Imcitin Special Precautions

GENERAL: There is clinical and laboratory evidence of partial cross-allergenicity between imipenem/cilastatin sodium and the other beta-lactam antibiotics, penicillins and cephalosporins. Severe hypersensitivity reactions have been reported with most beta-lactam antibiotics. Before therapy with imipenem/cilastatin sodium, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. If an allergic reaction to imipenem/cilastatin sodium occurs, the drug should be discontinued and appropriate measures undertaken.
Case reports in the literature have shown that co-administration of carbapenems, including imipenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing tile risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of imipenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of IMCITIN is necessary, supplemental anti-convulsant therapy should be considered (see Interactions).
Because Clostridium difficile-associated colitis has been reported with imipenem/cilastatin sodium, therefore, it should be considered and prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Central Nervous System: As with other beta-lactam antibiotics, CNS side effects such as myoclonic activity, confusional states, or seizures have been reported, especially when recommended dosages based on renal function and body weight were exceeded. These experiences have been reported most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) and/or compromised renal function in whom accumulation of the administered entities could occur. Hence, close adherence to recommended dosage schedules is urged, especially in these patients (see Dosage & Administration).
Anticonvulsant therapy should be continued in patients with a known seizure disorder.
If focal tremors, myoclonus or seizures occur, patients should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted. If CNS symptoms continue, the dosage of imipenem/cilastatin sodium should be decreased or discontinued.
Patients with creatinine clearances of ≤5 mL/min/1.73 m² should not receive imipenem/cilastatin sodium unless hemodialysis is instituted within 48 hours. For patients on hemodialysis, imipenem/cilastatin sodium is recommend only when the benefit outweighs the potential risk of seizures.
Use in Children: Clinical data are insufficient to recommend the use of imipenem/cilastatin sodium for children under 3 months of age, or pediatric patients with impaired renal function. (See also Dosage & Administration.)