Coralan心健朗

Coralan Warnings

ivabradine

Manufacturer:

Servier

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Warnings
Lack of Benefit on Clinical Outcomes in Patients with Symptomatic Chronic Stable Angina Pectoris: Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes (eg, myocardial infarction or cardiovascular death) (see Pharmacodynamics under Actions).
Measurement of Heart Rate: Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour monitoring should be considered when determining resting heart rate before initiation of ivabradine treatment and in patients on treatment with ivabradine when titration is considered. This also applies to patients with a low heart rate, in particular when heart rate decreases below 50 bpm, or after dose reduction (see Dosage & Administration).
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). The risk of developing atrial fibrillation may be higher in chronic heart failure patients treated with lvabradine. Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I antiarrhythmics. Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
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 <50 bpm or symptoms of bradycardia persist (see Dosage & Administration).
Combination with Calcium Channel Blockers: 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: Pharmacodynamics under Actions).
Chronic Heart Failure: Heart failure must be stable before considering lvabradine treatment. lvabradine should be used with caution in heart failure patients with NYHA functional classification IV due to limited amount of data in this population.
Stroke: The use of ivabradine is not recommended immediately after a stroke since no data are available in these situations.
Visual Function: Ivabradine influences on retinal function (see Pharmacology: Pharmacodynamics 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.
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