Vabomere(meropenem and vaborbactam)
VABOMERE™ (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
VABOMERE :4 g (2g meropenem and 2g vaborbactam)
NDC NO. NDC 65293-009-06
VABOMERE Rx
Generic Name and Formulations:
Meropenem, vaborbactam 2g/vial (containing meropenem 1g + vaborbactam 1g); pwd for IV infusion after reconstitution and dilution; sodium content 10.9mEq/vial; preservative-free.
Company:
The Medicines Company
Monograph added. Indications for VABOMERE:
Susceptible complicated urinary tract infections (cUTI) including pyelonephritis.
Adult:
Give by IV infusion over 3hrs. ≥18yrs (eGFR ≥50mL/min/1.73m2): 4g every 8hrs. Renal impairment (eGFR 30–49mL/min/1.73m2): 2g every 8hrs; (eGFR 15–29mL/min/1.73m2): 2g every 12hrs; (eGFR <15mL/min/1.73m2): 1g every 12hrs. Give after hemodialysis session. All: treat for up to 14 days.
Children:
<18yrs: not established.
Warnings/Precautions:
Previous hypersensitivity to penicillins, cephalosporins, other beta-lactams, or other allergens. Discontinue immediately if allergic reaction occurs. CNS disorders (eg, brain lesions, history of seizures). Bacterial meningitis. Renal impairment (thrombocytopenia possible). Reeva luate dose if focal tremors, myoclonus, or seizures occur. Discontinue if C. difficile-associated diarrhea suspected or confirmed. Pregnancy. Nursing mothers.
Interactions:
Concomitant valproic acid or divalproex sodium: not recommended; if use necessary, consider supplemental anticonvulsant. Potentiated by probenecid: not recommended.
Pharmacological Class:
Carbapenem + beta-lactamase inhibitor.
Adverse Reactions:
Headache, phlebitis/infusion site reactions, diarrhea; serious hypersensitivity reactions, C. difficile-associated diarrhea, possible neuromotor impairment (eg, seizures, delirium, paresthesias), superinfection.
Generic Availability:
NO
How Supplied:
Single-dose vials—6 |
