Product Dossier

PIPERTAZ SANDOZ

Product Dossier for PIPERTAZ SANDOZ (piperacillin sodium, tazobactam sodium, Sandoz). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

PiperTaz Sandoz contains piperacillin (as the sodium salt) 4 g and tazobactam (as the sodium salt) 500 mg. PiperTaz Sandoz 4 g/0.5 g powder for injection is a white to off-white, sterile lyophilised powder. PiperTaz Sandoz is an injectable antibacterial combination, consisting of the semisynthetic antibiotic piperacillin sodium and the β-lactamase inhibitor tazobactam sodium, for intravenous administration. Piperacillin, a broad-spectrum, semisynthetic 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 β-lactamases, and the presence of tazobactam in the piperacillin/tazobactam formulation enhances and extends the antibiotic spectrum of piperacillin to include many β-lactamase producing bacteria normally resistant to it.

Approved indications

PiperTaz Sandoz (piperacillin/tazobactam) is indicated in the treatment of serious bacterial infections caused by susceptible strains of β-lactamase producing organisms in the following conditions: — Lower respiratory tract infections — Urinary tract infections (complicated and uncomplicated) — Intra-abdominal infections — Skin and skin structure infections — Bacterial septicaemia — Gynaecological infections In hospitalised children aged 2 to 12 years, PiperTaz Sandoz (piperacillin/tazobactam) is indicated for the treatment of serious intra-abdominal infections.

Dosing overview

The usual intravenous dosage for adults and children with normal renal function is 4 g piperacillin/0.5 g tazobactam given every eight hours. The total daily dose depends on the severity and localisation of the infection and can vary from 2 g piperacillin/0.25 g tazobactam to 4 g piperacillin/0.5 g tazobactam administered every six or eight hours. For children aged 2 to 12 years, weighing up to 40 kg, and with normal renal function, the recommended dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram every 8 hours. For children aged 2 to 12 years weighing over 40 kg, follow the adult dose guidance. PiperTaz Sandoz (piperacillin/tazobactam) may be given by slow intravenous infusion (20–30 minutes). Therapy is recommended to be a minimum of 5 days and a maximum of 14 days, considering that dose administration should continue at least 48 hours after the resolution of clinical signs and symptoms.

Key safety warnings

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid [including shock]) reactions have been reported in patients on penicillin/cephalosporin therapy, including piperacillin/tazobactam. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Serious anaphylactic/anaphylactoid reactions (including shock) require immediate emergency treatment with adrenaline, oxygen, intravenous steroids and airway management, including intubation. Severe cutaneous adverse reactions (SCAR), such as Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking β-lactam antibiotics, and when SCAR is suspected, piperacillin/tazobactam should be discontinued immediately and an alternative treatment should be considered. Rare cases of haemophagocytic lymphohistiocytosis (HLH) have been observed following therapy (>10 days) with piperacillin/tazobactam, often as a complication of DRESS; HLH is a pathologic immune activation which leads to excessive systemic inflammation and can be life threatening. Antibiotic-associated pseudomembranous colitis has been reported with many antibiotics including piperacillin, with a toxin produced by Clostridioides difficile appearing to be the primary cause, and the severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Leucopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed. Neurological complications in the form of convulsions (seizures) may occur when high doses are administered, especially in patients with impaired renal function. Combined use of piperacillin/tazobactam and vancomycin may be associated with an increased risk of acute kidney injury.

Contraindications

The use of piperacillin/tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins and/or cephalosporins or β-lactamase inhibitors or any of its excipients.

Regulatory history

PIPERTAZ SANDOZ 4 g/0.5 g powder for injection in bottle form was first listed on the Australian Register of Therapeutic Goods on 10 December 2008. PIPERTAZ SANDOZ 4 g/0.5 g powder for injection in vial form was first listed on 13 February 2026.