Coralan

Coralan

ivabradine

Manufacturer:

Servier
Concise Prescribing Info
Contents
Ivabradine
Indications/Uses
Symptomatic treatment of chronic stable angina pectoris: in CAD adults w/ normal sinus rhythm & heart rate ≥70 bpm, in adults unable to tolerate or w/ a contraindication to the use of β-blockers, or in combination w/ β-blockers in patients inadequately controlled w/ an optimal β-blocker dose. Chronic heart failure (NYHA II-IV class) w/ systolic dysfunction, in adult patients in sinus rhythm & whose heart rate is ≥75 bpm, in combination w/ standard therapy including β-blocker therapy or when β-blocker therapy is contraindicated or not tolerated.
Dosage/Direction for Use
Symptomatic treatment of chronic stable angina pectoris Starting dose: Not exceed 5 mg twice daily in patients <75 yr (2.5 mg twice daily in patients ≥75 yr). May be increased to the next higher dose after 3-4 wk if the patient is still symptomatic, if the initial dose is well tolerated & if resting heart rate remains >60 bpm. Maintenance dose: Not exceed 7.5 mg twice daily. Discontinue if there is no improvement in angina symptoms w/in 3 mth. Chronic heart failure Starting dose: 5 mg twice daily in patients <75 yr (2.5 mg twice daily in patients ≥75 yr). After 2 wk of treatment, dose can be increased to 7.5 mg twice daily (5 mg twice daily in patients ≥75 yr) if resting heart rate is persistently >60 bpm or decreased to 2.5 mg twice daily if resting heart rate is persistently <50 bpm or in case of bradycardia. For both indications, if, during treatment, heart rate decreases <50 bpm or in case of bradycardia symptoms, dose must be titrated downward (& discontinued if it persists despite dose reduction).
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Resting heart rate <70 bpm prior to treatment; cardiogenic shock; acute MI; severe hypotension (<90/50 mmHg); severe hepatic insufficiency; sick sinus syndrome; SA block; unstable or acute heart failure; pacemaker dependent (heart rate imposed exclusively by the pacemaker); unstable angina; AV block of 3rd degree; combination w/ strong cytochrome P450 3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) & nefazodone; combination w/ verapamil or diltiazem. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Indicated only for symptomatic treatment of chronic stable angina pectoris. Serial heart rate measurements, ECG or ambulatory 24-hr monitoring should be considered before initiation of treatment & when titration is considered. Not recommended in patients w/ atrial fibrillation & other cardiac arrhythmias that interfere with sinus node function. Monitor regularly ivabradine-treated patients for the occurrence of atrial fibrillation. Increased risk of developing atrial fibrillation. Monitor closely patients w/ chronic heart failure & intraventricular conduction defects. Not recommended in AV block of 2nd degree. Treatment must not be initiated <70 bpm, during treatment, if resting heart rate decreases persistently <50 bpm or in case of symptomatic bradycardia, the dose must be down-titrated or treatment discontinued if it persists. Combination w/ heart rate reducing Ca channel blockers (eg, verapamil, diltiazem). Chronic heart failure NYHA class IV patients. Not recommended immediately after a stroke. Patients w/ retinitis pigmentosa. Hypotension. Non urgent DC-cardioversion should be considered 24 hr after the last dose. Avoid in patients w/ congenital QT syndrome or treated w/ QT prolonging medicinal products. Monitor BP in hypertensive patients requiring BP treatment modification. Contains lactose.
Adverse Reactions
Luminous phenomena (phosphenes). Headache, blurred vision, dizziness, bradycardia, AV 1st degree block (ECG prolonged PQ interval), ventricular extrasystoles, atrial fibrillation, uncontrolled BP. Eosinophilia, hyperuricaemia, syncope, diplopia, visual impairment, vertigo, palpitations, supraventricular extrasystoles, ECG prolonged QT interval, hypotension, dyspnoea, nausea, constipation, diarrhoea, abdominal pain, angioedema, rash, muscle cramps, asthenia, fatigue, elevated creatinine in blood. Erythema, pruritus, urticaria, malaise. AV 2nd & 3rd degree block, sick sinus syndrome.
Drug Interactions
Contraindicated: Strong CYP3A4 inhibitors; verapamil & diltiazem. Not recommended: QT prolonging medicinal products, grapefruit juice. W/ precautions: K-depleting diuretics (thiazide diuretics & loop diuretics), moderate CYP3A4 inhibitors, CYP3A4 inducers.
MIMS Class
Anti-Anginal Drugs
ATC Classification
C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Coralan FC tab 5 mg
Packing/Price
56's (Rp538,720/pak)
Form
Coralan FC tab 7.5 mg
Packing/Price
56's (Rp538,720/pak)
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