Zosyn Pharmacy Bulk Package
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Questions & Answers
Side Effects & Adverse Reactions
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC/ANAPHYLACTOID) REACTIONS (INCLUDING SHOCK) HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH PENICILLINS INCLUDING ZOSYN. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH ZOSYN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, ZOSYN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC/ANAPHYLACTOID REACTIONS (INCLUDING SHOCK) REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ZOSYN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients receiving ZOSYN (see ADVERSE REACTIONS). If patients develop a skin rash they should be monitored closely and ZOSYN discontinued if lesions progress.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β‑lactamase producing strains of Escherichia coli.
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.
History
There is currently no drug history available for this drug.
Other Information
The PHARMACY BULK VIAL is a container of sterile preparation which contains many single doses for parenteral use. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
ZOSYN (piperacillin and tazobactam for injection, USP) is an injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the β‑lactamase inhibitor tazobactam sodium for intravenous administration.
Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine- carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane- 2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:
Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia- 1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:
ZOSYN, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The formulation also contains 9 mg of edetate disodium dihydrate (EDTA) and sodium citrate.
Each ZOSYN 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 g of tazobactam sufficient for delivery of multiple doses.
ZOSYN is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.79 mEq (64 mg) of Na+ per gram of piperacillin in the combination product.
Sources
Zosyn Pharmacy Bulk Package Manufacturers
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Wyeth Piperacillin Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer
![Zosyn Pharmacy Bulk Package (Piperacillin Sodium And Tazobactam Sodium) Injection, Powder, Lyophilized, For Solution [Wyeth Piperacillin Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zosyn Pharmacy Bulk Package | Wyeth Piperacillin Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer
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).
Nosocomial PneumoniaInitial 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% DextroseZOSYN 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 InsufficiencyIn 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 hFor 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 TherapyThe 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 PatientsFor 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 Pharmacy Bulk Package Not for Direct InfusionRECONSTITUTED 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 Diluents0.9% 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 Solutions0.9% Sodium Chloride for Injection
Sterile Water for Injection‡
Dextran 6% in Saline
Dextrose 5%
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 ReconstitutionZOSYN 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 (20ºC to 25ºC [68ºF to 77ºF]) 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.
-
Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
Zosyn Pharmacy Bulk Package | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
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).
Nosocomial PneumoniaInitial 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% DextroseZOSYN 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 InsufficiencyIn 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 hFor 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 TherapyThe 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 PatientsFor 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 Pharmacy Bulk Package
Not for Direct InfusionRECONSTITUTED 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 Diluents0.9% Sodium Chloride for Injection
Sterile Water for Injection2
Dextrose 5%
Bacteriostatic Saline/Parabens
Bacteriostatic Water/Parabens
Bacteriostatic Saline/Benzyl Alcohol
Bacteriostatic Water/Benzyl AlcoholReconstituted 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.
2 Maximum recommended volume per dose of Sterile Water for Injection is 50 mL. Compatible Intravenous Solutions0.9% Sodium Chloride for Injection
Sterile Water for Injection2
Dextran 6% in Saline
Dextrose 5%
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 ReconstitutionZOSYN 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.
![Zosyn Pharmacy Bulk Package (Tazobactam Sodium And Piperacillin Sodium) Injection, Powder, Lyophilized, For Solution [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=81b0bb45-ce9d-43e7-b181-64315e14be55&name=zosyn-06.jpg)
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