Ivabradine STELLA 7.5 mg

Rx

Indications

• For the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm (beats per minute).
• In combination with standard therapy for treatment of chronic heart failure in patients in sinus rhythm and whose heart rate is ≥ 75 bpm.

Dosage

• The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years. In patients aged 75 years or more, a lower starting dose: 2.5 mg twice daily.
• Adjust dose according to heart rate after two weeks of treatment.
• The maintenance dose should not exceed 7.5 mg twice daily.
• Ivabradine should therefore be used with precaution in patients with renal impairment.
• No dose adjustment is required in patients with mild hepatic impairment. Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. Ivabradine is contraindicated for use in patients with severe hepatic insufficiency.
• The safety and efficacy of ivabradine in children aged below 18 years have not been established.

Usage

• Ivabradine STELLA 7.5 mg is administered orally twice daily, once in the morning and once in the evening during meals.
• The dose can be decreased if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension. Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

• Hypersensitivity to ivabradine or to any of the ingredients.
• Resting heart rate below 70 bpm prior to treatment, cardiogenic shock, acute myocardial infarction, hypotension lower than 90/50 mmHg, sick sinus syndrome, sino-atrial block, unstable or acute heart failure, unstable angina, pacemaker dependent, AV-block of 3^rd degree.
• Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone, with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
• Severe hepatic insufficiency.
• Pregnancy, lactation and women of childbearing potential not using appropriate contraceptive measures.

Very common

• Luminous phenomena (phosphenes).

Common

• Headache (generally during the first month of treatment), dizziness (possibly related to bradycardia),
• Blurred vision,
• Bradycardia, AV 1st degree block (ECG prolonged PQ interval), ventricular extrasystoles, atrial fibrillation,
• Uncontrolled blood pressure.

• Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes.
• 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.
• Ivabradine is not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
• In patients treated with ivabradine the risk of developing atrial fibrillation is increased. Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics.
• Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
• Ivabradine is not recommended in patients with AV-block of 2nd degree.
• Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is contraindicated.
• Heart failure must be stable before considering ivabradine treatment.
• The use of ivabradine is not recommended immediately after a stroke.
• Ivabradine influences on retinal function.
• Ivabradine is contraindicated in patients with severe hypotension (blood pressure < 90/50 mmHg).
• The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided. Heart rate reduction, as caused by ivabradine, may exacerbate QT prolongation, which may give rise to severe arrhythmias, in particular torsade de pointes.
• Ivabradine STELLA 7.5 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Women of childbearing potential should use appropriate contraceptive measures during treatment.
• Ivabradine is contraindicated during pregnancy and breast-feeding.
• Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes. The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night. Ivabradine has no influence on the ability to use machines.