Piperacillin And Tazobactam
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Uses
Piperacillin and tazobactam for injection is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.
Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates 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 fewer than 10 cases.
Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus.
Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli.
Community-acquired pneumonia (moderate severity only) caused by β-lactamase producing isolates of Haemophilus influenzae.
Nosocomial pneumonia (moderate to severe) caused by β-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumannii, 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 (2)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat infections that are proven or strongly suspected to be caused by 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
Piperacillin and tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial 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-piperazinecarboxamido)-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:
Piperacillin and tazobactam for injection, 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 product does not contain excipients or preservatives.
Each piperacillin and tazobactam for injection 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.7 mEq (108 mg) of sodium.
Each piperacillin and tazobactam for injection 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.0 mEq (162 mg) of sodium.
Each piperacillin and tazobactam for injection 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.4 mEq (216 mg) of sodium.
Piperacillin and tazobactam for injection is a monosodium salt of piperacillin and a monosodium salt of tazobactam containing a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product.
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Piperacillin And Tazobactam Manufacturers
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Fresenius Kabi Usa, Llc
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Piperacillin And Tazobactam | Fresenius Kabi Usa, Llc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection 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). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)
Renal Function
(creatinine clearance,
All Indications
Nosocomial
mL/min)
(except nosocomial pneumonia)
Pneumonia
>40 mL/min
3.375 q6h
4.5 q6h
20-40 mL/min*
2.25 q6h
3.375 q6h
<20 mL/min*
2.25 q8h
2.25 q6h
Hemodialysis**
2.25 q12h
2.25 q8h
CAPD
2.25 q12h
2.25 q8h
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysFor 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsSingle Dose Vials
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 alcoholReconstituted piperacillin and tazobactam for injection 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 for Single Dose Vials
0.9% Sodium chloride for injection
Sterile water for injection‡
Dextran 6% in saline
Dextrose 5%LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.6 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, Piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, piperacillin and tazobactam for injection is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides
Aminoglycoside
Piperacillin and Tazobactam
Dose
(grams)Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Range a
(mg/mL)Acceptable Diluents
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
aThe concentration ranges in Table 2 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam 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.
-
Fresenius Kabi Usa, Llc
Piperacillin And Tazobactam | Fresenius Kabi Usa, Llc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection 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). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)
Renal Function
(creatinine clearance,
All Indications
Nosocomial
mL/min)
(except nosocomial pneumonia)
Pneumonia
>40 mL/min
3.375 q6h
4.5 q6h
20-40 mL/min*
2.25 q6h
3.375 q6h
<20 mL/min*
2.25 q8h
2.25 q6h
Hemodialysis**
2.25 q12h
2.25 q8h
CAPD
2.25 q12h
2.25 q8h
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysFor 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsPharmacy Bulk Package Bottles
Reconstituted stock solution must be transferred and further diluted for intravenous infusion.
The pharmacy bulk package bottle 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 package bottle 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 package bottle 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 for Pharmacy Bulk Bottles
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 alcoholReconstituted piperacillin and tazobactam for injection 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 for Pharmacy Bulk Package Bottles and Single Dose Vials
0.9% Sodium chloride for injection
Sterile water for injection‡
Dextran 6% in saline
Dextrose 5%LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from pharmacy bulk package bottles is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. The pharmacy bulk package bottle should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).
Pharmacy bulk package bottles 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). Pharmacy bulk package bottles 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from bulk package bottles can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.6 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, piperacillin and tazobactam is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides
Aminoglycoside
Piperacillin and Tazobactam
Dose
(grams)Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Rangea
(mg/mL)Acceptable Diluents
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
aThe concentration ranges in Table 2 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam 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.
-
Fresenius Kabi Usa, Llc
Piperacillin And Tazobactam | Fresenius Kabi Usa, Llc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection 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). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)
Renal Function
(creatinine clearance,
All Indications
Nosocomial
mL/min)
(except nosocomial pneumonia)
Pneumonia
>40 mL/min
3.375 q6h
4.5 q6h
20-40 mL/min*
2.25 q6h
3.375 q6h
<20 mL/min*
2.25 q8h
2.25 q6h
Hemodialysis**
2.25 q12h
2.25 q8h
CAPD
2.25 q12h
2.25 q8h
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysFor 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsPharmacy Bulk Package Bottles
Reconstituted stock solution must be transferred and further diluted for intravenous infusion.
The pharmacy bulk package bottle 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 package bottle 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 package bottle 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 for Pharmacy Bulk Bottles
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 alcoholReconstituted piperacillin and tazobactam for injection 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 for Pharmacy Bulk Package Bottles and Single Dose Vials
0.9% Sodium chloride for injection
Sterile water for injection‡
Dextran 6% in saline
Dextrose 5%LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from pharmacy bulk package bottles is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. The pharmacy bulk package bottle should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).
Pharmacy bulk package bottles 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). Pharmacy bulk package bottles 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from bulk package bottles can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.6 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, piperacillin and tazobactam is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides
Aminoglycoside
Piperacillin and Tazobactam
Dose
(grams)Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Rangea
(mg/mL)Acceptable Diluents
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
aThe concentration ranges in Table 2 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam 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.
-
App Pharmaceuticals, Llc
Piperacillin And Tazobactam | Bjwc
• if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule:Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
1 piece every
1 to 2 hours
1 piece every
2 to 4 hours
1 piece every
4 to 8 hours
• nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider. -
App Pharmaceuticals, Llc
Piperacillin And Tazobactam | Dolgencorp, Llc
• do not take more than directed • the smallest effective dose should be usedadults and children 12 years and older
• take 1 tablet every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 tablet, 2 tablets may be used • do not exceed 6 tablets in 24 hours, unless directed by a doctorchildren under 12 years
• ask a doctor -
Wg Critical Care, Llc
Piperacillin And Tazobactam | Wg Critical Care, Llc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection 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). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)
Renal Function
(creatinine clearance,
All Indications
Nosocomial
mL/min)
(except nosocomial pneumonia)
Pneumonia
>40 mL/min
3.375 q6h
4.5 q6h
20-40 mL/min*
2.25 q6h
3.375 q6h
<20 mL/min*
2.25 q8h
2.25 q6h
Hemodialysis**
2.25 q12h
2.25 q8h
CAPD
2.25 q12h
2.25 q8h
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysFor 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsSingle Dose Vials
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 alcoholReconstituted piperacillin and tazobactam for injection 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 for Single Dose Vials
0.9% Sodium chloride for injection
Sterile water for injection‡
Dextran 6% in saline
Dextrose 5%LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.6 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, Piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, piperacillin and tazobactam for injection is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides
Aminoglycoside
Piperacillin and Tazobactam
Dose
(grams)Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Range a
(mg/mL)Acceptable Diluents
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
aThe concentration ranges in Table 2 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam 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.
-
Wg Critical Care, Llc
Piperacillin And Tazobactam | Wg Critical Care, Llc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection 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). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)
Renal Function
(creatinine clearance,
All Indications
Nosocomial
mL/min)
(except nosocomial pneumonia)
Pneumonia
>40 mL/min
3.375 q6h
4.5 q6h
20-40 mL/min*
2.25 q6h
3.375 q6h
<20 mL/min*
2.25 q8h
2.25 q6h
Hemodialysis**
2.25 q12h
2.25 q8h
CAPD
2.25 q12h
2.25 q8h
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysFor 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsPharmacy Bulk Package Bottles
Reconstituted stock solution must be transferred and further diluted for intravenous infusion.
The pharmacy bulk package bottle 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 package bottle 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 package bottle 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 for Pharmacy Bulk Bottles
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 alcoholReconstituted piperacillin and tazobactam for injection 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 for Pharmacy Bulk Package Bottles and Single Dose Vials
0.9% Sodium chloride for injection
Sterile water for injection‡
Dextran 6% in saline
Dextrose 5%LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from pharmacy bulk package bottles is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. The pharmacy bulk package bottle should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).
Pharmacy bulk package bottles 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). Pharmacy bulk package bottles 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from bulk package bottles can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.6 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, piperacillin and tazobactam is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides
Aminoglycoside
Piperacillin and Tazobactam
Dose
(grams)Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Rangea
(mg/mL)Acceptable Diluents
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
aThe concentration ranges in Table 2 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam 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.
-
Cardinal Health
Piperacillin And Tazobactam | Cardinal Health
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
The usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam).
Nosocomial Pneumonia
Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 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, piperacillin and tazobactam and the aminoglycoside are recommended for separate administration. Piperacillin and tazobactam 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, piperacillin and tazobactam is compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides under the following conditions:
TABLE 4
Aminoglycoside
Piperacillin
and Tazobactam Dose (grams)
Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Range* (mg/mL)
Acceptable Diluents
Amikacin
2.25, 3.375, 4.5
50, 100, 150
1.75 to 7.5
0.9%Sodium Chloride or 5% Dextrose
Gentamicin
2.25, 3.375, 4.5
100, 150
0.7 to 3.32
0.9% Sodium Chloride
*The concentration ranges in Table 4 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete dosage and administration instructions.
Piperacillin and tazobactam is not compatible with tobramycin for simultaneous co-administration via Y-site infusion. Compatibility of piperacillin and tazobactam with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam 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 piperacillin and tazobactam.
Renal Insufficiency
In patients with renal insufficiency (Creatinine Clearance ≤ 40 mL/min), the intravenous dose of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection for patients with renal insufficiency are as follows:
Recommended Dosing of Piperacillin and Tazobactam for injection 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
>40 mL/min
3.375 q 6 h
4.5 q 6 h
20 to 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
* 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 piperacillin and tazobactam for injection should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
Duration of Therapy
The usual duration of piperacillin and tazobactam for injection treatment is from seven to ten days. However, the recommended duration of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection in pediatric patients with impaired renal function.
Directions for Reconstitution and Dilution for Use
Intravenous Administration
For conventional vials, reconstitute piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection 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° to 25°C (68° to 77°F), or after 48 hours if stored at refrigerated temperature 2° to 8°C (36° 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 piperacillin and tazobactam for injection solution should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous diluent 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 Diluent Solutions
0.9% Sodium Chloride for Injection
Sterile Water for Injection‡
Dextrose 5%
Dextran 6% in Saline
LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of Sterile Water for Injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Piperacillin and tazobactam for injection can be used in ambulatory intravenous infusion pumps.
Stability of Piperacillin and Tazobactam for Injection Following Reconstitution
Piperacillin and tazobactam for injection is stable in glass and plastic containers (plastic syringes, IV 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° to 25°C (68° to 77°F), or after 48 hours if stored at refrigerated temperature 2° to 8°C (36° to 46°F). Vials should not be frozen after reconstitution.
Stability studies in the IV 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Stability of piperacillin and tazobactam for injection 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 (IV bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer’s instructions. Stability of piperacillin and tazobactam for injection 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.
Nosocomial Pneumonia
Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 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, piperacillin and tazobactam and the aminoglycoside are recommended for separate administration. Piperacillin and tazobactam 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, piperacillin and tazobactam is compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides under the following conditions:
TABLE 4
Aminoglycoside
Piperacillin
and Tazobactam Dose (grams)
Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Range* (mg/mL)
Acceptable Diluents
Amikacin
2.25, 3.375, 4.5
50, 100, 150
1.75 to 7.5
0.9%Sodium Chloride or 5% Dextrose
Gentamicin
2.25, 3.375, 4.5
100, 150
0.7 to 3.32
0.9% Sodium Chloride
*The concentration ranges in Table 4 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete dosage and administration instructions.
Piperacillin and tazobactam is not compatible with tobramycin for simultaneous co-administration via Y-site infusion. Compatibility of piperacillin and tazobactam with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam 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 piperacillin and tazobactam.
Renal Insufficiency
In patients with renal insufficiency (Creatinine Clearance ≤ 40 mL/min), the intravenous dose of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection for patients with renal insufficiency are as follows:
Recommended Dosing of Piperacillin and Tazobactam for injection 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
>40 mL/min
3.375 q 6 h
4.5 q 6 h
20 to 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
* 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 piperacillin and tazobactam for injection should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
Duration of Therapy
The usual duration of piperacillin and tazobactam for injection treatment is from seven to ten days. However, the recommended duration of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection in pediatric patients with impaired renal function.
Directions for Reconstitution and Dilution for Use
Intravenous Administration
For conventional vials, reconstitute piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection 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° to 25°C (68° to 77°F), or after 48 hours if stored at refrigerated temperature 2° to 8°C (36° 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 piperacillin and tazobactam for injection solution should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous diluent 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 Diluent Solutions
0.9% Sodium Chloride for Injection
Sterile Water for Injection‡
Dextrose 5%
Dextran 6% in Saline
LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of Sterile Water for Injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Piperacillin and tazobactam for injection can be used in ambulatory intravenous infusion pumps.
Stability of Piperacillin and Tazobactam for Injection Following Reconstitution
Piperacillin and tazobactam for injection is stable in glass and plastic containers (plastic syringes, IV 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° to 25°C (68° to 77°F), or after 48 hours if stored at refrigerated temperature 2° to 8°C (36° to 46°F). Vials should not be frozen after reconstitution.
Stability studies in the IV 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Stability of piperacillin and tazobactam for injection 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 (IV bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer’s instructions. Stability of piperacillin and tazobactam for injection 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.
-
Auromedics Pharma Llc
Piperacillin And Tazobactam | Auromedics Pharma Llc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
2.2 Nosocomial Pneumonia
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (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 (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days
>40 mL/min
3.375 q 6 h
4.5 q 6 h
20 to 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationSingle dose vials
2.7 Compatibility with Aminoglycosides
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 piperacillin and tazobactam for injection solutions for single dose vials 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 for Single Dose Vials
0.9% sodium chloride for injection
sterile water for injection‡
Dextran 6% in salineDextrose 5%
LACTATED RINGER'S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam Powder Formulation Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.Due to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam 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, piperacillin and tazobactam is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides Aminoglycoside Piperacillin and Tazobactam Dose (grams) Piperacillin and Tazobactam Diluent Volumea (mL) Aminoglycoside Concentration
Rangeb
(mg/mL) Acceptable Diluents a Diluent volumes apply only to single vials
b The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam 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 to 7.5
0.9% sodium chloride or 5% dextrose
Gentamicin
2.25
3.375
4.5
50,
100
150
0.7 to 3.32
0.9% sodium chloride or 5% dextrose
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam 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 piperacillin and tazobactam.
Piperacillin and tazobactam is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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. -
Hospira, Inc
Piperacillin And Tazobactam | Hospira, Inc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (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 (0.67 g piperacillin/0.08 g tazobactam) 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.
It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Directions for Reconstitution and Dilution for UseADD-Vantage® System Admixtures
Dextrose 5% in Water (50 or 100 mL)
0.9% Sodium Chloride (50 or 100 mL)
For ADD-Vantage® vials reconstitution directions see Instructions for Use of the ADD-Vantage® System
LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.
Stability studies with the admixed ADD-Vantage® system have demonstrated chemical stability (potency, pH of reconstituted solution and clarity of solution) for up to 24 hours at room temperature. (Note: The admixed ADD-Vantage® should not be refrigerated or frozen after reconstitution.). Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
2.6 Instructions for Use of the ADD-Vantage® SystemTo Open Diluent Container:
Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container (Use Aseptic Technique):
1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: A. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Do not access vial with syringe.
B. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
To Prepare Admixture:
1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 5. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 6. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 7. Mix container contents thoroughly and use within the specified time.
Preparation for Administration (Use Aseptic Technique):
1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides * The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
AminoglycosidePiperacillin and
Tazobactam for
Injection Dose
(grams)Piperacillin and
Tazobactam for
Injection Diluent
Volume (mL)Aminoglycoside
Concentration
Range*
(mg/mL)
Acceptable
DiluentsAmikacin
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
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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.
-
Hospira, Inc
Piperacillin And Tazobactam | Hospira, Inc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosais isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (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 (0.67 g piperacillin/0.08 g tazobactam) 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.
It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsSingle dose vials
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 piperacillin and tazobactam for injection solutions for single dose vials 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 for Single Dose Vials
0.9% sodium chloride for injection
sterile water for injection‡
Dextran 6% in saline
Dextrose 5%
LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single dose vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single dose vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides * Diluent volumes apply to single dose vials † The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
AminoglycosidePiperacillin and
Tazobactam for
Injection Dose
(grams)Piperacillin and
Tazobactam for
Injection Diluent
Volume* (mL)Aminoglycoside
Concentration
Range†
(mg/mL)
Acceptable
DiluentsAmikacin
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
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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.
-
Hospira, Inc
Piperacillin And Tazobactam | Hospira, Inc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (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 (0.67 g piperacillin/0.08 g tazobactam) 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.
It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Directions for Reconstitution and Dilution for UseADD-Vantage® System Admixtures
Dextrose 5% in Water (50 or 100 mL)
0.9% Sodium Chloride (50 or 100 mL)
For ADD-Vantage® vials reconstitution directions see Instructions for Use of the ADD-Vantage® System
LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.
Stability studies with the admixed ADD-Vantage® system have demonstrated chemical stability (potency, pH of reconstituted solution and clarity of solution) for up to 24 hours at room temperature. (Note: The admixed ADD-Vantage® should not be refrigerated or frozen after reconstitution.). Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
2.6 Instructions for Use of the ADD-Vantage® SystemTo Open Diluent Container:
Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container (Use Aseptic Technique):
1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows: A. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Do not access vial with syringe.
B. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
To Prepare Admixture:
1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 5. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 6. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 7. Mix container contents thoroughly and use within the specified time.
Preparation for Administration (Use Aseptic Technique):
1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides * The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
AminoglycosidePiperacillin and
Tazobactam for
Injection Dose
(grams)Piperacillin and
Tazobactam for
Injection Diluent
Volume (mL)Aminoglycoside
Concentration
Range*
(mg/mL)
Acceptable
DiluentsAmikacin
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
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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.
-
Hospira, Inc
Piperacillin And Tazobactam | Hospira, Inc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosais isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (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 (0.67 g piperacillin/0.08 g tazobactam) 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.
It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsSingle dose vials
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 piperacillin and tazobactam for injection solutions for single dose vials 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 for Single Dose Vials
0.9% sodium chloride for injection
sterile water for injection‡
Dextran 6% in saline
Dextrose 5%
LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single dose vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single dose vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides * Diluent volumes apply to single dose vials † The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
AminoglycosidePiperacillin and
Tazobactam for
Injection Dose
(grams)Piperacillin and
Tazobactam for
Injection Diluent
Volume* (mL)Aminoglycoside
Concentration
Range†
(mg/mL)
Acceptable
DiluentsAmikacin
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
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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.
-
Sandoz Inc
Piperacillin And Tazobactam | Sandoz Inc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosais isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (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 (0.67 g piperacillin/0.08 g tazobactam) 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.
It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsSingle dose vials
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 piperacillin and tazobactam for injection solutions for single dose vials 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 for Single Dose Vials
0.9% sodium chloride for injection
sterile water for injection‡
Dextran 6% in saline
Dextrose 5%
LACTATED RINGER’S SOLUTION IS NOT COMPATIBLE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single dose vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single dose vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides * Diluent volumes apply to single dose vials † The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
AminoglycosidePiperacillin and
Tazobactam for
Injection Dose
(grams)Piperacillin and
Tazobactam for
Injection Diluent
Volume* (mL)Aminoglycoside
Concentration
Range†
(mg/mL)
Acceptable
DiluentsAmikacin
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
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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.
-
Sandoz Inc
Piperacillin And Tazobactam | Sandoz Inc
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection 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). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)
Renal Function(creatinine clearance,
All Indications
Nosocomial
mL/min)
(except nosocomial pneumonia)
Pneumonia
>40 mL/min
3.375 q6h
4.5 q6h
20-40 mL/min*
2.25 q6h
3.375 q6h
<20 mL/min*
2.25 q8h
2.25 q6h
Hemodialysis**
2.25 q12h
2.25 q8h
CAPD
2.25 q12h
2.25 q8h
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysFor 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsSingle Dose Vials
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 alcoholReconstituted piperacillin and tazobactam for injection 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 for Pharmacy Bulk Package Bottles and Single Dose Vials
0.9% Sodium chloride for injection
Sterile water for injection‡
Dextran 6% in saline
Dextrose 5%LACTATED RINGER’S SOLUTION IS NOT COMPATIBILE WITH PIPERACILLIN AND TAZOBACTAM FOR INJECTION.
‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature 2°C to 8°C (36°F to 46°F).
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.6 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, Piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, piperacillin and tazobactam for injection is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides
Aminoglycoside
Piperacillin and Tazobactam
Dose
(grams)Piperacillin and Tazobactam Diluent Volume (mL)
Aminoglycoside Concentration Range a
(mg/mL)Acceptable Diluents
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
aThe concentration ranges in Table 2 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam for injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam 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.
-
Apotex Corporation
Piperacillin And Tazobactam | Apotex Corporation
Piperacillin and Tazobactam for Injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and Tazobactam for Injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam) * Creatinine clearance for patients not receiving hemodialysis
** 0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysRenal Function
(creatinine clearance,
mL/min)All Indications (except nosocomial
pneumonia)Nosocomial
Pneumonia>40 mL/min
3.375 q 6 h
4.5 q 6 h
20 to 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder Formulations Single dose vialsReconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials0.9% sodium chloride for injection
Sterile water for injection
Dextrose 5%
Bacteriostatic saline/parabens
Bacteriostatic water/parabens
Bacteriostatic saline/benzyl alcohol
Bacteriostatic water/benzyl alcoholReconstituted piperacillin and tazobactam for injection solution for single dose vials 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 for Single Dose Vials0.9% sodium chloride for injection
sterile water for injection‡
Dextran 6% in saline
Dextrose 5%
Lactated Ringer’s Solution is not compatible with piperacillin and tazobactam for injection‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and Tazobactam for Injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and Tazobactam for Injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and Tazobactam for Injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and Tazobactam for Injection reconstituted from single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).
Single dose 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. Piperacillin and Tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and Tazobactam for Injection reconstituted from single vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and Tazobactam for injection 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, piperacillin and tazobactam for injection is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides a Diluent volumes apply only to single vials
b The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.Aminoglycoside
Piperacillin and Tazobactam for Injection Dose (grams)
Piperacillin and Tazobactam for Injection Diluent Volumea(mL)
Aminoglycoside Concentration Rangeb
(mg/mL)Acceptable Diluents
Amikacin
2.25, 3.375, 4.5
50, 100, 150
1.75 to 7.5
0.9% sodium chloride or 5% dextrose
Gentamicin
2.25
3.375
4.5100
1500.7 to 3.32
0.9% sodium chloride
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and Tazobactam for Injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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.
-
Apotex Corporation
Piperacillin And Tazobactam | Apotex Corporation
Piperacillin and Tazobactam for Injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and Tazobactam for Injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam) * Creatinine clearance for patients not receiving hemodialysis
** 0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysRenal Function
(creatinine clearance,All Indications (except nosocomial
Nosocomial
mL/min)
pneumonia)
Pneumonia
>40 mL/min
3.375 q 6 h
4.5 q 6 h
20 to 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder Formulations Pharmacy bulk vialsReconstituted stock solution must be transferred and further diluted for intravenous 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 4 hours if stored at room temperature (20°C to 25°C [68°F to 77°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.
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
Compatible Reconstitution Diluents for Pharmacy Vials0.9% sodium chloride for injection
Sterile water for injection
Dextrose 5%
Bacteriostatic saline/parabens
Bacteriostatic water/parabens
Bacteriostatic saline/benzyl alcohol
Bacteriostatic water/benzyl alcoholReconstituted piperacillin and tazobactam for injection solution for bulk vials 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 for Pharmacy Vials0.9% sodium chloride for injection
sterile water for injection‡
Dextran 6% in saline
Dextrose 5%
Lactated Ringer’s Solution is not compatible with piperacillin and tazobactam for injection‡ Maximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and Tazobactam for Injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and Tazobactam for Injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and Tazobactam for Injection should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of Piperacillin and Tazobactam for Injection Powder Formulations Following Reconstitution
Piperacillin and Tazobactam for Injection reconstituted from bulk vials 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 4 hours at room temperature.
Pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 4 hours if stored at room temperature (20°C to 25°C [68°F to 77°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. Piperacillin and Tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and Tazobactam for Injection reconstituted from bulk vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and Tazobactam for injection 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, piperacillin and tazobactam for injection is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides a Diluent volumes apply only to bulk pharmacy containers
b The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam for injection has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.Aminoglycoside
Piperacillin and Tazobactam for Injection
Dose (grams)Piperacillin and Tazobactam for Injection Diluent Volumea(mL)
Aminoglycoside Concentration Rangeb
(mg/mL)Acceptable
DiluentsAmikacin
2.25, 3.375, 4.5
50, 100, 150
1.75 to 7.5
0.9% sodium chloride or 5% dextrose
Gentamicin
2.25
3.375
4.5100
1500.7 to 3.32
0.9% sodium chloride
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and Tazobactam for Injection is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection 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.
-
Agila Specialties Private Limited
Piperacillin And Tazobactam | Agila Specialties Private Limited
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.1 Adult PatientsThe usual total daily dose of piperacillin and tazobactam for injection for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin/1.5 g tazobactam). The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.
2.2 Nosocomial PneumoniaInitial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin/2 g tazobactam). The recommended duration of piperacillin and tazobactam for injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.
2.3 Renal ImpairmentIn patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of actual renal function impairment. The recommended daily doses of piperacillin and tazobactam for injection for patients with renal impairment are as follows:
Table 1: Recommended Dosing of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal-Impairment (As total grams piperacillin/tazobactam) * Creatinine clearance for patients not receiving hemodialysis † 0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days Renal Function
(creatinine clearance, mL/min)
All Indications
(except nosocomial pneumonia)
Nosocomial Pneumonia
>40 mL/min
3.375 q 6 h
4.5 q 6 h
20 to 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 piperacillin and tazobactam for injection (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of piperacillin and tazobactam for injection is necessary for CAPD patients.
2.4 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 piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.
It has not been determined how to adjust piperacillin and tazobactam for injection dosage in pediatric patients with renal impairment.
2.5 Reconstitution and Dilution of Powder FormulationsSingle dose vials
Reconstitute piperacillin and tazobactam for injection vials with a compatible reconstitution diluent from the list provided below.
2.25 g, 3.375 g, and 4.5 g piperacillin and tazobactam for injection should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.
Compatible Reconstitution Diluents for Single Dose Vials
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 piperacillin and tazobactam for injection solutions for single dose vials 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 for Single Dose Vials
0.9% sodium chloride for injection
sterile water for injectiona
Dextran 6% in saline
Dextrose 5%
Lactated Ringer's Solution is not compatible with Piperacillin and Tazobactam for Injection.
aMaximum recommended volume per dose of sterile water for injection is 50 mL.
Piperacillin and tazobactam for injection should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.
Piperacillin and tazobactam for injection is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.
Piperacillin and tazobactam for injection should not be added to blood products or albumin hydrolysates.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
Stability of piperacillin and tazobactam for injection Powder Formulations Following Reconstitution
Piperacillin and tazobactam for injection reconstituted from single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents.
Single dose 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. Piperacillin and tazobactam for injection contains no preservatives. Appropriate consideration of aseptic technique should be used.
Piperacillin and tazobactam for injection reconstituted from single vials can be used in ambulatory intravenous infusion pumps. Stability of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection is not affected when administered using an ambulatory intravenous infusion pump.
2.7 Compatibility with AminoglycosidesDue to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam for injection and aminoglycosides are recommended for separate administration. Piperacillin and tazobactam for injection 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, piperacillin and tazobactam is compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:
Table 2: Compatibility with Aminoglycosides * Diluent volumes apply only to single vials † The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10 to 15 mg/kg/day in two daily doses for amikacin and 3 to 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 piperacillin and tazobactam has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions. Aminoglycoside
Piperacillin and Tazobactam
Dose (grams)
Piperacillin and Tazobactam Diluent Volume* (mL)
Aminoglycoside Concentration Range†(mg/mL)
Acceptable Diluents
Amikacin
2.25, 3.375,
4.5
50, 100, 150
1.75 to 7.5
0.9% sodium chloride or 5% dextrose
Gentamicin
2.25
3.375
4.5
50,
100
150
0.7 to 3.32
0.9% sodium chloride or 5% dextrose
Only the concentration and diluents for amikacin or gentamicin with the dosages of piperacillin and tazobactam for injection 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 piperacillin and tazobactam for injection.
Piperacillin and tazobactam is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of piperacillin and tazobactam for injection with other aminoglycosides has not been established.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.
-
Mylan Institutional Llc
Piperacillin And Tazobactam | Paramesh Banerji Life Sciences Llc
Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician.
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