Piperacillin and Tazobactam

PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM

Manufacturer: Fresenius Kabi USA, LLC

Score: 148.0

Quick Summary

Piperacillin and Tazobactam for injection is a combination antibacterial drug consisting of piperacillin, a penicillin-class antibacterial, and tazobactam, a β-lactamase inhibitor. It is used for the treatment of moderate to severe infections caused by susceptible bacteria, including intra-abdominal infections, skin and skin structure infections, female pelvic infections, community-acquired pneumonia, and nosocomial pneumonia. Key clinical findings indicate the drug's efficacy and safety for these indications, with common adverse reactions including diarrhea, constipation, nausea, headache, and insomnia. Important safety information includes warnings about allergic reactions, contraindications in patients with a history of allergic reactions to penicillins, cephalosporins, or β-lactamase inhibitors, and potential interactions with other medications. The main dosing recommendations are 3.375 g every 6 hours for adults, with adjustments for patients with renal impairment. Special population considerations include use in pregnancy, nursing mothers, pediatric patients, and geriatric patients, with caution advised in these populations due to potential risks.

Key Clinical Findings and Indications

Intra-abdominal infections
Skin and skin structure infections
Female pelvic infections
Community-acquired pneumonia
Nosocomial pneumonia

Important Safety Information

Warning

Allergic reactions, including anaphylaxis, can occur with piperacillin and tazobactam for injection.

Contraindications

History of allergic reactions to penicillins, cephalosporins, or β-lactamase inhibitors

Adverse Reactions

Diarrhea
Constipation
Nausea
Headache
Insomnia

Dosing Recommendations

General Guidance

Adjustments for patients with renal impairment: 2.25 g every 6 hours for creatinine clearance 20-40 mL/min, 2.25 g every 8 hours for creatinine clearance <20 mL/min

Intra-abdominal infections

Adult Dose

3.375 g every 6 hours

Pediatric Dose

100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours

Nosocomial pneumonia

Adult Dose

4.5 g every 6 hours

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy only if clearly needed
Piperacillin/tazobactam teratology studies have revealed no evidence of harm to the fetus

Nursing Mothers

Caution should be exercised when piperacillin and tazobactam for injection is administered to a nursing woman
Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied

Pediatric Use

Use in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies
Safety and efficacy in pediatric patients less than 2 months of age have not been established

Geriatric Use

Patients over 65 years are not at an increased risk of developing adverse effects solely because of age
Dosage should be adjusted in the presence of renal impairment