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Cardiac Arrhythmias: Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (eg, ventricular or supraventricular tachycardia). Ivabradine is therefore, not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
It is recommended to regularly clinically monitor ivabradine-treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (eg, in case of exacerbated angina, palpitations, irregular pulse).
Use in Patients with AV-block of 2nd Degree: Ivabradine is not recommended in patients with AV-block of 2nd degree.
Use in Patients with a Low Heart Rate: Ivabradine must not be initiated in patients with a pre-treatment resting heart rate <60 bpm (see Contraindications). If during treatment, resting heart rate decreases persistently <50 bpm or the patient experiences symptoms related to bradycardia eg, dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate is <50 bpm or symptoms of bradycardia persist (see Dosage & Administration).
Combination with Other Antianginal Therapies: Concomitant use of ivabradine with heart rate-reducing calcium channel blockers eg, verapamil or diltiazem is not recommended (see Interactions). No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers eg, amlodipine. Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established. (See Pharmacology under Actions.)
Chronic Heart Failure: Heart failure must be appropriately controlled before considering ivabradine treatment. The use of ivabradine is contraindicated in heart failure patients with NYHA functional classification III-IV, due to a lack of data on clinical efficacy and safety (see Contraindications). Caution is needed in patients with asymptomatic left ventricular dysfunction, as well as in heart failure patients with NYHA functional classification II due to a limited number of patients studied.
Stroke: The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Visual Function: Ivabradine influences on retinal function (see Pharmacology under Actions). To date, there is no evidence of a toxic effect of ivabradine on the retina, but the effects of long-term ivabradine treatment beyond 1 year on retinal function are currently not known. Cessation of treatment should be considered if any unexpected deterioration in visual function occurs. Caution should be exercised in patients with retinitis pigmentosa.
Excipients: Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Coralan.
