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Drug Details

IKOREL

• Drug Class Description
  Potassium channel activators.
• Generic Name
  Nicorandil
• Presentation
  Tablets, off-white, round, with faceted edges, scored on one side and bearing the inscription IK10 (10mg) or IK20 (20mg).
• Description
  Nicorandil 10mg or 20mg
• Indications
  

  Ikorel tablets are indicated for the following:

  • The prevention and long term treatment of chronic stable angina pectoris

  • A reduction in the risk of acute coronary syndromes in patients with chronic stable angina and at least one of the following risk factors: Previous MI Previous CABG CHD on angiography or a positive exercise test together with one of the following: LVH on ECG, left ventricular dysfunction, Age 65, diabetes mellitus, hypertension or documented vascular disease

• Adult Dosage
  

  Route of administration: oral.

  Adults: The recommended starting dose is 10mg nicorandil twice daily, although 5mg twice daily may be employed in patients particularly susceptible to headache. Subsequently the dosage should be titrated upward depending on the clinical response. The usual therapeutic dosage is in the range 10 to 20mg nicorandil twice daily, although up to 30mg twice daily may be employed if necessary.

• Child Dosage
  

  A paediatric dosage has not been established and use of nicorandil is not recommended.

• Elderly Dosage
  

  There is no special requirement for dosage reduction in elderly patients. As with all medicines, the lowest effective dosage should be used.

• Contra Indications
  

  Ikorel is contraindicated in patients with cardiogenic shock, left ventricular failure with low filling pressures and in hypotension. It is also contraindicated in patients who have demonstrated an idiosyncratic response or hypersensitivity to nicorandil. Due to the risk of severe hypotension, the concomitant use of Ikorel and phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is contraindicated.

• Special Precautions
  

  The use of nicorandil should be avoided in patients with depleted blood volume, low systolic blood pressure, acute pulmonary oedema or acute myocardial infarction with acute left ventricular failure and low filling pressures.

  Therapeutic doses of nicorandil may lower the blood pressure of hypertensive patients and therefore nicorandil, as with other antianginal agents, should be used with care when prescribed with antihypertensive drugs.

  Gastrointestinal ulceration, skin ulceration, and ulcers of the mucosal membranes have been reported with nicorandil. These tend to be refractory to treatment and most only respond to withdrawal of nicorandil treatment

• Interactions
  

  No pharmacological or pharmacokinetic interactions have been observed in humans or animals with beta-blockers, digoxin, rifampicin, cimetidine, acenocoumarol, a calcium antagonist or a combination of digoxin and furosemide. Nevertheless, there is the possibility that nicorandil may potentiate the hypotensive effects of other vasodilators, tricyclic antidepressants or alcohol.

  As the hypotensive effects of nitrates or nitric oxide donors are potentiated by phosphodiesterase 5 inhibitors, the concomitant use of Ikorel and phosphodiesterase 5 inhibitors is contraindicated.

  Gastrointestinal perforations in the context of concomitant use of nicorandil and corticosteroids have been reported. Caution is advised when concomitant use is considered.

• Adverse Drug Reactions
  

  The following definitions apply to the frequency terminology used hereafter:

  Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).

   

  SOC	FREQUENCY	ADR
  Nervous system disorders	Very common	Headache, particularly during the first few days of treatment.
  	Common	Dizziness
  Cardiac disorders	Common	Increase in heart rate, following the administration of high doses
  Vascular disorders	Common	Cutaneous vasodilation with flushing
  	Uncommon	Decrease in blood pressure.
  Gastrointestinal disorders	Common	Nausea and vomiting
  	Rare	Gastrointestinal ulcerations such as stomatitis, mouth ulcers, tongue ulcers, intestinal and anal ulcers. These ulcers, if advanced, may develop into perforation, fistula, or abscess formation.
  Hepato-biliary disorders	Very rare	Liver disorders such as hepatitis, cholestasis, or jaundice.
  Skin and subcutaneous tissue disorders	Rare	Different types of rash, pruritus.
  	Very rare	Angio-oedema. Skin and mucosal ulcerations (mainly peri-anal ulcerations, genital ulcerations and parastomal ulcerations).
  Musculoskeletal & connective tissue disorders	Rare	Myalgia
  General disorders and administration site conditions	Common	Feeling of weakness

   

  Additional Information

  In addition, the following events have been reported at a different frequency in the IONA (Impact of Nicorandil in Angina) study which was conducted in subjects at high risk of cardiovascular events only.

   

  Skin and subcutaneous tissue disorders

  Uncommon – angio-oedema

  Gastrointestinal disorders

  Common – rectal bleeding.

  Uncommon – mouth ulcers

  Very rare – abdominal pain

   

  Musculoskeletal & connective tissue disorders

  Uncommon - myalgia