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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

    Usual Dosage

    3.375g q6h for 7-10 days

    Nosocomial Pneumonia

    Initial: 4.5g q6h for 7-14 days plus an aminoglycoside

    Aminoglycoside treatment should be continued in patients from whom Pseudomonas aeruginosa is isolated

    PEDIATRIC DOSAGE

    Peritonitis

    ≤40kg:
    2-9 Months of Age: 80mg-10mg/kg q8h
    ≥9 Months of Age: 100mg-12.5mg/kg q8h

    >40kg:
    Use adult dose

    Appendicitis

    ≤40kg:
    2-9 Months of Age: 80mg-10mg/kg q8h
    ≥9 Months of Age: 100mg-12.5mg/kg q8h

    >40kg:
    Use adult dose

    DOSE MODIFICATION

    Renal Impairment
    Adults:

    Usual Dosage:
    CrCl >40mL/min: 3.375g q6h
    CrCl 20-40mL/min: 2.25g q6h
    CrCl <20mL/min: 2.25g q8h
    Hemodialysis: 2.25g q12h (max: 2.25g q12h)
    Administer an additional 0.75g dose following each hemodialysis session on hemodialysis days
    Continuous Ambulatory Peritoneal Dialysis: 2.25g q12h

    Nosocomial Pneumonia:
    CrCl >40mL/min: 4.5g q6h
    CrCl 20-40mL/min: 3.375g q6h
    CrCl <20mL/min: 2.25g q6h
    Hemodialysis: 2.25g q8h (max: 2.25g q8h)
    Administer an additional 0.75g dose following each hemodialysis session on hemodialysis days
    Continuous Ambulatory Peritoneal Dialysis: 2.25g q8h

    Elderly
    Start at lower end of dosing range

    ADMINISTRATION

    IV route. Infuse over 30 min
    Do not mixed with other drugs

    Compatible Reconstitution Diluents
    0.9% NaCl for inj
    Sterile water for inj
    Dextrose 5%
    Bacteriostatic saline/parabens
    Bacteriostatic water/parabens
    Bacteriostatic saline/benzyl alcohol
    Bacteriostatic water/benzyl alcohol

    Compatible IV Sol
    0.9% NaCl for inj
    Sterile water for inj
    Dextran 6% in saline
    Dextrose 5%
    Lactated Ringer's sol

    IV
    Preparation

    Use single dose vials immediately after reconstitution
    Reconstitute 2.25g, 3.375g, and 4.5g single dose vials with 10mL, 15mL, and 20mL, respectively with a compatible reconstitution diluent
    Further dilute reconstituted sol in a compatible IV sol (recommended volume per dose of 50mL to 150mL)
    During the infusion it is desirable to discontinue the primary infusion sol

    Refer to PI for further preparation/administration instructions and compatibility with aminoglycosides

    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, 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.