- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of ivabradine.
Chronic heart failure with sinus rhythm above 74 bpm
Chronic stable angina (normal sinus rhythm), heart rate > 69bpm
Treatment of chronic stable angina pectoris
Symptomatic treatment of chronic stable angina pectoris in patients with coronary artery disease, with normal sinus rhythm whose heart rate is greater than or equal to 70 beats per minute (bpm), who are either contraindicated for use or intolerant of beta blockers, or in combination with beta blockers in patients inadequately controlled with an optimal beta blocker dose.
Treatment of chronic heart failure
Treatment of chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is greater than or equal to 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Treatment of chronic stable angina
Recommended starting dose of ivabradine should not exceed 5mg twice daily.
After 3 or 4 weeks the dose may be increased to 7.5mg twice daily depending on the therapeutic response.
If the patient's heart rate decreases persistently below 50 bpm at rest or bradycardia related symptoms such as dizziness, fatigue or hypotension occur during therapy, reduce the dose by downward titration possibly as low as 2.5mg twice daily if necessary.
Treatment of chronic heart failure
Recommended starting dose of ivabradine is 5mg twice daily.
After 2 weeks the dose may be increased to 7.5mg twice daily if resting heart rate is persistently above 60 bpm.
If the patient's heart rate decreases persistently below 50 bpm at rest or bradycardia related symptoms such as dizziness, fatigue or hypotension occur during therapy, reduce the dose by downward titration to 2.5mg twice daily if necessary. If the heart rate is between 50 bpm and 60 bpm, the dose of 5mg twice daily should be maintained.
In patients aged 75 years and over a lower starting dose of 2.5mg twice daily may be considered initially and titrated upwards if necessary.
Children under 18 years
Sinus node dysfunction
Systolic blood pressure < 90mmHg
Acute phase of cerebrovascular accident
Bradycardia with pulse rate at rest < 70bpm before treatment of angina
Bradycardia with pulse rate at rest < 75bpm before tx of heart failure
Long QT syndrome
Second degree atrioventricular block
Severe hepatic impairment
Sinoatrial exit block
Third degree atrioventricular block
Torsade de pointes
Uncontrolled cardiac failure
Precautions and Warnings
Family history of long QT syndrome
Females of childbearing potential
Patients over 75 years
Bradycardia with a pulse rate of 50 bpm
Cardiac conduction defects
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Moderate hepatic impairment
New York Heart Association class IV failure
Prior to electrical cardioversion
Renal impairment - creatinine clearance below 15ml/minute
Control cardiac failure before starting treatment
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
CHF: Treatment to be initiated and supervised by a specialist
Reduce initial dose in the elderly
Monitor cardiac function by ECG
Monitor ECG in patients at risk of QT prolongation
Monitor for atrial fibrillation
Monitor for syncope and bradycardia
Monitor heart rate
Monitor serum electrolytes
Review treatment if atrial fibrillation occurs
Consider discontinuing if visual function deteriorates unexpectedly
Withhold therapy for 24 hours before elective direct current cardioversion
Angina: Discontinue if no improvement within 3 months
Discontinue if pulse rate < 50 beats per minute persists
Advise patient not to take St John's wort concurrently
Advise patient to avoid grapefruit products
Female: Ensure adequate contraception during treatment
Not recommended in patients with atrial fibrillation or other cardiac arrhythmias which interfere with sinus node function.
Ivabradine loses its efficacy in the presence of a tachyarrhythmia and is not effective in the treatment or prevention of arrhythmias.
Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Not recommended for immediate use following a stroke as there is no data available for these patients.
Ivabradine may cause transient luminous visual effects (mainly phosphenes) which should be taken into account when considering driving or operating machinery or other situations where sudden variations in light intensity may occur.
Pregnancy and Lactation
Ivabradine is contraindicated in pregnancy.
There is limited data on the use of ivabradine during pregnancy.
Animal studies have shown embryotoxic and teratogenic effects. The human risk is unknown.
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 ).
Ivabradine is contraindicated in breastfeeding.
Animal studies indicated ivabradine is excreted in the breast milk.
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
Blood pressure changes
First degree AV block
Prolongation of QT interval
Second and third degree AV block
Serum creatinine increased
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 ).
Last Full Review Date: September 2018
Summary of Product Characteristics: Ivabradine 2.5mg tablets. Aspire Pharma Ltd. Revised May 2018.
Summary of Product Characteristics: Procoralan. Servier Laboratories Ltd. Revised October 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 September 2018.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.