. pneumoniae (DRSP) 2

Dosing and Administration

The standard pediatric dose is 14 mg/kg/day, which can be administered once daily or divided into two doses 2, 1. The suspension formulation is very well accepted among children with superior taste compared to other oral antimicrobials 2, 5, 3.

Important Caveats

Cefdinir should not be used as first-line therapy when high-dose amoxicillin or amoxicillin-clavulanate is appropriate. 2 It is reserved for penicillin-allergic patients or as an alternative agent. The drug has no activity against staphylococci and limited activity against highly penicillin-resistant pneumococci 2.

A common pitfall is the formation of a reddish stool discoloration when cefdinir is given with iron-containing products, which is benign and due to a nonabsorbable complex formation 1. However, cefdinir can be safely administered with iron-fortified infant formula 1.

Off-Label Use

While not FDA-approved for urinary tract infections, recent data suggests cefdinir provides 95.6% susceptibility against common urinary pathogens in children, comparable to ceftriaxone (97.7%) and superior to trimethoprim-sulfamethoxazole (84.9%) 7. However, activity drops to 64.7% against opportunistic or nosocomial pathogens 7.