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DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023

Opsonin Pharma Ltd. · Tablet
/ Piece
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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.
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.
Potassium-channel activator
Store in a cool and dry place, protected from light.