Piperacillin, Tazobactam 36 g/152mL
Piperacillin Sodium, Tazobactam Sodium · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Sagent Pharmaceuticals
Piperacillin, Tazobactam is a injection, powder, lyophilized, for solution containing piperacillin sodium, tazobactam sodium at 36 g/152mL, taken intravenous. Manufactured by Sagent Pharmaceuticals.
Key Facts
- Brand Name
- Piperacillin, Tazobactam
- Generic Name
- Piperacillin Sodium, Tazobactam Sodium
- NDC Code (Product)
25021-181- Manufacturer
- Sagent Pharmaceuticals
- Strength
- 36 g/152mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA208675
- Marketing Start
- 02/28/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Piperacillin and Tazobactam for 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 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, piperacillin and tazobactam 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 following members of the Bacteroides fragilis group: …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adult Patients with Indications Other than Nosocomial Pneumonia: The usual daily dosage of piperacillin and tazobactam for injection for adults is 3.375 grams every six hours totaling 13.5 grams (12.0 grams piperacillin and 1.5 grams tazobactam). ( 2.1 ) Adult Patients with Nosocomial Pneumonia : Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 grams every six hours plus an aminoglycoside, totaling 18.0 grams (16.0 grams piperacillin and 2.0 grams 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 Injection 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 (8…
Contraindications
4 CONTRAINDICATIONS Piperacillin and tazobactam 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 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 requiring hemodialysis, …
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 Sagent Pharmaceuticals at 1-866-625-1618 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 trials of anothe…
Frequently Asked Questions
What is Piperacillin, Tazobactam used for?
Piperacillin, Tazobactam contains Piperacillin Sodium, Tazobactam Sodium. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Piperacillin, Tazobactam a controlled substance?
Piperacillin, Tazobactam is not classified as a controlled substance by the DEA.
What is the generic name for Piperacillin, Tazobactam?
The generic name for Piperacillin, Tazobactam is Piperacillin Sodium, Tazobactam Sodium. There are no other listed brand versions of Piperacillin Sodium, Tazobactam Sodium.
What is the NDC code for Piperacillin, Tazobactam 36 g/152mL?
The NDC (National Drug Code) for Piperacillin, Tazobactam 36 g/152mL is 25021-181, listed by Sagent Pharmaceuticals.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)