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  • Zosyn
    (piperacillin/tazobactam)

    THERAPEUTIC CLASS

    Beta-lactamase inhibitor/broad-spectrum penicillin

    DEA CLASS

    RX

    INDICATIONS

    Treatment of appendicitis (complicated by rupture or abscess), peritonitis, uncomplicated/complicated skin and skin structure infections (eg, cellulitis, cutaneous abscess, ischemic/diabetic foot infections), postpartum endometritis, pelvic inflammatory disease, moderate community-acquired pneumonia, and moderate to severe nosocomial pneumonia caused by susceptible strains of microorganisms.

    ADULT DOSAGE

    Adults: Infuse IV over 30 min. Usual: 3.375g q6h for 7-10 days. CrCl 20-40mL/min: 2.25g q6h. CrCl <20mL/min: 2.25g q8h. Hemodialysis/Continuous Ambulatory Peritoneal Dialysis (CAPD): 2.25g q12h. Give one additional dose of 0.75g following each hemodialysis session. Nosocomial Pneumonia: 4.5g q6h for 7-14 days plus an aminoglycoside. CrCl 20-40mL/min: 3.375g q6h. CrCl <20mL/min: 2.25g q6h. Hemodialysis/CAPD: 2.25g q8h. Give one additional dose of 0.75g following each hemodialysis session. Elderly: Start at lower end of dosing range.

    PEDIATRIC DOSAGE

    Pediatrics: Infuse IV over 30 min. Appendicitis/Peritonitis: ≤40kg: ≥9 Months: 100mg-12.5mg/kg q8h. 2-9 Months: 80mg-10mg/kg q8h. >40kg: Use adult dose.

    ADMINISTRATION

    IV route. Administer by IV infusion over 30 min. Refer to PI for instructions for reconstitution and dilution.

    HOW SUPPLIED

    Inj: (Piperacillin-Tazobactam) 2g-0.25g, 3g-0.375g, 4g-0.5g [vial]; 2g-0.25g/50mL, 3g-0.375g/50mL, 4g-0.5g/100mL [Galaxy]. Also available as a Pharmacy Bulk Package.

    CONTRAINDICATIONS

    History of allergic reactions to cephalosporins.

    WARNINGS/PRECAUTIONS

    Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, including shock, reported; d/c and institute appropriate therapy if an allergic reaction occurs. Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; monitor closely if skin rash occurs and d/c if lesions progress. Clostridium difficile-associated diarrhea (CDAD) reported; d/c if CDAD is suspected or confirmed. Bleeding manifestations, sometimes associated with abnormalities of coagulation tests, reported; d/c and institute appropriate therapy if bleeding manifestations occur. Leukopenia/neutropenia may occur and is most frequently associated with prolonged administration. May cause neuromuscular excitability or convulsions with higher than recommended dose, particularly in the presence of renal failure. Caution with restricted salt intake. Monitor electrolytes periodically with low K+ reserves. May result in bacterial resistance with use in the absence of a proven/suspected bacterial infection. Increased incidence of rash and fever in cystic fibrosis patients reported. Lab test interactions may occur. Caution with renal impairment (CrCl ≤40mL/min). Caution in elderly patients.

    ADVERSE REACTIONS

    Diarrhea, headache, constipation, N/V, insomnia, rash, fever, dyspepsia, pruritus, oral candidiasis.

    DRUG INTERACTIONS

    May inactivate aminoglycosides. May decrease serum concentrations of tobramycin; monitor aminoglycoside serum concentrations in patients with end-stage renal disease. Probenecid prolongs T1/2; avoid coadministration unless the benefit outweighs the risk. Test coagulation parameters more frequently with high doses of heparin, oral anticoagulants, or other drugs that may affect blood coagulation system or thrombocyte function. Piperacillin: May prolong neuromuscular blockade of vecuronium or any nondepolarizing muscle relaxants. May increase risk of hypokalemia with cytotoxic therapy or diuretics. May reduce methotrexate clearance; monitor methotrexate concentrations and for toxicity.

    PREGNANCY AND LACTATION

    Category B, caution in nursing.

    MECHANISM OF ACTION

    Piperacillin: Broad-spectrum penicillin (PCN); exerts bactericidal activity by inhibiting septum formation and cell-wall synthesis of susceptible bacteria. Tazobactam: β-lactamase enzyme inhibitor.

    PHARMACOKINETICS

    Absorption: IV administration of multiple doses resulted in different parameters. Distribution: Plasma protein binding (30%); crosses the placenta. Piperacillin: Vd=0.243L/kg, found in breast milk. Elimination: Kidneys. Piperacillin: Urine (68% unchanged). Tazobactam: Urine (80% unchanged). Refer to PI for information on additional pharmacokinetic parameters.

    ASSESSMENT

    Assess for previous hypersensitivity reaction to PCN, cephalosporins, or other allergens. Assess for history of bleeding disorder, conditions with restricted salt intake, cystic fibrosis, renal impairment, hypokalemia, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor hematopoietic function (especially with prolonged therapy [≥21 days]), renal function, and serum electrolytes periodically. Monitor for signs/symptoms of electrolyte imbalance (eg, hypokalemia), hypersensitivity reactions, CDAD, serious skin reactions, leukopenia/neutropenia, bleeding manifestations, and for neuromuscular excitability or convulsions. Monitor for rash and fever in cystic fibrosis patients.

    PATIENT COUNSELING

    Inform about risks/benefits of therapy. Counsel that drug only treats bacterial, not viral (eg, common cold), infections. Instruct to take ud; inform that skipping doses or not completing full course may decrease effectiveness and increase resistance. Advise to d/c and notify physician if watery/bloody diarrhea (with or without stomach cramps and fever) even as late as ≥2 months after the last dose, or an allergic reaction occurs. Instruct to notify physician if pregnant/nursing.

    STORAGE

    Vial: Prior to Reconstitution: 20-25°C (68-77°F). Reconstituted: Use immediately after reconstitution. Discard any unused portion after 24 hours if stored at 20-25°C (68-77°F) or after 48 hours if stored at 2-8°C (36-46°F). Do not freeze vials after reconstitution. Galaxy Container: ≤-20°C (-4°F). Thawed Sol: 2-8°C (36-46°F) for 14 days, or 20-25°C (68-77°F) for 24 hrs. Do not refreeze.