Skip to main content

IMIPENEM / CILASTATIN RAN (Sun Pharma ANZ Pty Ltd)

Product name
IMIPENEM / CILASTATIN RAN
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
cilastatin sodium, imipenem monohydrate
Registration type
New generic medicine
Indication

[TRADE NAME] is indicated for the treatment of serious infections caused by susceptible strains of micro-organisms in the diseases listed below:

  1. Lower respiratory tract infections.
  2. Intra-abdominal infections.
  3. Gynaecological infections.
  4. Bacterial septicaemia.
  5. Bone and joint infections.
  6. Skin and skin structure infections.
  7. Endocarditis.
  8. Polymicrobial infections. [TRADE NAME] is indicated for polymicrobial infections including those in which S. pneumoniae (pneumonia, septicaemia), Group A betahaemolytic streptococcus (skin and skin structure), or non-penicillinase-producing S. aureus is one of the causative organisms. However, monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G. Efficacy against polymicrobial infection in the immunocompromised host has not yet been established. Although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections caused by Pseudomonas aeruginosa, bacterial eradication may not necessarily be achieved. As with other beta-lactam antibiotics, strains of Pseudomonas aeruginosa may develop resistance rapidly on treatment with [TRADE NAME]. When clinically appropriate during therapy of Pseudomonas aeruginosa infections, periodic susceptibility testing should be done. Infections resistant to other antibiotics, for example, cephalosporins, penicillin, and aminoglycosides, may respond to treatment with [TRADE NAME]. [TRADE NAME] is not indicated for the treatment of meningitis.