Piperacillin and Tazobactam and Sodium Chloride 3 g/50mL
Piperacillin and Tazobactam and Sodium Chloride · INJECTION, SOLUTION · B. Braun Medical Inc.
Piperacillin and Tazobactam and Sodium Chloride is a injection, solution containing piperacillin and tazobactam and sodium chloride at 3 g/50mL, taken intravenous. Manufactured by B. Braun Medical Inc..
Key Facts
- Brand Name
- Piperacillin and Tazobactam and Sodium Chloride
- Generic Name
- Piperacillin and Tazobactam and Sodium Chloride
- NDC Code (Product)
0264-3448- Manufacturer
- B. Braun Medical Inc.
- Strength
- 3 g/50mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA206056
- Marketing Start
- 09/30/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1 ) Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2 ) Skin and skin structure infections in adults ( 1.3 ) Female pelvic infections in adults ( 1.4 ) Community-acquired pneumonia in adults ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection and Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Intra-abdominal Infections Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION If a dose of Piperacillin and Tazobactam for Injection and Sodium Chloride injection is required that is not equal to 2.25 g, 3.375 g, or 4.5 g, this product is not recommended for use and an alternative formulation of piperacillin and tazobactam for injection should be considered ( 2.1 ). Adult Patients With Indications Other Than Nosocomial Pneumonia; The usual daily dosage of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, for intravenous use for adults is 3.375 g every 6 ( six ) hours. ( 2.2 ) Adult Patients with Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, for intravenous use at a dosage of 4.5 g every 6 ( six ) hours plus an aminoglycoside. (2.3 ) Adult Patients with Renal Impairment: Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) and dialysis patients should be reduced, based on the degree of renal impairment. ( 2.4 ) Pediatric Patients by Indication and Age: See Table below ( 2.5 ) Recommended Dosage of Piperacillin and Tazobactam for Injection and Sodium Chlor…
Contraindications
4 CONTRAINDICATIONS Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or betalactamase inhibitors. Patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Piperacillin and Tazobactam for Injection and Sodium Chloride Injection administration can significantly reduce tobramycin concentrations in hemodialysis patients. Monitor tobramycin concentrations in these patients. ( 7.1 ) Probenecid prolongs the half-lives of piperacillin and tazobactam and should not be co-administered with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection unless the benefit outweighs the risk. ( 7.2 ) Co-administration of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection with vancomycin may increase the incidence of acute kidney injury. Monitor kidney function in patients receiving Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and vancomycin. ( 7.3 ) Monitor coagulation parameters in patients receiving Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and heparin or oral anticoagulants. ( 7.4 ) Piperacillin and Tazobactam for Injection and Sodium Chloride Injection may prolong the neuromuscular blockade of vecuronium and other non-depolarizing neuromuscular blockers. Monitor for adverse reactions related to neuromuscular blockade. ( 7.5 ) 7.1 Aminogl…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Adverse Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.3) ] Rhabdomyolysis [see Warnings and Precautions (5.4) ] Hematologic Adverse Reactions [see Warnings and Precautions (5.5) ] Central Nervous System Adverse Reactions [see Warnings and Precautions (5.6) ] Nephrotoxicity in Critically Ill Patients [see Warnings and Precautions (5.7) ] High Sodium Load and Electrolyte Effects [see Warnings and Precautions (5.8) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug …
Frequently Asked Questions
What is Piperacillin and Tazobactam and Sodium Chloride used for?
Piperacillin and Tazobactam and Sodium Chloride contains Piperacillin and Tazobactam and Sodium Chloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Piperacillin and Tazobactam and Sodium Chloride a controlled substance?
Piperacillin and Tazobactam and Sodium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Piperacillin and Tazobactam and Sodium Chloride?
The generic name for Piperacillin and Tazobactam and Sodium Chloride is Piperacillin and Tazobactam and Sodium Chloride. There are no other listed brand versions of Piperacillin and Tazobactam and Sodium Chloride.
What is the NDC code for Piperacillin and Tazobactam and Sodium Chloride 3 g/50mL?
The NDC (National Drug Code) for Piperacillin and Tazobactam and Sodium Chloride 3 g/50mL is 0264-3448, listed by B. Braun Medical Inc..
Other Piperacillin and Tazobactam and Sodium Chloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)