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warnings
WARNINGS CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE CLINICAL PHARMACOLOGY). BEFORE THERAPY WITH CEFUROXIME AXETIL PRODUCTS IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFUROXIME AXETIL PRODUCTS, OTHER 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 A CLINICALLY SIGNIFICANT ALLERGIC REACTION TO CEFUROXIME AXETIL PRODUCTS OCCURS, DISCONTINUE THE DRUG AND INSTITUTE APPROPRIATE THERAPY. 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. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime axetil for oral suspension, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
ADVERSE REACTIONS In clinical trials using multiple doses of cefuroxime axetil powder for oral suspension, pediatric patients (96.7% of whom were younger than 12 years of age) were treated with the recommended dosages of cefuroxime axetil (20 to 30 mg/kg/day divided twice a day up to a maximum dose of 500 or 1,000 mg/day, respectively). There were no deaths or permanent disabilities in any of the patients in these studies. Eleven U.S. patients (1.2%) discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. During clinical trials, discontinuation of therapy due to the taste and/or problems with administering this drug occurred in 13 (1.4%) pediatric patients enrolled at centers in the United States. The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil for oral suspension in multiple-dose clinical trials (n = 931 cefuroxime axetil-treated U.S. patients). Table 3: Adverse Reactions—Cefuroxime Axetil For Oral Suspension Multiple-Dose Dosing Regimens—Clinical Trials Incidence ≥ 1% Diarrhea/loose stools 8.6% Dislike of taste 5 % Diaper rash 3.4% Nausea/vomiting 2.6% Incidence < 1% but > 0.1% Abdominal pain Flatulence Gastrointestinal infection Candidiasis Vaginal irritation Rash Hyperactivity Irritable behavior Eosinophilia Positive direct Coombs’ test Elevated liver enzymes Viral illness Upper respiratory infection Sinusitis Cough Urinary tract infection Joint swelling Arthralgia Fever Ptyalism POSTMARKETING EXPERIENCE WITH CEFUROXIME AXETIL PRODUCTS In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with cefuroxime tablets or with cefuroxime axetil for oral suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation. General: The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritis, rash, serum sickness-like reaction, and urticaria. Gastrointestinal: Pseudomembranous colitis (see WARNINGS ). Hematologic: Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time. Hepatic: Hepatic impairment including hepatitis and cholestasis, jaundice. Neurologic: Seizure. Skin: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Urologic: Renal dysfunction. CEPHALOSPORIN-CLASS ADVERSE REACTIONS In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, and agranulocytosis. 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.
adverse reactions
POSTMARKETING EXPERIENCE WITH CEFUROXIME AXETIL PRODUCTS In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with cefuroxime tablets or with cefuroxime axetil for oral suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation. General: The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritis, rash, serum sickness-like reaction, and urticaria. Gastrointestinal: Pseudomembranous colitis (see WARNINGS ). Hematologic: Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time. Hepatic: Hepatic impairment including hepatitis and cholestasis, jaundice. Neurologic: Seizure. Skin: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Urologic: Renal dysfunction.
adverse reactions
CEPHALOSPORIN-CLASS ADVERSE REACTIONS In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, and agranulocytosis. 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.