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Nicorandil

Generic Medicine
Indications

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

Pharmacology

Nicorandil dilates arterioles and large coronary arteries by opening potassium channels and also stimulates guanylate cyclase, leading to venous vasodilation. As a result, it reduces preload and afterload and improves coronary blood flow.

Dosage Administration

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 the patient's 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.

Elderly: 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.

Interactions

Although no significant pharmacological or pharmacokinetic interactions have been observed in animal and human studies with Nicorandil when used with beta-blockers, calcium channel blockers, digoxin, digoxin/furosemide combination, rifampicin, and cimetidine, it cannot be ruled out that Nicorandil may enhance the effects of other vasodilators, tricyclic antidepressants, and antihypertensive drugs, especially when used with alcohol.

Contraindications

Nicorandil tablets are contraindicated in patients with known hypersensitivity to Nicorandil. Its use is also contraindicated in cardiogenic shock, acute myocardial infarction with acute left ventricular failure and low filling pressures, in patients with hypotension, and in those taking phosphodiesterase-5 inhibitors due to the risk of a significant drop in blood pressure. Nicorandil should be used with caution in patients who may have reduced blood volume or low systolic blood pressure (below 100 mm Hg). It should be avoided in patients with cardiogenic shock or acute myocardial infarction accompanied by acute left ventricular failure and low filling pressures. Treatment should be discontinued and appropriate measures taken if mouth ulceration, stomatitis, or persistent/severe buccal ulceration occurs. Caution is advised when using Nicorandil in patients with glaucoma. The hypotensive effects of other vasodilators, tricyclic antidepressants, or alcohol may be increased when used together with Nicorandil. Therapeutic doses of Nicorandil may lower blood pressure in hypertensive patients; therefore, caution is required when prescribing it alongside antihypertensive drugs. Animal studies on mutagenicity and carcinogenicity have not shown any harmful effects of Nicorandil under experimental conditions

Side Effects

Headache (especially at the beginning of treatment, usually transient); cutaneous vasodilation with flushing; nausea, vomiting, dizziness, and weakness have been reported; rarely oral ulceration and myalgia; at higher doses, reduction in blood pressure and/or increase in heart rate; angioedema has also been reported.

Pregnancy & Lactation

Although animal studies have not shown any harmful effects of Nicorandil on the fetus, its use has not been studied in human pregnancy. Use in pregnant women should only be considered if the expected benefit outweighs the potential risk. It is not known whether Nicorandil is excreted in human milk; therefore, caution is advised when administered to nursing mothers. Drug interactions: Although no pharmacological and/or pharmacokinetic interactions have been observed in animal and human studies with Nicorandil when used with beta-blockers, calcium antagonists, digoxin, a combination of digoxin/furosemide, rifampicin, and cimetidine, it cannot be excluded that Nicorandil may enhance the effects of other vasodilators, tricyclic antidepressants, and antihypertensive drugs when used concurrently, especially with alcohol.

Precautions & Warnings

Hypovolaemia, low systolic blood pressure, acute pulmonary oedema, and pregnancy. May impair the ability to drive or operate machinery.

Overdose Effects

In cases of overdose, symptoms may include peripheral vasodilation leading to a drop in blood pressure and reflex tachycardia. Management includes monitoring cardiac function and providing general supportive measures. If necessary, plasma volume should be increased by fluid replacement. In life-threatening situations, the use of vasopressors should be considered.

Therapeutic Class

Potassium-channel activator

Storage Conditions

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

Common Questions

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