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piperacillin/tazobactam (Rx)Brand and Other Names:Zosyn

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

piperacillin/tazobactam

powder for injection

  • (2g/250mg)/vial: 2.25g
  • (3g/375mg)/vial: 3.375g
  • (4g/500mg)/vial: 4.5g
  • (36g/4.5g)/vial: 40.5g
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Severe Infections

3.375 g (IV) q6hr; total of 13.5 g (piperacillin [12 g] per tazobactam [1.5 g]) for 7-10 days; administer over 30 min

Nosocomial Pneumonia

4.5 g IV q6 hr; add aminoglycoside; total of 18 g (piperacillin [16 g] per tazobactam [2 g]) for 7-14 days; continue aminoglycoside in P. aeruginosa patients

Community-aquired Pneumonia

3.375 g IV q6hr for 7-10 days

Diverticulitis/Intra-abdominal Abscess/ Peritonitis

3.375 g IV q6hr for 7-14 days or until clear

Complicated Intra-abdominal Infection

3.375 g IV q6hr for 4-7 days

Skin and Soft Tissue Infection

3.375 g IV q6-8hr for 7-14 days

Dosing Considerations

Dosing range

  • 3.375 g IV q6hr, OR 4.5 g IV q6-8hr; not to exceed 18 g/day

Dosing Modifications

Renal impairment

  • CrCl >40 mL/min: Dose adjustment not necessary
  • CrCl 20-40 mL/min: 2.25 g IV q6hr, OR 3 g/0.375 g IV q6hr (for nosocomial pneumonia), OR extended infusion of 3.375 g IV over 4 hr q12hr (off-label)
  • CrCl <20 mL/min: 2.25 g IV q8hr, OR 2.25 g IV q6hr (for nosocomial pneumonia)

Dosage Forms & Strengths

piperacillin/tazobactam

powder for injection

  • (2g/250mg)/vial: 2.25g
  • (3g/375mg)/vial: 3.375g
  • (4g/500mg)/vial: 4.5g
  • (36g/4.5g)/vial: 40.5g
more...

Usual Dosing Range

<2 months: Safety and efficacy not established

2-9 months: 80 mg (piperacillin component)/kg q6hr 

9 months and <40 kg: 100 mg (piperacillin component)/kg q8hr

>40 kg: 3.375 g (IV) q6hr; a total of 13.5 g for 7-10 days; administer over 30 min

Cystic Fibrosis (Off-label)

350-450 mg/kg/day IV/IM divided q6hr 

Appendicitis, Peritonitis

<2 months: Safety and efficacy not established

2-9 months: 80 mg (piperacillin component)/kg q8hr  

9 months and ≤40 kg: 100 mg (piperacillin component)/kg q8hr

>40 kg: 3.375 g (IV) q6hr for 7-10 days; administer over 30 min

Complicated Intra-abdominal Infection

200-300 mg/kg/day IV divided q6-8hr  

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Interactions

Interaction Checker

piperacillin/tazobactam and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea (7-11%)

            1-10%

            Constipation (1-8%)

            Headache (1-8%)

            Insomnia (4-7%)

            Nausea (2-7%)

            Fever (2-5%)

            Oral candidiasis (2-4%)

            Rash (2-4%)

            Vomiting (2-4%)

            Dyspepsia (3%)

            Pruritus (3%)

            Pain (2-3%)

            Hypertension (2%)

            Leukopenia (1%)

            Thrombocytopenia (1.4%)

            <1%

            Anaphylaxis

            Agranulocytosis

            Thrombocytopenia

            Eosinophilia, melena

            Leukopenia

            Positive Coombs test

            Prolonged PT and PTT

            Transient LFT and creatinine elevations

            Seizure

            Pulmonary edema

            Pulmonary embolism

            Postmarketing Reports

            Gastrointestinal: Hepatitis, jaundice

            Hematologic: Hemolytic anemia, agranulocytosis, pancytopenia

            Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock)

            Renal: Interstitial nephritis

            Skin and appendages: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis exfoliative

            Respiratory, thoracic and mediastinal disorders: Epistaxis, eosinophilic pneumonia

            Drug reaction with eosinophilia and systemic symptoms (DRESS)

            Acute generalized exanthematous pustulosis

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            Warnings

            Contraindications

            Allergy to penicillins, cephalosporins, imipenem, beta-lactamase inhibitors

            Cautions

            Risk of bleeding complications, especially in renal impairment; discontinue if thrombocytopenia or bleeding occurs

            Leukopenia/neutropenia associated with prolonged therapy; periodic assessment of hematopoietic function should be performed, especially with prolonged therapy that is ≥ 21 days

            Serious skin reactions reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis, generalized exanthematous pustulosis; discontinue if reaction occurs

            Monitor renal, hepatic, and especially hematopoietic functions during prolonged treatment

            Prolonged use may result in fungal or bacterial superinfection

            Administering therapy in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

            Clostridium difficile associated diarrhea (CDAD) reported; if CDAD suspected or confirmed, may need to discontinue ongoing antibacterial drug use not directed against C. difficile; appropriate fluid and electrolyte management, protein supplementation may need to be implemented; antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

            Increased frequency of rash and fever reported in cyctic fibrosis patients receiving piperacillin

            Risk of seizures may increase in patients with history of seizures when administered at higher than recommended doses given IV in the presence of renal impairment

            Consider sodium content (2.79 mEq/g piperacillin) in patients requiring sodium restriction

            Perform periodic electrolyte determinations in patients with low potassium reserves and who are receiving cytotoxic therapy or diuretics and consider possibility of hypokalemia in patients who have potentially low potassium reserves

            Increased frequency of fever and rash reported in patients with cystic fibrosis receiving piperacillin

            Use caution in patients with renal impairment or underdeveloped kidneys due to sodium load and adverse effects of high serum concentrations of penicillin; dose adjustment may be necessary

            Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given IV (particularly in presence of renal failure)

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Low concentrations of piperacillin excreted in breast milk; tazobactam unknown; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Antipseudomonal penicillin plus beta-lactamase inhibitor; inhibits biosynthesis of cell wall mucopeptide synthesis by binding to 1 or more of the penicillin-binding proteins and is effective during active-multiplication stage

            Absorption

            Peak plasma time: 30 minutes following infusion

            Bioavailability: 71% (piperacillin IM); 84% (tazobactam IM)

            Distribution

            Protein bound: Piperacillin (25-33%); tazobactam (31-32%)

            Lungs, intestinal mucosa, skin, muscle, uterus, ovary, prostate, gallbladder, and bile; low CSF penetration in noninflamed meninges

            Metabolism

            Hepatic to desethyl metabolite (piperacillin) and inactive metabolite (tazobactam)

            Elimination

            Half-life: 0.7-1.2 hr

            Excretion

            • Piperacillin: Urine (68%); feces (10-20%)
            • Tazobactam: Urine (80%)
            • Both also excreted in bile
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            Administration

            IV Incompatibilities

            Y-site: Acyclovir, alatrofloxacin, amiodarone, amphotericin B, amphotericin B cholesteryl sulfate, azithromycin, chlorpromazine, cisatracurium (at high concentrations of cisatracurium; may be compatible at low concentrations), cisplatin, dacarbazine, daunorubicin, dobutamine, doxorubicin, doxorubicin liposomal, doxycycline, droperidol, famotidine, ganciclovir, gatifloxacin, gemcitabine, haloperidol, hydroxyzine, idarubicin, minocycline, mitomycin, mitoxantrone, nalbuphine, prochlorperazine, promethazine, streptozocin, and vancomycin(?)

            IV Compatibilities

            Y-site (partial list): Ca-gluconate, cimetidine, clindamycin, cotrimoxazole, dexamethasone Na-phosphate, diphenhydramine, furosemide, granisetron, heparin, magnesium sulfate, metronidazole, morphine, ondansetron, KCl, ranitidine, and zidovudine

            IV Preparation

            Use single-dose vials immediately after reconstitution

            Reconstitute with 5 mL of diluent per 1 g of piperacillin and then further dilute

            Compatible diluents include NS, SW, dextran 6%, D5W, D5W with KCl 40 mEq, bacteriostatic saline, and bacteriostatic water for injection

            IV Administration

            Infusion over 30 min

            Discontinue primary infusion, if possible, during infusion and administer aminoglycosides separately from Zosyn

            Storage

            Store at controlled room temperature

            Reconstituted solution is stable in NS or D5W for 24 hr at room temperature and for 7 days when refrigerated

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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