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Piperacillin Sodium and Tazobactam Sodium: Dosage and Administration

Reconstitution and Administration

Piperacillin sodium and tazobactam sodium is administered by IV infusion over 30 minutes.

IV Infusion

Vials of piperacillin sodium and tazobactam sodium labeled as containing 2 g of piperacillin and 0.25 g of tazobactam, 3 g of piperacillin and 0.375 g of tazobactam, or 4 g of piperacillin and 0.5 g of tazobactam should be reconstituted with 10, 15, or 20 mL, respectively, of compatible diluent and shaken thoroughly until the contents are dissolved. Diluents that can be used for reconstitution include 0.9% sodium chloride injection, sterile water for injection, 5% dextrose injection, and bacteriostatic water for injection or bacteriostatic sodium chloride injection (with parabens or benzyl alcohol).

Piperacillin Sodium

Lactated Ringer’s injection is incompatible with and should not be used to reconstitute piperacillin sodium and tazobactam sodium injection.Reconstituted single-dose vials of piperacillin sodium and tazobactam sodium injection should be used immediately after reconstitution and any unused injection should be discarded after 24 hours if stored at a room temperature of 20-25°C or after 48 hours if refrigerated at 2-8°C. Prior to administration, reconstituted piperacillin sodium and tazobactam sodium can be diluted further to the desired volume (usually 50-150 mL) with a compatible diluent. Diluents that are compatible with piperacillin sodium and tazobactam sodium include 0.9% sodium chloride injection, sterile water for injection (maximum recommended volume is 50 mL), 5% dextrose injection, and 6% dextran in 0.9% sodium chloride injection. Pharmacy bulk packages containing 36 g of piperacillin and 4.5 g of tazobactam are reconstituted by adding 152 mL of a compatible IV solution to the vial to provide a solution containing 200 mg/mL of piperacillin and 25 mg/mL of tazobactam.

Pharmacy bulk packages of the drug are not intended for direct IV infusion; prior to administration, solutions reconstituted in the pharmacy bulk package must be further diluted with a compatible IV solution.

The commercially available frozen injections of piperacillin sodium and tazobactam sodium should be stored at -20°C or lower. Frozen injections should be thawed at room temperature (20-25°C) or under refrigeration (2-8°C); frozen injections should not be thawed by immersion in water baths or by microwave irradiation. Once thawed, the solutions are stable for 24 hours at a room temperature of 20-25°C or 14 days when refrigerated at 2-8°C and should not be refrozen. ADD-Vantage® vials of piperacillin sodium and tazobactam sodium should be diluted according to the manufacturer’s labeling. In addition, when an ADD-Vantage® infusion is used, the accompanying labeling should be consulted for proper methods of administration and associated precautions.

When reconstituted as directed in 0.9% sodium chloride or 5% dextrose, piperacillin sodium and tazobactam sodium solutions prepared from Zosyn® ADD-Vantage® vials are stable for 24 hours at room temperature; these reconstituted solutions should not be refrigerated or frozen. Piperacillin sodium and tazobactam sodium should not be admixed with other drugs and should not be added to blood products or albumin hydrolysates. If an aminoglycoside is administered concomitantly with piperacillin sodium and tazobactam sodium (e.g., for the treatment of nosocomial pneumonia), the drugs should be administered separately.

Dosage

Dosage of piperacillin sodium and tazobactam sodium is expressed in terms of the total of the piperacillin and tazobactam content of the fixed combination (i.e., grams of Zosyn®). Potency of both piperacillin sodium and tazobactam sodium are expressed in terms of the bases of the drugs. Commercially available piperacillin sodium and tazobactam sodium contains an 8:1 ratio of piperacillin to tazobactam.

The dosage of piperacillin sodium and tazobactam sodium recommended by the manufacturer for adults and children 12 years of age or older is 3.375 g (3 g of piperacillin and 0.375 g of tazobactam) every 6 hours.

When used in conjunction with an aminoglycoside for the treatment of nosocomial pneumonia, the recommended dosage of piperacillin sodium and tazobactam sodium is 4.5 g (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours. Treatment with the aminoglycoside should be continued in patients in whom Ps. aeruginosa is isolated; however, if nosocomial pneumonia is not caused by Ps. aeruginosa, the aminoglycoside may be discontinued at the discretion of the clinician, taking into account severity of the infection and the patient’s clinical and bacteriologic progress. The usual duration of piperacillin sodium and tazobactam sodium therapy is 7-10 days; however, the recommended duration for the treatment of nosocomial pneumonia is 7-14 days. Duration should be based on the severity of the infection and the patient’s clinical and bacteriologic progress. For most acute infections, therapy should be continued for at least 48-72 hours after the patient becomes asymptomatic or evidence of eradication of the infection is obtained.

Dosage in Renal and Hepatic Impairment

In patients with creatinine clearances of 40 mL/minute or less, dosage of piperacillin sodium and tazobactam sodium should be decreased based on the degree of renal impairment. In patients with nosocomial pneumonia and renal impairment who are receiving concomitant aminoglycoside therapy, dosage of the aminoglycoside should be adjusted according to the recommendations for that drug.

The manufacturer recommends that adults and children 12 years of age or older with creatinine clearances of 20-40 mL/minute receive 2.25 g (2 g of piperacillin and 0.25 g of tazobactam) every 6 hours and that those with creatinine clearances less than 20 mL/minute receive 2.25 g (2 g of piperacillin and 0.25 g of tazobactam) every 8 hours. However, for nosocomial pneumonia, a dosage of 3.375 g (3 g of piperacillin and 0.375 g of tazobactam) every 6 hours should be used for patients with creatinine clearances of 20-40 mL/minute or a dosage of 2.25 g (2 g of piperacillin and 0.25 g of tazobactam) every 6 hours for those with clearances less than 20 mL/minute. Both piperacillin and tazobactam are removed by hemodialysis and, to a lesser extent, by peritoneal dialysis.

For patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), the manufacturer recommends a dosage of 2.25 g (2 g of piperacillin and 0.25 g of tazobactam) every 12 hours for most infections and a dosage of 2.25 g (2 g of piperacillin and 0.25 g of tazobactam) every 8 hours for those with nosocomial pneumonia. These are the maximum dosages recommended by the manufacturer for hemodialysis patients. However, because a 4-hour period of hemodialysis removes approximately 30-40% of a dose of piperacillin sodium and tazobactam sodium, a supplemental dose of 0.75 g (0.67 g of piperacillin and 0.08 g of tazobactam) should be given following each dialysis period.

Supplemental doses of the drug are not necessary in patients undergoing CAPD. Although serum half-lives of piperacillin and tazobactam are prolonged in patients with hepatic cirrhosis compared with healthy patients, this effect is not clinically important and does not necessitate a change in piperacillin sodium and tazobactam sodium dosage in patients with hepatic impairment.

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