Coralan

Coralan

ivabradine

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ivabradine HCl
Indications/Uses
Treatment of CAD: Symptomatic treatment of chronic stable angina pectoris in CAD adult w/ normal sinus rhythm & heart rate ≥70 beats/min. Indicated in adult unable to tolerate or w/ a CI to the use of β-blockers; or in combination w/ β-blockers in patient inadequately controlled w/ an optimal β-blocker dose. Treatment of chronic heart failure: Chronic heart failure NYHA class II-IV w/ systolic dysfunction in adults w/ sinus rhythm & whose heart rate is ≥75 beats/min in combination w/ standard therapy including β-blocker therapy or when β-blocker is contraindicated or not tolerated.
Dosage/Direction for Use
5 mg bid. After 3-4 wk, increase to 7.5 mg bid. Elderly 2.5 mg morning & evening.
Administration
Should be taken with food: Take during meals. Avoid excessive consumption of grapefruit juice.
Contraindications
Resting heart rate <70 beats/min prior to treatment, cardiogenic shock, heart rhythm disorder, acute MI, severe hypotension (<90/50 mmHg), unstable angina, heart failure which has recently become worse, severe hepatic insufficiency, pacemaker-dependent patient. Concomitant potent CYP3A4 inhibitors, verapamil or diltiazem. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation. Childn <18 yr.
Special Precautions
Heart rhythm disorders, sustained atrial fibrillation, long QT syndrome, symptoms of bradycardia (eg, tiredness, dizziness or shortness of breath), recent stroke, mild to moderate hypotension, uncontrolled BP, especially after change in antihypertensive treatment, severe heart failure or heart failure w/ ECG abnormality, chronic eye retinal disease, moderate hepatic insufficiency, severe renal insufficiency. May cause temporary luminous visual phenomena (phosphenes) which may impair ability to drive or operate machinery.
Adverse Reactions
Luminous visual phenomena (phosphenes, onset is generally w/in the 1st 2 mth of treatment or resolved during or after treatment), blurred vision, bradycardia (particularly w/in 1st 2-3 mth of initiation), 1st-degree AV block, ventricular extrasystoles, atrial fibrillation, uncontrolled BP, headache, dizziness.
Drug Interactions
QT-prolonging drugs. CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV-PIs, nefazodone, diltiazem & verapamil) & inducers (eg, rifampicin, barbiturates, phenytoin, St. John's wort). Decreased blood K level w/ diuretics eg, furosemide, hydrochlorothiazide, indapamide. Grapefruit juice.
MIMS Class
ATC Classification
C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Coralan FC tab 5 mg
Packing/Price
56's (P1,462/box)
Form
Coralan FC tab 7.5 mg
Packing/Price
56's (P1,475.17/box)
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