Piperacillin Sodium / Tazobactam SodiumPronunciation
Pronunciation: PI-per-a-SIL-in SO-dee-um/TAZ-oh-BAK-tam SO-dee-um
Class: Antibiotic, Extended-spectrum penicillin
- Injection, powder for solution piperacillin 2 g and tazobactam 0.25 g
- Injection, powder for solution piperacillin 3 g and tazobactam 0.375 g
- Injection, powder for solution piperacillin 4 g and tazobactam 0.5 g
- Injection, powder for solution piperacillin 36 g and tazobactam 4.5 g (bulk)
- Injection, solution piperacillin 2 g and tazobactam 0.25 g
- Injection, solution piperacillin 3 g and tazobactam 0.375 g
- Injection, solution piperacillin 4 g and tazobactam 0.5 g
Inhibits bacterial cell wall mucopeptide synthesis.
Indications and Usage
Treatment of moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam–susceptible, beta-lactamase–producing strains of microorganisms in the following conditions: appendicitis (complicated by rupture or abscess), uncomplicated and complicated skin and skin structure infections, peritonitis, postpartum endometritis or pelvic inflammatory disease, community-acquired pneumonia (moderate severity only), nosocomial pneumonia (moderate to severe).
History of allergic reactions to penicillins, cephalosporins, or beta-lactamase inhibitors; hypersensitivity to any component of the product.
Dosage and Administration
Administer by IV infusion over 30 min.Nosocomial Pneumonia
IV Start with 4.5 g every 6 h plus an aminoglycoside (administered separately) for 7 to 14 days.Healthy Renal Function (CrCl 90 mL/min or more)
IV 3.375 g every 6 h, totaling 13.5 g (piperacillin 12 g/tazobactam 1.5 g), for 7 to 10 days.Children 2 mo of age and older
IV Piperacillin 80 mg/tazobactam 10 mg per kg every 8 h. Children weighing more than 40 kg with healthy renal function should receive the adult dose.Children 2 mo of age and older with appendicitis and/or peritonitis
IV Children between 2 and 9 mo of age – piperacillin 80 mg/tazobactam 10 mg per kg every 8 h. Children 9 mo of age and older weighing up to 40 kg – piperacillin 100 mg/tazobactam 12.5 mg per kg every 8 h. Children weighing more than 40 kg – Administer the adult dose.Renal Function Impairment
Adults CrCl more than 40 mL/min
IV 4.5 g every 6 h (nosocomial pneumonia). 3.375 g every 6 h (other indications).CrCl 20 to 40 mL/min
IV 3.375 g every 6 h (nosocomial pneumonia). 2.25 g every 6 h (other indications).CrCl less than 20 mL/min
IV 2.25 g every 6 h (nosocomial pneumonia). 2.25 g every 8 h (other indications).
There are no dosage recommendations for children with renal function impairment.Hemodialysis
IV Max dosage is 2.25 g every 8 h for nosocomial pneumonia and every 12 h for other indications, plus 1 additional dose of 0.75 g following each dialysis period.Continuous Ambulatory Peritoneal Dialysis (CAPD)
IV 2.25 g every 8 h for nosocomial pneumonia and every 12 h for other indications.Elderly
Start at the low end of the dose range.
- 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 preparing 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 dextrose 5% injection. Add 5 mL diluent per gram of piperacillin being reconstituted and swirl until dissolved.
- Further dilute reconstituted solution with compatible diluent to prescribed volume (eg, 50 to 150 mL).
- Piperacillin/tazobactam in Galaxy containers should not be used in children who require less than the adult dose.
- 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 h if stored at room temperature or after 48 h 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 h at room temperature and up to 7 days if refrigerated.
- Admixed solution in the ADD-Vantage system is stable for up to 24 h 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 h.
- 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 h at room temperature or 7 days if refrigerated. Do not refreeze thawed solutions.
May form microbiologically inactive complexes; do not mix in the same container.Anticoagulants/Heparin
Frequently monitor coagulation parameters.Methotrexate
May reduce Cl of methotrexate.Probenecid
Increases and prolongs half-life of penicillin levels.Vecuronium
Neuromuscular blockade may be prolonged.
Ringer's lactate 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.
The incidences stated for the following adverse reactions were reported with piperacillin/tazobactam administration alone. Adverse reactions occurring with administration of piperacillin/tazobactam in combination with other antibiotics (eg, an aminoglycoside) are not included. Adverse reactions occurring in children are similar to those reported in adults.
Headache (8%); insomnia (7%); agitation (2%); anxiety, dizziness (1%).
Rash, including bullous, eczematoid, maculopapular, and urticarial (4%); pruritus (3%); erythema multiforme, Stevens-Johnson syndrome, TEN (postmarketing).
Diarrhea (11%); constipation (8%); nausea (7%); dyspepsia, vomiting (3%); stool changes (2%); abdominal pain (1%).
Interstitial nephritis, renal failure (postmarketing).
Agranulocytosis, anemia, hemolytic anemia, pancytopenia, thrombocytosis (postmarketing).
Cholestatic jaundice, hepatitis (postmarketing).
Anaphylactic/anaphylactoid reactions (including shock), hypersensitivity reactions (postmarketing).
Fever, moniliasis, pain (2%); chest pain, edema (1%); candidal superinfections (postmarketing).
Periodically assess hematopoietic function, especially with prolonged therapy (ie, 21 days or more). Perform periodic electrolyte determinations in patients with low potassium reserves.
Category B .
Excreted in low concentrations in human milk.Tazobactam
Safety and efficacy not established in children younger than 2 mo of age.
Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.
Serious and sometimes fatal hypersensitivity reactions have occurred.
Adjust dose accordingly.
Prolonged use of antibiotics may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.
Hemorrhagic manifestations associated with abnormalities of coagulation tests (bleeding time, platelet aggregation, PT) may occur. Abnormalities revert to normal when drug is discontinued.
May occur if higher than recommended doses are used.
Patients with cystic fibrosis
May experience higher incidence of adverse reactions when treated with piperacillin.
Is unlikely to provide benefit and may increase risk of development of drug-resistant bacteria.
May occur because of overgrowth of Clostridium difficile ; consider the possibility in patients in whom diarrhea develops.
Product contains 2.79 mEq (64 mg) of sodium; consider this when treating patients requiring restricted sodium intake.
Convulsions, diarrhea, nausea, neuromuscular excitability, vomiting.
- Advise patient or caregiver that medication will be prepared by 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 the following signs of superinfection to health care provider: black “furry” tongue, foul-smelling stools, vaginal itching or discharge, white patches in mouth.
- 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 and not to treat at home.
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