Tazosyn(2 gm+0.25 gm)/vial

Piperacillin and tazobactam is a broad-spectrum injectable antibiotic combination used for the treatment of systemic and/or local bacterial infections caused by susceptible gram-positive and gram-negative organisms, including:

• Intra-abdominal infections, including complicated appendicitis and peritonitis
• Nosocomial (hospital-acquired) pneumonia
• Community-acquired pneumonia
• Skin and skin structure infections
• Female pelvic infections
• Bacterial septicaemia
• Bone and joint infections
• Febrile neutropenia, in combination with an aminoglycoside
• Polymicrobial infections generally, given its broad spectrum against a wide range of gram-positive, gram-negative, and anaerobic organisms

Contains piperacillin (as piperacillin sodium, a penicillin-class antibiotic) and tazobactam (as tazobactam sodium, a beta-lactamase inhibitor) as active ingredients, supplied as a powder for reconstitution for intravenous infusion, in various combined vial strengths.

Piperacillin and tazobactam is a combination injectable antibiotic that pairs piperacillin, a broad-spectrum penicillin-class antibiotic, with tazobactam, a beta-lactamase inhibitor that protects piperacillin from being broken down by certain bacterial resistance enzymes. This combination gives it very broad activity against a wide range of gram-positive, gram-negative, and anaerobic bacteria, making it a commonly used option for serious, often polymicrobial, hospital-treated infections, including intra-abdominal infections, hospital-acquired pneumonia, and infections in patients with neutropenia and fever.

Therapeutic Class: Antibiotic Combination (Extended-spectrum Penicillin + Beta-lactamase Inhibitor)

Piperacillin and tazobactam are widely distributed into tissues and body fluids, including intestinal mucosa, gallbladder, lung, and female reproductive tissue, supporting its use across a broad range of infection sites. Both components are eliminated primarily by the kidneys, requiring dose adjustment in renal impairment; clearance may be significantly increased in patients undergoing continuous renal replacement therapy, sometimes requiring higher, individualized doses in that specific setting.

• Given only by intravenous infusion, by trained healthcare professionals, typically over 30 minutes (or, in some extended-infusion protocols, over longer periods per institutional practice)
• The infusion site is monitored, since irritant/vesicant-type reactions (thrombophlebitis, and, rarely, more significant tissue reactions) have been reported at the injection site
• Should not be mixed with aminoglycosides in the same IV solution or tubing, since mixing beta-lactam antibiotics with aminoglycosides in vitro can substantially inactivate the aminoglycoside; give at separate sites/times if both are needed

The following should be assessed by a healthcare professional before combining with piperacillin and tazobactam:

• Aminoglycosides: should not be mixed together in the same IV solution, since this can inactivate the aminoglycoside; give as separate infusions.
• Warfarin and other anticoagulants: piperacillin can prolong prothrombin time; monitor INR closely if combined.
• Probenecid: prolongs the half-life of both piperacillin and tazobactam by reducing their renal clearance.
• Vecuronium and other neuromuscular blocking agents: piperacillin has been implicated in prolonging the neuromuscular blockade of vecuronium when used together.
• Methotrexate: limited data suggest piperacillin may reduce methotrexate clearance, increasing toxicity risk, due to competition for renal tubular secretion.
• Oral hormonal contraceptives: penicillin-class antibiotics may reduce their effectiveness; an additional contraceptive method is generally advised during treatment.

Common side effects

• Diarrhoea
• Nausea, vomiting
• Constipation
• Headache
• Rash

Serious side effects (seek urgent medical attention)

• Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, including shock: more likely in individuals with a history of penicillin, cephalosporin, or carbapenem hypersensitivity, or sensitivity to multiple allergens; discontinue immediately and institute appropriate emergency treatment if a reaction occurs.
• Severe cutaneous adverse reactions: including Stevens-Johnson syndrome and toxic epidermal necrolysis - widespread rash, blistering, or peeling skin requires immediate medical attention.
• Bleeding manifestations, sometimes associated with abnormalities in coagulation tests (clotting time, platelet aggregation, prothrombin time), more likely in patients with renal failure; discontinue and treat appropriately if bleeding occurs.
• Signs of kidney or liver problems: reduced urination, swelling, yellowing of the skin or eyes.
• Severe or persistent diarrhoea, which may indicate Clostridioides difficile-associated colitis.
• Increased incidence of fever and rash reported specifically in cystic fibrosis patients receiving piperacillin.

Pregnancy

Piperacillin and tazobactam has been used during pregnancy for serious infections when clinically necessary; use should be guided by the treating physician, weighing the benefit of treating a serious infection against any potential risk.

Breastfeeding

Both components pass into breast milk in small amounts; use during breastfeeding should be discussed with a healthcare professional, with the nursing infant monitored for diarrhoea or thrush.

• Penicillin/cephalosporin/beta-lactamase inhibitor allergy: a careful allergy history should be taken before starting therapy, given the risk of serious, occasionally fatal hypersensitivity reactions.
• Monitor renal, hepatic, and especially haematopoietic (blood cell) function during prolonged treatment.
• Use with caution in patients with a bleeding tendency or on anticoagulant therapy, given the platelet and clotting function effects seen with extended-spectrum penicillins, particularly in renal failure.
• Administering this antibiotic without a proven or strongly suspected bacterial infection is unlikely to benefit the patient and increases the risk of antibiotic-resistant bacteria developing.
• Dose adjustment is required in renal impairment, given predominantly renal elimination of both components.

Overdose may cause exaggerated gastrointestinal effects (nausea, vomiting, diarrhoea) and, in significant overdose or with renal impairment, an increased risk of neuromuscular excitability or seizures, given accumulation of penicillin-class antibiotics. Suspected significant overdose should be evaluated by a healthcare professional; treatment is generally supportive, and haemodialysis can help remove both piperacillin and tazobactam from the blood in cases of severe overdose with renal impairment.

Store unreconstituted powder at controlled room temperature, protected from light, as directed on the product label. Reconstituted and diluted infusion solutions should be used within the manufacturer's specified time frame, which varies depending on the diluent and storage temperature (refrigerated versus room temperature); discard any unused portion after this period.

• Renal impairment: Requires dose or interval adjustment based on creatinine clearance; clearance may be increased in patients on continuous renal replacement therapy, requiring individualized, often higher, dosing.
• Children 2 months and older: Established for use, with weight-based dosing determined by the treating physician; safety and efficacy have not been established in children younger than 2 months.
• Cystic fibrosis patients: May require a specific higher-frequency dosing regimen and closer monitoring for fever and rash, which occur more commonly in this population.
• Haemodialysis patients: Require a supplemental dose after each dialysis session on dialysis days.

Treatment duration depends on the specific infection and clinical response, commonly ranging from several days to two weeks or longer for more serious infections (such as nosocomial pneumonia or intra-abdominal infections), as determined by the treating physician based on clinical and, where relevant, microbiological response.

The lyophilized powder must be reconstituted with an appropriate diluent (commonly sterile water for injection, 0.9% sodium chloride, or another compatible IV fluid, per the specific product's instructions) immediately before use, then further diluted for infusion as directed. Do not mix with aminoglycosides in the same solution or administration line. Reconstituted and diluted solutions should be used according to the manufacturer's stability data.

Drug Class: Ureidopenicillin (piperacillin) combined with a beta-lactamase inhibitor (tazobactam)

Piperacillin works by binding to penicillin-binding proteins involved in bacterial cell wall synthesis, disrupting the ability of susceptible bacteria to build and maintain their cell walls, which kills the bacteria. Tazobactam itself has little direct antibacterial activity, but it binds to and inactivates a broad range of bacterial beta-lactamase enzymes that would otherwise destroy piperacillin, protecting the antibiotic and restoring its effectiveness against many resistant organisms.

Piperacillin and tazobactam is used in children 2 months of age and older for indications including complicated appendicitis/peritonitis, nosocomial pneumonia, and other serious infections, with weight-based dosing (commonly around 100 mg/kg piperacillin component per dose, given three times daily, up to adult maximums) determined by the treating physician. Safety and efficacy have not been established in infants younger than 2 months.