Product image of Imipenem/Cilastatin Fresenius Kabi (Cilastatin Sodium, Imipenem Monohydrate) supplied by GNH India

Imipenem/Cilastatin Fresenius Kabi

Active Ingredient:
Cilastatin Sodium, Imipenem Monohydrate
Origin:
EU

Imipenem/Cilastatin Fresenius Kabi (Cilastatin Sodium, Imipenem Monohydrate)

Imipenem/Cilastatin, the active ingredient in Imipenem/Cilastatin Fresenius Kabi, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats severe bacterial infections such as complicated intra‑abdominal, urinary tract, and lower respiratory infections in hospitalized patients.

GNH India supplies Imipenem/Cilastatin Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Fresenius Kabi Limited

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Indications & Clinical Uses

Imipenem/Cilastatin is a broad‑spectrum carbapenem used for serious bacterial infections affecting various organ systems.

  • Complicated intra‑abdominal infections: provides bacterial eradication in patients with severe abdominal sepsis.
  • Complicated urinary tract infections: eliminates resistant uropathogens in hospitalized individuals.
  • Lower respiratory tract infections (pneumonia): treats severe community‑acquired or hospital‑acquired pneumonia.
  • Skin and soft tissue infections: resolves deep or necrotizing infections caused by Gram‑negative and Gram‑positive organisms.
  • Febrile neutropenia: offers empiric coverage for high‑risk neutropenic patients with fever.

How It Works

  • Imipenem binds to penicillin‑binding proteins, inhibiting the synthesis of bacterial cell wall peptidoglycan and leading to cell lysis. Cilastatin, co‑administered, blocks renal dehydropeptidase I, preventing enzymatic degradation of imipenem and thereby maintaining therapeutic concentrations in the urine and plasma.

Side Effects

Adverse reactions may occur with any antimicrobial therapy and should be monitored.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: may be watery and self‑limiting.
  • Rash: erythematous skin eruption.
  • Headache: transient and usually resolves.
  • Elevated liver enzymes: mild transaminase increase.
  • Injection site pain: discomfort at the infusion site.

Serious or Rare Side Effects

  • Seizures: especially in patients with renal impairment or CNS disorders.
  • Anaphylaxis: acute hypersensitivity reaction requiring immediate treatment.
  • Clostridioides difficile infection: severe colitis risk.
  • Stevens‑Johnson syndrome/toxic epidermal necrolysis: rare severe skin reactions.
  • Severe neutropenia or thrombocytopenia: hematologic suppression.
  • Acute renal failure: worsening kidney function in susceptible individuals.

Precautions & Warnings

Careful assessment and monitoring are required before and during therapy.

  • Renal function: adjust dosage in patients with impaired kidney function.
  • Allergy: avoid in individuals with known hypersensitivity to carbapenems or β‑lactam antibiotics.
  • Seizure risk: monitor patients with a history of epilepsy or CNS disorders.
  • Pregnancy and lactation: use only if the potential benefit justifies the potential risk to the fetus or infant.
  • Concomitant nephrotoxic drugs: increase monitoring of renal parameters.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Imipenem/Cilastatin may interact with several medicines; some require avoidance while others need close monitoring.

Major Interactions (Avoid)

  • Valproic acid: may reduce serum valproate levels, risking loss of seizure control.
  • Cisplatin: combined use can increase nephrotoxicity.
  • Other carbapenems: additive toxicity and overlapping spectrum.

Moderate Interactions (Monitor Closely)

  • Probenecid: can raise imipenem concentrations, requiring dose adjustment.
  • Loop diuretics: may potentiate renal adverse effects.
  • Warfarin: may alter INR, necessitating coagulation monitoring.

Frequently Asked Questions

Imipenem/Cilastatin is indicated for severe bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, hospital‑acquired or community‑acquired pneumonia, skin and soft tissue infections, and febrile neutropenia in hospitalized patients.

The drug combines imipenem, which binds to penicillin‑binding proteins and blocks bacterial cell‑wall synthesis, with cilastatin, which inhibits renal dehydropeptidase I, preventing the breakdown of imipenem and maintaining effective drug levels in the body.

The prescribed dose and dosing interval are determined by the treating physician based on the type and severity of infection, patient weight, renal function, and other clinical factors. Exact regimens should not be inferred without a medical order.

Safety data are limited; the drug should be used during pregnancy or lactation only if the potential therapeutic benefit justifies any potential risk to the fetus or infant. Clinicians must evaluate each case individually.

Submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.

Imipenem/Cilastatin offers a broad spectrum of activity similar to other carbapenems but includes cilastatin to protect the drug from renal degradation, resulting in higher urinary concentrations. Choice among carbapenems depends on local resistance patterns, pharmacokinetic considerations, and patient‑specific factors.

The injectable solution should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Keep the product in its original packaging until use to maintain stability.

Imipenem/Cilastatin is given by intravenous infusion. The infusion rate and dilution volume are determined by the prescribing clinician, and the medication should be administered using aseptic technique in a clinical setting.

Serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders, severe allergic reactions such as anaphylaxis, Clostridioides difficile‑associated colitis, and rare but life‑threatening skin reactions like Stevens‑Johnson syndrome.

Patients with a known hypersensitivity to imipenem, cilastatin, other carbapenems, or any β‑lactam antibiotics should not receive this medication. Caution is also advised for individuals with a history of seizures, severe renal impairment, or severe hepatic dysfunction.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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