SUPRAX® is indicated for the treatment of otitis media caused by H. influenzae (β-lactamase +/- strains), M. (Branhamella) catarrhalis (most of which are β-lactamase positive), and S. pyogenes;* a pharyngitis and tonsillitis caused by S. pyogenes; acute exacerbations of chronic bronchitis caused by S. pneumoniae and H. influenzae (β-lactamase positive and negative strains); and uncomplicated urinary tract infections caused by E. coli and P. mirabilis. *Efficacy for this organism in this organ system was studied in fewer than 10 patients.
IMPORTANT SAFETY CONSIDERATIONS
The most common adverse event related or probably related to SUPRAX® was GI upset. Several patients developed severe diarrhea and/or documented pseudomembranous colitis, and a few required hospitalization. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving suspension was comparable to the incidence seen in adult patients receiving tablets. SUPRAX® is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
WARNINGS: BEFORE THERAPY WITH SUPRAX® IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO SUPRAX® OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.