Randil Tablets – Nicorandil 10 mg, 20 mg

  • Each Randil 10mg tablet contains: Nicorandil 10mg.
  • Each Randil 20mg tablet contains: Nicorandil 20mg

Therapeutic indications

Randil tablets are indicated for the following:

  1. The prevention and long term treatment of chronic stable angina pectoris.
  2. 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:
      1. LVH on ECG,
      2. left ventricular dysfunction,
      3. Age > 65, diabetes mellitus (type I or II excluding those on sulphonylureas),
      4. hypertension or documented vascular disease

Posology and method of administration

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.

Elderly: For elderly patients use of the lowest effective dose is recommended.

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

Contraindications

  • Randil is contraindicated in patients with hypersensitivity to nicorandil or any of the excipients.
  • Nicorandil must not be used in the case of cardiogenic shock, hypotension or left ventricular failure with low filling pressure.
  • Concurrent use of nicorandil and phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is contraindicated since it can lead to a serious drop in blood pressure.

Special warnings and precautions for use

Gastrointestinal ulcerations, skin and mucosal ulceration have been reported with nicorandil. These are refractory to treatment and most only respond to withdrawal of nicorandil treatment. If ulcerations develop, nicorandil should be discontinued.

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

Nicorandil must be used with caution in patients who may have blood volume depletion or in those who present,

  • low systolic blood pressure (e.g below 100 mm Hg),
  • acute pulmonary oedema or acute myocardial infarction with acute left ventricular failure and low filling pressures.

Caution is advised if nicorandil is used in combination with other medicinal products with blood pressure lowering effect.

The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake.

Besides the nicorandil tablets, each blister contains active substance-free silica gel as desiccant in a separate sachet which is marked accordingly. The patients should be advised not to take this sachet. Although any accidental intake of this desiccant is usually harmless.

Paediatric patients: Randil is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.

Interaction with other medicinal products and other forms of interaction

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

Concurrent use of nicorandil and phosphodiester-ase 5 inhibitors, e.g. sildenafil, tadalfil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure. Therapeutic doses of nicorandil may lower the blood pressure of hypotensive patients.

If nicorandil is used concomitantly with antihypertensive agents or other medicinal products with blood-pressure-lowering effect (e.g vasodilators, tricyclic antidepressants, alcohol) the blood-pressure-lowering effect may be increased.

Pregnancy & lactation

Pregnancy: Although animal studies have not shown any teratogenic effect of nicorandil, the medicinal product has not been studied in human pregnancy; therefore, Randil must only be used in pregnant women if the anticipated benefit outweighs any potential risks.

Lactation: Animal studies have shown that
nicorandil is excreted in small amounts into the breast milk. It is not known whether nicorandil is excreted in human milk, therefore Randil is not recommended during breast feeding.

Effects on ability to drive and use machines

Blood pressure-lowering effects of nicorandil can reduce the ability to drive or to use machines. This effect can be increased in conjunction with alcohol or other products with blood-pressure-lowering effect (e.g. vasodilators, tricyclic antidepressants).

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

Undesirable effects

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).
FreqADR
very commonheadache, particularly during the first few days of treatment
commondizziness
commonincrease heart rate, following the adminstration of high doses
commoncutaneous vasodilation with flushing
uncommondrecrease in blood pressure
commonnausea and vomiting
rareGI ulceration, such as stomatitis, mouth ulcers, tongue ulcers, interstinal and anal ulcers.
very rareliver disorders, such as hepatitis, cholestasis, or jaundice
raredifferent types of rash, pruritus
commonfeeling of weakness
Randil side effects
Randil Tablets
Randil Tablets

Refernaces ATC code: C01DX16

Randil Tablets produced by ADWIA Co, S.A.E. 10TH of Ramadan City, Egypt

Reporting side effects

  • email: phv@adwia.com
  • webiste: phv.adwia.com

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