Tazolitt Adverse Reactions

(See Table 2):

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Nosocomial Pneumonia Trials: (See Table 3):

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For adverse drug reactions that appeared in both studies the higher frequency is presented.
Other trials: Nephrotoxicity: In a randomized, multicenter controlled trial in 1200 adult critically ill patients, piperacillin/tazobactam was found to be a risk factor for renal failure (odds ratio 1.7, 95% Ci 1.18 to 2.43), and associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs.
Pediatrics: Studies of piperacillin/tazobactam in pediatric patients suggest a similar safety profile to that seen adults. In a prospective, randomized, comparative, open-label clinical trial of pediatric patients with severe intra-abdominal infections (including appendicitis and/or peritonitis), 273 patients were treated with piperacillin/tazobactam (112.5 mg/kg every 8 hours) and 269 patients were treated with cefotaxime (50 mg/kg) plus metronidazole (7.5 mg/kg) every 8 hours. In this trial, treatment-emergent adverse events were reported by 146 patients, 73 (26.7%) in the piperacillin/tazobactam group and 73 (27.1%) in the cefotaxime/metronidazole group. Six patients (2.2%) in the piperacillin/tazobactam group and 5 patients (1.9%) in the cefotaxime/metronidazole group discontinued due to an adverse event.
Adverse Laboratory Events: On the trials reported, including that of nosocomial lower respiratory tract infections in which a higher dose of piperacillin/tazobactam was used in combination with an aminoglycoside, changes in laboratory parameters include: Hematologic: Decrease in hemoglobin and hematocrit, thrombocytopenia, increases in platelet count, eosinophilia, leukopenia, neutropenia. These patients were withdrawn from therapy; some had accompanying systemic symptoms (e.g., fever, rigors, chills).
Coagulation: Positive direct Coombs' test, prolonged partial thromboplastin time.
Hepatic: Transient elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin.
Renal: Increases in serum creatinine, blood urea nitrogen.
Additional laboratory events include abnormalities in electrolytes (i.e., increases and decreases in sodium, potassium, and calcium), hyperglycemia, decreases in total protein or albumin, blood glucose decreased, gamma-glutamyl transferase increased, hypokalemia, and bleeding time prolonged.