TAZOPEN 4.5

It is indicated for the treatment of the following systemic and/or local bacterial infections: Nosocomial pneumonia (moderate to severe), Community-acquired pneumonia (moderate severity only), Uncomplicated & complicated skin & skin structure infections including cellulitis, cutaneous abscesses & ischemic/diabetic foot infections Postpartum endometritis or pelvic inflammatory disease Appendicitis (complicated by rupture or abscess) & peritonitis It may also be used in the management of neutropenic patients (adults, adolescents & children) with fever suspected to be due to bacterial infections.

Broad Spectrum Penicillin

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

Piperacillin/Tazobactam may be given by slow intravenous infusion (over 20-30 minutes). The usual dosage for adults & children over 12 years is given every eight hours. The total daily dose of Piperacillin/Tazobactam depends on the severity & localization of the infection & can vary from 2.25 gm to 4.50 gm administered in every six or eight hourly. In neutropenia the recommended dose is Piperacillin/Tazobactam 4.5 gm given in every six hours in combination with an aminoglycoside.

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored. Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary. Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk. Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function. Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin. Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Hypersensitivity to Piperacillin or any of the beta-lactam antibiotics & to Tazobactam or any other beta-lactamase inhibitor.

Nausea, vomiting, diarrhoea; less commonly stomatitis, dyspepsia, constipation, jaundice, hypotension, headache, insomnia & injection-site reactions; rarely abdominal pain, hepatitis, oedema, fatigue, & eosinophilia; very rarely hypoglycemia, hypokalemia, pancytopenia, Stevens-Johnson syndrome & toxic epidermal necrolysis.

Piperacillin/Tazobactam should only be used during pregnancy if clearly indicated. Piperacillin is excreted in low concentrations in breast milk. Women who are breast-feeding should be treated only if clearly indicated.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.