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ZOSYN (piperacillin and tazobactam for injection, USP) is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, β-lactamase producing strains of the designated microorganisms in the specified conditions listed below:
Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β-lactamase producing strains of Escherichia coli or the following members of the Bacteroides fragilis group: B.fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus. The individual members of this group were studied in less than 10 cases.
Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by piperacillin-resistant, β-lactamase producing strains of Staphylococcus aureus.
Community-acquired pneumonia (moderate severity only) caused by piperacillin-resistant, β-lactamase producing strains of Haemophilus influenzae.
Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant, β-lactamase producing strains of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumanii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside). (See DOSAGE AND ADMINISTRATION.)
ZOSYN (piperacillin and tazobactam for injection, USP) is indicated only for the specified conditions listed above. Infections caused by piperacillin-susceptible organisms, for which piperacillin has been shown to be effective, are also amenable to ZOSYN treatment due to its piperacillin content. The tazobactam component of this combination product does not decrease the activity of the piperacillin component against piperacillin-susceptible organisms. Therefore, the treatment of mixed infections caused by piperacillin-susceptible organisms and piperacillin-resistant, β-lactamase producing organisms susceptible to ZOSYN should not require the addition of another antibiotic. (See DOSAGE AND ADMINISTRATION.)
ZOSYN is useful as presumptive therapy in the indicated conditions prior to the identification of causative organisms because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic organisms.
Appropriate cultures should usually be performed before initiating antimicrobial treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ZOSYN. Antimicrobial therapy should be adjusted, if appropriate, once the results of culture(s) and antimicrobial susceptibility testing are known.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN (piperacillin and tazobactam) injection and other antibacterial drugs, ZOSYN (piperacillin and tazobactam) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
ZOSYN should be administered by intravenous infusion over 30 minutes.
The usual 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).
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.
|Aminoglycoside|| ZOSYN Dose
| ZOSYN Diluent
| Aminoglycoside Concentration Range*
|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|
|*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.|
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.
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)
|>40 mL/min||3.375 q6h||4.5 q 6 h|
|20-40 mL/min*||2.25 q 6 h||3.375 q6h|
|<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|
| * Creatinine clearance for patients not receiving hemodialysis
** 0.75 g should be administered following each hemodialysis session on hemodialysis days
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.
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
Pharmacy Bulk Package
Not for Direct Infusion
RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION
The pharmacy bulk vial is for use in a hospital pharmacy admixture service only under a laminar flow hood. After reconstitution, entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and contents should be dispensed as aliquots into intravenous solution using aseptic technique. Use entire contents of pharmacy bulk vial promptly. Discard 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]).
Reconstitute the pharmacy bulk vial with exactly 152 mL of a compatible reconstitution diluent, listed below, to a concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam. Shake well until dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.
Compatible Reconstitution Diluents
0.9% Sodium Chloride for Injection
Sterile Water for Injection‡
Bacterio static 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‡
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.)
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.
The pharmacy bulk vial should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature (20°C to 25°C [68°F to 77°F]) or after storage for 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).
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 (piperacillin and tazobactam for injection, USP) 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 or discoloration prior to administration, whenever solution and container permit.
‡ Maximum recommended volume per dose of Sterile Water for Injection is 50 mL.
ZOSYN (piperacillin and tazobactam for injection, USP) is supplied as a powder in the pharmacy bulk vial as follows:
Each ZOSYN 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams tazobactam, 9 mg of edetate disodium dihydrate (EDTA), and 1800 mg of sodium citrate. Each pharmacy bulk vial contains 100.4 mEq (2,304 mg) of sodium.
ZOSYN (piperacillin and tazobactam for injection, USP) pharmacy bulk vials should be stored at controlled room temperature 20°C to 25°C (68°F to 77°F) prior to reconstitution.
ZOSYN (piperacillin and tazobactam for injection, USP) is also supplied as follows:
2.25 g single-dose vial containing piperacillin sodium equivalent to 2 g of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 5.58 mEq (128 mg) of sodium. Supplied 10/box - NDC 0206-8852-16
3.375 g single-dose vial containing piperacillin sodium equivalent to 3 g of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 8.38 mEq (192 mg) of sodium. Supplied 10/box - NDC 0206-8854-16
4.5 g single-dose vial containing piperacillin sodium equivalent to 4 g of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 11.17 mEq (256 mg) of sodium. Supplied 10/box - NDC 0206-8855-16
ZOSYN (piperacillin and tazobactam injection) in Galaxy Container (PL 2040 Plastic) is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in single-dose plastic containers as follows:
2.25 g (piperacillin sodium equivalent to 2 g piperacillin/tazobactam sodium equivalent to 0.25 g tazobactam) in 50 mL. Each container has 5.58 mEq (128 mg) of sodium. Supplied 24/box - NDC 0206-8860-02
3.375 g (piperacillin sodium equivalent to 3 g piperacillin/tazobactam sodium equivalent to 0.375 g tazobactam) in 50 mL. Each container has 8.38 mEq (192 mg) of sodium. Supplied 24/box - NDC 0206-8861-02
4.5 g (piperacillin sodium equivalent to 4 g piperacillin/tazobactam sodium equivalent to 0.5 g tazobactam) in 100 mL. Each container has 11.17 mEq (256 mg) of sodium. Supplied 12/box - NDC 0206-8862-02
1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; 21st Informational Supplement. CLSI document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011
2. CLSI. Methods for Dilution Antimicrobial Susceptibility Test for Bacteria that Grow Aerobically; Approved Standard - 8th ed. CLSI document M07-A8, 2009.
3. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Test; Approved Standard - 10th ed.CLSI document M02-A10, 2009.
4. CLSI. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard - 7th ed. CLSI document M11-A7, 2007.
This product's label may have been updated. For current package insert and further product information, please visit www.pfizer.com or call our medical communications department toll-free at 1-800-438-1985. Distributed by Wyeth Pharmaceuticals In: A subsidiary of Pfizer Inc Philadelphia, PA 19101.
Last reviewed on RxList: 6/22/2012
This monograph has been modified to include the generic and brand name in many instances.
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