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

Imipenem/Cilastatin Aptapharma

Active Ingredient:
Cilastatin, Imipenem Anhydrate
Origin:
EU

Imipenem/Cilastatin Aptapharma (Cilastatin, Imipenem Anhydrate)

Imipenem, the active ingredient in Imipenem/Cilastatin Aptapharma, is a carbapenem antibiotic presented as an intravenous formulation for use in hospitalized patients. It is combined with cilastatin to treat a range of serious bacterial infections, including complicated intra‑abdominal infections, complicated urinary tract infections, hospital‑acquired bacterial pneumonia, skin and soft‑tissue infections, and severe sepsis or septic shock.

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

Manufacturer / TM Owner

Apta Medica Internacional D.O.O.

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Indications & Clinical Uses

Imipenem/cilastatin is a carbapenem antibiotic used to treat severe bacterial infections across several organ systems.

  • Complicated intra‑abdominal infections: provides broad‑spectrum coverage to eradicate Gram‑negative, Gram‑positive and anaerobic pathogens.
  • Complicated urinary tract infections: eliminates resistant uropathogens causing pyelonephritis and cystitis.
  • Hospital‑acquired bacterial pneumonia: targets multidrug‑resistant organisms responsible for ventilator‑associated pneumonia.
  • Skin and soft‑tissue infections: treats deep or necrotizing infections where other agents may fail.
  • Severe sepsis and septic shock: offers rapid bactericidal activity in critically ill patients.

How It Works

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

Side Effects

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: may be watery and self‑limiting.
  • Rash: erythematous skin eruptions.
  • Injection site reactions: pain, erythema, or swelling at the infusion site.

Serious or Rare Side Effects

  • Seizures: especially in patients with pre‑existing CNS disorders or high plasma concentrations.
  • Clostridioides difficile‑associated colitis: severe diarrhea with possible pseudomembranous colitis.
  • Anaphylaxis: rapid onset of airway compromise, hypotension, and urticaria.
  • Stevens‑Johnson syndrome/toxic epidermal necrolysis: extensive skin detachment and mucosal involvement.
  • Renal toxicity: elevated serum creatinine or reduced urine output.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Renal function assessment: adjust dosing in patients with impaired clearance.
  • Seizure risk evaluation: avoid in individuals with a history of epilepsy or CNS disease.
  • Hypersensitivity screening: discontinue if signs of allergic reaction appear.
  • Concomitant CNS depressants: use with caution as they may lower seizure threshold.
  • Dose adjustment in renal impairment: follow established guidelines for reduced creatinine clearance.
  • Store at below 25°C: keep in the original pack, protect from moisture and light.

Avoid Interactions

Imipenem/cilastatin may interact with other medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Valproic acid: reduces valproate levels, risking seizure breakthrough.
  • Probenecid: decreases renal clearance, increasing imipenem toxicity.
  • Ganciclovir: carbapenems may diminish antiviral efficacy.

Moderate Interactions (Monitor Closely)

  • Loop diuretics: heightened risk of nephrotoxicity.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): may exacerbate renal impairment.
  • Warfarin: possible alteration of INR, requiring closer monitoring.

Frequently Asked Questions

Imipenem/Cilastatin Aptapharma is indicated for serious bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, hospital‑acquired bacterial pneumonia, skin and soft‑tissue infections, and severe sepsis or septic shock. It provides broad‑spectrum coverage against Gram‑positive, Gram‑negative and anaerobic organisms.

Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, leading to cell lysis. Cilastatin, included in the formulation, blocks renal dehydropeptidase I, preventing enzymatic breakdown of imipenem and maintaining effective drug levels in the bloodstream and kidneys.

The dosage of Imipenem/Cilastatin Aptapharma is determined by the prescribing clinician based on the type and severity of infection, patient weight, renal function, and local antimicrobial guidelines. Healthcare professionals should follow the recommended dosing regimen on the product label.

Safety data for Imipenem/Cilastatin in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians should assess each case individually 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 necessary import documentation.

Imipenem/cilastatin offers a broad spectrum of activity similar to other carbapenems like meropenem or ertapenem, but the addition of cilastatin protects the drug from renal degradation, allowing higher urinary concentrations. Choice among carbapenems depends on local resistance patterns, pharmacokinetic considerations, and specific infection sites.

The product should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and light. Reconstituted solutions must be used promptly according to the manufacturer’s instructions and discarded if not administered within the recommended time frame.

Imipenem/Cilastatin is given by intravenous infusion. The reconstituted solution is administered over a period specified by the prescribing information, typically 30 minutes to 1 hour, depending on the dose and patient condition. Infusion rates should be adjusted for renal function when necessary.

Serious risks include seizures, especially in patients with pre‑existing CNS disorders or high plasma concentrations, Clostridioides difficile‑associated colitis, severe allergic reactions such as anaphylaxis, and rare but life‑threatening skin reactions like Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Patients with a known hypersensitivity to imipenem, cilastatin, or any component of the formulation should avoid this medication. Caution is also advised for individuals with a history of seizures, severe renal impairment, or those receiving interacting drugs such as valproic acid or probenecid without appropriate monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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