Vexpinem 500 Warnings

There is some clinical and laboratory evidence of partial cross-allergenicity between imipenem/cilastatin and the other beta-lactam antibiotics, penicillins and cephalosporins. Severe reactions (including anaphylaxis) have been reported with most beta-lactam antibiotics.
Before initiating therapy with imipenem/cilastatin, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. If an allergic reaction to imipenem/cilastatin occurs, the drug should be discontinued and appropriate measures undertaken.
Pseudomembranous colitis, reported with virtually all antibiotics, can range from mild to life-threatening in severity. Imipenem/cilastatin should be prescribed with caution in patients with a history of gastro-intestinal disease, particularly colitis. Treatment-related diarrhoea should always be considered as a pointer of diagnosis. While studies indicate that a toxin of Clostridium difficile is one of the primary causes of antibiotic-associated colitis, other causes should be considered.
Paediatric use:The clinical data demonstrating the efficacy and safety of Imipenem/Cilastatin in children is rather limited. Therefore, caution should be exercised when administering this drug to children 3 years and above.
Central nervous system: Note: Imipenem/Cilastatin is not indicated against central nervous system infections.
Patients with CNS disorders and/or compromised renal function (accumulation of imipenem/cilastatin may occur) have shown CNS side effects, especially when recommended dosages based on body weight and renal function were exceeded. Hence it is recommended that the dosage schedules of imipenem/cilastatin should be strictly adhered to, and established anticonvulsant therapy continued.
If focal tremors, myoclonus or convulsions occur, the patient should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted. If these symptoms continue, the dosage should be reduced, or imipenem/cilastatin withdrawn completely.
Under the treatment of imipenem/cilastatin asthenia and the aggravation of myasthenia gravis may occur. Therefore, in case of any symptom indicating an exacerbation of myasthenia gravis a physician must be consulted.
Use in patients with renal insufficiency: Patients with creatinine clearances of <5 mL/min should not receive imipenem/cilastatin unless haemodialysis is instituted within 48 hours. For patients on haemodialysis, imipenem/cilastatin is recommended only when the benefit outweighs the potential risk of convulsions.