Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated: 1. In patients unable to tolerate or with a contraindication to the use of beta-blockers, or 2. In combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose & 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.
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 & 1 tablet in the evening during meals.
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 ivabradine 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, 3rd degree AV block, combination with strong cytochrome P450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors). 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.
Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, & dizziness.
Pregnancy: There are no or limited amount of data from the use of Ivabradine in pregnant women. Therefore, Ivabradine is contraindicated during pregnancy. Breast-feeding: Animal studies indicate that Ivabradine is excreted in milk. Therefore, Ivabradine is contra-indicated during breastfeeding.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
.png&w=384&q=75)