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 a sterile powder for intravenous infusion use. It treats a range of serious bacterial infections in hospitalized adults and children when other agents are unsuitable.
GNH India supplies Imipenem/Cilastatin Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

Manufacturer / TM Owner

Fresenius Kabi Ab

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Indications & Clinical Uses

  • Imipenem/Cilastatin is a broad‑spectrum carbapenem used for severe bacterial infections across several organ systems.
  • Complicated intra‑abdominal infection: provides rapid bacterial eradication to resolve intra‑abdominal sepsis.
  • Complicated urinary tract infection: eliminates resistant uropathogens causing pyelonephritis and cystitis.
  • Complicated skin and soft tissue infection: treats deep tissue infections where Gram‑negative and anaerobic coverage is needed.
  • Hospital‑acquired and ventilator‑associated pneumonia: offers coverage against multidrug‑resistant respiratory pathogens.
  • Severe sepsis and septic shock: delivers timely bactericidal activity to improve outcomes in systemic infection.

How It Works

  • Imipenem binds to penicillin‑binding proteins, inhibiting the final stages of bacterial cell‑wall peptidoglycan synthesis, which leads to cell lysis. Cilastatin, co‑administered, blocks renal dehydropeptidase I, preventing enzymatic degradation of imipenem and thereby extending its plasma half‑life and antibacterial activity.

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.
  • Headache: transient and usually resolves without intervention.
  • Infusion site phlebitis: local irritation at the IV site.
  • Elevated liver enzymes: transient increase in transaminases.

Serious or Rare Side Effects

  • Seizures: especially in patients with renal impairment or CNS disorders.
  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Clostridioides difficile colitis: antibiotic‑associated colitis presenting with profuse diarrhea.
  • Neutropenia or thrombocytopenia: significant drops in blood cell counts.
  • Renal toxicity: worsening kidney function in susceptible individuals.

Precautions & Warnings

  • Careful assessment and monitoring are required before and during therapy.
  • Renal function: adjust dose in patients with impaired kidney function.
  • Seizure risk: monitor patients with a history of seizures or CNS disorders.
  • Allergy: avoid in individuals with known hypersensitivity to carbapenems.
  • Drug interactions: review concomitant medications that may lower seizure threshold.
  • Pregnancy and lactation: use only when the potential benefit justifies the potential risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Imipenem/Cilastatin may interact with several agents; awareness helps prevent adverse outcomes.

Major Interactions (Avoid)

  • Valproic acid: may reduce imipenem plasma concentrations, compromising efficacy.
  • Cisplatin: concurrent use can increase nephrotoxicity.
  • Other carbapenems: redundant therapy may increase toxicity without added benefit.

Moderate Interactions (Monitor Closely)

  • Loop diuretics: may exacerbate renal impairment.
  • Phenobarbital: may lower seizure threshold when combined.
  • Other nephrotoxic drugs (e.g., aminoglycosides): monitor renal function closely.

Frequently Asked Questions

Imipenem/Cilastatin is indicated for serious bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, complicated skin and soft tissue infections, hospital‑acquired or ventilator‑associated pneumonia, and severe sepsis or septic shock. It is typically reserved for cases where other antibiotics are ineffective or contraindicated.

Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, leading to cell lysis. Cilastatin is added to block renal dehydropeptidase I, an enzyme that would otherwise degrade imipenem, thereby prolonging its antibacterial activity and maintaining therapeutic drug levels.

The dosing regimen for Imipenem/Cilastatin is determined by the prescribing clinician based on the type and severity of infection, patient weight, renal function, and local guidelines. Healthcare professionals should refer to the product label and adjust the dose as needed for each individual patient.

Safety data in pregnancy and lactation are limited. Imipenem/Cilastatin should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians should discuss the risk‑benefit profile with the patient and consider alternative therapies when appropriate.

To place an order, 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 if needed), and import documentation.

Imipenem/Cilastatin offers a broad spectrum of activity against Gram‑positive, Gram‑negative, and anaerobic bacteria, similar to meropenem or ertapenem. Its unique combination with cilastatin protects the drug from renal degradation, allowing higher plasma concentrations. Choice among carbapenems depends on local resistance patterns, pharmacokinetic considerations, and specific infection sites.

The product should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen. Once reconstituted, the solution should be used promptly according to the label instructions and any remaining solution discarded if not used within the recommended time frame.

Imipenem/Cilastatin is supplied as a sterile powder for injection and is administered intravenously. The powder is reconstituted with the appropriate diluent, then infused over a specified period, usually 30 minutes to 1 hour, under aseptic conditions by qualified healthcare personnel.

The most serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders, severe allergic reactions such as anaphylaxis, and Clostridioides difficile‑associated colitis. Monitoring for neurological signs, allergic symptoms, and gastrointestinal disturbances is essential during therapy.

Patients with a known hypersensitivity to imipenem, cilastatin, or any other carbapenem should avoid this medication. Caution is also advised for individuals with a history of seizures, severe renal impairment, or those receiving interacting drugs that significantly lower the seizure threshold.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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