Usual Adult Dose for Nosocomial Pneumonia

1.25 g IV every 6 hours for 4 to 14 days

Uses: For the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to susceptible Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, K oxytoca, K pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens

Usual Adult Dose for Pyelonephritis

1.25 g IV every 6 hours for 4 to 14 days

Comments:

• Approval of this indication based on limited clinical safety and efficacy data for this drug.

Use: In patients with limited or no alternative treatment options, for the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E cloacae, E coli, K aerogenes, K pneumoniae, and P aeruginosa

Usual Adult Dose for Urinary Tract Infection

1.25 g IV every 6 hours for 4 to 14 days

Comments:

• Approval of this indication based on limited clinical safety and efficacy data for this drug.

Use: In patients with limited or no alternative treatment options, for the treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible E cloacae, E coli, K aerogenes, K pneumoniae, and P aeruginosa

Usual Adult Dose for Intraabdominal Infection

1.25 g IV every 6 hours for 4 to 14 days

Comments:

• Approval of this indication based on limited clinical safety and efficacy data for this drug.

Use: In patients with limited or no alternative treatment options, for the treatment of complicated intraabdominal infections due to susceptible Bacteroides caccae, B fragilis, B ovatus, B stercoris, B thetaiotaomicron, B uniformis, B vulgatus, Citrobacter freundii, E cloacae, E coli, Fusobacterium nucleatum, K aerogenes, K oxytoca, K pneumoniae, Parabacteroides distasonis, and P aeruginosa

Renal Dose Adjustments

Estimated CrCl 60 to 89 mL/min: 1 g IV every 6 hours
Estimated CrCl 30 to 59 mL/min: 750 mg IV every 6 hours
Estimated CrCl 15 to 29 mL/min: 500 mg IV every 6 hours
Estimated CrCl less than 15 mL/min: Not recommended unless hemodialysis started within 48 hours.

Comments:

• CrCl should be monitored in patients with fluctuating renal function.
• CrCl calculated using Cockcroft-Gault formula.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
History of known severe hypersensitivity (severe systemic allergic reaction [e.g., anaphylaxis]) to an active component or any of the ingredients

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

Consult WARNINGS section for additional precautions.

Dialysis

ESRD on hemodialysis: 500 mg IV every 6 hours
Peritoneal dialysis: Data not available

Comments:

• Administration should be timed to follow hemodialysis.
• For patients maintained on hemodialysis, this drug should be administered after hemodialysis and at intervals timed from the end of that hemodialysis session.
• The active components are removed from circulation during hemodialysis.

Other Comments

1.25 g imipenem/cilastatin/relebactam contains 500 mg imipenem, 500 mg cilastatin, and 250 mg relebactam
1 g imipenem/cilastatin/relebactam contains 400 mg imipenem, 400 mg cilastatin, and 200 mg relebactam
750 mg imipenem/cilastatin/relebactam contains 300 mg imipenem, 300 mg cilastatin, and 150 mg relebactam
500 mg imipenem/cilastatin/relebactam contains 200 mg imipenem, 200 mg cilastatin, and 100 mg relebactam

Administration advice:

• Administer by IV infusion over 30 minutes.
• Do not coadminister this drug through the same IV line (or cannula) with drug products other than those listed below as compatible injectable drugs; consult the respective manufacturer product information of coadministered drug(s) to confirm compatibility of simultaneous coadministration.

Storage requirements:

• Before constitution: Store vials at 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (59F to 86F); keep vials in the carton.
• After constitution and further dilution in infusion bag: Solution maintains satisfactory potency for at least 2 hours at room temperature (up to 30C) or for at least 24 hours refrigerated at 2C to 8C (36F to 46F); do not freeze solution.

Reconstitution/preparation techniques:

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

IV compatibility:

• Compatible Diluents: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose Injection, USP plus 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP plus 0.45% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP plus 0.225% Sodium Chloride Injection, USP
• Compatible Injectable Drugs (for use with 5% Dextrose USP or 0.9% Sodium Chloride USP Injection as diluents): Dexmedetomidine, dopamine, epinephrine, fentanyl, heparin, midazolam, norepinephrine, phenylephrine
• No compatibility data are available for other drug products.
• Incompatible (physically): Propofol in 5% Dextrose, USP or 0.9% Sodium Chloride, USP

General:

• Duration of therapy should be guided by severity and location of infection and patient clinical response.
• 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 elderly patients

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Contact healthcare provider if severe watery or bloody diarrhea develops.