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General: Bleeding manifestation have occurred in some patients receiving (beta)-lactam antibiotics, including piperacillin. These reactions have sometimes been associated with abnormalities of coagulation tests such as clotting time, platelet aggregation, and prothrombin time, and are more likely to occur in patients with renal failure. If bleeding manifestations occurs Piperacillin and Tazobactam Sodium should be discontinued and appropriate therapy instituted.
As with other penicillins, patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously.
This should be considered when treating patients requiring restricted salt intake. Periodic electrolyte determinations should be performed in patients with low potassium reserves, and the possibility of hypokalemia should be kept in mind with patients who have potentially low potassium reserves, and who are receiving cytotoxic therapy diuretics.
Use in Pregnancy: Reproduction studies have been performed in rats and have revealed no evidence of impaired fertility due to piperacillin/tazobactam administered up to a dose which is similar to the maximum recommended human daily dose based on body-surface area (mg/m2).
Use in Lactation: Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied. Caution should be exercised when Piperacillin and Tazobactam Sodium is administered to a nursing woman.
Use in Children: Safety and efficacy in pediatric patients have not been established.
Use in the Elderly: Patients over 65 years are not at increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal insufficiency.
