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

Imipenem/Cilastatin Aptapharma

Active Ingredient:
Cilastatin, Imipenem
Origin:
EU

Imipenem/Cilastatin Aptapharma (Cilastatin, Imipenem)

Imipenem, the active ingredient in Imipenem/Cilastatin Aptapharma, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats serious bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, skin and soft tissue infections, nosocomial pneumonia, and septicemia in hospitalized patients.

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 by inhibiting cell‑wall synthesis.

  • Complicated intra‑abdominal infections: provides broad‑spectrum coverage to eradicate Gram‑negative, Gram‑positive and anaerobic pathogens.
  • Complicated urinary tract infections: eliminates resistant Enterobacteriaceae and other uropathogens.
  • Skin and soft tissue infections: treats mixed bacterial infections including MRSA‑susceptible strains.
  • Nosocomial pneumonia: offers potent activity against hospital‑acquired respiratory pathogens.
  • Septicemia: delivers rapid bactericidal effect in systemic bloodstream infections.

How It Works

  • Imipenem binds to penicillin‑binding proteins, inhibiting the final stages of bacterial cell‑wall peptidoglycan synthesis, leading to cell lysis. Cilastatin, co‑administered, inhibits renal dehydropeptidase I, preventing enzymatic degradation of imipenem and thereby increasing its plasma concentration and renal excretion stability.

Side Effects

Adverse reactions may occur with any antimicrobial therapy and should be monitored.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: may be watery and self‑limiting.
  • Vomiting: occasional episodes after infusion.
  • Rash: erythematous skin eruptions.
  • Injection site phlebitis: pain or redness at IV site.
  • Elevated liver enzymes: transient hepatic enzyme rise.

Serious or Rare Side Effects

  • Seizures: risk increases with high doses or renal impairment.
  • Anaphylaxis: severe allergic reaction requiring immediate intervention.
  • Clostridioides difficile‑associated diarrhea: possible colitis.
  • Thrombophlebitis: clot formation in veins.
  • Renal toxicity: worsening kidney function in susceptible patients.

Precautions & Warnings

Careful assessment and monitoring are required before and during therapy.

  • Renal function assessment: adjust dosing in patients with impaired renal clearance.
  • History of seizures: monitor for neurotoxicity and consider alternative agents.
  • β‑lactam allergy: evaluate risk of cross‑reactivity before initiating.
  • Concurrent nephrotoxic drugs: use with caution to avoid additive kidney injury.
  • Pregnancy and lactation: safety not established; weigh benefits against potential risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Imipenem/Cilastatin may interact with several medications; monitoring is advised.

Major Interactions (Avoid)

  • Valproic acid: carbapenems reduce serum valproate levels, increasing seizure risk.
  • Nephrotoxic agents (e.g., aminoglycosides, vancomycin): may exacerbate renal impairment.
  • CNS depressants: potential additive neurotoxic effects.

Moderate Interactions (Monitor Closely)

  • Diuretics: monitor electrolytes and renal function.
  • Warfarin: may alter INR, requiring coagulation monitoring.
  • Oral contraceptives: possible reduction in efficacy, advise alternative contraception.

Frequently Asked Questions

Imipenem/Cilastatin Aptapharma is indicated for the treatment of serious bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, skin and soft tissue infections, nosocomial pneumonia, and septicemia. It provides broad‑spectrum coverage against Gram‑negative, Gram‑positive and anaerobic organisms.

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

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 other clinical factors. Only a qualified healthcare professional should set the appropriate dosing regimen.

The safety of Imipenem/Cilastatin in pregnancy and lactation has not been definitively established. It should be used only if the potential 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, 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 where required) and necessary import documentation.

Imipenem/Cilastatin offers a broad spectrum of activity similar to other carbapenems like meropenem, but the addition of cilastatin protects imipenem from renal degradation, allowing higher and more stable plasma concentrations. Choice between agents depends on local resistance patterns, pharmacokinetic considerations, and clinician preference.

Imipenem/Cilastatin Aptapharma should be stored at 2‑8 °C in a refrigerator. Keep the vials in their original packaging, protect from light, and avoid freezing or shaking the solution. Do not use if the product has been exposed to temperatures outside this range.

The medication is supplied as an injectable solution for intravenous infusion. It is administered by a healthcare professional, typically over a 30‑ to 60‑minute infusion period, following aseptic technique and according to the dosing instructions provided by the prescriber.

The most serious adverse events include seizures, especially in patients with renal impairment or high doses, severe allergic reactions such as anaphylaxis, and Clostridioides difficile‑associated colitis. Prompt recognition and medical intervention are essential if these events occur.

Patients with a known hypersensitivity to imipenem, cilastatin, or any other β‑lactam antibiotics should avoid this medication. Caution is also advised for individuals with a history of seizures, severe renal impairment, or those receiving interacting drugs that may increase toxicity.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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