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Cefiderocol Dosage

Applies to the following strengths: 1 g

Usual Adult Dose for Pyelonephritis

2 g IV every 8 hours
Duration of therapy: 7 to 14 days

Comments:
-Recommended for patients with CrCl 60 to 119 mL/min
-Approval based on limited clinical safety and efficacy data.
-Therapy duration should be guided by severity of infection and patient's clinical status for up to 14 days.

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
Duration of therapy: 7 to 14 days

Comments:
-Recommended for patients with CrCl 60 to 119 mL/min
-Approval based on limited clinical safety and efficacy data.
-Therapy duration should be guided by severity of infection and patient's clinical status for up to 14 days.

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

Renal Dose Adjustments

CrCl at least 120 mL/min: 2 g IV every 6 hours
CrCl 60 to 119 mL/min: 2 g IV every 8 hours
CrCl 30 to 59 mL/min: 1.5 g IV every 8 hours
CrCl 15 to 29 mL/min: 1 g IV every 8 hours
ESRD (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 fluctuation 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

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

Comments:
-This drug is removed by hemodialysis; hemodialysis should be completed at the latest possible time before starting dosing of this drug.

Other Comments

Administration advice:
-Administer via IV infusion over 3 hours.

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
-Diluted infusion solution (in the infusion bag): Stable for up to 4 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, antibiotics 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: Renal function in patients with CrCl less than 60 mL/min and patients with CrCl at least 120 mL/min (regularly); 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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