Piperacillin

Piperacillin Manufacturers

• Sagent Pharmaceuticals
  

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  Piperacillin | Sagent Pharmaceuticals

  

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  Piperacillin and tazobactam for injection should be administered by intravenous infusion over 30 minutes.

  2.1 Adult Patients

  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). 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 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). 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 Impairment

  In 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 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 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 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 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 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° 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 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 Aminoglycosides

  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

  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.

  Aminoglycoside Piperacillin and Tazobactam Dose
  (grams) Piperacillin and Tazobactam 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
  4.5 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.

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