Each vial contains: Imipenem IP (sterile) equivalent to anhydrous Imipenem 500 mg, Cilastatin Sodium IP (sterile) equivalent to Cliastatin 500 mg, Sodium Bicarbonate IP (sterile) as a buffer.
Indicated for the treatment of serious lower respiratory/UTI, intra-abdominal, bone and joint infections, endocarditis and bacterial septicaemia.
Imipenem, is the parent compound produced by the filamentous bacterium Streptomyces cattleya. Imipenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). Cilastatin sodium is a competitive, reversible and specific inhibitor of dehydropeptidase-I, the renal enzyme which metabolizes and inactivates Imipenem. It is devoid of intrinsic antibacterial activity and does not affect the antibacterial activity of Imipenem.
Adults and adolescents: For patients with normal renal function (creatinine clearance of >70ml/min/1.73m2), the recommended dose regimens are:500 mg/500 mg every 6 hours OR 1000 mg/1000 mg every 8 hours OR every 6 hours.
Hypersensitivity to the active substances or to any of the excipients or to any other carbapenem antibacterial agent.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. Seizures and other CNS adverse reactions, such as confusional states and myoclonic activity. Increased Seizure Potential Due to Interaction with Valproic Acid. Clostridium difficile Associated Diarrhea. Hepatic function should be closely monitored during treatment with Imipenem/cilastatin due to the risk of hepatic toxicity.
Pregnancy Category C. Not known whether Imipenem-cilastatin sodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Imipenem is administered to a nursing woman. Imipenem is not recommended in paediatric patients with CNS infections because of the risk of seizures. Imipenem is not recommended in paediatric patients less than 30 kg with renal impairment, as no data are available.
Concomitant use of Imipenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered.Generalized seizures have been reported in patients who received ganciclovir. Do not co-administer unless benefit outweighs risk. Concomitant administration of Imipenem and probenecid results in increases in the plasma level and half-life of Imipenem. Concomitant administration is not recommended
The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to Micromax were nausea, diarrhoea, vomiting, rash, fever, hypotension, seizures, dizziness, pruritus, urticaria and somnolence.
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