Imipenem/Cilastatin Accord Healthcare (Cilastatin Sodium, Imipenem Monohydrate)

• Imipenem/cilastatin is a carbapenem antibiotic used to treat serious bacterial infections affecting various organ systems.
• Complicated intra‑abdominal infections: achieves bacterial eradication and clinical cure.
• Complicated urinary tract infections: provides bacterial clearance and resolution of infection.
• Complicated skin and soft tissue infections: delivers rapid bacterial elimination and promotes healing.
• Hospital‑acquired and ventilator‑associated pneumonia: treats resistant Gram‑negative and Gram‑positive pathogens.
• Severe sepsis: helps control systemic infection and supports recovery.

• Imipenem binds to penicillin‑binding proteins, inhibiting the synthesis of bacterial cell walls and leading to cell lysis. Cilastatin, co‑administered, inhibits renal dehydropeptidase I, preventing enzymatic degradation of imipenem and thereby maintaining therapeutic plasma concentrations for effective antibacterial activity.

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

Common Side Effects

• Nausea: mild to moderate gastrointestinal upset.
• Vomiting: occasional emesis.
• Diarrhea: may be watery or loose.
• Headache: transient cranial discomfort.
• Rash: skin erythema or pruritus.
• Elevated liver enzymes: mild hepatic enzyme rise.

Serious or Rare Side Effects

• Seizures: especially in patients with renal impairment.
• Anaphylaxis: severe allergic reaction requiring immediate care.
• Clostridioides difficile‑associated diarrhea: colitis risk.
• Neutropenia: reduced neutrophil count.
• Thrombocytopenia: low platelet levels.
• Renal failure: acute kidney injury in susceptible individuals.

Careful assessment is required before initiating therapy.

• Renal function: adjust dose in patients with impaired renal clearance.
• History of seizures: monitor for neurotoxicity and consider alternative agents.
• Allergic reactions: avoid in individuals with known penicillin or carbapenem allergy.
• Concomitant valproic acid: may reduce valproate levels, monitor therapeutic concentrations.
• Pregnancy: use only when benefits outweigh potential risks.
• Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Drug interactions can affect efficacy and safety.

Major Interactions (Avoid)

• Valproic acid: reduces serum valproate concentrations, risking seizure breakthrough.
• Other carbapenems: additive neurotoxic risk, especially seizures.
• High‑dose aminoglycosides: increased nephrotoxicity potential.

Moderate Interactions (Monitor Closely)

• Diuretics: may alter renal clearance of the drug.
• NSAIDs: potential additive renal impairment.
• Warfarin: possible INR fluctuations, monitor coagulation.
• Rifampin: may induce hepatic enzymes, reducing drug levels.
• Loop diuretics: monitor electrolytes and renal function.