Imipenem/Cilastatin Hikma Farmacêutica (Portugal) (Cilastatin, Imipenem)

Imipenem/Cilastatin is a broad‑spectrum carbapenem antibiotic used to treat serious bacterial infections affecting various organ systems.

• Complicated intra‑abdominal infections: achieves bacterial eradication in the peritoneal cavity and reduces infection‑related morbidity.
• Complicated urinary tract infections: provides rapid clearance of uropathogens, including resistant strains.
• Nosocomial pneumonia: improves lung infection outcomes in hospitalized patients, including ventilator‑associated cases.
• Skin and soft tissue infections: resolves deep tissue infections caused by Gram‑negative and Gram‑positive organisms.
• Septicemia: controls bloodstream infection and helps prevent organ failure.

• Imipenem binds to penicillin‑binding proteins, inhibiting the final stage 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 plasma concentrations. This combined action yields a potent, broad‑spectrum antibacterial effect against many Gram‑positive, Gram‑negative and anaerobic organisms. The drug’s stability against most β‑lactamases further extends its activity in resistant infections.

Like all antibiotics, Imipenem/Cilastatin may cause adverse reactions, ranging from mild to severe.

Common Side Effects

• Nausea: mild gastrointestinal discomfort.
• Diarrhea: may be watery and self‑limiting.
• Rash: transient skin erythema.
• Elevated liver enzymes: mild, reversible changes in hepatic labs.
• Injection site pain: discomfort at the infusion site.

Serious or Rare Side Effects

• Seizures: especially in patients with renal impairment or high doses.
• Severe allergic reactions: anaphylaxis, angioedema, or Stevens‑Johnson syndrome.
• Clostridioides difficile colitis: potentially life‑threatening diarrhea.
• Thrombocytopenia: marked reduction in platelet count.
• Renal dysfunction: acute kidney injury in susceptible individuals.

Prior to prescribing Imipenem/Cilastatin, clinicians should consider several safety precautions to minimize risk.

• Renal function: adjust dose in patients with impaired kidney function.
• Seizure risk: avoid high doses in individuals with a history of seizures or CNS disorders.
• Allergy history: screen for hypersensitivity to β‑lactam antibiotics.
• Concomitant nephrotoxins: monitor when used with other kidney‑affecting drugs.
• Pregnancy and lactation: use only if benefits outweigh potential risks.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

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

Major Interactions (Avoid)

• Valproic acid: may reduce antiepileptic levels, risking seizure breakthrough.
• Carbapenem‑inducing agents: concurrent use with other carbapenems can increase toxicity.

Moderate Interactions (Monitor Closely)

• Diuretics (e.g., furosemide): may enhance nephrotoxic potential; monitor renal function.
• Probenecid: can increase plasma concentrations of imipenem; adjust dose if needed.
• Anticoagulants (warfarin): may alter INR; check coagulation parameters regularly.