Product image of Imicilex (Cilastatin, Imipenem Anhydrate) supplied by GNH India

Imicilex

Active Ingredient:
Cilastatin, Imipenem Anhydrate
Origin:
EU

Imicilex (Cilastatin, Imipenem Anhydrate)

Imipenem/cilastatin, the active ingredient in Imicilex, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats a range of serious bacterial infections, including complicated intra‑abdominal infections, complicated urinary tract infections, nosocomial pneumonia, skin and soft‑tissue infections, and septicemia, primarily in hospitalized adult patients requiring parenteral therapy.

GNH India supplies Imicilex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide. The company adheres to EU GMP standards and provides cold‑chain logistics for injectable products.

Manufacturer / TM Owner

Pharmacenter Europe Kft.

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Indications & Clinical Uses

Imicilex (imipenem/cilastatin) is used for severe bacterial infections that require intravenous therapy.

  • Complicated intra‑abdominal infections: provides broad‑spectrum coverage to eradicate Gram‑negative, Gram‑positive and anaerobic pathogens.
  • Complicated urinary tract infections: eliminates resistant uropathogens in patients with upper urinary tract involvement.
  • Nosocomial pneumonia: treats hospital‑acquired lung infections caused by multidrug‑resistant organisms.
  • Skin and soft‑tissue infections: resolves deep tissue infections where oral agents are insufficient.
  • Septicemia: rapidly clears bloodstream infections caused by susceptible bacteria.

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, inhibits renal dehydropeptidase I, preventing enzymatic degradation of imipenem and thereby maintaining therapeutic plasma concentrations. The combination yields a potent, broad‑spectrum carbapenem activity against aerobic and anaerobic bacteria.

Side Effects

Adverse reactions to Imicilex may vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: may be watery and self‑limiting.
  • Headache: transient cranial discomfort.
  • Infusion site reactions: erythema, pain or phlebitis at the injection site.
  • Rash: mild maculopapular skin eruption.

Serious or Rare Side Effects

  • Seizures: especially in patients with renal impairment or CNS disorders.
  • Severe allergic reactions: anaphylaxis, angioedema, or Stevens‑Johnson syndrome.
  • Clostridioides difficile colitis: antibiotic‑associated severe diarrhea.
  • Elevated liver enzymes: hepatotoxicity in susceptible individuals.
  • Thrombocytopenia: marked reduction in platelet count.

Precautions & Warnings

Clinicians should observe several precautions when prescribing Imicilex to ensure patient safety.

  • Renal function: adjust dose in patients with impaired clearance to avoid accumulation.
  • Hypersensitivity: avoid in individuals with known allergy to carbapenems or β‑lactams.
  • Seizure risk: monitor neurologic status, particularly in patients with CNS disorders.
  • Valproic acid co‑administration: may reduce valproate levels and precipitate seizures.
  • Electrolyte imbalance: correct hypokalemia and hypomagnesemia before therapy.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Imicilex can interact with other medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • Valproic acid: reduces plasma valproate concentrations, increasing seizure risk.
  • Probenecid: may increase imipenem levels, heightening toxicity potential.

Moderate Interactions (Monitor Closely)

  • Warfarin: carbapenems may enhance anticoagulant effect; monitor INR.
  • Diuretics (e.g., furosemide): may exacerbate electrolyte disturbances; check electrolytes.
  • Rifampin: may induce hepatic enzymes and lower imipenem concentrations; adjust dose if needed.

Frequently Asked Questions

Imicilex contains imipenem/cilastatin and is indicated for the treatment of severe bacterial infections that require intravenous therapy, such as complicated intra‑abdominal infections, complicated urinary tract infections, hospital‑acquired (nosocomial) pneumonia, skin and soft‑tissue infections, and septicemia caused by susceptible organisms.

Imipenem inhibits penicillin‑binding proteins, blocking the final steps of bacterial cell‑wall synthesis and causing cell lysis. Cilastatin is co‑administered to inhibit renal dehydropeptidase I, an enzyme that would otherwise degrade imipenem, thereby preserving its plasma concentration and extending its antibacterial activity.

The dose of Imicilex is individualized by the prescribing clinician based on the type and severity of infection, patient weight, renal function, and local susceptibility patterns. Dosage regimens are established in clinical guidelines and should be followed as directed by a qualified healthcare professional.

Safety data for imipenem/cilastatin in pregnancy and lactation are limited. The drug should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians must evaluate each case and discuss potential risks with the patient.

To order Imicilex, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets. After the request, the sales team will verify trade or institutional credentials and respond with pricing, availability, shipping details (including cold‑chain where required) and any necessary import documentation.

Both imipenem/cilastatin (Imicilex) and meropenem belong to the carbapenem class and provide broad‑spectrum coverage against many Gram‑negative, Gram‑positive and anaerobic bacteria. Imipenem is often combined with cilastatin to prevent renal degradation, whereas meropenem does not require this inhibitor. Differences in stability, dosing frequency, and specific activity against certain resistant strains may influence the choice of agent based on local antibiograms and clinical judgment.

Imicilex should be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking the solution. Proper cold‑chain handling is essential to maintain drug potency and sterility.

Imicilex is given as an intravenous infusion. The powder is reconstituted with the appropriate diluent, then further diluted in compatible IV fluids as recommended by the manufacturer. Administration should be performed by qualified healthcare personnel, following aseptic technique and the infusion rate specified in the prescribing information.

The most serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders; severe hypersensitivity reactions such as anaphylaxis or Stevens‑Johnson syndrome; and Clostridioides difficile‑associated colitis, which can lead to life‑threatening diarrhea. Prompt recognition and management of these reactions are critical.

Imicilex is contraindicated in individuals with a known hypersensitivity to imipenem, cilastatin, or any other carbapenem antibiotics. Patients with severe renal impairment should not receive standard doses without appropriate adjustment, and those with a history of seizures should be used with caution. Clinicians must assess each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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