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Zosyn Dosage

Generic name: PIPERACILLIN SODIUM 2g in 50mL, TAZOBACTAM SODIUM 0.25g in 50mL
Dosage form: injection, solution
Drug class: Beta-lactamase inhibitors

Medically reviewed by Drugs.com. Last updated on Apr 1, 2023.

Important Administration Instructions

If a dose of ZOSYN is required that does not equal 2.25 g, 3.375 g, or 4.5 g, ZOSYN injection in GALAXY Containers is not recommended for use and an alternative formulation of ZOSYN should be considered.

Dosage in Adult Patients With Indications Other Than Nosocomial Pneumonia

The usual total daily dosage of ZOSYN for adult patients with indications other than nosocomial pneumonia is 3.375 g every six hours [totaling 13.5 g (12.0 g piperacillin and 1.5 g tazobactam)], to be administered by intravenous infusion over 30 minutes. The usual duration of ZOSYN treatment is from 7 to 10 days.

Dosage in Adult Patients With Nosocomial Pneumonia

Initial presumptive treatment of adult patients with nosocomial pneumonia should start with ZOSYN at a dosage of 4.5 g every six hours plus an aminoglycoside, [totaling 18.0 g (16.0 g piperacillin and 2.0 g tazobactam)], administered by intravenous infusion over 30 minutes. The recommended duration of ZOSYN treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.

Dosage in Adult Patients With Renal Impairment

In adult patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of ZOSYN should be reduced based on the degree of renal impairment. The recommended daily dosage of ZOSYN for patients with renal impairment administered by intravenous infusion over 30 minutes is described in Table 1.

Table 1: Recommended Dosage of ZOSYN in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin and tazobactam)*
*
Administer ZOSYN by intravenous infusion over 30 minutes.
†
Creatinine clearance for patients not receiving hemodialysis
‡
0.75 g (0.67 g piperacillin and 0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days

Creatinine clearance, mL/min

All Indications (except nosocomial pneumonia)

Nosocomial Pneumonia

Greater than 40 mL/min

3.375 every 6 hours

4.5 every 6 hours

20 to 40 mL/min†

2.25 every 6 hours

3.375 every 6 hours

Less than 20 mL/min†

2.25 every 8 hours

2.25 every 6 hours

Hemodialysis‡

2.25 every 12 hours

2.25 every 8 hours

CAPD

2.25 every 12 hours

2.25 every 8 hours

For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g ZOSYN (0.67 g piperacillin and 0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of ZOSYN is necessary for CAPD patients.

Dosage in Pediatric Patients With Appendicitis/Peritonitis or Nosocomial Pneumonia

The recommended dosage for pediatric patients with appendicitis and/or peritonitis or nosocomial pneumonia aged 2 months of age and older, weighing up to 40 kg, and with normal renal function, is described in Table 2 [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].

Table 2: Recommended Dosage of ZOSYN in Pediatric Patients 2 Months of Age and Older, Weighing Up to 40 kg, and With Normal Renal Function*†
*
Administer ZOSYN by intravenous infusion over 30 minutes
†
If a dose of ZOSYN is required that does not equal 2.25 g, 3.375 g, or 4.5 g, ZOSYN injection in GALAXY Containers is not recommended for use and an alternative formulation of ZOSYN should be considered [see Use in Specific Populations (8.4)].

Age

Appendicitis and/or Peritonitis

Nosocomial Pneumonia

2 months to 9 months

90 mg/kg

(80 mg piperacillin and 10 mg tazobactam) every 8 (eight) hours

90 mg/kg

(80 mg piperacillin and 10 mg tazobactam)

every 6 (six) hours

Older than 9 months of age

112.5 mg/kg

(100 mg piperacillin and 12.5 mg tazobactam)

every 8 (eight) hours

112.5 mg/kg

(100 mg piperacillin and 12.5 mg tazobactam)

every 6 (six) hours

Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose [see Dosage and Administration (2.2, 2.3)].

Dosage of ZOSYN in pediatric patients with renal impairment has not been determined.

Directions for Use of ZOSYN Injection

Important Administration Instructions for ZOSYN Injection in GALAXY Containers

Administer ZOSYN Injection in GALAXY Containers using sterile equipment, after thawing to room temperature.

ZOSYN containing EDTA is compatible for co-administration via a Y-site intravenous tube with Lactated Ringer’s injection, USP.

Do NOT add supplementary medication.

Unused portions of ZOSYN Injection should be discarded.

Do NOT use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Thawing of Plastic Container

Thaw frozen container at room temperature 20°C to 25°C [68°F to 77°F] or under refrigeration (2°C to 8°C [36°F to 46°F]). Do not force thaw by immersion in water baths or by microwave irradiation.

Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection, the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

Administration Instructions for ZOSYN Injection in GALAXY Containers to Adult Patients

Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

Administration Instruction for ZOSYN Injection in GALAXY Containers to Pediatric Patients Weighing up to 40 kg

If a dose of ZOSYN is required that does not equal 2.25 g, 3.375 g, or 4.5 g, ZOSYN injection in GALAXY Containers is not recommended for use and an alternative formulation of ZOSYN should be considered.

Storage of ZOSYN Injection

Store in a freezer capable of maintaining a temperature of -20°C (-4°F).

For GALAXY Containers, the thawed solution is stable for 14 days under refrigeration (2°C to 8°C [36°F to 46°F]) or 24 hours at room temperature 20°C to 25°C [68°F to 77°F]. Do not refreeze thawed ZOSYN Injection.

Compatibility With Aminoglycosides

Due to the in vitro inactivation of aminoglycosides by piperacillin, ZOSYN and aminoglycosides are recommended for separate administration. ZOSYN and aminoglycosides should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated [see Drug Interactions (7.1)].

In circumstances where co-administration via Y-site is necessary, ZOSYN formulations containing EDTA are compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides under the following conditions:

Table 3: Compatibility with Aminoglycosides
*
The concentration ranges in Table 3 are based on administration of the aminoglycoside in divided doses (10-15 mg/kg/day in two daily doses for amikacin and 3-5 mg/kg/day in three daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with ZOSYN containing EDTA has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
†
ZOSYN 3.375 g per 50 mL GALAXY Containers are NOT compatible with gentamicin for co-administration via a Y-site due to the higher concentrations of piperacillin and tazobactam.

Aminoglycoside

ZOSYN Dose

(grams)

Aminoglycoside

Concentration

Range*

(mg/mL)

Acceptable Diluents

Amikacin

2.25

3.375

4.5

1.75 - 7.5

0.9% sodium chloride or 5% dextrose

Gentamicin

2.25

3.375†

4.5

0.7 - 3.32

0.9% sodium chloride or 5% dextrose

Only the concentration and diluents for amikacin or gentamicin with the dosages of ZOSYN listed above have been established as compatible for co-administration via Y-site infusion. Simultaneous co-administration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by ZOSYN.

ZOSYN is not compatible with tobramycin for simultaneous co-administration via Y-site infusion. Compatibility of ZOSYN with other aminoglycosides has not been established.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Further information

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