Drugs List

Therapeutic Indications

Uses

Treatment of stable angina pectoris

Nicorandil is indicated for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).

Contraindications

Children under 18 years
Acute pulmonary oedema
Breastfeeding
Cardiogenic shock
Hypovolaemia
Left ventricular dysfunction
Severe hypotension

Precautions and Warnings

G6PD deficiency
Gastrointestinal diverticula
New York Heart Association class III failure
New York Heart Association class IV failure
Pregnancy

Advise patient ability to drive or operate machinery may be impaired
Monitor for skin, mucosal, ocular or gastrointestinal ulceration
Advise patient to report any eye irritation promptly
Consider discontinuation if skin, mucosal, ocular or GI ulceration occurs
Withdrawal of drug should take place under a cardiologist's supervision
Advise patient that the effects of alcohol may be potentiated

Nicorandil can cause serious skin, mucosal, and eye ulceration; including gastrointestinal ulcers, which may progress to perforation, haemorrhage, fistula or abscess. Stop treatment if ulceration occurs and consider an alternative.

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

The tablets are sensitive to moisture, hence the patient should be advised to keep the tablets in their blister until intake. Each blister contains active substance-free silica gel tablets as desiccant in a separate blister segment which is marked accordingly. The patient must be advised not to take these. Although accidental intake of this desiccant is usually harmless, it may alter the scheduled intake of the active tablets.

Pregnancy and Lactation

Pregnancy

Use nicorandil with caution in pregnancy.

At the time of writing, there is insufficient experience concerning exposed pregnancies and their outcomes. The manufacturers report that animal studies have not shown any teratogenic effects. Nicorandil should not be used in pregnancy unless there is no safer alternative.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Nicorandil is contraindicated in breastfeeding.

At the time of writing, there is insufficient experience concerning the use of nicorandil during breastfeeding. It is unknown if nicorandil is excreted in human breast milk. Animal studies have shown that nicorandil is excreted in small amounts into breast milk. Avoid breastfeeding whilst taking nicorandil therapy.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anal ulceration
Angioedema
Aphthous ulcers
Changes in hepatic function
Cholestasis
Conjunctival ulcer
Conjunctivitis
Corneal ulcer
Cutaneous vasodilation
Diplopia
Dizziness
Flushing
Gastro-intestinal abscess
Gastro-intestinal fistulae
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Gastro-intestinal ulceration
Headache
Hepatitis
Hyperkalaemia
Hypotension
Increased heart rate
Jaundice
Mouth ulcers
Myalgia
Nausea
Pruritus
Rash
Rectal bleeding
Skin ulcer
Stomatitis
Tongue ulceration
Ulceration of mucous membrane
Vomiting
Weakness

Presentation

Oral formulation of nicorandil

Drugs List

Therapeutic Indications

Uses

Treatment of stable angina pectoris

Nicorandil is indicated for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Acute pulmonary oedema
Breastfeeding
Cardiogenic shock
Hypovolaemia
Left ventricular dysfunction
Severe hypotension

Precautions and Warnings

G6PD deficiency
Gastrointestinal diverticula
New York Heart Association class III failure
New York Heart Association class IV failure
Pregnancy

Advise patient ability to drive or operate machinery may be impaired
Monitor for skin, mucosal, ocular or gastrointestinal ulceration
Advise patient to report any eye irritation promptly
Consider discontinuation if skin, mucosal, ocular or GI ulceration occurs
Withdrawal of drug should take place under a cardiologist's supervision
Advise patient that the effects of alcohol may be potentiated

Nicorandil can cause serious skin, mucosal, and eye ulceration; including gastrointestinal ulcers, which may progress to perforation, haemorrhage, fistula or abscess. Stop treatment if ulceration occurs and consider an alternative.

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

The tablets are sensitive to moisture, hence the patient should be advised to keep the tablets in their blister until intake. Each blister contains active substance-free silica gel tablets as desiccant in a separate blister segment which is marked accordingly. The patient must be advised not to take these. Although accidental intake of this desiccant is usually harmless, it may alter the scheduled intake of the active tablets.

Pregnancy and Lactation

Pregnancy

Use nicorandil with caution in pregnancy.

At the time of writing, there is insufficient experience concerning exposed pregnancies and their outcomes. The manufacturers report that animal studies have not shown any teratogenic effects. Nicorandil should not be used in pregnancy unless there is no safer alternative.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Nicorandil is contraindicated in breastfeeding.

At the time of writing, there is insufficient experience concerning the use of nicorandil during breastfeeding. It is unknown if nicorandil is excreted in human breast milk. Animal studies have shown that nicorandil is excreted in small amounts into breast milk. Avoid breastfeeding whilst taking nicorandil therapy.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anal ulceration
Angioedema
Aphthous ulcers
Changes in hepatic function
Cholestasis
Conjunctival ulcer
Conjunctivitis
Corneal ulcer
Cutaneous vasodilation
Diplopia
Dizziness
Flushing
Gastro-intestinal abscess
Gastro-intestinal fistulae
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Gastro-intestinal ulceration
Headache
Hepatitis
Hyperkalaemia
Hypotension
Increased heart rate
Jaundice
Mouth ulcers
Myalgia
Nausea
Pruritus
Rash
Rectal bleeding
Skin ulcer
Stomatitis
Tongue ulceration
Ulceration of mucous membrane
Vomiting
Weakness

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: December 2015

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 6 May 2016.

Summary of Product Characteristics: Ikorel 10mg Tablets. Zentiva. Revised September 2015.
Summary of Product Characteristics: Ikorel 20mg Tablets. Zentiva. Revised September 2015.

Drug Safety Update, MHRA 11th June 2008
https://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON017928
Last accessed: 8 December, 2015

Drug Safety Update, MHRA 21st January 2016
https://www.mhra.gov.uk
Last accessed: 6 May, 2016