No interactions of nicorandil have been observed with beta-blockers, digoxin, rifampicin, cimetidine, acenocoumarol, calcium channel blockers, or frusemide. Possibility of hypotensive interaction with alcohol, tricyclics or other vasodilators however exists.

Headache is often reported side effect which is usually transitory and occuring at the start of therapy. Other effects reported include cutaneous vasodilation, flushing, dizziness, nausea, vomiting and weakness. Hypotension and reflux tachycardia may occur with high doses.

Cardiogenic shock, LVF with low filling pressure, hypotension, hypersensitivity. Special precautions: Nicrandil should be avoided or used only with caution, in patients with hypovolemia, low BP, or acute pulmonary edema. Driving or operating machinery or carrying out activities which require alertness should be avoided, while under Nicarandil therapy, until it is established that the performance is unimpaired.

Date of Approval-    January 1997

Indications-

Angina Reduction in risk of coronary events in patients with chronic stable angina

Dosage-

The usual initial dose is 10mg twice daily. 5mg twice daily dose is employed in patients susceptible to headache. Subseqent dosage titration is made as per clinical response. Usual dose range is 10-20mg twice daily, however, if required upto 30mg twice daily may be given.

Patients should be warned not to drive or operate machinery until it is established that their performance is unimpaired.

Pharmacology:

Nicorandil exhibits a dual pharmacodynamic machanism. Although nicorandil is a member of the potassium channel activators, it is now quite clear that many of its vasodilatory properties do not arise from potassium channel medicated hyperpolarization of vascular smooth muscle. The chemical structure of nicorandil combines nicotinamide with a nitrate that is thought to react with sulfihydril group in smooth muscle cells to either activate guanylate cyclase or facilitate release of NO, leading to increased cyclic GMP. Nicrandil reduces coronary vascular resistence & overal improves the blood flow to the post-stenotic regions & the oxygen balance in the myocrdium.

Pharmacokinetics:

Nicorandil is absorbed from GIT without any significant first-pass metabolism. Peak plasma concentrations are acheived 30-60 minutes after oral dose. Metabolism is mainly by denitration and about 20% of an administered dose is excreted in the urine mainly as metabolites. The elimination half-life is about one hour. Nicrandil is only slightly bound to plasma proteins. No clinically significant changes in the pharmacokinetic profile have been seen in the elderly or in patients with hepatic disease or chronic renal failure.

Not reported

The safety of nicorandil during pregnancy is not established as yet. The use during pregnancy should be advocated only if the potential benefit clarly justifies the potential risk to the fetus. It is not known whether nocandil is excreted in human milk. Given this, breast feeding should be avoided by lactating mothers who undergo nicorandil therapy.