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General: The selection of NIMEDINE to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
Hypersensitivity: Serious and occasionally fatal hypersensitivity (including anaphylactoid and severe cutaneous adverse reactions) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. Before initiating therapy with NIMEDINE, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to NIMEDINE occurs, discontinue the therapy immediately. Serious anaphylactic reactions require immediate emergency treatment.
Haematology: A positive direct or indirect Coombs test may develop during treatment with NIMEDINE.
Antibacterial spectrum: The antibacterial spectrum of NIMEDINE should be taken into account especially in life-threatening conditions before embarking on any empiric treatment. Furthermore, due to the limited susceptibility of specific pathogens associated with e.g. bacterial skin and soft-tissue infections, to NIMEDINE, caution should be exercised. The use of NIMEDINE is not suitable for treatment of these types of infections unless the pathogen is already documented and known to be susceptible or there is a very high suspicion that the most likely pathogen(s) would be suitable for treatment. Concomitant use of an appropriate anti-MRSA agent may be indicated when MRSA infections are suspected or proven to be involved in the approved indications. Concomitant use of an aminoglycoside may be indicated when Pseudomonas aeruginosa infections are suspected or proven to be involved in the approved indications.
Interaction with valproic acid: The concomitant use of NIMEDINE and valproic acid/sodium valproate is not recommended.
Clostridium difficile: Antibiotic-associated colitis and pseudomembranous colitis have been reported with NIMEDINE and with nearly all other anti-bacterial agents and may range from mild to life-threatening in severity. It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of NIMEDINE. Discontinuation of therapy with NIMEDINE and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Meningitis: NIMEDINE is not recommended for the therapy of meningitis.
Central nervous system: CNS adverse reactions such as myoclonic activity, confusional states, or seizures have been reported, especially when recommended doses 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 dose schedules is urged especially in these patients. Anticonvulsant therapy should be continued in patients with a known seizure disorder.
Special awareness should be made to neurological symptoms or convulsions in children with known risk factors for seizures, or on concomitant treatment with medicinal products lowering the seizures threshold.
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 dose of NIMEDINE should be decreased or discontinued.
Patients with creatinine clearances of ≤5 ml/min/1.73 m2 should not receive NIMEDINE unless haemodialysis is instituted within 48 hours. For patients on haemodialysis, NIMEDINE is recommended only when the benefit outweighs the potential risk of seizures.
Effects on Ability to Drive and Use Machine: No studies on the effects on the ability to drive and use machines have been performed. However, there are some side effects (such as hallucination, dizziness, somnolence, and vertigo) associated with this product that may affect some patients' ability to drive or operate machinery.
Hepatic: Hepatic function should be closely monitored during treatment with NIMEDINE due to the risk of hepatic toxicity (such as increase in transaminases, hepatic failure and fulminant hepatitis).
Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with NIMEDINE. There is no dose adjustment necessary.
Renal impairment: Imipenem-cilastatin accumulates in patients with reduced kidney function. CNS adverse reactions may occur if the dose is not adjusted to the renal function.
Use in Children: Clinical data are insufficient to recommend the use of NIMEDINE in children under 1 year of age or paediatric patients with impaired renal function (serum creatinine >2 mg/dl). See also Central nervous system as previously mentioned.
NIMEDINE 500 mg/500 mg contains approximately 1.6 mEq (approximately 37.6 mg) of sodium which should be taken into consideration by patients on a controlled sodium diet.
