Coralan

Coralan

ivabradine

Manufacturer:

Servier

Distributor:

Zuellig Pharma
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, who are unable to tolerate or w/ 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) w/ systolic dysfunction in combination w/ standard therapy including β-blocker therapy, or when β-blocker is contraindicated or not tolerated in patients in sinus rhythm & whose heart rate is ≥75 bpm.
Dosage/Direction for Use
CAD Initially 5 mg bd, may be increased to 7.5 mg bd after 3-4 wk depending on the therapeutic response. Titrate dose downward or 2.5 mg bd if heart rate is <50 bpm or symptoms of bradycardia is present. Chronic heart failure Initially 5 mg bd, may be increased to 7.5 mg bd after 2 wk if resting heart rate is >60 bpm. If heart rate is between 50-60 bpm, 5 mg bd should be maintained. Elderly ≥75 yr 2.5 mg bd.
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) & hepatic insufficiency, sick sinus syndrome, SA block, pacemaker-dependent patient, unstable or acute heart failure & unstable angina, 3rd degree AV block. Concomitant w/ strong potent CYP3A4 inhibitors, macrolide antibiotics, HIV PIs & nefazodone; moderate CYP3A4 inhibitors eg, verapamil or diltiazem. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Atrial fibrillation or other cardiac arrhythmias; 2nd degree AV block, pre-treatment resting heart rate <70 bpm. Heart failure patients w/ NYHA functional classification IV; stroke. Patients w/ retinitis pigmentosa; mild to moderate hypotension; congenital QT syndrome or treated w/ QT prolonging medicinal drugs. Monitor BP in hypertensive patients requiring BP treatment modifications. Renal impairment (CrCl <15 mL/min) & moderate hepatic impairment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Childn <18 yr.
Adverse Reactions
Luminous phenomena (phosphenes), bradycardia; headache (generally during 1st mth of treatment), dizziness (possibly related to bradycardia); blurred vision; 1st degree AV block, ventricular extrasystoles, atrial fibrillation; uncontrolled BP.
Drug Interactions
May exacerbate heart rate reduction w/ QT-prolonging drugs eg, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone & non-CV QT prolonging drugs (eg, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, erythromycin IV). Moderate CYP3A4 inhibitors eg, diltiazem or verapamil. Potent CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV-PIs). Increased risk of arrhythmia w/ K-depleting diuretics (thiazide & loop diuretics); moderate CYP3A4 inhibitors (eg, fluconazole) & inducers (eg, rifampicin, barbiturates, phenytoin, St. John's wort; grapefruit juice).
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
Form
Coralan FC tab 7.5 mg
Packing/Price
56's
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