Nicorandil


Generic Medicine Info
Indications and Dosage
Oral
Stable angina
Adult: For patients who are inadequately controlled or have a contraindication or intolerance to the 1st-line treatment: Initially, 10 mg bid, may be increased if needed up to 40 mg bid based on individual response and tolerance. Usual dose range: 10-20 mg bid. In patients who are susceptible to headache: Initially, 5 mg bid.
Elderly: Initiate at the lowest effective dose.
Administration
May be taken with or without food.
Contraindications
Acute pulmonary oedema, severe hypotension, cardiogenic shock, cardiac decompensation, hypovolaemia, left ventricular failure with low filling pressure. Coadministration with phosphodiesterase 5 (PDE-5) inhibitors and soluble guanylate cyclase stimulators (e.g. riociguat).
Special Precautions
Patient with heart failure (NYHA class III and IV), hypertrophic obstructive cardiomyopathy, aortic stenosis, low systolic blood pressure, diverticular disease, G6PD deficiency, glaucoma, hyperkalaemia. Renal and hepatic impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Gastrointestinal ulceration which may lead to perforation, fistula, abscess formation, and haemorrhage; skin or mucosal ulceration (e.g. perianal, genital or parastomal ulceration), severe hypotension, dose-related headache (particularly during initial dosing). Rarely, severe hyperkalaemia, ocular effects (e.g. conjunctivitis, conjunctival and corneal ulcers).
Cardiac disorders: Chest pain, palpitation.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, rectal bleeding, dyspepsia.
General disorders and administration site conditions: Weakness, lethargy.
Infections and infestations: Skin abscess.
Investigations: Increased heart rate.
Musculoskeletal and connective tissue disorders: Myalgia, back pain.
Nervous system disorders: Dizziness, vertigo.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, bronchitis, respiratory tract disease.
Skin and subcutaneous tissue disorders: Rash, angioedema.
Vascular disorders: Cutaneous vasodilation, flushing.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor blood pressure and heart rate.
Overdosage
Symptoms: Reflex tachycardia, peripheral vasodilation with a fall in blood pressure. Management: Supportive treatment. Monitor cardiac function. May consider substitution of fluid to increase circulating plasma volume. Consider administering vasopressors in life-threatening situations.
Drug Interactions
Increased risk of gastrointestinal ulceration and haemorrhage with NSAIDs and aspirin. Increased risk of gastrointestinal perforation with corticosteroids. Hypotensive effects may be increased with antihypertensive drugs, other vasodilators, and TCAs. May increase the risk of hyperkalaemia with other agents that elevate serum K levels. Enhanced orthostatic hypotensive effect with dapoxetine.
Potentially Fatal: Significantly enhanced hypotensive effects with PDE-5 inhibitors (e.g. sildenafil, vardenafil, tadalafil) and soluble guanylate cyclase stimulators (e.g. riociguat).
Food Interaction
Hypotensive effect may be increased with alcohol.
Action
Description:
Mechanism of Action: Nicorandil, a nitrate derivative of nicotinamide, is an antianginal agent with a dual mechanism of action. It acts as a vasodilator by activating the K channels which cause vascular membrane hyperpolarisation, thereby dilating the arterioles and large coronary arteries and decreasing cardiac afterload. Additionally, its nitrate component relaxes the venous vascular smooth muscle by increasing cyclic guanosine monophosphate (cGMP) resulting in reduced preload.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Absolute bioavailability: 75%. Time to peak plasma concentration: 30-60 minutes.
Distribution: Plasma protein binding: 25-41.5%.
Metabolism: Metabolised in the liver via denitration into N-(2-hydroxyethyl)-nicotinamide (major metabolite), nicotinuric acid, nicotinamide, N-methylnicotinamide and nicotinic acid.
Excretion: Via urine (approx 20% mainly as metabolites, approx 1% as unchanged drug). Elimination half-life: Approx 1 hour.
Chemical Structure

Chemical Structure Image
Nicorandil

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 47528, Nicorandil. https://pubchem.ncbi.nlm.nih.gov/compound/Nicorandil. Accessed Apr. 27, 2023.

Storage
Store below 25°C. Protect from moisture.
MIMS Class
Anti-Anginal Drugs
ATC Classification
C01DX16 - nicorandil ; Belongs to the class of other vasodilators used in cardiac diseases.
References
Anon. Nicorandil. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/04/2023.

Buckingham R (ed). Nicorandil. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/04/2023.

Joint Formulary Committee. Nicorandil. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/04/2023.

Nicoril 10 mg Tablets (Rivopharm UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 04/04/2023.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Ikorel 10 mg and 20 mg Tablets data sheet 20 June 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 04/04/2023.

Disclaimer: This information is independently developed by MIMS based on Nicorandil from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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