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.

See also:

Further information

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

Medical Disclaimer