Durlobactam / Sulbactam Dosage

Medically reviewed by Drugs.com. Last updated on Dec 21, 2023.

Usual Adult Dose for Nosocomial Pneumonia

Durlobactam 1 g and sulbactam 1 g IV every 6 hours
Duration of therapy: 7 to 14 days

Comments:

• Limitations of Use: This drug is not indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
• This dosage is recommended for patients with CrCl 45 to 129 mL/min.
• The duration of therapy should be guided by the patient's clinical status.

Uses: For the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of A baumannii-calcoaceticus complex

Renal Dose Adjustments

Estimated CrCl at least 130 mL/min: Durlobactam 1 g and sulbactam 1 g IV every 4 hours
Estimated CrCl 45 to 129 mL/min: Durlobactam 1 g and sulbactam 1 g IV every 6 hours
Estimated CrCl 30 to 44 mL/min: Durlobactam 1 g and sulbactam 1 g IV every 8 hours
Estimated CrCl 15 to 29 mL/min: Durlobactam 1 g and sulbactam 1 g IV every 12 hours
Estimated CrCl less than 15 mL/min:

• For patients starting this drug: Durlobactam 1 g and sulbactam 1 g IV every 12 hours for the first 3 doses (0, 12, and 24 hours), followed by durlobactam 1 g and sulbactam 1 g IV every 24 hours after the third dose
• For patients whose CrCl declines below 15 mL/min while receiving this drug: Durlobactam 1 g and sulbactam 1 g IV every 24 hours

Comments:

• CrCl estimated by Cockcroft-Gault equation
• CrCl at least 130 mL/min may be seen in seriously ill patients receiving IV fluid resuscitation.
• Because renal function may change during the course of therapy, renal function should be monitored regularly and the dosage should be adjusted accordingly.

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended

Precautions

CONTRAINDICATIONS:

• History of known severe hypersensitivity to either active component 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, receiving intermittent hemodialysis (HD):

• For patients starting this drug: Durlobactam 1 g and sulbactam 1 g IV every 12 hours for the first 3 doses (0, 12, and 24 hours), followed by durlobactam 1 g and sulbactam 1 g IV every 24 hours after the third dose
• For patients whose CrCl declines below 15 mL/min while receiving this drug: Durlobactam 1 g and sulbactam 1 g IV every 24 hours

Comments:

• In patients requiring HD, HD should be completed at the latest possible time before the start of dosing; the dose should be administered immediately after the dialysis session has ended.
• Limited information is available to provide dosage recommendation for patients receiving continuous renal replacement therapy (CRRT) and therapy should be guided by the patient's clinical status; while on CRRT, a patient's residual renal function may change, which may warrant a change in dosage.
• Because renal function may change during the course of therapy, renal function should be monitored regularly and the dosage should be adjusted accordingly.

Other Comments

Administration advice:

• Administer all doses by IV infusion over 3 hours.
• The time between starting the reconstitution of the powders and the conclusion of the infusion should not exceed 24 hours.

Storage requirements:

• Do not freeze.
• Store vials in the refrigerator at 2C to 8C (36F to 46F); brief exposure to 8C to 15C (46F to 59F) permitted.
• Store prepared solution in the refrigerator at 2C to 8C (36F to 46F) until administration.
• The prepared solution should be brought to ambient room temperature (over 15 to 30 minutes) before infusion.

Reconstitution/preparation techniques:

• The powders must be reconstituted and further diluted before IV infusion; dilution must occur within 1 hour of reconstitution.
• Once reconstituted, both components should be added to a 100 mL infusion bag of 0.9% Sodium Chloride for Injection, USP.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP
• The compatibility of this drug for administration with solutions containing other drugs or other diluents has not been established; this drug should not be mixed with other drugs or physically added to solutions containing other drugs.

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/renal function (regularly)

Patient advice:

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

Further information

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

Medical Disclaimer