Piperacillin And Tazobactam
(Piperacillin Sodium And Tazobactam Sodium)Piperacillin And Tazobactam Prescribing Information
Warnings and Precautions, Rhabdomyolysis (
Rhabdomyolysis has been reported with the use of piperacillin and tazobactam for injection
Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of:
- Intra-abdominal infections in adult and pediatric patients 2 months of age and older ()
1.1 Intra-abdominal InfectionsPiperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of
Escherichia colior the following members of theBacteroides fragilisgroup:B. fragilis,B. ovatus,B. thetaiotaomicron, orB. vulgatus. - Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ()
1.2 Nosocomial PneumoniaPiperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of
Staphylococcus aureusand by piperacillin and tazobactam-susceptibleAcinetobacter baumannii,Haemophilus influenzae,Klebsiella pneumoniae, andPseudomonas aeruginosa(Nosocomial pneumonia caused byP. aeruginosashould be treated in combination with an aminoglycoside)[see Dosage and Administration (2)]. - Skin and skin structure infections in adults ()
1.3 Skin and Skin Structure InfectionsPiperacillin and tazobactam for injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of
Staphylococcus aureus. - Female pelvic infections in adults ()
1.4 Female Pelvic InfectionsPiperacillin and tazobactam for injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of
Escherichia coli. - Community-acquired pneumonia in adults ()
1.5 Community-acquired PneumoniaPiperacillin and tazobactam for injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of
Haemophilus influenzae.
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 or prevent infections that are proven or strongly suspected to be caused by bacteria. (
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 or prevent 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.
- Adult Patients With Indications Other Than Nosocomial Pneumonia;The usual daily dosage of piperacillin and tazobactam for injection, for intravenous use for adults is 3.375 g every six hours totaling 13.5 g (12 g piperacillin and 1.5 g tazobactam). ()
2.1 Dosage in Adult Patients with Indications Other Than Nosocomial PneumoniaThe usual total daily dosage of piperacillin and tazobactam for injection for adult patients with indications other than nosocomial pneumonia is 3.375 g every six hours [totaling 13.5 g (12 g piperacillin and 1.5 g tazobactam)], to be administered by intravenous infusion over 30 minutes. The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
- Adult Patients with Nosocomial Pneumonia:Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam for injection, for intravenous use at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18 g (16 g piperacillin and 2 g tazobactam). ()
2.2 Dosage in Adult Patients with Nosocomial PneumoniaInitial presumptive treatment of adult 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 and 2 g tazobactam)], administered by intravenous infusion over 30 minutes. 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. - Adult Patients with Renal Impairment:Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) and dialysis patients should be reduced, based on the degree of renal impairment. ()
2.3 Dosage in Adult Patients with Renal ImpairmentIn adult 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 based on the degree of renal impairment. The recommended daily dosage of piperacillin and tazobactam for injection for patients with renal impairment administered by intravenous infusion over 30 minutes is described in Table 1.
Table 1: Recommended Dosage of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin and tazobactam)# #Administer piperacillin and tazobactam for injection by intravenous infusion over 30 minutes.
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin and 0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysCreatinine clearance, mL/minAll Indications(except nosocomial pneumonia)NosocomialPneumoniaGreater than 40 mL/min 3.375 every 6 hours 4.5 every 6 hours 20 to 40 mL/min* 2.25 every 6 hours 3.375 every 6 hours Less than 20 mL/min* 2.25 every 8 hours 2.25 every 6 hours Hemodialysis** 2.25 every 12 hours 2.25 every 8 hours CAPD 2.25 every 12 hours 2.25 every 8 hours For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g piperacillin and tazobactam for injection (0.67 g piperacillin and 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.
- Pediatric Patients by Indication and Age:See Table below ()
2.4 Dosage in Pediatric Patients with Appendicitis/Peritonitis or Nosocomial PneumoniaThe recommended dosage for pediatric patients with appendicitis and/or peritonitis or nosocomial pneumonia aged 2 months of age and older, weighing up to 40 kg, and with normal renal function, is described in Table 2
[see Use in Specific Populations (8.4)andClinical Pharmacology (12.3)].Table 2: Recommended Dosage of Piperacillin and Tazobactam for Injection in Pediatric Patients 2 Months of Age and Older, Weighing Up to 40 kg, and With Normal Renal Function# #Administer piperacillin and tazobactam for injection by intravenous infusion over 30 minutes AgeAppendicitis and/or PeritonitisNosocomial Pneumonia2 months to 9 months 90 mg/kg
(80 mg piperacillin and 10 mg tazobactam)every 8 (eight) hours90 mg/kg
(80 mg piperacillin and 10 mg tazobactam)every 6 (six) hoursOlder than 9 months of age 112.5 mg/kg
(100 mg piperacillin and 12.5 mg tazobactam)every 8 (eight) hours112.5 mg/kg
(100 mg piperacillin and 12.5 mg tazobactam)every 6 (six) hoursPediatric patients weighing over 40 kg and with normal renal function should receive the adult dose
[see Dosage and Administration (2.1, 2.2)].Dosage of piperacillin and tazobactam for injection in pediatric patients with renal impairment has not been determined.
Recommended Dosage of piperacillin and tazobactam for injection, for intravenous use for Pediatric Patients 2 months of Age and Older, Weighing up to 40 Kg and With Normal Renal Function | ||
Age | Appendicitis and /or Peritonitis | Nosocomial Pneumonia |
2 months to 9 months | 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 8 ( hourseight ) | 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 6 ( hourssix ) |
Older than 9 months | 112.5 mg/kg (100 mg piperacillin and 12.5 mg tazobactam) every 8 ( eight) hours | 112.5 mg/kg (100 mg piperacillin and 12.5 mg tazobactam) every 6 ( six) hours |
- Administer piperacillin and tazobactam for injection by intravenous infusion over 30 minutes to both adult and pediatric patients. (,
2.1 Dosage in Adult Patients with Indications Other Than Nosocomial PneumoniaThe usual total daily dosage of piperacillin and tazobactam for injection for adult patients with indications other than nosocomial pneumonia is 3.375 g every six hours [totaling 13.5 g (12 g piperacillin and 1.5 g tazobactam)], to be administered by intravenous infusion over 30 minutes. The usual duration of piperacillin and tazobactam for injection treatment is from 7 to 10 days.
,2.2 Dosage in Adult Patients with Nosocomial PneumoniaInitial presumptive treatment of adult 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 and 2 g tazobactam)], administered by intravenous infusion over 30 minutes. 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 Dosage in Adult Patients with Renal ImpairmentIn adult 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 based on the degree of renal impairment. The recommended daily dosage of piperacillin and tazobactam for injection for patients with renal impairment administered by intravenous infusion over 30 minutes is described in Table 1.
Table 1: Recommended Dosage of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin and tazobactam)# #Administer piperacillin and tazobactam for injection by intravenous infusion over 30 minutes.
*Creatinine clearance for patients not receiving hemodialysis
**0.75 g (0.67 g piperacillin and 0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis daysCreatinine clearance, mL/minAll Indications(except nosocomial pneumonia)NosocomialPneumoniaGreater than 40 mL/min 3.375 every 6 hours 4.5 every 6 hours 20 to 40 mL/min* 2.25 every 6 hours 3.375 every 6 hours Less than 20 mL/min* 2.25 every 8 hours 2.25 every 6 hours Hemodialysis** 2.25 every 12 hours 2.25 every 8 hours CAPD 2.25 every 12 hours 2.25 every 8 hours For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g piperacillin and tazobactam for injection (0.67 g piperacillin and 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 Dosage in Pediatric Patients with Appendicitis/Peritonitis or Nosocomial PneumoniaThe recommended dosage for pediatric patients with appendicitis and/or peritonitis or nosocomial pneumonia aged 2 months of age and older, weighing up to 40 kg, and with normal renal function, is described in Table 2
[see Use in Specific Populations (8.4)andClinical Pharmacology (12.3)].Table 2: Recommended Dosage of Piperacillin and Tazobactam for Injection in Pediatric Patients 2 Months of Age and Older, Weighing Up to 40 kg, and With Normal Renal Function# #Administer piperacillin and tazobactam for injection by intravenous infusion over 30 minutes AgeAppendicitis and/or PeritonitisNosocomial Pneumonia2 months to 9 months 90 mg/kg
(80 mg piperacillin and 10 mg tazobactam)every 8 (eight) hours90 mg/kg
(80 mg piperacillin and 10 mg tazobactam)every 6 (six) hoursOlder than 9 months of age 112.5 mg/kg
(100 mg piperacillin and 12.5 mg tazobactam)every 8 (eight) hours112.5 mg/kg
(100 mg piperacillin and 12.5 mg tazobactam)every 6 (six) hoursPediatric patients weighing over 40 kg and with normal renal function should receive the adult dose
[see Dosage and Administration (2.1, 2.2)].Dosage of piperacillin and tazobactam for injection in pediatric patients with renal impairment has not been determined.
- Piperacillin and tazobactam for injection and aminoglycosides should be reconstituted, diluted, and administered separately. Co-administration via Y-site can be done under certain conditions. ()
2.6 Compatibility with AminoglycosidesDue to the
in vitroinactivation 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[seeDrug Interactions (7.1)].
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 5: Compatibility with Aminoglycosides Aminoglycoside Piperacillin and Tazobactam Dose (grams) Piperacillin and Tazobactam Diluent Volumea(mL) Aminoglycoside Concentration
Rangeb
(mg/mL)Acceptable Diluents aDiluent volumes apply only to single-dose vials
bThe concentration ranges in Table 5 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.
Amikacin2.25
3.375
4.550
100
1501.75 to 7.5 0.9% sodium chloride or 5% dextrose
Gentamicin2.25
3.375
4.550
100
1500.7 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 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.
Piperacillin and tazobactam is not compatible with tobramycin for simultaneous co-administration 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. - See the full prescribing information for the preparation and administration instructions for piperacillin and tazobactam for injection single-dose vials.
Piperacillin and Tazobactam for Injection, USP is supplied as a white to off-white sterile, cryodesiccated powder in vials:
- 2.25 g single-dose vial (piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam).
- 3.375 g single-dose vial (piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam).
- 4.5 g single-dose vial (piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam).
Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) should be reduced based on the degree of renal impairment. (
In adult 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 based on the degree of renal impairment. The recommended daily dosage of piperacillin and tazobactam for injection for patients with renal impairment administered by intravenous infusion over 30 minutes is described in Table 1.
| #Administer piperacillin and tazobactam for injection by intravenous infusion over 30 minutes. *Creatinine clearance for patients not receiving hemodialysis **0.75 g (0.67 g piperacillin and 0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days | |||||||||||||||||
Creatinine clearance, mL/min | All Indications (except nosocomial pneumonia) | Nosocomial Pneumonia | |||||||||||||||
| Greater than 40 mL/min | 3.375 every 6 hours | 4.5 every 6 hours | |||||||||||||||
| 20 to 40 mL/min* | 2.25 every 6 hours | 3.375 every 6 hours | |||||||||||||||
| Less than 20 mL/min* | 2.25 every 8 hours | 2.25 every 6 hours | |||||||||||||||
| Hemodialysis** | 2.25 every 12 hours | 2.25 every 8 hours | |||||||||||||||
| CAPD | 2.25 every 12 hours | 2.25 every 8 hours | |||||||||||||||
For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g piperacillin and tazobactam for injection (0.67 g piperacillin and 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.
In patients with 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 renal function impairment
Piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.