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

Imipenem/Cilastatin Actavis

Active Ingredient:
Cilastatin Sodium, Imipenem Monohydrate
Origin:
EU

Imipenem/Cilastatin Actavis (Cilastatin Sodium, Imipenem Monohydrate)

Imipenem/Cilastatin, the active ingredient in Imipenem/Cilastatin Actavis, is a carbapenem antibiotic presented as an injectable solution for intravenous use. It treats a range of serious bacterial infections in hospitalized adults and children, including intra‑abdominal, urinary, skin, respiratory and neutropenic infections.

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

Manufacturer / TM Owner

Teva B.V

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Indications & Clinical Uses

Imipenem/Cilastatin is a broad‑spectrum carbapenem used for severe bacterial infections affecting several organ systems.

  • Complicated intra‑abdominal infections: provides bacterial eradication in patients with intra‑abdominal sepsis.
  • Complicated urinary tract infections: clears resistant uropathogens in complicated cystitis and pyelonephritis.
  • Skin and soft‑tissue infections: treats deep or necrotizing infections caused by Gram‑negative and Gram‑positive organisms.
  • Lower respiratory tract infections (pneumonia): effective against hospital‑acquired and ventilator‑associated pneumonia.
  • Febrile neutropenia: offers rapid coverage for high‑risk neutropenic patients with suspected bacterial infection.

How It Works

  • Imipenem binds to 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 maintaining therapeutic plasma concentrations.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: may be watery and self‑limiting.
  • Vomiting: occasional emesis after infusion.
  • Headache: transient cranial discomfort.
  • Infusion site phlebitis: local irritation at the IV site.
  • Elevated liver enzymes: transient increase in transaminases.

Serious or Rare Side Effects

  • Seizures: especially in patients with renal impairment or CNS disease.
  • Anaphylaxis: severe allergic reaction requiring immediate intervention.
  • Clostridioides difficile colitis: antibiotic‑associated diarrhea.
  • Renal impairment: worsening kidney function.
  • Thrombocytopenia: reduced platelet count.
  • Neutropenia: decreased neutrophil count increasing infection risk.

Precautions & Warnings

Careful assessment and monitoring are required before and during therapy.

  • Renal function monitoring: adjust dose in patients with reduced creatinine clearance.
  • Central nervous system effects: avoid in patients with a history of seizures.
  • Hypersensitivity: discontinue if signs of allergic reaction appear.
  • Pregnancy safety: category B; use only when benefit outweighs risk.
  • Concomitant nephrotoxic drugs: increase vigilance for renal toxicity.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Drug‑drug interactions can modify efficacy or safety.

Major Interactions (Avoid)

  • Valproic acid: co‑administration may reduce valproate levels and increase seizure risk.
  • Other carbapenems: concurrent use can increase neurotoxicity.
  • Probenecid: may decrease renal clearance of imipenem, raising plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Diuretics: monitor electrolytes and renal function.
  • NSAIDs: increased risk of renal impairment.
  • Anticoagulants (e.g., warfarin): watch for altered INR values.

Frequently Asked Questions

Imipenem/Cilastatin Actavis is indicated for severe bacterial infections such as complicated intra‑abdominal infections, complicated urinary tract infections, skin and soft‑tissue infections, hospital‑acquired or ventilator‑associated pneumonia, and febrile neutropenia. It provides broad‑spectrum coverage against many Gram‑negative, Gram‑positive and anaerobic organisms.

Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, disrupting peptidoglycan cross‑linking and causing cell lysis. Cilastatin is added to inhibit renal dehydropeptidase I, an enzyme that would otherwise degrade imipenem, thereby preserving its plasma concentration and antibacterial activity.

The exact dose and infusion rate are determined by the prescribing clinician based on the infection type, severity, patient weight, age, and renal function. Dosing regimens are individualized and should follow the latest clinical guidelines and the product’s prescribing information.

Imipenem/Cilastatin is classified as pregnancy category B, indicating that animal studies have not shown risk to the fetus and there are no adequate human studies. It may be used during pregnancy when the potential benefit justifies the risk. Limited data are available for breastfeeding; the decision should be made by a healthcare professional.

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 similar to other carbapenems such as meropenem or ertapenem, but its combination with cilastatin protects the drug from renal degradation, allowing higher plasma levels. Choice among carbapenems depends on local resistance patterns, pharmacokinetic considerations, and specific patient factors.

The product should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Reconstituted solutions are generally stable for a limited period at room temperature; always follow the manufacturer’s instructions for preparation and use.

Imipenem/Cilastatin is supplied as a powder for solution for injection and is administered intravenously. The reconstituted solution is infused over a specified period, typically 30 minutes, under aseptic conditions. Administration details, including infusion rate, are determined by the prescriber.

Serious adverse events include seizures, especially in patients with renal impairment or pre‑existing CNS disorders, severe allergic reactions such as anaphylaxis, Clostridioides difficile‑associated colitis, and significant renal toxicity. Prompt recognition and medical intervention are essential if these events occur.

Patients with a known hypersensitivity to imipenem, cilastatin, or any component of the formulation should avoid the drug. Caution is also advised for individuals with a history of seizures, severe renal impairment, or those receiving valproic acid, unless the benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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