Product image of Imipenem/Cilastatine Hikma (Cilastatin Sodium, Imipenem Monohydrate) supplied by GNH India

Imipenem/Cilastatine Hikma

Active Ingredient:
Cilastatin Sodium, Imipenem Monohydrate
Origin:
EU

Imipenem/Cilastatine Hikma (Cilastatin Sodium, Imipenem Monohydrate)

Imipenem/cilastatin, the active ingredient in Imipenem/Cilastatine Hikma, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats a range of serious bacterial infections, including intra‑abdominal, urinary tract, respiratory, skin and soft‑tissue, and bloodstream infections, primarily in hospitalized adult patients.

GNH India supplies Imipenem/Cilastatine Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Imipenem/cilastatin is used for severe bacterial infections that require broad‑spectrum intravenous therapy.

  • Complicated intra‑abdominal infections: provides rapid bacterial eradication and clinical cure.
  • Complicated urinary tract infections: eliminates resistant Gram‑negative and Gram‑positive pathogens.
  • Nosocomial pneumonia: offers coverage against multidrug‑resistant organisms in ventilated patients.
  • Skin and soft tissue infections: treats deep or extensive infections caused by susceptible bacteria.
  • Septicemia: delivers bactericidal activity in systemic bloodstream infections.

How It Works

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

Side Effects

Adverse reactions may occur with any intravenous antibiotic and should be monitored.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: may be watery and self‑limiting.
  • Rash: erythematous skin eruption.
  • Injection site pain: local discomfort at the infusion site.

Serious or Rare Side Effects

  • Seizures: especially in patients with renal impairment or CNS disorders.
  • Clostridioides difficile colitis: severe diarrhea with pseudomembranous colitis.
  • Anaphylaxis: acute, potentially life‑threatening hypersensitivity.
  • Stevens‑Johnson syndrome: severe mucocutaneous reaction.

Precautions & Warnings

Use of Imipenem/Cilastatine Hikma requires careful clinical assessment and monitoring.

  • Assess renal function: adjust dosing in patients with impaired clearance.
  • Monitor for seizures: avoid in patients with a history of epilepsy.
  • Evaluate for hypersensitivity: discontinue if an allergic reaction occurs.
  • Use caution in CNS disorders: increased risk of neurotoxicity.
  • Adjust dose in renal impairment: follow renal dosing guidelines.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Imipenem/cilastatin can interact with several concomitant medicines, influencing efficacy or safety.

Major Interactions (Avoid)

  • Valproic acid: reduces valproate levels, risking seizure breakthrough.
  • Probenecid: decreases renal clearance, increasing imipenem exposure.
  • Cyclosporine: heightened nephrotoxicity risk.

Moderate Interactions (Monitor Closely)

  • Diuretics: may potentiate neurotoxic effects.
  • Aminoglycosides: combined renal toxicity requires renal function monitoring.

Frequently Asked Questions

Imipenem/Cilastatine Hikma is indicated for severe bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, hospital‑acquired (nosocomial) pneumonia, skin and soft‑tissue infections, and septicemia. It is administered intravenously in hospitalized patients who need broad‑spectrum coverage against Gram‑positive, Gram‑negative, and anaerobic organisms.

Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, preventing the cross‑linking of peptidoglycan strands, which leads to cell lysis. Cilastatin, co‑formulated with imipenem, blocks renal dehydropeptidase I, an enzyme that would otherwise degrade imipenem, thereby preserving its antibacterial activity in the bloodstream.

The dosage of Imipenem/Cilastatine Hikma is individualized by the prescribing clinician based on the type and severity of infection, patient weight, renal function, and local susceptibility patterns. Healthcare professionals determine the appropriate infusion rate, frequency, and duration according to established clinical guidelines.

Imipenem/cilastatin is classified as Pregnancy Category B, indicating that animal studies have not shown fetal risk, but there are no adequate controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. Caution is advised during breastfeeding, as the drug may be excreted in milk; a risk‑benefit assessment should be performed by the prescriber.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide. After the request, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain logistics if needed), and assist with import documentation.

Imipenem/cilastatin offers a broad spectrum of activity similar to other carbapenems such as meropenem or ertapenem, but it is distinguished by its co‑administration with cilastatin, which protects the drug from renal degradation, allowing higher plasma concentrations. Choice among carbapenems often depends on local resistance patterns, dosing convenience, and specific infection sites.

The product must be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to use, the solution should be inspected for particulate matter and discoloration. If the product is removed from refrigeration, it should be used within the time frame specified in the product label.

Imipenem/Cilastatine Hikma is given as an intravenous infusion. The recommended infusion time varies with the dose and patient condition, typically ranging from 15 to 60 minutes. Administration should be performed by qualified healthcare personnel in a clinical setting, with appropriate monitoring for infusion‑related reactions.

Serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders, Clostridioides difficile‑associated colitis, severe hypersensitivity reactions such as anaphylaxis, and rare but life‑threatening skin reactions like Stevens‑Johnson syndrome. Prompt recognition and discontinuation of therapy are essential if any of these events occur.

Patients with a known hypersensitivity to imipenem, cilastatin, or any component of the formulation should not receive the drug. Caution is also advised for individuals with a history of seizures, severe renal impairment without dose adjustment, or those receiving concomitant medications that lower the seizure threshold.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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