PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
Clinical safety rating: safe
No significant drug interactions Can cause hypernatremia and fluid overload.
Piperacillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). Tazobactam is a beta-lactamase inhibitor that protects piperacillin from degradation by beta-lactamases.
| Metabolism | Piperacillin is partially metabolized to a minor metabolite (desethyl piperacillin). Tazobactam is metabolized to a single inactive metabolite. Both are primarily eliminated renally. |
| Excretion | Piperacillin: ~70-80% renal (glomerular filtration and tubular secretion), ~10-20% biliary; Tazobactam: ~80-85% renal, ~10% biliary; both primarily excreted unchanged in urine; small fecal elimination (<5%). |
| Half-life | Piperacillin: 0.7-1.2 hours (normal renal function), extends to 2-6 hours in renal impairment; Tazobactam: 0.8-1.2 hours (normal renal function), extends to 4-8 hours in severe renal impairment; clinically relevant for dosing interval adjustments in renal dysfunction. |
| Protein binding | Piperacillin: ~16-30% bound to serum proteins (primarily albumin); Tazobactam: ~20-30% bound; both exhibit moderate binding. |
| Volume of Distribution | Piperacillin: Vd ≈ 0.18-0.3 L/kg (total body water distribution); Tazobactam: Vd ≈ 0.2-0.35 L/kg; distributes well into tissues, including bile, lung, kidney, and inflammatory fluids; limited CNS penetration unless meninges inflamed. |
| Bioavailability | Intravenous: 100% (only route); not orally bioavailable due to instability in gastric acid and poor absorption. |
| Onset of Action | Intravenous: immediate (minutes) for antibacterial effect; peak serum concentrations achieved by end of infusion. |
| Duration of Action | Approximately 6-8 hours for susceptible organisms; depends on renal function and MIC; typically dosed every 6 hours (or adjusted for renal impairment) to maintain free drug concentrations above MIC for >50% of dosing interval. |
3.375 g (piperacillin 3 g / tazobactam 0.375 g) IV every 6 hours for 7-10 days; extended infusion dosing: 3.375 g IV over 4 hours every 8 hours.
| Dosage form | POWDER |
| Renal impairment | CrCl 20-40 mL/min: 2.25 g IV every 6 hours; CrCl <20 mL/min: 2.25 g IV every 8 hours; hemodialysis: 2.25 g IV every 12 hours with an additional dose after each dialysis session. |
| Liver impairment | No dose adjustment required for hepatic impairment; caution in severe hepatic impairment due to potential for bleeding risk (piperacillin may prolong PT). |
| Pediatric use | Neonates (<1 month): 90 mg/kg (piperacillin component) IV every 8 hours (for GA <37 weeks) or every 6 hours (for GA ≥37 weeks); Infants and children (≥1 month): 90 mg/kg (piperacillin component) IV every 6 hours; maximum dose 4.5 g (piperacillin 4 g / tazobactam 0.5 g) every 6 hours. |
| Geriatric use | Initiate with dosing based on renal function; monitor for bleeding risk (piperacillin can cause coagulopathy) and electrolyte disturbances (sodium load from sodium chloride); consider extended infusion for efficacy in elderly with renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Breastfeeding | Piperacillin and tazobactam are excreted into breast milk in low concentrations; M/P ratio not established. Considered compatible with breastfeeding due to poor oral bioavailability in infants. Monitor for diarrhea or rash in the infant. |
| Teratogenic Risk | Pregnancy category B. No evidence of teratogenicity in animal studies; insufficient human data. Risk cannot be ruled out in first trimester; use only if clearly needed. No documented fetal harm with standard doses. |
■ FDA Black Box Warning
No FDA black box warning.
| Common Effects | fluid replacement |
| Serious Effects |
["Hypersensitivity to any penicillin, cephalosporin, beta-lactamase inhibitor, or any component of the formulation.","History of allergic reaction to other beta-lactams (e.g., cephalosporins, carbapenems)."]
| Precautions | ["Serious and occasionally fatal hypersensitivity reactions (including anaphylaxis) have been reported.","Clostridium difficile-associated diarrhea (CDAD) may occur.","Bleeding manifestations have been reported, especially in patients with renal impairment or receiving high doses.","Neuromuscular excitability or convulsions may occur with high doses or in patients with renal failure.","Electrolyte disturbances due to sodium content.","Renal function should be monitored periodically."] |
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| Fetal Monitoring | Monitor renal function, hepatic enzymes, and complete blood count (CBC) periodically. Assess for signs of hypersensitivity or superinfection. Fetal monitoring not routinely required but consider if maternal infection poses risk. |
| Fertility Effects | No known effect on human fertility. Animal studies showed no impairment of fertility at recommended doses. |