Usual Adult Dose for Pyelonephritis

2 g IV every 8 hours for 7 to 14 days

Comments:

• Recommended for patients with CrCl 60 to 119 mL/min

Use: In patients with limited/no alternative treatment options, for the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex

Usual Adult Dose for Urinary Tract Infection

2 g IV every 8 hours for 7 to 14 days

Comments:

• Recommended for patients with CrCl 60 to 119 mL/min

Use: In patients with limited/no alternative treatment options, for the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex

Usual Adult Dose for Nosocomial Pneumonia

2 g IV every 8 hours for 7 to 14 days

Comments:

• Recommended for patients with CrCl 60 to 119 mL/min

Uses: For the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to susceptible Acinetobacter baumannii complex, E coli, E cloacae complex, K pneumoniae, P aeruginosa, and Serratia marcescens

Renal Dose Adjustments

CrCl at least 120 mL/min: 2 g IV every 6 hours

Estimated CrCl 30 to 59 mL/min: 1.5 g IV every 8 hours
Estimated CrCl 15 to 29 mL/min: 1 g IV every 8 hours
Estimated CrCl less than 15 mL/min without intermittent hemodialysis: 0.75 g IV every 12 hours

Comments:

• CrCl estimated by Cockcroft-Gault equation.
• In patients with fluctuating renal function, CrCl should be monitored and dose should be adjusted accordingly.

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended.

Precautions

CONTRAINDICATIONS:
Known history of severe hypersensitivity to the active component, any of the ingredients, or other beta-lactam antibacterial drugs

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Estimated CrCl less than 15 mL/min with intermittent hemodialysis: 0.75 g IV every 12 hours

Continuous renal replacement therapy (CRRT):

• Effluent flow rate up to 2 L/hour: 1.5 g IV every 12 hours
• Effluent flow rate 2.1 to 3 L/hour: 2 g IV every 12 hours
• Effluent flow rate 3.1 to 4 L/hour: 1.5 g IV every 8 hours
• Effluent flow rate at least 4.1 L/hour: 2 g IV every 8 hours

Comments:

• This drug is removed by hemodialysis; for patients receiving intermittent hemodialysis, this drug should be administered immediately after completion of hemodialysis.
• For patients receiving CRRT (including continuous venovenous hemofiltration [CVVH], continuous venovenous hemodialysis [CVVHD], and continuous venovenous hemodiafiltration [CVVHDF]), dose should be based on effluent flow rate in CRRT.
• The above recommendations are intended to provide initial dosing in patients receiving CRRT; dosing regimens may need to be altered based on residual renal function and patient's clinical status.
• Effluent flow rate is ultrafiltrate flow rate for CVVH, dialysis flow rate for CVVHD, and ultrafiltrate flow rate plus dialysis flow rate for CVVHDF.

Other Comments

Administration advice:

• Administer via IV infusion over 3 hours.
• Duration of therapy should be guided by patient's clinical status.

Storage requirements:

• Unreconstituted vials: Store refrigerated at 2C to 8C (36F to 46F); protect from light; store in carton until time of use.
• Reconstituted solution (in the vial): Should be immediately transferred and diluted into infusion bag; can be stored up to 1 hour at room temperature in the vial
• Diluted infusion solution (in the infusion bag): Stable for up to 6 hours at room temperature; may refrigerate at 2C to 8C (36F to 46F) for up to 24 hours, protected from light, and then complete the infusion within 6 hours at room temperature

Reconstitution/preparation techniques:

• This drug must be reconstituted and then diluted before IV infusion.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP
• Compatibility for administration with solutions containing other drugs or other diluents not established.

General:

• To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

Monitoring:

• Renal: CrCl in patients with fluctuating renal function; renal function in patients with CrCl less than 60 mL/min, receiving intermittent hemodialysis, receiving CRRT, and with CrCl at least 120 mL/min (regularly during therapy); renal function in elderly patients

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Serious allergic reaction require immediate treatment.
• Contact healthcare provider if severe watery or bloody diarrhea occurs.