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

Imipenem/Cilastatina Hikma

Active Ingredient:
Cilastatin Sodium, Imipenem Monohydrate
Origin:
EU

Imipenem/Cilastatina Hikma (Cilastatin Sodium, Imipenem Monohydrate)

Imipenem/Cilastatin, the active ingredient in Imipenem/Cilastatin Hikma, is a carbapenem antibiotic presented as a sterile powder for reconstitution for intravenous use. It treats severe bacterial infections in hospitalized adults and children when other antibiotics are ineffective.

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

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Imipenem/Cilastatin is a broad‑spectrum carbapenem used for serious bacterial infections in the following settings:

  • Complicated intra‑abdominal infections: effective bacterial eradication in patients with intra‑abdominal sepsis.
  • Complicated urinary tract infections: clears resistant uropathogens causing pyelonephritis and cystitis.
  • Complicated skin and soft‑tissue infections: treats deep tissue infections caused by multidrug‑resistant organisms.
  • Lower respiratory tract infections (community‑acquired and hospital‑acquired): resolves pneumonia caused by Gram‑negative and Gram‑positive bacteria.
  • Febrile neutropenia: provides empiric coverage for high‑risk neutropenic patients.

How It Works

  • Imipenem binds to multiple 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

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: severe allergic reaction requiring immediate medical attention.
  • Clostridioides difficile colitis: antibiotic‑associated diarrhea.
  • Stevens‑Johnson syndrome: rare mucocutaneous necrolysis.
  • Severe neutropenia: marked reduction in white blood cells.
  • Acute renal failure: abrupt loss of kidney function.

Precautions & Warnings

Before initiating therapy, consider the following precautions:

  • Renal function assessment: adjust dose in patients with impaired kidney function.
  • Allergy history: avoid in individuals with known carbapenem or beta‑lactam hypersensitivity.
  • Seizure risk: monitor patients with a history of epilepsy or CNS disorders.
  • Concomitant valproic acid: avoid due to reduced plasma levels and loss of seizure control.
  • Pregnancy and lactation: use only if the potential benefit justifies the potential risk to the fetus or infant.
  • Store at below 25°C: keep in the original container, protect from moisture and light.

Avoid Interactions

Imipenem/Cilastatin may interact with several drugs:

Major Interactions (Avoid)

  • Valproic acid: reduces valproate levels, increasing seizure risk.
  • Renal dehydropeptidase inhibitors: may increase imipenem toxicity.
  • Penicillins or other beta‑lactams: cross‑reactivity can trigger allergic reactions.
  • Probenecid: can raise imipenem plasma concentrations.
  • Monoamine oxidase inhibitors: not recommended due to unknown interaction risk.

Moderate Interactions (Monitor Closely)

  • Diuretics: may enhance nephrotoxic potential.
  • CNS depressants: additive risk of seizures.
  • Anticoagulants (warfarin): monitor INR as imipenem may affect coagulation parameters.

Frequently Asked Questions

Imipenem/Cilastatin Hikma is indicated for severe bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, complicated skin and soft‑tissue infections, lower respiratory tract infections (both community‑acquired and hospital‑acquired), and febrile neutropenia in high‑risk patients.

The drug combines imipenem, which binds to penicillin‑binding proteins and blocks bacterial cell‑wall synthesis, with cilastatin, which inhibits the renal enzyme dehydropeptidase I. This inhibition prevents rapid degradation of imipenem, maintaining effective drug concentrations in the bloodstream.

The dosage of Imipenem/Cilastatin Hikma is determined by the prescribing clinician based on the type and severity of infection, patient weight, renal function, and other clinical factors. No fixed regimen is provided here; the prescriber sets the appropriate dose.

Safety data for Imipenem/Cilastatin in pregnancy and lactation are limited. It should be used only if the potential therapeutic benefit justifies any potential risk to the fetus or infant, and the decision should be made by the treating physician.

To place an order, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies 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 similar to other carbapenems but includes cilastatin to inhibit renal degradation, allowing higher and more sustained plasma levels. This can be advantageous in patients with reduced renal function compared with carbapenems that lack a renal protector.

Store the product at temperatures below 25 °C, in its original packaging, protected from moisture and light. Do not freeze the reconstituted solution and use it within the time frame specified in the product labeling.

Imipenem/Cilastatin is given intravenously. The sterile powder is reconstituted with the appropriate diluent and infused over a prescribed period, typically 30 minutes to 1 hour, under aseptic conditions by qualified healthcare personnel.

The most serious risks 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, or any other carbapenem or beta‑lactam antibiotics should not receive this medication. Caution is also advised for individuals with a history of seizures, severe renal impairment, or those taking interacting medications without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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