Description:
IndicationsSymptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivanor? is indicated:In patients unable to tolerate or with a contra-indication to the use of beta-blockers, orIn combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.?Pharmacologyvabradine 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.?Dosage & AdministrationThe 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 2.5mg 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: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).Renal insufficiency: Use with caution in patients with creatinine clearance <15ml/min.Hepatic impairment: Use with caution in patients with moderate hepatic impairment; contra-indicated in severe hepatic impairment. Children and adolescents: Not recommended.?InteractionQT 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.?ContraindicationsHistory 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 P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).?Side EffectsVisual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.?Pregnancy & LactationMale and female fertility were not affected in rats in studies. There is no or little information about ivabradine's usage in pregnant women. As a result, ivabradine is not recommended during pregnancy. Ivabradine is eliminated in milk, according to animal research. As a result, ivabradine should not be used while breastfeeding.?Precautions & WarningsMild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, moderate hepatic insufficiency, severe renal insufficiency.?Therapeutic ClassAnti-anginal and anti-ischaemic medications?Storage ConditionsKeep the temperature below 30?C and away from light and moisture. Keep out of children's reach.
