U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. Imipenem-cilastatin-relebactam Injection
  1. Development Resources

Imipenem-cilastatin-relebactam Injection

FDA Identified Breakpoints

 

Minimum Inhibitory
Concentrations
(mcg/mL)

Disk Diffusion a
(zone diameter in mm)

Pathogen

S

I

R

S

I

R

Enterobacteriaceae b

M-100 standard is recognized

Pseudomonas aeruginosa

M-100 standard is recognized

Acinetobacter calcoaceticus-baumannii complex

≤2/4

4/4

≥8/4

-

-

-

Haemophilus influenzae

≤4/4

-

-

-

-

-

Anaerobes c,d

M-100 standard is recognized

-

-

-

S = Susceptible; I = Intermediate; R = Resistant

a For disk diffusion, use paper disks impregnated with imipenem/relebactam at a concentration of 10/25 mcg.
b Clinical efficacy was shown for Klebsiella aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Klebsiella oxytoca.
c Clinical efficacy was shown for Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Fusobacterium nucleatum, Parabacteroides distasonis.
d Agar dilution method.

Back to Top