Piperacillin-Tazobactam

Piperacillin/Tazobactam is a prescription medication used to treat bacterial infections such as intra-abdominal infections, Nosocomial Pneumonia, Skin and Skin Structure Infections, Female Pelvic Infections, and Community-acquired Pneumonia.

• Piperacillin/Tazobactam is available under the following different brand names: Zosyn.

Common side effects of Piperacillin/Tazobactam include:

• constipation, 
• joint pain, 
• stuffy nose, 
• sore throat, 
• pain in arms or legs, 
• diarrhea, 
• nausea, 
• fatigue, 
• gas, 
• heartburn, 
• headache, and
• mild muscle pain

Serious side effects of Piperacillin/Tazobactam include:

• hives, 
• difficulty breathing, 
• swelling of your face, lips, tongue, or throat, 
• unexplained muscle pain, tenderness, or weakness with fever, 
• unusual tiredness, 
• muscle wasting and muscle breakdown (rhabdomyolysis),
• upper stomach pain, 
• little or no urination, 
• swelling in feet or ankles, 
• shortness of breath, 
• confusion, 
• memory problems, 
• fever, 
• dark urine, 
• increased thirst or hunger, 
• drowsiness, 
• loss of appetite, and 
• yellowing of the skin or eyes (jaundice)

Rare side effects of Piperacillin/Tazobactam include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

Adult dosages

Injection, lyophilized powder for reconstitution

• (2g/250mg)/vial: 2.25g
• (3g/375mg)/vial: 3.375g
• (4g/500mg)/vial: 4.5g
• (36g/4.5g)/vial: 40.5g

Premix bag

• 2.25g/50mL
• 3.375g/50mL
• 4.5g/100mL

Intra-abdominal Infections: 

• 3.375 g via IV every 6 hours (totaling 13.5 g [12 g piperacillin/1.5 g tazobactam]) for 7-10 days

Nosocomial Pneumonia

• 4.5 g via IV every 6 hours (totaling 18 g [16 g piperacillin/2 g tazobactam]) for 7-14 days; continue aminoglycoside in P. aeruginosa patients

Skin and Skin Structure Infections

• 3.375 g via IV every 6 hours (totaling 13.5 g [12 g piperacillin/1.5 g tazobactam]) for 7-10 days

Female Pelvic Infections

• 3.375 g via IV every 6 hours (totaling 13.5 g [12 g piperacillin/1.5 g tazobactam]) for 7-10 days

Community-acquired Pneumonia

• 3.375 g via IV every 6 hours (totaling 13.5 g [12 g piperacillin/1.5 g tazobactam]) for 7-10 days

Pediatric dosage

Intra-abdominal Infections: 

• safety and efficacy not established in children younger than 2 months of age
• children 2-9 months: weighing 40 kg or less: 90 mg/kg (80 mg piperacillin/10mg tazobactam) via IV every 8 hours
• children older than 9 months: weighing 40 kg or less: 112.5 mg/kg (100 mg piperacillin/12.5 mg tazobactam) via IV every 8 hours
• children older than 9 months: weighing more than 40 kg: 3.375 g IV every 6 hours (totaling 13.5 g [12 g piperacillin/1.5 g tazobactam]) for 7-10 days

Nosocomial Pneumonia

• safety and efficacy not established in children younger than 2 months of age
• children 2-9 months: weighing 40 kg or less: 90 mg/kg (80 mg piperacillin/10 mg tazobactam) via IV every 6 hours
• children older than 9 months: weighing 40 kg or less: 112.5 mg/kg (100 mg piperacillin/12.5 mg tazobactam) via IV every 6 hours
• children older than 9 months: weighing more than 40 kg: 4.5 g via IV every 6 hours (totaling 18 g [16 g piperacillin/2 g tazobactam]) for 7-14 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages."

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Piperacillin/Tazobactam has no known severe interactions with any drugs.
• Piperacillin/Tazobactam has serious interactions with at least 12 other drugs.
• Piperacillin/Tazobactam has moderate interactions with at least 17 other drugs. 
• Piperacillin/Tazobactam has mild interactions with at least 15 other drugs.

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Allergy to penicillins, cephalosporins, imipenem, beta-lactamase inhibitors 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Piperacillin/Tazobactam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Piperacillin/Tazobactam?”

Cautions

• Risk of bleeding complications, especially in renal impairment; discontinue if thrombocytopenia or bleeding occurs
• Leukopenia/neutropenia associated with prolonged therapy; periodic assessment of hematopoietic function should be performed, especially with prolonged therapy that is 21 days or greater
• Serious skin reactions reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis, generalized exanthematous pustulosis; discontinue if reaction occurs
• Monitor renal, hepatic, and especially hematopoietic functions during prolonged treatment
• Prolonged use may result in fungal or bacterial superinfection
• Administering drug in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases risk of development of drug-resistant bacteria
• Clostridium difficile associated diarrhea (CDAD) reported; if CDAD suspected or confirmed, may need to discontinue ongoing antibacterial drug use not directed against C. difficile; appropriate fluid and electrolyte management, protein supplementation may need to be implemented; antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
• Increased frequency of rash and fever reported in cystic fibrosis patients receiving piperacillin
• Risk of seizures may increase in patients with history of seizures when administered at higher than recommended doses given IV in the presence of renal impairment
• Consider sodium content (2.79 mEq/g piperacillin) in patients requiring sodium restriction
• Perform periodic electrolyte determinations in patients with low potassium reserves and who are receiving cytotoxic therapy or diuretics and consider possibility of hypokalemia in patients who have potentially low potassium reserves
• Increased frequency of fever and rash reported in patients with cystic fibrosis receiving piperacillin
• Use caution in patients with renal impairment or underdeveloped kidneys due to sodium load and adverse effects of high serum concentrations of penicillin; dose adjustment may be necessary
• Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given IV (particularly in presence of renal failure); closely monitor patients with renal impairment or seizure disorders for signs and symptoms of neuromuscular excitability or convulsions (seizures)

Pregnancy and Lactation

• Piperacillin and Tazobactam cross placenta in humans. Insufficient data available with Piperacillin and/or Tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. 
• Piperacillin is excreted in human milk; Tazobactam concentrations in human milk have not been studied. There is no information available on effects of Piperacillin and Tazobactam on breastfed child or on milk production.