January 1998
ROCKVILLE, Md. - A new broad-spectrum cephalosporin, cefdinir (Omnicef, Warner-Lambert), was recently approval by the Food and Drug Administration.
For children 12 years and younger, cefdinir is indicated for the treatment of acute otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. The drug is also indicated for pharyngitis caused by Streptococcus pyogenes and uncomplicated skin and skin structure infections caused by Staphylococcus aureus and S. pyogenes. The pediatric formulation is a strawberry-flavored suspension.
Cefdinir was also approved for the treatment of community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute sinusitis, pharyngitis in adolescents (children 12 years and older) and adults.
Cefdinir is not active against Enterococcus, Pseudomonas, Enterobacter or methicillin-resistant Staphylococcus.
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In four controlled studies conducted in patients with streptococcal pharyngitis, cefdinir was compared with 10 days of penicillin in children, adolescents and adults. One study involved pediatric patients and the other enrolled patients older than 12 years. Each compared 10 days of cefdinir taken four times daily or twice daily to penicillin 250 mg or 10 mg/kg four times daily.
All dosages of cefdinir were superior to penicillin in both groups of patients in eradicating S. pyogenes.
In a controlled, double-blind study in patients older than 12 with community-acquired pneumonia, cefdinir taken twice daily was compared with cefaclor (Ceclor, Lilly) 500 mg taken three times daily. The following clinical cure rates, based on strict evaluability and microbiological response criteria six to 14 days post-therapy, were obtained: S. pneumoniae 100%, H. influenzae 85%, M. catarrhalis 100% and H. parainfluenzae 91%. These rates were comparable to cefaclor.
Another controlled, blinded study in patients older than 12 years was conducted in Europe. Cefdinir taken twice daily was compared with amoxicillin/ clavulanate (Augmentin, SmithKline Beecham) 500/125 mg taken three times daily. The rates were again comparable.
Safety and efficacy in neonates and infants younger than 6 months has not been established, based on information from the package insert. Use of cefdinir for the treatment of acute maxillary sinusitis in patients 6 months to 12 years is supported in clinical trials.
The dosage is flexible and cefdinir can be taken with or without food. The pediatric dosing regimen is either once daily (14 mg/kg) or twice daily (two doses of 7 mg/kg). The dosing regimen for adolescents is one 300 mg capsule twice daily; two 300 mg capsules can be taken once daily.
In clinical trials, 1,893 pediatric patients were treated with 14/mg/kg/day. Most adverse events were mild and self-limiting and involved the gastrointestinal tract. Discontinuations were primarily attributed to diarrhea. No deaths or permanent disabilities were attributed to the drug.
Cefdinir should not be used in patients with known allergy to cephalosporin antibiotics.
The company plans a full-scale launch for the product later this year, according to company spokesman Jeff Baum.
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