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| |  Omnicef, A Broad Spectrum Cephalosporin Antibiotic, Available In The U.S. MORRIS PLAINS, NJ -- Oct. 1, 1998 -- Parke-Davis’s Omnicef (R) (cefdinir), an extended spectrum cephalosporin antibiotic indicated for adult and adolescent (age 13 years or older) use, is now available in the United States. The newest in the U.S. cephalosporin category, Omnicef covers key pathogens in a wide range of illnesses from acute maxillary sinusitis (sinus infections), to acute exacerbations of chronic bronchitis (AECB), to pharyngitis and tonsillitis (strep throat), to community-acquired pneumonia (CAP) and uncomplicated skin and skin structure infections (SSSIs). Omnicef has been used outside the U.S. by more than 70 million patients for the last seven years. Because Omnicef treats a wide range of gram-positive and gram-negative organisms causing community-acquired infections, it gives physicians a simple choice when treating patients with these illnesses. Omnicef has the gram-negative coverage expected from an oral third-generation cephalosporin while still retaining activity against common community-acquired gram-positive organisms. Omnicef dosing is convenient, can be given once a day for most indications and can be taken without regard to meals. In an extensive controlled clinical trial program involving more than 13,000 patients over a four-year period, Omnicef was proven to be an effective, well-tolerated therapy for a wide variety of community infections. For patients with a previous hypersensitivity reaction to penicillins, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented. If an allergic reaction to Omnicef occurs, the drug should be discontinued. Omnicef should not be used in patients with a known allergy to the cephalosporin class of antibiotics. The most frequently reported adverse reactions in clinical trials were diarrhea (16 percent), vaginal moniliasis (five percent of women), nausea (three percent) and headache (two percent). Most adverse events were mild and self limiting in nature with a low (three percent) discontinuation rate due to associated adverse events. Omnicef is indicated for the treatment of adult and adolescent patients with mild to moderate infections caused by susceptible strains of the designated micro-organisms in the following conditions: community-acquired pneumonia and acute exacerbations of chronic bronchitis caused by Haemophilus influenzae, Haemophilus parainfluenzae and Moraxella catarrhalis (including beta-lactamase-producing strains of each) and Streptococcus pneumoniae(penicillin-susceptible strains only); acute maxillary sinusitis caused by Haemophilus influenzae and Moraxella catarrhalis (including beta-lactamase-producing strains of each) and Streptococcus pneumoniae (penicillin-susceptible strains only); uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) and Streptococcus pyogenes; and pharyngitis/tonsillitis caused by Streptococcus pyogenes. Omnicef is effective in the eradication of S. pyogenes from the oropharynx. Omnicef has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
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