TENZA INJECTION 4.5 g
Piperacillin and Tazobactam for Injection USP
Strength: Piperacillin 4 g + Tazobactam 0.5 g (Total 4.5 g per vial)
Dosage Form: Powder for Solution for Injection/Infusion
Route of Administration: Intravenous (IV) use only
Family: Broad-Spectrum Penicillin Antibiotic Combined with a Beta-Lactamase Inhibitor
Composition: Each vial contains Piperacillin Sodium equivalent to Piperacillin 4 g and Tazobactam Sodium equivalent to Tazobactam 0.5 g.
Indications: TENZA Injection is indicated for the treatment of susceptible bacterial infections, including complicated intra-abdominal infections, hospital-acquired and ventilator-associated pneumonia, complicated skin and soft-tissue infections, and certain infections of the urinary tract. Its use depends on the infecting organism, local resistance patterns, and approved prescribing information.
Mode of Action: Piperacillin is a broad-spectrum penicillin antibiotic that inhibits bacterial cell-wall synthesis, leading to bacterial cell death. Tazobactam inhibits certain beta-lactamase enzymes produced by bacteria, helping protect piperacillin from enzymatic degradation and extending its activity against susceptible beta-lactamase-producing organisms.
Clinical Benefits: TENZA provides combined antibacterial activity against a range of susceptible Gram-positive and Gram-negative bacteria, including certain organisms that produce beta-lactamase enzymes. It supports effective treatment of serious bacterial infections when selected according to culture results and clinical assessment.
Therapeutic Benefits: The combination of piperacillin and tazobactam offers broad-spectrum coverage and may be useful in hospital settings where infections are severe, complicated, or caused by susceptible mixed bacterial populations. Appropriate treatment can help control infection and reduce the risk of infection-related complications.
Dosage and Administration: The dose, dosing interval, and duration depend on the type and severity of infection, the patient's age and clinical condition, kidney function, and the results of microbiological testing. TENZA must be reconstituted and administered intravenously by a qualified healthcare professional according to the approved product instructions. Dose adjustment is required in patients with impaired renal function when indicated. The 4.5 g vial contains 4 g of piperacillin and 0.5 g of tazobactam.
Side Effects: Possible adverse effects include diarrhea, nausea, vomiting, constipation, headache, rash, itching, and injection-site reactions. Laboratory changes may include alterations in liver enzymes, blood counts, or kidney function.
Serious Adverse Effects: Serious reactions may include anaphylaxis, severe skin reactions, antibiotic-associated colitis, significant blood-cell abnormalities, seizures in susceptible patients, and kidney-related complications. Immediate medical evaluation is required if severe allergic symptoms or other serious reactions occur.
Contraindications: TENZA should not be used in patients with a known history of severe hypersensitivity to piperacillin, tazobactam, other penicillins, or any product component. Assess the history of allergy to other beta-lactam antibiotics before treatment.
Precautions: Use cautiously in patients with renal impairment, a history of allergies, bleeding disorders, or a tendency to develop electrolyte disturbances. Monitor renal function, blood counts, and other relevant laboratory parameters during prolonged treatment. Antibiotic therapy should be guided by clinical assessment and susceptibility testing whenever available.
Drug Interactions: Concomitant use with anticoagulants may increase bleeding risk and require monitoring. The combination may interact with methotrexate and other medicines affected by renal function. Concurrent use with certain aminoglycosides requires appropriate administration and compatibility precautions. Inform the treating healthcare professional about all medicines being used.
Use During Pregnancy: Use during pregnancy only when clinically indicated after a healthcare professional has assessed the potential benefits and risks. Follow the approved prescribing information.
Use During Breastfeeding: Piperacillin and tazobactam may pass into breast milk. Treatment should be guided by a healthcare professional, with consideration of potential effects on the nursing infant.
Storage and Handling: Store according to the manufacturer's approved product instructions. Reconstitute and dilute using compatible solutions and observe the recommended stability and storage conditions after preparation. Inspect the prepared solution before administration and do not use it if visible particles or abnormal discoloration are present.
Antibiotic Stewardship: TENZA should be used only for infections caused by, or strongly suspected to be caused by, susceptible bacteria. Culture and susceptibility results should guide treatment when available. Unnecessary use may contribute to antimicrobial resistance.
Product Presentation: One vial containing Piperacillin 4 g and Tazobactam 0.5 g, for intravenous use only.
Product Summary: TENZA 4.5 g Injection combines piperacillin, a broad-spectrum penicillin antibiotic, with tazobactam, a beta-lactamase inhibitor. This combination provides broad antibacterial activity against susceptible organisms and is intended for the treatment of selected serious bacterial infections under professional medical supervision.
Company: LINCOLN