Usual Adult Dose for Pyelonephritis

4 g IV every 8 hours
Duration of therapy: Up to 14 days

Use: For the treatment of patients with complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex

Usual Adult Dose for Urinary Tract Infection

4 g IV every 8 hours
Duration of therapy: Up to 14 days

Use: For the treatment of patients with complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex

Renal Dose Adjustments

Estimated glomerular filtration rate (GFR) at least 50 mL/min/1.73 m2: No adjustment recommended.
Estimated GFR 30 to 49 mL/min/1.73 m2: 2 g IV every 8 hours
Estimated GFR 15 to 29 mL/min/1.73 m2: 2 g IV every 12 hours
Estimated GFR less than 15 mL/min/1.73 m2: 1 g IV every 12 hours

Comments:

• Estimated GFR (eGFR) based on the Modification of Diet in Renal Disease equation.
• Serum creatinine levels and eGFR should be monitored at least daily in patients with changing renal function; the dose of this drug should be adjusted accordingly.
• Total duration of therapy is for up to 14 days.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to either active component, any of the ingredients, or other drugs in the same class
• Demonstrated anaphylactic reactions to beta-lactam antibacterial agents

Dialysis

Hemodialysis: Dose (adjusted for eGFR) should be administered after a hemodialysis session.
Peritoneal dialysis: Data not available

Other Comments

4 g meropenem-vaborbactam contains 2 g meropenem and 2 g vaborbactam
2 g meropenem-vaborbactam contains 1 g meropenem and 1 g vaborbactam
1 g meropenem-vaborbactam contains 0.5 g meropenem and 0.5 g vaborbactam

Administration advice:

• Administer all doses by IV infusion over 3 hours.
• Must complete IV infusion of the diluted solution within 4 hours if stored at room temperature or 22 hours if stored refrigerated.

• Powder (prior to constitution): Store vials at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Diluted solution: May store at room temperature or refrigerated at 2C to 8C (36F to 46F); IV infusion must be completed within 4 or 22 hours, respectively.

• Constitute vial(s) with 0.9% Sodium Chloride Injection, USP; mix gently to dissolve.
• The constituted solution must be diluted further (immediately) in a 0.9% Sodium Chloride Injection, USP infusion bag prior to IV infusion.
• The manufacturer product information should be consulted.

• Only compatible with 0.9% Sodium Chloride Injection, USP
• Compatibility with other drugs not established.

• 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.
• Final infusion concentration (after dilution): 4 to 16 mg/mL; the manufacturer product information should be consulted.

• Renal: Renal function in elderly patients; serum creatinine levels and eGFR in patients with changing renal function (at least daily)

• Avoid missing doses and complete the entire course of therapy.
• Do not operate machinery or motorized vehicles until it is reasonably well established that this drug is well tolerated.
• Consult physician at once if watery and bloody stools (with or without stomach cramps and fever) develop.