Product image of Imipenem/Cilastatin Hikma Farmacêutica Portugal (Cilastatin, Imipenem) supplied by GNH India

Imipenem/Cilastatin Hikma Farmacêutica Portugal

Active Ingredient:
Cilastatin, Imipenem
Origin:
EU

Imipenem/Cilastatin Hikma Farmacêutica Portugal (Cilastatin, Imipenem)

Imipenem, the active ingredient in Imipenem/Cilastatin Hikma Farmacêutica Portugal, is a carbapenem presented as a powder for solution for injection for intravenous use. It treats severe bacterial infections, including complicated intra‑abdominal infections, complicated urinary tract infections, skin and soft‑tissue infections, nosocomial pneumonia, and septicemia, primarily in hospitalized adult patients.

GNH India supplies Imipenem/Cilastatin Hikma Farmacêutica Portugal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide. The company adheres to EU GMP standards and provides reliable cold‑chain logistics to ensure product integrity across global markets.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Imipenem/Cilastatin is a broad‑spectrum carbapenem antibiotic indicated for serious infections affecting various organ systems.

  • Complicated intra‑abdominal infections: achieves bacterial eradication in the peritoneal cavity and associated tissues.
  • Complicated urinary tract infections: provides effective coverage of Gram‑negative and Gram‑positive pathogens in the urinary system.
  • Skin and soft‑tissue infections: eliminates resistant bacteria in deep or extensive dermal lesions.
  • Nosocomial pneumonia: treats hospital‑acquired lung infections caused by multidrug‑resistant organisms.
  • Septicemia: rapidly clears bloodstream infections in critically ill patients.

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‑formulated in a fixed ratio, inhibits renal dehydropeptidase I, an enzyme that would otherwise degrade imipenem in the proximal tubules, thereby prolonging the active drug concentration in plasma and urine. The combined action results in a potent, time‑dependent bactericidal effect against a wide range of aerobic and anaerobic bacteria.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate gastrointestinal discomfort.
  • Diarrhea: may be watery and self‑limiting.
  • Headache: transient cranial pain.
  • Rash: erythematous skin eruption.
  • Elevated liver enzymes: transient increase in transaminases.
  • Injection site pain: local discomfort after administration.

Serious or Rare Side Effects

  • Seizures: particularly in patients with renal impairment or high doses.
  • Anaphylaxis: acute, potentially life‑threatening hypersensitivity reaction.
  • Clostridioides difficile colitis: severe diarrhea due to bacterial overgrowth.
  • Renal toxicity: acute kidney injury in susceptible individuals.

Precautions & Warnings

Prior to initiating Imipenem/Cilastatin therapy, several safety considerations should be evaluated.

  • Renal function: assess creatinine clearance and adjust dose in impairment.
  • History of seizures: avoid or use with caution in patients with CNS disorders.
  • Hypersensitivity: confirm no allergy to β‑lactams or carbapenems.
  • Concomitant valproic acid: discontinue or replace, as carbapenems reduce valproate levels.
  • Pregnancy and lactation: use only if benefits outweigh potential risks, as safety data are limited.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Imipenem/Cilastatin can interact with other medicines, influencing efficacy or safety.

Major Interactions (Avoid)

  • Valproic acid: carbapenems markedly decrease serum valproate concentrations, risking seizure breakthrough.
  • Probenecid: may increase imipenem plasma levels, heightening neurotoxicity risk.
  • High‑dose aminoglycosides: combined nephrotoxic potential can exacerbate renal injury.

Moderate Interactions (Monitor Closely)

  • Diuretics: may enhance renal clearance, requiring dose reassessment.
  • Oral contraceptives: potential reduction in hormonal efficacy, advise backup contraception.
  • NSAIDs: may increase risk of renal impairment when used together.

Frequently Asked Questions

Imipenem/Cilastatin is a carbapenem antibacterial indicated for the treatment of severe, hospital‑acquired infections such as complicated intra‑abdominal infections, complicated urinary tract infections, skin and soft‑tissue infections, nosocomial pneumonia, and septicemia. It is administered intravenously to patients who require broad‑spectrum coverage against both aerobic and anaerobic bacteria.

Imipenem inhibits bacterial cell‑wall synthesis by binding to penicillin‑binding proteins, preventing the cross‑linking of peptidoglycan strands and leading to cell lysis. Cilastatin, included in the formulation, blocks renal dehydropeptidase I, an enzyme that would otherwise degrade imipenem, thereby extending its plasma and urinary concentrations and enhancing antibacterial activity.

The dose of Imipenem/Cilastatin is individualized by the prescribing clinician based on the type and severity of infection, the patient’s renal function, body weight, and other clinical factors. No fixed dosing regimen is provided here; healthcare professionals should follow local guidelines and adjust dosing as needed.

Safety data for Imipenem/Cilastatin in pregnancy and lactation are limited, and the product is classified as pregnancy category unknown. It should be used only if the potential therapeutic benefit justifies the potential risk to the fetus. Caution is also advised for nursing mothers, as the drug may be excreted in breast milk.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity of Imipenem/Cilastatin. GNH India supplies hospitals, pharmacies, and procurement teams across international markets. After submission, the sales team will verify trade or institutional credentials and respond with pricing, availability, shipping details (including cold‑chain handling if required), and any necessary import documentation.

Imipenem/Cilastatin offers a broad spectrum of activity comparable to other carbapenems such as meropenem or ertapenem, but it includes cilastatin to inhibit renal dehydropeptidase I, which can enhance renal stability. Choice among carbapenems often depends on local resistance patterns, dosing convenience, and specific pharmacokinetic properties; clinicians should consider these factors when selecting therapy.

Imipenem/Cilastatin powder for injection should be stored at 2‑8 °C (refrigerated). Keep the product in its original container, protect it from light, and avoid freezing or shaking the vial. Maintaining the cold‑chain ensures drug stability and potency until reconstitution.

The medication is supplied as a sterile powder that must be reconstituted with a compatible diluent. After preparation, it is administered intravenously, typically via infusion over a prescribed period. Administration should be performed by qualified healthcare personnel in a clinical setting, following aseptic technique and manufacturer instructions.

Serious adverse events include seizures, especially in patients with renal impairment or when high doses are used, and severe hypersensitivity reactions such as anaphylaxis. Additionally, Clostridioides difficile‑associated colitis can occur, and renal toxicity may develop in susceptible individuals. Prompt medical attention is required if any of these events are suspected.

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

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GNH India Pharmaceuticals Limited

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Last updated:

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