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  • Zosyn
    (piperacillin/tazobactam)

    THERAPEUTIC CLASS

    Beta-lactamase inhibitor/broad-spectrum penicillin (PCN)

    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

    General Dosing

    Usual: 3.375g q6h for 7-10 days; administer by IV infusion over 30 min

    Nosocomial Pneumonia

    Moderate to Severe:
    Initial:
    4.5g q6h plus an aminoglycoside for 7-14 days; administer Zosyn by IV infusion over 30 min

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

    Other Indications

    Treatment of the Following Infections Caused by Susceptible Organisms:
    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

    PEDIATRIC DOSAGE

    Peritonitis

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

    >40kg: Use adult dose

    Administer by IV infusion over 30 min

    Appendicitis

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

    >40kg: Use adult dose

    Administer by IV infusion over 30 min

    DOSING CONSIDERATIONS

    Renal Impairment
    Adults:
    All Indications (Except Nosocomial Pneumonia):
    CrCl >40mL/min: 3.375g q6h
    CrCl 20-40mL/min: 2.25g q6h
    CrCl <20mL/min (Not Receiving Hemodialysis): 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 (Not Receiving Hemodialysis): 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.
    During the infusion it is desirable to d/c the primary infusion sol.

    Single-Dose Vials
    Reconstitute 2.25g, 3.375g, and 4.5g vials w/ 10mL, 15mL, and 20mL, respectively w/ a compatible reconstitution diluent; swirl until dissolved.
    Further dilute reconstituted sol in a compatible IV sol (recommended volume per dose of 50mL to 150mL).
    Use immediately after reconstitution; discard any unused portion after 24 hrs if stored at 20-25°C (68-77°F) or after 48 hrs if stored at 2-8°C (36-46°F). Do not freeze vials after reconstitution.

    Do not mix w/ other drugs in a syringe or infusion bottle.
    Not chemically stable in sol that contain only sodium bicarbonate and sol that significantly alter the pH.
    Do not add to blood products or albumin hydrolysates.

    Compatible Reconstitution Diluents:
    0.9% NaCl for inj
    Sterile water for inj (SWFI)
    D5
    Bacteriostatic saline/parabens
    Bacteriostatic water/parabens
    Bacteriostatic saline/benzyl alcohol
    Bacteriostatic water/benzyl alcohol

    Compatible IV Sol:
    0.9% NaCl for inj
    SWFI (max recommended volume per dose of SWFI is 50mL)
    Dextran 6% in saline
    D5
    Lactated Ringer's sol (compatible only w/ reformulated Zosyn containing EDTA and is compatible for co-administration via a Y-site)

    Galaxy Containers
    Administer using sterile equipment, after thawing to room temperature.
    Zosyn containing EDTA is compatible for co-administration via a Y-site IV tube w/ Lactated Ringer's inj.
    Do not add supplementary medication.
    Discard unused portions.
    Do not use plastic containers in series connections.

    Thawing of Plastic Container:
    Thaw frozen container at 20-25°C (68-77°F) or 2-8°C (36-46°F); do not force thaw by immersion in water baths or by microwave irradiation.
    Thawed solution is stable for 14 days at 2-8°C (36-46°F) or 24 hrs at 20-25°C (68-77°F); do not refreeze.

    Refer to PI for further stability information and for compatibility w/ aminoglycosides.

    HOW SUPPLIED

    Inj: (Piperacillin/Tazobactam) 2g/0.25g (2.25g), 3g/0.375g (3.375g), 4g/0.5g (4.5g) [vial]; (2g/0.25g [2.25g])/50mL, (3g/0.375g [3.375g])/50mL, (4g/0.5g [4.5g])/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. Severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction w/ eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis) may occur; monitor closely if a skin rash develops and d/c if lesions progress. Clostridium difficile-associated diarrhea (CDAD) reported; may need to d/c if CDAD is suspected or confirmed. Bleeding manifestations, sometimes associated w/ abnormalities of coagulation tests, reported; d/c and institute appropriate therapy if bleeding manifestations occur. Leukopenia/neutropenia may occur and is most frequently associated w/ prolonged administration. May cause neuromuscular excitability or convulsions w/ higher than recommended doses, particularly in the presence of renal failure. Caution in patients w/ restricted salt intake. Monitor electrolytes periodically in patients w/ low K+ reserves. May result in bacterial resistance w/ use in the absence of a proven/suspected bacterial infection. Associated w/ increased incidence of fever and rash in cystic fibrosis patients reported. Lab test interactions may occur.

    ADVERSE REACTIONS

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

    DRUG INTERACTIONS

    Piperacillin may inactivate aminoglycosides. May decrease serum concentrations of tobramycin; monitor aminoglycoside levels in patients w/ ESRD. Probenecid prolongs T1/2; avoid coadministration unless the benefit outweighs the risk. Test coagulation parameters more frequently w/ high doses of heparin, oral anticoagulants, or other drugs that may affect blood coagulation system or thrombocyte function. Caution w/ cytotoxic therapy or diuretics; consider possibility of hypokalemia. Piperacillin: May prolong neuromuscular blockade of vecuronium or any nondepolarizing muscle relaxants. May reduce methotrexate (MTX) clearance; monitor MTX levels as well as the signs/symptoms of MTX toxicity.

    PREGNANCY AND LACTATION

    Category B, caution in nursing.

    MECHANISM OF ACTION

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

    PHARMACOKINETICS

    Distribution: Plasma protein binding (30%); crosses the placenta. Piperacillin: Found in breast milk in low concentrations. Metabolism: Piperacillin: Desethyl metabolite (minor microbiologically active). Elimination: Kidneys. T1/2=0.7-1.2 hrs. Piperacillin: Urine (68% unchanged), bile. Tazobactam: Urine (80% unchanged), bile.

    Refer to PI for additional pharmacokinetic parameters.

    ASSESSMENT

    Assess for previous hypersensitivity reaction to PCN, cephalosporins, or β-lactamase inhibitors; salt intake restriction; cystic fibrosis; low K+ reserves; renal impairment; pregnancy/nursing status and possible drug interactions.

    MONITORING

    Monitor hematopoietic function (especially w/ prolonged therapy [≥21 days]), renal function, and serum electrolytes periodically. Monitor for hypersensitivity reactions, CDAD, severe cutaneous 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 bacterial resistance. Advise to d/c and notify physician if experiencing watery/bloody diarrhea (w/ or w/o stomach cramps and fever) even as late as ≥2 months after the last dose, or an allergic reaction. Instruct to notify physician if pregnant/nursing.

    STORAGE

    Vials: 20-25°C (68-77°F). Galaxy Containers: At or below -20°C (-4°F).