ADVERSE REACTIONS
Ceftazidime is generally well-tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.
The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology:
Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients).
Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash and fever. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibiotics, including ceftazidime. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely.
Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in 500) and abdominal pain (1 in 416). The onset of pseudomembranous colitis symptoms may occur during or after treatment (see WARNINGS).
Central Nervous System Reactions (fewer than 1%) include headache, dizziness and paresthesia. Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, asterixis and neuromuscular excitabiIity have been reported in renally impaired patients treated with unadjusted dosage regimens of ceftazidime (see PRECAUTIONS: General).
Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis.
Hematologic: Rare cases of hemolytic anemia have been reported.
Laboratory Test Changes noted during Tazicef (ceftazidime for injection, USP) clinical trials were transient and included: eosinophilia (1 in 13), positive Coombs’ test without hemolysis (1 in 23), thrombocytosis (1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT) (1 in 15), LDH (1 in 18), GGT (1 in 19) and alkaline phosphatase (1 in 23). As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen and/or serum creatinine were observed occasionally. Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis were seen very rarely.
Observed During Clinical Practice: In addition to the adverse events reported from clinical trials, the following events have been identified during post-approval use of ceftazidime. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ceftazidime.
General: Anaphylactic or anaphylactoid reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest), including laryngeal edema, stridor, and urticaria; pain at injection site.
Hepatobiliary Tract and Pancreas: Hyperbilirubinemia.
Renal and Genitourinary: Renal impairment.
Cephalosporin-Class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with ceftazidime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Adverse Reactions: Urticaria, colitis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.
Altered Laboratory Tests: Prolonged prothrombin time, false-positive test for urinary glucose, elevated bilirubin, pancytopenia.
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