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FDA Clears Broad Spectrum Cephalosporin Antibiotic For Adults And Children MORRIS PLAINS, NJ -- December 8, 1997 -- The United States Food and Drug Administration (FDA) has granted marketing clearance to Warner-Lambert Co.’s Omnicef(R) (cefdinir), a broad spectrum cephalosporin antibiotic for adult and pediatric use. In an extensive controlled clinical trial program involving over 13,000 patients (9,600 adults and 3,400 children) over a four-year period, Omnicef (cefdinir) capsules and Omnicef (cefdinir) powder for oral suspension have proven to be effective, well-tolerated therapies for a wide variety of community infections. In adults and adolescents, Omnicef is indicated for the treatment of community acquired pneumonia, acute exacerbation of chronic bronchitis, acute bacterial sinusitis (sinus infections), pharyngitis and tonsillitis caused by Streptococcus pyogenes (strep throat) and uncomplicated skin and skin structure infections. In children, Omnicef is indicated for the treatment of acute bacterial otitis, media (middle ear infections), acute bacterial sinusitis, pharyngitis and tonsillitis caused by Streptococcus pyogenes and uncomplicated skin and skin structure infections. The adult formulation of Omnicef is a 300 milligram capsule. The pediatric formulation is a strawberry-flavored suspension. Dosing is flexible and Omnicef can be taken without regard to meals. In adults and adolescents, physicians may direct patients to take two 300 mg. capsules once daily or one 300 mg, capsule twice daily for most infections. The pediatric dosing regimen, in most instances, is also either once daily (14 milligram per kilogram of the child's weight) or twice daily (two doses of 7 mg./kg.). Omnicef is dosed twice daily for pneumonia and skin infections. Omnicef has proven to be well tolerated in clinical trials. Most side effects involved the gastrointestinal tract. Omnicef should not be used in patients with a known allergy to the cephalosporin class of antibiotics. E-mail this page to a friend or colleague! To print, use this version