Ivaten Tablet

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivaten tablet is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60 bpm.

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Since ivabradine has been studied in a limited number of patients aged 75 years or more, a lower starting dose should be considered for these patients (2.5mg twice daily i.e. one half 5mg tablet twice daily) before up-titration if necessary.

Renal insufficiency: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15ml/min. No data are available in patients with creatinine clearance below 15ml/min. Ivabradine should therefore be used with precaution in this population.

Hepatic 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 contra-indicated for use in patients with severe hepatic insufficiency.

Children and adolescents: Ivabradine is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with Ivaten should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

Other Anti-anginal & Anti-ischaemic drugs

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.