Piperacillin and Tazobactam 36 g/180mL
Piperacillin and Tazobactam · INJECTION, POWDER, FOR SOLUTION · Fresenius Kabi USA, LLC
Piperacillin and tazobactam is an antibiotic combination given by injection to treat bacterial infections. Tazobactam works with piperacillin to help fight bacteria that might otherwise resist piperacillin alone.
Key Facts
- Brand Name
- Piperacillin and Tazobactam
- Generic Name
- Piperacillin and Tazobactam
- NDC Code (Product)
65219-256- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 36 g/180mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203720
- Marketing Start
- 11/16/2017
Recall History
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Apotex Inc.
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Astral SteriTech Private Ltd.
Lack of Assurance of Sterility
Apotex Corp.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Apotex Inc.
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
AuroMedics Pharma LLC
Presence of Particulate Matter: identified as glass and silicone material
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a β-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 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection, USP and other antibacterial drugs, Piperacillin and Tazobactam for Injection, USP 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 is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of Escherichia coli or the fo…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Adult Patients With Indications Other Than Nosocomial Pneumonia: The usual daily dosage of piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin and 1.5 g tazobactam) ( 2.1 ) • Adult Patients with Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin and 2.0 g tazobactam). ( 2.2 ) • 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. ( 2.3 ) • Pediatric Patients by Indication and Age: See Table below ( 2.4 ) Recommended Dosage of Piperacillin and Tazobactam for Pediatric Patients 2 months of Age and Older, Weighing up to 40 Kg and With Normal Renal Function Age Appendicitis and/or Peritonitis Nosocomial Pneumonia 2 months to 9 months 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 8 ( eight ) hours 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 6 ( six ) hours Older th…
Contraindications
4 CONTRAINDICATIONS Piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase 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 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 unless the benefit outweighs the risk. ( 7.2 ) • Co-administration of piperacillin and tazobactam with vancomycin may increase the incidence of acute kidney injury. Monitor kidney function in patients receiving piperacillin and tazobactam and vancomycin. ( 7.3 ) • Monitor coagulation parameters in patients receiving piperacillin and tazobactam and heparin or oral anticoagulants. ( 7.4 ) • Piperacillin and tazobactam 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 Aminoglycosides Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. In vivo inactivation When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease …
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 )] • 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 WG Critical Care, LLC at 1-866-562-4708 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 cannot be directly compared to rates in the clinical trial…
Frequently Asked Questions
What is Piperacillin and Tazobactam used for?
Piperacillin and tazobactam is an antibiotic combination given by injection to treat bacterial infections. Tazobactam works with piperacillin to help fight bacteria that might otherwise resist piperacillin alone.
Is Piperacillin and Tazobactam a controlled substance?
Piperacillin and Tazobactam is not classified as a controlled substance by the DEA.
What is the generic name for Piperacillin and Tazobactam?
The generic name for Piperacillin and Tazobactam is Piperacillin and Tazobactam. There are 3 other brand versions of Piperacillin and Tazobactam.
What is the NDC code for Piperacillin and Tazobactam 36 g/180mL?
The NDC (National Drug Code) for Piperacillin and Tazobactam 36 g/180mL is 65219-256, listed by Fresenius Kabi USA, LLC.
Other Piperacillin and Tazobactam Dosages
- Piperacillin and Tazobactam3 g/15mL0781-9213
- Piperacillin and Tazobactam4 g/20mL35369-0501
- Piperacillin and Tazobactam36 g/180mL35369-0504
- Piperacillin and Tazobactam2 g/10mL83634-104
- Piperacillin and Tazobactam4 g/20mL0781-3114
- Piperacillin and Tazobactam3 g/15mL65219-436
- Piperacillin and Tazobactam2 g/10mL68001-506
- Piperacillin and Tazobactam3 g/15mL0781-3113
- Piperacillin and Tazobactam2 g/10mL35369-0502
Other Piperacillin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)