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/Cilastatin Hikma, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats serious bacterial infections in hospitalized patients, including complicated intra‑abdominal, urinary tract, skin and soft‑tissue, lower respiratory tract infections, and febrile neutropenia.

GNH India supplies Imipenem/Cilastatin Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable cold‑chain logistics for injectable products globally.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Imipenem/cilastatin is a broad‑spectrum carbapenem antibiotic used to treat severe bacterial infections in various organ systems.

  • Complicated intra‑abdominal infections: eradicates mixed aerobic and anaerobic pathogens, helping resolve peritonitis and intra‑abdominal sepsis.
  • Complicated urinary tract infections: eliminates resistant Gram‑negative organisms, facilitating cure of pyelonephritis and complicated cystitis.
  • Complicated skin and soft‑tissue infections: provides coverage against MRSA‑like organisms and polymicrobial flora in deep tissue infections.
  • Community‑acquired and hospital‑acquired lower respiratory tract infections: treats pneumonia caused by resistant Streptococcus pneumoniae, Pseudomonas aeruginosa and other pathogens.
  • Febrile neutropenia: offers rapid bactericidal activity in immunocompromised patients with fever of unknown origin.

How It Works

  • Imipenem binds to penicillin‑binding proteins, inhibiting the final transpeptidation step of bacterial cell‑wall synthesis, which leads to cell lysis. Cilastatin, co‑administered as a renal dehydropeptidase‑I inhibitor, prevents enzymatic degradation of imipenem in the proximal tubules, thereby maintaining therapeutic plasma concentrations and extending the antibacterial effect. The combined formulation achieves broad activity against Gram‑positive, Gram‑negative and anaerobic bacteria, including many multidrug‑resistant strains.

Side Effects

Imipenem/cilastatin may be associated with a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: mild stomach upset.
  • Diarrhea: loose stools.
  • Headache: transient cranial discomfort.
  • Rash: erythematous skin eruption.

Serious or Rare Side Effects

  • Seizures: increased risk, especially with renal impairment.
  • Anaphylaxis: severe allergic reaction with hives and airway swelling.
  • Clostridioides difficile‑associated diarrhea: potentially severe colitis.

Precautions & Warnings

Before initiating imipenem/cilastatin therapy, clinicians should consider several safety precautions to minimize risks.

  • Renal function assessment: evaluate creatinine clearance and adjust dose in impairment.
  • Monitor for seizures: observe patients with CNS disorders or electrolyte abnormalities.
  • Hypersensitivity screening: avoid use in individuals with known carbapenem allergy.
  • Concomitant valproic acid: discontinue or replace, as imipenem reduces valproate levels.
  • Use with caution in pregnant or breastfeeding patients: benefits must outweigh potential risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Imipenem/cilastatin can interact with other medicines, affecting efficacy or safety.

Major Interactions (Avoid)

  • Valproic acid: reduces plasma valproate concentrations, risking loss of seizure control.
  • Probenecid: may increase imipenem levels, heightening neurotoxicity risk.

Moderate Interactions (Monitor Closely)

  • Loop diuretics (e.g., furosemide): additive nephrotoxic potential, monitor renal function.
  • Aminoglycosides (e.g., gentamicin): combined nephrotoxicity, adjust dosing as needed.
  • Warfarin: possible alteration of INR, check coagulation parameters regularly.

Frequently Asked Questions

Imipenem/Cilastatin Hikma is an intravenous carbapenem antibiotic indicated for the treatment of severe, hospital‑acquired bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, complicated skin and soft‑tissue infections, lower respiratory tract infections (both community‑ and hospital‑acquired), and febrile neutropenia in immunocompromised patients.

Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, preventing the cross‑linking of peptidoglycan strands and causing cell lysis. Cilastatin, co‑administered, blocks renal dehydropeptidase‑I, an enzyme that would otherwise degrade imipenem, thereby preserving its plasma concentration and extending its antibacterial activity.

The prescribed dose of Imipenem/Cilastatin is individualized by the treating physician based on the type and severity of infection, the patient’s renal function, age, weight, and any concomitant medications. Dosing adjustments are especially important in patients with impaired kidney function to avoid accumulation and toxicity.

The safety of Imipenem/Cilastatin in pregnancy and lactation has not been definitively established. It should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made in consultation with a healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Imipenem/Cilastatin Hikma. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain handling where required) and import documentation.

Imipenem/cilastatin offers a broad spectrum of activity that includes many Gram‑positive, Gram‑negative and anaerobic organisms, similar to other carbapenems such as meropenem and ertapenem. Compared with meropenem, imipenem has a slightly higher risk of seizure activity, especially in patients with renal dysfunction, while ertapenem lacks activity against Pseudomonas aeruginosa. Choice of agent depends on the pathogen profile and patient‑specific factors.

Imipenem/Cilastatin Hikma should be stored in a refrigerator at 2‑8 °C. Keep the vials in their original packaging, protect them from light, and do not freeze or shake the solution. Once reconstituted, the solution should be used promptly according to the manufacturer’s stability guidelines.

The medication is supplied as a sterile injectable solution for intravenous infusion. It must be reconstituted with the appropriate diluent, then administered over a recommended infusion time (usually 30 minutes) under aseptic conditions. The exact infusion rate and duration are determined by the prescribing clinician based on the clinical scenario.

Serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders; severe hypersensitivity reactions such as anaphylaxis; and Clostridioides difficile‑associated colitis, which can be life‑threatening. Prompt recognition and medical intervention are essential if any of these events occur.

Imipenem/Cilastatin is contraindicated in individuals with a known hypersensitivity to imipenem, cilastatin, or any other carbapenem antibiotics. Caution is also advised for patients with a history of seizures, severe renal impairment, or those receiving valproic acid, as the drug can reduce valproate levels and increase seizure risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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