Generic

Ivabradine

Indications

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine 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.

Pharmacology

Ivabradine is a natural heart rate reducer. It works by inhibiting the cardiac pacemaker I f current, which regulates heart rhythm by controlling spontaneous diastolic depolarization in the sinus node. Ivabradine reduces cardiac strain and hence oxygen consumption by lowering heart rate. Ivabradine also prolongs diastole, allowing for greater coronary artery perfusion and higher oxygen delivery to the heart. The cardiac effects are limited to the sinus node; they have no influence on intra-atrial, atrioventricular, or intraventricular conduction times, myocardial contractility, or ventricular repolarization.

Dosage & Administration

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: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Interaction

Medications that extend the QT wave are not advised. Medications that extend the QT wave in the heart (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Medications that do not extend the QT wave in the heart (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). Because QT wave lengthening can be worsened by heart rate decrease, simultaneous use of cardiovascular and noncardiovascular QT wave prolonging pharmaceutical drugs with ivabradine should be avoided. Close cardiac monitoring is required if the combination appears to be essential.

Contraindications

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 Effects

Blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness are all signs of ventricular extrasystoles.

Pregnancy & Lactation

Male 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 & Warnings

Patients with mild to severe hypotension, atrial fibrillation, congenital QT syndrome, or those using QT wave prolonging medications Hepatic insufficiency is moderate, while renal insufficiency is severe.

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs

Storage Conditions

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

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.