Piperacillin Sodium/Tazobactam Sodium

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|Piperacillin Sodium/Tazobactam Sodium

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Piperacillin Sodium/Tazobactam Sodium

Pronouncation: (PIH-per-uh-SILL-in SO-dee-uhm/TAZZ-oh-BACK-tam SO-dee-uhm)
Class: Antibiotic, Extended spectrum penicillin

Trade Names:
Zosyn
- Powder for Injection 2 g piperacillin, 0.25 g tazobactam
- Powder for Injection 3 g piperacillin, 0.375 g tazobactam
- Powder for Injection 4 g piperacillin, 0.5 g tazobactam
- Powder for Injection 36 g piperacillin, 4.5 g tazobactam (bulk)
- Solution 2 g piperacillin, 0.25 g tazobactam
- Solution 3 g piperacillin, 0.375 g tazobactam
- Solution 4 g piperacillin, 0.5 g tazobactam

Mechanism of Action

Pharmacology

Inhibits bacterial cell wall mucopeptide synthesis.

Pharmacokinetics

Distribution

Widely distributed in human tissues and body fluids, including intestinal mucosa, gallbladder, lung, female reproductive tissues, interstitial fluid, and bile. Penetrates CSF in the presence of inflamed meninges.

Elimination

Serum t ½ is 0.7 to 1.2 hr. Approximately 68% of piperacillin and 80% of tazobactam are excreted unchanged in urine.

Special Populations

Renal Function Impairment

Elimination t ½ is increased 2-fold for piperacillin and 4-fold for tazobactam in Ccr below 20 mL/min.

Indications and Usage

Treatment of moderate to severe infections caused by piperacillin-resistant piperacillin/tazobactam-susceptible, β-lactamase producing strains of microorganisms in the following conditions: appendicitis (complicated by rupture or abscess); uncomplicated and complicated skin and skin structure infections; postpartum endometritis or pelvic inflammatory disease; community-acquired pneumonia (moderate severity only); nosocomial pneumonia (moderate to severe).

Contraindications

History of allergic reactions to penicillins, cephalosporins, or β-lactamase inhibitors; hypersensitivity to any component of the product.

Dosage and Administration

Administer by IV infusion over 30 min.

Nosocomial Pneumonia
Adults

IV Start with 4.5 g q 6 hr plus an aminoglycoside (administered separately) for 7 to 14 days.

Normal Renal Function (Ccr 90 mL/min or more)
Adults

IV 3.375 g q 6 hr totaling 13.5 g (12 g piperacillin/1.5 g tazobactam) for 7 to 10 days.

Renal Insufficiency
Adults

IV Ccr greater than 40 mL/min: 3.375 g q 6 hr (all indications), and 4.5 g q 6 hr (nosocomial pneumonia). Ccr 20 to 40 mL/min: 2.25 g q 6 hr (all indications), and 3.375 g q 6 hr (nosocomial pneumonia). Ccr less than 20 mL/min: 2.25 g q 8 hr (all indications), and 2.25 g q 6 hr (nosocomial pneumonia).

Hemodialysis
Adults

IV Max dose 2.25 g q 8 hr for nosocomial pneumonia and q 12 hr for other indications plus 1 additional dose of 0.75 g following each dialysis period.

Continuous Ambulatory Peritoneal Dialysis (CAPD)
Adults

IV 2.25 g q 8 hr for nosocomial pneumonia and q 12 hr for other indications.

General Advice

  • For IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration. May be used in ambulatory IV infusion pump.
  • Multiple concentrations are available for reconstitution. Ensure proper concentration is being used.
  • If using ADD-Vantage antibiotic vial, carefully follow manufacturer"s instructions for assembling vial and flexible 50- or 100-mL diluent container, reconstituting drug, and preparation for administration.
  • If using regular vial with powder for injection, reconstitute with sterile or bacteriostatic water for injection, sterile or bacteriostatic sodium chloride for injection, or 5% dextrose injection. Add 5 mL of diluent per g of piperacillin being reconstituted and swirl until dissolved.
  • Further dilute reconstituted solution with compatible diluent to prescribed volume (eg, 50 to 150 mL).
  • Do not administer if solution is cloudy, discolored, or contains particulate matter.
  • Administer as intermittent infusion over 30 min by direct injection or through a Y-type IV infusion set already in place. If using Y-type IV infusion set, temporarily discontinue administration of any other solution during infusion of piperacillin.

Storage/Stability

  • Store powder for injection at controlled room temperature (68° to 77°F). Use reconstituted solution immediately or dilute for infusion. Discard any unused portion after 24 hr if stored at room temperature or after 48 hr if stored in refrigerator (36° to 46°F). Do not freeze vials after reconstitution.
  • Diluted solution in IV bags is stable for up to 24 hr at room temperature and up to 7 days if refrigerated.
  • Admixed solution in the ADD-Vantage system is stable for up to 24 hr at room temperature. Do not refrigerate or freeze the admixed ADD-Vantage system solution after reconstitution.
  • Diluted solution in ambulatory IV infusion pump is stable for up to 12 hr.
  • Store premixed, frozen solutions at or below 4°F. Thaw at room temperature (72°F) or in refrigerator (39°F). Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solution is stable for 24 hr at room temperature or 7 days if refrigerated. Do not refreeze thawed solutions.

Drug Interactions

Aminoglycosides

May form microbiologically inactive complexes and should not be mixed in the same container.

Anticoagulants/Heparin

Frequently monitor coagulation parameters.

Methotrexate

May reduce Cl of methotrexate.

Probenecid

Increases and prolongs t ½ of penicillin levels.

Vecuronium

Neuromuscular blockade may be prolonged.

Incompatibility

Ringer"s lactated solution.

Laboratory Test Interactions

False-positive reaction for glucose in the urine using a copper-reduction method (eg, Clinitest ) but not with enzyme-based tests (eg, Diastix , Tes-Tape ). False-positive results for Aspergillus have been reported using the Bio-Rad Laboratories" Platelia Aspergillus EIA Test .

Adverse Reactions

The incidence stated for the following adverse reaction were reported with Zosyn administration alone. Adverse reactions occurring with administration of Zosyn in combination with other antibiotics (eg, an aminoglycoside) are not included.

Cardiovascular

Hypertension (2%); chest pain (1%).

CNS

Headache (8%); insomnia (7%); agitation (2%); anxiety, dizziness (1%).

Dermatologic

Rash, including maculopapular, bullous, urticarial, and eczematoid (4%); pruritus (3%); erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).

EENT

Rhinitis (1%).

GI

Diarrhea (11%); constipation (8%); nausea (7%); dyspepsia, vomiting (3%); stool changes (2%); abdominal pain (1%).

Genitourinary

Interstitial nephritis, renal failure (postmarketing).

Hematologic-Lymphatic

Agranulocytosis, anemia, hemolytic anemia, pancytopenia, thrombocytosis (postmarketing).

Hepatic

Cholestatic jaundice, hepatitis (postmarketing).

Hypersensitivity

Anaphylactic/anaphylactoid reactions, including shock (postmarketing).

Local

Phlebitis (1%).

Musculoskeletal

Prolonged muscle relaxation.

Respiratory

Dyspnea (1%).

Miscellaneous

Fever, moniliasis, pain (2%); edema (1%); candidal superinfections (postmarketing).

Precautions

Pregnancy

Category B .

Lactation

Piperacillin

Excreted in low concentrations in human milk.

Tazobactam

Undetermined.

Children

Safety and efficacy not established.

Hypersensitivity

Serious and sometimes fatal hypersensitivity reactions have occurred.

Renal Function

Adjust dose accordingly.

Superinfection

Prolonged use of antibiotics may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Bleeding abnormalities

Hemorrhagic manifestations associated with abnormalities of coagulation tests (bleeding time, PT, platelet aggregation) may occur. Abnormalities should revert to normal when drug is discontinued.

Cystic fibrosis patients

May experience higher incidence of side effects when treated with piperacillin.

Prophylactic use

Is unlikely to provide benefit and may increase risk of development of drug-resistant bacteria.

Pseudomembranous colitis

May occur because of overgrowth of clostridium difficile; consider the possibility in patients in whom diarrhea develops.

Sodium content

Product contains 2.35 mEq (54 mg) of sodium, which should be considered when treating patients requiring restricted sodium intake.

Overdosage

Symptoms

Neuromuscular excitability, convulsions, nausea, vomiting, diarrhea.

Patient Information

  • Explain name, action, and potential side effects of drug.
  • Advise patient or caregiver that medication will be prepared by a health care provider and administered in a health care setting.
  • Review dosing schedule and prescribed length of therapy with patient. Advise patient that dose, dosing frequency, and duration of therapy are dependent on site of infection, severity of infection, and response to treatment.
  • Advise patient or caregiver to immediately inform health care provider if injection site pain or redness, skin rash, hives, itching, or shortness of breath occur during treatment.
  • Advise patient or caregiver to report signs of superinfection to health care provider: black “furry” tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
  • Warn patient or caregiver that diarrhea containing blood or pus may be a sign of a serious disorder and, if noted after discharge, to seek medical care if noted and not treat at home.
  • Advise patient or caregiver that after discharge follow-up visits and lab tests may be required and to keep appointments.




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