Zosyn Dosage

Generic name: piperacillin sodium and tazobactam sodium
Dosage form: injection, powder, lyophilized, for solution

See also:

This dosage information does not include all the information needed to use Zosyn safely and effectively. See full prescribing information for Zosyn.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

ZOSYN should be administered by intravenous infusion over 30 minutes.

The usual total daily dose of ZOSYN for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam).

Nosocomial Pneumonia

Initial presumptive treatment of 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/2.0 g tazobactam). Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeruginosa is isolated. If Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician.

Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, ZOSYN and the aminoglycoside are recommended for separate administration. ZOSYN and the aminoglycoside should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated. (See PRECAUTIONS, Drug Interactions.)

In circumstances where co-administration via Y-site is necessary, reformulated ZOSYN containing EDTA supplied in vials or bulk pharmacy containers is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:

The following compatibility information does not apply to the ZOSYN (piperacillin/tazobactam) formulation not containing EDTA. This information does not apply to ZOSYN in Galaxy® containers. Refer to the package insert for ZOSYN Galaxy containers for instructions.

TABLE 4
Aminoglycoside ZOSYN Dose
(grams)
ZOSYN Diluent
Volume
(mL)
Aminoglycoside
Concentration
Range*
(mg/mL)
Acceptable Diluents
*The concentration ranges in Table 4 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.
Amikacin 2.25,
3.375, 4.5
50,
100, 150
1.75
- 7.5
0.9%
Sodium Chloride or 5% Dextrose
Gentamicin 2.25,
3.375, 4.5
50,
100, 150
0.7
- 3.32
0.9%
Sodium Chloride or 5% Dextrose

ZOSYN is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of ZOSYN with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of ZOSYN listed above have been established as compatible for coadministration via Y-site infusion. Simultaneous coadministration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by ZOSYN.

Renal Insufficiency

In patients with renal insufficiency (Creatinine Clearance ≤ 40 mL/min), the intravenous dose of ZOSYN (piperacillin and tazobactam for injection, USP) should be adjusted to the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglycoside therapy, the aminoglycoside dosage should be adjusted according to the recommendations of the manufacturer. The recommended daily doses of ZOSYN for patients with renal insufficiency are as follows:

Recommended Dosing of ZOSYN in Patients with Normal Renal Function and Renal Insufficiency (As total grams piperacillin/tazobactam)
Renal Function
(Creatinine Clearance, mL/min)
All Indications (except nosocomial pneumonia) Nosocomial Pneumonia
* Creatinine clearance for patients not receiving hemodialysis

** 0.75 g should be administered following each hemodialysis session on hemodialysis days

>40 mL/min 3.375 q 6 h 4.5 q 6 h
20-40 mL/min* 2.25 q 6 h 3.375 q 6 h
<20 mL/min* 2.25 q 8 h 2.25 q 6 h
Hemodialysis** 2.25 q 12 h 2.25 q 8 h
CAPD 2.25 q 12 h 2.25 q 8 h

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 should be administered following each dialysis period on hemodialysis days. No additional dosage of ZOSYN is necessary for CAPD patients.

Duration of Therapy

The usual duration of ZOSYN treatment is from seven to ten days. However, the recommended duration of ZOSYN treatment of nosocomial pneumonia is 7 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient's clinical and bacteriological progress.

Pediatric Patients

For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended ZOSYN dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended ZOSYN dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours (see PRECAUTIONS, General, Pediatric Use and CLINICAL PHARMACOLOGY). Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. There are no dosage recommendations for ZOSYN in pediatric patients with impaired renal function.

Directions for Reconstitution and Dilution for Use

Intravenous Administration

For conventional vials, reconstitute ZOSYN per gram of piperacillin with 5 mL of a compatible reconstitution diluent from the list provided below.

2.25 g, 3.375 g, and 4.5 g ZOSYN should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.

Pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Compatible Reconstitution Diluents

0.9% Sodium Chloride for Injection

Sterile Water for Injection

Dextrose 5%

Bacteriostatic Saline/Parabens

Bacteriostatic Water/Parabens

Bacteriostatic Saline/Benzyl Alcohol

Bacteriostatic Water/Benzyl Alcohol

Reconstituted ZOSYN solution should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous solution listed below. Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

Compatible Intravenous Solutions

0.9% Sodium Chloride for Injection

Sterile Water for Injection

Dextrose 5%

Dextran 6% in Saline

Lactated Ringer's Solution (Compatible only with reformulated ZOSYN containing EDTA and is compatible for co-administration via a Y-site).

Maximum recommended volume per dose of Sterile Water for Injection is 50 mL.

ZOSYN should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

ZOSYN is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

ZOSYN should not be added to blood products or albumin hydrolysates.

ZOSYN can be used in ambulatory intravenous infusion pumps.

Stability of ZOSYN Following Reconstitution

ZOSYN is stable in glass and plastic containers (plastic syringes, I.V. bags, and tubing) when used with compatible diluents.

Pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]). Vials should not be frozen after reconstitution.

Stability studies in the I.V. bags have demonstrated chemical stability (potency, pH of reconstituted solution, and clarity of solution) for up to 24 hours at room temperature and up to one week at refrigerated temperature. ZOSYN contains no preservatives. Appropriate consideration of aseptic technique should be used.

Stability of ZOSYN in an ambulatory intravenous infusion pump has been demonstrated for a period of 12 hours at room temperature. Each dose was reconstituted and diluted to a volume of 37.5 mL or 25 mL. One-day supplies of dosing solution were aseptically transferred into the medication reservoir (I.V. bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer's instructions. Stability of ZOSYN is not affected when administered using an ambulatory intravenous infusion pump.

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

Hide
(web2)