FDA label 43cb99f4-5e3f-4ae5-92ed-51bde26dea6d

WARNINGS BEFORE THERAPY WITH SUPRAX (CEFIXIME) CHEWABLE TABLET 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 BETA-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 (CEFIXIME) CHEWABLE TABLETS OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime. Antibiotics, including Suprax (cefixime) chewable tablets, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs. Treatment with broad spectrum antibiotics, including Suprax (cefixime) chewable tablets, alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of severe antibiotic-associated diarrhea including pseudomembranous colitis. Pseudomembranous colitis has been reported with the use of Suprax (cefixime) chewable tablets and other broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins); therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment and may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, management should include fluids, electrolytes, and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile . Other causes of colitis should be excluded.

ADVERSE REACTIONS Most of adverse reactions observed in clinical trials were of a mild and transient nature. Five percent (5%) of patients in the U.S. trials discontinued therapy because of drug-related adverse reactions. The most commonly seen adverse reactions in U.S. trials of the immediate-release tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the BID or the QD regimen. Clinically mild gastrointestinal side effects occurred in 20% of all patients, moderate events occurred in 9% of all patients and severe adverse reactions occurred in 2% of all patients. Individual event rates included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving immediate-release tablets. These symptoms usually responded to symptomatic therapy or ceased when cefixime was discontinued. Several patients developed severe diarrhea and/or documented pseudomembranous colitis, and a few required hospitalization. The following adverse reactions have been reported following the use of cefixime. Incidence rates were less than 1 in 50 (less than 2%), except as noted above for gastrointestinal events. Gastrointestinal (see above): Diarrhea, loose stools, abdominal pain, dyspepsia, nausea, and vomiting. Several cases of documented pseudomembranous colitis were identified during the studies. The onset of pseudomembranous colitis symptoms may occur during or after therapy. Hypersensitivity Reactions : Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported. Hepatic : Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice. Renal : Transient elevations in BUN or creatinine, acute renal failure. Central Nervous System : Headaches, dizziness, seizures. Hemic and Lymphatic Systems : Transient thrombocytopenia, leukopenia, neutropenia, and eosinophilia. Prolongation in prothrombin time was seen rarely. Abnormal Laboratory Tests : Hyperbilirubinemia. Other : Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis. In addition to the adverse reactions listed above which have been observed in patients treated with cefixime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Adverse reactions : Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION and OVERDOSAGE .) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Abnormal Laboratory Tests : Positive direct Coombs test, elevated LDH, pancytopenia, agranulocytosis.