Imipenem/Cilastatin Hikma (Cilastatin Sodium, Imipenem Monohydrate)

Imipenem/Cilastatin is indicated for severe bacterial infections affecting various organ systems.

• Complicated intra‑abdominal infections: eradication of susceptible pathogens causing peritonitis and intra‑abdominal sepsis.
• Complicated urinary tract infections: treatment of infections caused by resistant Gram‑negative organisms.
• Skin and soft‑tissue infections: management of serious cellulitis, abscesses and wound infections.
• Community‑acquired and hospital‑acquired pneumonia: therapy for severe pneumonic infections due to susceptible bacteria.
• Severe sepsis and septic shock: broad‑spectrum coverage in critically ill patients with systemic infection.

• Imipenem binds to penicillin‑binding proteins, inhibiting the final steps of bacterial cell‑wall peptidoglycan synthesis, leading to cell lysis. Cilastatin, co‑administered, inhibits renal dehydropeptidase I, preventing enzymatic degradation of imipenem in the kidneys, thereby maintaining therapeutic concentrations and extending its antibacterial activity. The combination provides a time‑dependent bactericidal effect against a broad spectrum of Gram‑positive, Gram‑negative and anaerobic organisms.

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

Common Side Effects

• Nausea or vomiting
• Diarrhea, including mild colitis
• Headache
• Rash or mild skin irritation
• Infusion site pain or phlebitis

Serious or Rare Side Effects

• Seizures, especially in patients with CNS disorders
• Anaphylaxis or severe allergic reactions
• Clostridioides difficile‑associated colitis
• Acute renal dysfunction
• Thrombocytopenia or neutropenia
• Elevated liver enzymes or hepatitis

Use Imipenem/Cilastatin with caution in specific clinical situations.

• Renal function: dose adjustment may be required in patients with impaired renal function.
• Seizure risk: monitor patients with pre‑existing central nervous system disorders.
• Allergy: avoid in individuals with known hypersensitivity to β‑lactam antibiotics.
• Hepatic monitoring: observe liver enzymes during prolonged therapy.
• Pregnancy and lactation: use only if the benefit outweighs the potential risk.
• Store at 2‑8°C: keep refrigerated, protect from light, do not freeze.

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

Major Interactions (Avoid)

• Valproic acid: concomitant use may reduce valproate levels and precipitate seizures.
• Cimetidine or other renal dehydropeptidase inhibitors: may increase imipenem concentrations, raising toxicity risk.
• Probenecid: can decrease renal clearance of imipenem, enhancing exposure.

Moderate Interactions (Monitor Closely)

• Diuretics: may increase the risk of nephrotoxicity.
• Anticoagulants (e.g., warfarin): monitor INR as antibiotics can affect plasma protein binding.
• Other broad‑spectrum antibiotics: assess for additive toxicity or antagonism.