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Important safety information
Hypersensitivity to any of the β-lactams (including penicillins and cephalosporins) or to β-lactamase inhibitors.
Before initiating therapy with Tazocin, careful inquiry should be made concerning previous hypersensitivity reactions to penicllin, cephalosporins, carbapenems or other beta-lactam agents. If an allergic reaction occurs, Tazocin must be discontinued immediately and appropriate alternative therapy instituted.
Tazocin may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis. If patients develop a skin rash, they should be monitored closely and Tazocin discontinued with lesions progress.
Rare cases of haemophagocytic lymphohistiocytosis (HLH) have been observed following therapy (>10 days) with Tazocin, often as a complication of DRESS. If Tazocin is suspected as a possible trigger, treatment should be discontinued.
Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhoea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
Tazocin may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken.
Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions sometimes have 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 occur, the antibiotic should be discontinued and appropriate therapy instituted.
This product contains 2.84 mEq (65 mg) of sodium per gram of piperacillin which may increase a patient's overall sodium intake.
Hypokalaemia may occur in patients with low potassium reserves or those receiving concomitant medicinal products that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
Leukopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed.
As with treatment with other penicillins, neurological complications in the form of convulsions may occur when high doses are administered, especially in patients with impaired renal function.
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