Advertisement
Advertisement
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/ 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 w/ sinus rhythm & heart rate ≥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 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), sick sinus syndrome, SA & 3rd degree AV block, unstable or acute heart failure, pacemaker-dependent, unstable angina. Concomitant use w/ strong CYP3A4 inhibitors eg, azole antifungals, macrolides, HIV PIs & nefazodone; moderate CYP3A4 inhibitors eg, verapamil or diltiazem. Severe hepatic insufficiency. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.
Special Precautions
Not recommended in atrial fibrillation or other cardiac arrhythmias interfering w/ sinus node function; 2nd degree AV block; stroke. Not to be initiated in patients w/ pre-treatment resting heart rate <70 bpm. Chronic heart failure w/ intraventricular conduction defects, ventricular dyssynchrony; heart failure NYHA class IV; retinitis pigmentosa; mild to moderate hypotension. Avoid use in congenital QT syndrome or treated w/ QT-prolonging medicinal drugs. Measure heart rate before & during treatment. Monitor BP in hypertensive patients requiring BP treatment modifications. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ dihydropyridine Ca-channel blockers. May affect ability to drive & use machines. Renal (CrCl <15 mL/min) & moderate hepatic impairment. Paed <18 yr.
Adverse Reactions
Luminous phenomena (phosphenes). Headache, dizziness; blurred vision; bradycardia, 1st degree AV block, ventricular extrasystoles, atrial fibrillation; uncontrolled BP.
Drug Interactions
Exacerbated heart rate reduction w/ CV- (eg, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone) & non-CV QT-prolonging drugs (eg, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, erythromycin IV). Severe arrhythmia w/ K-depleting diuretics eg, thiazide & loop diuretics. Increased plasma conc w/ potent CYP3A4 inhibitors eg, ketoconazole, josamycin. Increased AUC & added heart rate reduction w/ moderate CYP3A4 inhibitors eg, diltiazem, verapamil. Increased exposure w/ grapefruit juice. Decreased exposure & activity w/ CYP3A4 inducers eg, rifampicin, barbiturates, phenytoin, St. John's wort. Monitor heart rate w/ moderate CYP3A4 inhibitors eg, fluconazole.
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
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement