Piperacillin and Tazobactam

PIPERACILLIN AND TAZOBACTAM — piperacillin sodium and tazobactam sodium injection, powder, lyophilized, for solution
Wockhardt USA LLC.

1 INDICATIONS AND USAGE

1.1 Intra-abdominal Infections

Piperacillin and tazobactam for injection, USP 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 coli or the following members of the Bacteroides fragilis group: B. fragilis , B. ovatus , B. thetaiotaomicron , or B. vulgatus.

1.2 Nosocomial Pneumonia

Piperacillin and tazobactam for injection, USP 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 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)].

1.3 Skin and Skin Structure Infections

Piperacillin and tazobactam for injection, USP 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.

1.4 Female Pelvic Infections

Piperacillin and tazobactam for injection, USP is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of Escherichia coli.

1.5 Community-acquired Pneumonia

Piperacillin and tazobactam for injection, USP is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of Haemophilus influenzae.

1.6 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and tazobactam for injection, USP and other antibacterial drugs, Piperacillin and tazobactam for injection, USP 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients With Indications Other Than Nosocomial Pneumonia

The 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/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 Pneumonia

Initial 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/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. aeruginosa is isolated.

2.3 Dosage in Adult Patients With 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/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days

Table 1: Recommended Dosage of Piperacillin and Tazobactam for Injection in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin/tazobactam)#
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/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 Pneumonia

The 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) and Clinical Pharmacology (12.3)].

# Administer piperacillin and tazobactam for injection by intravenous infusion over 30 minutes

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#
Age Appendicitis and/or Peritonitis Nosocomial Pneumonia
2 months to 9 months 90 mg/kg (80 mg piperacillin/10 mg tazobactam) every 8 (eight) hours 90 mg/kg (80 mg piperacillin/10 mg tazobactam) every 6 (six) hours
Older than 9 months of age 112.5 mg/kg (100 mg piperacillin/12.5 mg tazobactam) every 8 (eight) hours 112.5 mg/kg (100 mg piperacillin/12.5 mg tazobactam) every 6 (six) hours

Pediatric 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.

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