Coralan

Coralan

ivabradine

Manufacturer:

Servier

Distributor:

DKSH
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. 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. CHF. NYHA class II-IV w/ systolic dysfunction, in patients in sinus rhythm & whose heart rate is ≥70 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 Patients ≥75 yr 2.5 mg bid. Patients <75 yr Starting dose should not exceed 5 mg bid, may be increased to the next higher dose after 3-4 wk if patient is still symptomatic, initial dose is well tolerated & resting heart rate remains >60 bpm. Titrate dose downward if heart rate <50 bpm persist or bradycardia occurs. CHF Patients ≥75 yr 2.5 mg bid, may be increased to 5 mg bid after 2 wk if resting heart rate is persistently >60 bpm. Decrease to 2.5 mg bid if resting heart rate is <50 bpm or bradycardia occurs. Patients <75 yr Starting dose is 5 mg bid, may be increased to 7.5 mg bid after 2 wk if resting heart rate is persistently >60 bpm. Decrease to 2.5 mg bid if resting heart rate is <50 bpm or bradycardia occurs. Elderly ≥75 yr Initially 2.5 mg bid.
Administration
Should be taken with food: Avoid excessive consumption of grapefruit juice.
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, 3rd-degree AV block; combination w/ strong CYP450 3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolides (clarithromycin, erythromycin, josamycin, telithromycin), HIV PIs (nelinavir, ritonavir) & nefazodone; combination w/ verapamil or diltiazem. Women of child-bearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
For symptomatic treatment only in patients w/ chronic stable angina pectoris. Serial heart rate measurements, ECG or ambulatory 24-hr monitoring before initiation of treatment & when titration is considered. Not recommended in patients w/ atrial fibrillation & other cardiac arrhythmias that interfere w/ sinus node function; monitor regularly patients for the occurrence of atrial fibrillation; increased risk of atrial fibrillation development. Carefully reconsider treatment if atrial fibrillation develops. Closely monitor patients w/ CHF & intraventricular conduction defects; not recommended in 2nd degree AV block. Do not initiate treatment in <70 bpm. During treatment; titrate downward or discontinue treatment if resting heart rate decreases persistently <50 bpm or in case of symptomatic bradycardia persists. Combination w/ heart rate reducing Ca channel blockers (eg, verapamil, diltiazem) is contraindicated. CHF NYHA class IV patients. Stroke. Not recommended immediately after a stroke. Patients w/ retinitis pigmentosa. Hypotension; consider non-urgent DC-cardioversion 24 hr after the last dose. Avoid use in patients w/ congenital QT syndrome or treated w/ QT prolonging drugs. Monitor use in hypertensive patients requiring BP treatment modification; monitor BP. Possible occurrence of transient luminous phenomena. 
Adverse Reactions
Headache, dizziness; luminous phenomena (phosphenes); blurred vision; bradycardia, 1st-degree AV block (ECG-prolonged PQ interval), ventricular extrasystoles; uncontrolled BP, eosinophilia, hyperuricaemia, syncope, diplopia, visual impairment, vertigo, palpitations, supraventricular extrasystoles, hypotension, dyspnoea, nausea, constipation, diarrhoea, abdominal pain, angioedema, rash, muscle cramps, asthenia, fatigue, elevated creatinine in blood, ECG prolonged QT interval, erythema, pruritus, urticaria, malaise, atrial fibrillation, AV 2nd & 3rd degree block, sick sinus syndrome. 
Drug Interactions
Contraindicated: Strong CYP3A4 inhibitors; verapamil & diltiazem. Not recommended: QT prolonging drugs, moderate CYP3A4 inhibitors, grapefruit juice. Caution: K-depleting diuretics (thiazide & loop diuretics), other moderate CYP3A4 inhibitors, CYP3A4 inducers.
MIMS Class
ATC Classification
C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Coralan FC tab 5 mg
Packing/Price
4 × 14's
Form
Coralan FC tab 7.5 mg
Packing/Price
4 × 14's
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