This 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 and complicated skin and skin structure infections, including cellulitis, cutaneous
Abscesses and ischemic/diabetic foot infections
Postpartum endometritis or pelvic inflammatory disease
Appendicitis (complicated by rupture or abscess) and peritonitis
Management of neutropenic patients (adults, adolescents and children) with fever suspected to be due to bacterial infections.
Broad spectrum penicillins, Other beta-lactam Antibiotics
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 penicillanic acid sulfone derivative with β-lactamase inhibitory properties. In combination, tazobactam enhances the activity of piperacillin against β-lactamase-producing bacteria. Piperacillin and tazobactam has a wide range of activity and is active against gm+ve and gm-ve aerobic and anaerobic bacteria.
Adults and children over 12 years: Piperacillin & Tazobactam may be given by slow intravenous infusion (over 20-30 minutes). The usual dosage for adults and children over 12 years is Piperacillin 4 gm and Tazobactam 0.5 gm IV infusion given every eight hours. The total daily dose of Piperacillin & Tazobactam depends on the severity and localization of the infection and can vary from 2.25 gm to 4.50 gm administered every six or eight hours. In neutropenia the recommended dose is Piperacillin 4 gm and Tazobactam 0.5 gm given every six hours in combination with an aminoglycoside.
For children weighing less than 40 kg: The dose should be adjusted to 90 mg/kg administered every six hours, in combination with an aminoglycoside, not exceeding 4.5 gm every six hours.
Children under 2 years: Piperacillin & Tazobactam is not recommended for use in children below 2 years old due to insufficient data on safety.
Duration of Therapy: The duration of therapy should be guided by the severity of the infection and the patient’s clinical and bacteriological progress. In acute infections, treatment with Piperacillin & Tazobactam should be continued for 48 hours beyond the resolution of clinical symptoms or the fever.
Interaction with Probenecid: Concurrent administration of Probenecid and Piperacillin/Tazobactam produced a longer half-life and lower renal clearance for both Piperacillin and Tazobactam. However, peak plasma concentrations of either drug are unaffected.
Interaction with anticoagulants: During simultaneous administration of heparin, oral anticoagulants and other drugs which may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.
Interaction with vecuronium: Piperacillin when used concomitantly with Vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non polarizing muscle relaxants could be prolonged in the presence of Piperacillin. This should be taken into account when Piperacillin/Tazobactam is used perioperatively.
Interaction with methotrexate: Piperacillin may reduce the excretion of methotrexate. Serum levels of methotrexate should be monitored in patients on methotrexate therapy
Hypersensitivity to Piperacillin or any of the beta-lactam antibiotics and to Tazobactam or any other beta-lactamase inhibitor.
Nausea, vomiting, diarrhoea; less commonly stomatitis, dyspepsia, constipation, jaundice, hypotension, headache, insomnia, and injection-site reactions; rarely abdominal pain, hepatitis, oedema, fatigue, and eosinophilia; very rarely hypoglycemia, hypokalaemia, pancytopenia, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Pregnancy & Lactation
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.
Patient with cystic fibrosis, history of seizure disorder. Renal impairment. Children. Pregnancy and lactation.
There have been post-marketing reports of overdose with Piperacillin/Tazobactam. The majority of those events experienced including nausea, vomiting, and diarrhoea have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure).
Use in Special Population
Renal insufficiency in adults, elderly and children (over 40 kg):
CrCl 20-80 ml/min: Total Dosage 13.5 gm/day & Divided doses 4.5 gm 8 hourly
CrCl <20 ml/min: Total Dosage 9 gm/day & Divided doses 4.5 gm 12 hourly For patients on hemodialysis, the maximum daily dose is Piperacillin & Tazobactam 9 gm. In addition, (because hemodialysis removes 30%-50% of Piperacillin in four hours) one additional dose of Piperacillin & Tazobactam 2.25 gm should be administered following each dialysis period. Renal insufficiency in children aged 2-12 years (or body weight less than 40 kg): CrCl >40: No adjustment necessary
CrCl 20-39: Recommended Dosage 90 mg/kg 8 hourly & Maximum Daily Dosage 13.5 gm/day
CrCl <20: Recommended Dosage 90 mg/kg 12 hourly & Maximum Daily Dosage 9 gm/day
For children weighing <50 kg on hemodialysis the recommended dose is 45 mg/kg every eight hours. Each patient must be monitored closely for signs of drug toxicity. Drug dose and interval should be adjusted accordingly.
Reconstitute initially (2.25 g in 10 mL, 4.5 g in 20 mL) with water for inj, glucose 5% or NaCl 0.9%, then further dilute to 50-150 mL with compatible infusion soln.
When reconstituted with water for injections or saline, reconstituted solutions will remain stable for 24 hours at 25°C and for 48 hours at 4°C.
From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.