Nicorandil tablet is contra-indicated in patients who have shown hypersensitivity to Nicorandil. Use is contra-indicated with cardiogenic shock and acute myocardial infarction with acute left ventricular failure and low filling pressures, in patients with hypotension, and in patients taking phosphodiesterase-5 inhibitors because concurrent use of Nicorandil can lead to a serious drop in blood pressure. Warnings and precautions: Nicorandil should be used with caution in patients who may have blood volume depletion or in those who present with low systolic blood pressure (below 100 mm Hg). The use of the drug in patients with cardiogenic shock, or acute myocardial infarction with acute left ventricular failure and low filling pressures should be avoided. Nicorandil should be discontinued and appropriate measures taken if mouth ulceration, stomatitis or persistent or severe buccal ulcerations, appear. Caution is advised for the use of Nicorandil in patients with glaucoma. The hypotensive effect of other vasodilators, tricyclic antidepressants or alcohol can be increased by administration in combination with Nicorandil. Therapeutic doses of Nicorandil may lower the blood pressure of hypertensive patients and Nicorandil therefore, as with other antianginal agents, should be used with care when prescribed with antihypertensive drugs. Animal mutagenicify and carcinogenicity studies have not revealed any adverse effect of Nicorandil when used under experimental conditions.
Headache (usually transitory), flushing, dizziness, nausea, vomiting and weakness. Hypotension and reflex tachycardia at high doses.
Although animal studies have not shown any harmful effect of Nicorandil to the foetus, has not been studied in human pregnancy. Use in pregnant women requires that the anticipated benefit be weighed against possible hazard. It is not known whether the drug is excreted in human milk. Caution should be exercised when Nicorandil is administered to a nursing mother. Drug interactions: Although no pharmacological and/or pharmacokinetic interaction has been obsen/ed in animal and human studies with Nicorandil associated with beta-blockers, calcium antagonists, digoxin, a combination of digoxin/furosemide, rifampicin, and cimetidine, it is not excluded that the drug may nevertheless potentiate the effect of other vasodilators, tricyclic antidepressants and antihypertensive drugs administered concurrently, especially in combination with alcohol.
Hypovolaemia, low systolic BP, acute pulmonary oedema, pregnancy. May impair ability to drive or operate machinery.
ln the case of overdosage, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia. In such an event, monitoring of cardiac function and general supportive measures should be used. If not successful, circulating plasma volume should be increased by substitution of fluid. ln life-threatening situations, administration of vasopressors should be considered.
Potassium-channel activator
Store in a cool and dry place, protected from light.
