8). Gastrointestinal ulcerations Nicorandil induced ulceration may occur at different locations in the same patient. They are refractory to treatment and most only respond to withdrawal of nicorandil treatment. 8). Healthcare professionals should be aware of the importance of a timely diagnosis of nicorandil-induced ulcerations and of a rapid withdrawal of nicorandil treatment in case of occurrence of such ulcerations.
Based on available information, the time between starting nicorandil use and the onset of ulceration ranges from shortly after initiating nicorandil treatment to several years after starting nicorandil. Gastrointestinal haemorrhage secondary to gastrointestinal ulceration has been reported with nicorandil.
Patients taking acetylsalicylic acid or NSAIDs (Non Steroid Anti Inflammatory Drugs) concomitantly are at increased risk for severe complications such as gastrointestinal haemorrhage. 5). If advanced, ulcers may develop into perforation, fistula, or abscess formation.
Patients with diverticular disease may be at particular risk of fistula formation or bowel perforation during nicorandil treatment. Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported.
Therefore, caution is advised when concomitant use of corticosteroids is considered. Eye ulcerations Very rare conjunctivitis, conjunctival ulcer and corneal ulcer have been reported with nicorandil. Patients should be advised of the signs and symptoms and monitored closely for corneal ulcerations.
8). 8). Heart failure Due to lack of data, caution is advised to use nicorandil in patients with heart failure class NHYA III or IV. Hyperkalaemia Severe hyperkalaemia has been very rarely reported with nicorandil. 8). Desiccant The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake.
Paediatric population Nicorandil is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group. G6PD deficiency Nicorandil should be used with caution in patients with glucose-6-phosphate-dehydrogenase deficiency.
Nicorandil acts in parts through its organic nitrate moiety. The metabolism of organic nitrates can result in the formation of nitrites which may trigger methaemoglobinaemia in patients with glucose-6-phosphate dehydrogenase deficiency.