ADVERSE REACTIONS
CLAFORAN is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.
The most frequent adverse reactions (greater than 1%) are:
Local (4.3%) - Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.
Hypersensitivity (2.4%) - Rash, pruritus, fever, eosinophilia and less frequently urticaria and anaphylaxis (e.g., angioedema, bronchospasm, malaise possibly culminating in shock).
Gastrointestinal (1.4%) - Colitis, diarrhea, nausea, and vomiting.
Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment.
Nausea and vomiting have been reported rarely.
Less frequent adverse reactions (less than 1%) are:
Cardiovascular System - Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.
Hematologic System - Neutropenia, transient leukopenia, eosinophilia, thrombocytopenia and agranulocytosis have been reported. Some individuals have developed positive direct Coombs Tests during treatment with CLAFORAN and other cephalosporin antibiotics. Rare cases of hemolytic anemia have been reported.
Genitourinary System - Moniliasis, vaginitis.
Central Nervous System - Administration of high doses of beta-lactam antibiotics, including cefotaxime, particularly in patients with renal insufficiency may result in encephalopathy (e.g. impairment of consciousness, abnormal movements and convulsions). Headache.
Liver - Transient elevations in SGOT, SGPT, serum LDH, gamma GT, bilirubin, and serum alkaline phosphatase levels have been reported. These laboratory abnormalities, which may also be explained by the infection, may rarely exceed twice the upper limit of the normal range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic. Hepatitis, sometimes with jaundice, has been reported.
Kidney - As with some other cephalosporins, interstitial nephritis and transient elevations of BUN and creatinine have been occasionally observed with CLAFORAN.
Cutaneous - As with other cephalosporins, isolated cases of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
Cephalosporin Class Labeling
In addition to the adverse reactions listed above which have been observed in patients treated with cefotaxime sodium, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and false-positive test for urinary glucose.
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.
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