Nicorandil is indicated for the prevention and long-term treatment of angina pectoris.

Nicorandil dilates arterioles and large coronary arteries by opening the potassium channels, and stimulates guanylate cyclase causing venous vasodilatation. It therefore reduces preload and afterload, and improves coronary blood flow.

Adult: The usual therapeutic range is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily, in the morning and in the evening preferably, and should be titrated upwards in accordance with patients needs, response and tolerance up to 40 mg twice daily, if necessary. An even lower starting dose of 5 mg twice daily may be used in patients particularly prone to headache.

Eldery: There are no special dosage requirements for elderly patients, but as with all medicines the lowest effective dose should be used. Nicorandil should be administered with care, using low starting dosages, in the elderly.

Children: Not recommended. Nicorandil should be used with caution in patients with serious hepatic dysfunction.

Hepatic Impairment: Dose reduction may be necessary.

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.

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 (especially on initiation, usually transitory); cutaneous vasodilation with flushing; nausea, vomiting, dizziness, weakness also reported; rarely oral ulceration and myalgia; at high dosage, reduction in blood pressure and/or increase in heart rate; angioedema, also reported.

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.

Store in a cool and dry place, protected from light.