Coralan

Symptomatic treatment of chronic stable angina pectoris in CAD adults w/ normal sinus rhythm & heart rate ≥70 bpm unable to tolerate or w/ contraindication to β-blockers; in combination w/ β-blockers in patients inadequately controlled w/ optimal β-blocker dose. Chronic heart failure (NYHA II-IV class) w/ systolic dysfunction, in 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.

Symptomatic treatment of chronic stable angina pectoris Patient <75 yr Starting dose: Not exceed 5 mg twice daily. 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 & resting heart rate remains >60 bpm. Maintenance dose: Not exceed 7.5 mg twice daily. Titrate dose downward if heart rate is <50 bpm at rest or symptoms related to bradycardia occurs. Chronic heart failure Recommended starting dose: 5 mg twice daily. May be increased to 7.5 mg twice daily after 2 wk 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 symptoms of bradycardia occur. Maintain dose of 5 mg twice daily if heart rate is between 50-60 bpm. Titrate dose downward if heart rate is persistently <50 bpm at rest or symptoms related to bradycardia occurs; titrate dose upward if heart rate is persistently >60 bpm at rest. Elderly ≥75 yr Initially 2.5 mg twice daily before necessary up-titration.

Should be taken with food: Avoid consumption of grapefruit juice.

Hypersensitivity. Resting heart rate <70 bpm prior to treatment; cardiogenic shock; acute MI; severe hypotension (<90/50 mmHg); 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), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV PIs (nelfinavir, ritonavir) & nefazodone; moderate CYP3A4 inhibitors w/ heart rate reducing properties eg, verapamil or diltiazem. Severe hepatic insufficiency. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

Discontinue or titrate downward if heart rate remains <50 bpm or symptoms of bradycardia persist. Not to be initiated in patients w/ pre-treatment resting heart rate <70 bpm. Not recommended in patients w/ atrial fibrillation & other cardiac arrhythmias that interfere w/ sinus node function; 2nd degree AV-block; to use immediately after stroke. Increased risk of developing atrial fibrillation. Chronic heart failure NYHA class IV patients; retinitis pigmentosa; mild to moderate hypotension. Consider treatment cessation if any unexpected deterioration in visual function occurs. Avoid use in patients w/ congenital QT syndrome or treated w/ QT prolonging medicinal products. Monitor serial heart rate measurements, ECG or 24-hr ambulatory when determining resting heart rate before treatment initiation, in patients on treatment when titration is considered & patients w/ low heart rate; for occurrence of sustained or paroxysmal atrial fibrillation; chronic heart failure patients w/ intraventricular conduction defects & ventricular dyssynchrony; cardiac function in patients w/ congenital QT syndrome treated w/ QT prolonging medicinal products; BP when treatment modifications are made in chronic heart failure patients. Consider non-urgent DC-cardioversion 24 hr after the last dose. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ dihydropyridine Ca-channel blockers. May impair ability to drive. Renal impairment (CrCl <15 mL/min). Moderate hepatic impairment. Women of childbearing potential should use appropriate contraceptive measures during treatment. Childn <18 yr.

Luminous phenomena (phosphenes). Headache (generally during 1st mth of treatment), dizziness (possibly related to bradycardia); blurred vision; bradycardia, AV 1st degree block (ECG prolonged PQ interval), ventricular extrasystoles, atrial fibrillation, uncontrolled BP.

May exacerbate QT prolongation by heart rate reduction w/ CV (eg, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone) & non-CV (eg, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, IV erythromycin) QT prolonging medicinal products. Increased risk of arrhythmia w/ K-depleting diuretics (eg, thiazide & loop diuretics). Increased plasma conc w/ CYP3A4 inhibitors. Decreased plasma conc w/ CYP3A4 inducers. Increased mean plasma exposure w/ potent CYP3A4 inhibitors (eg, ketoconazole & josamycin). Increased exposure & additional heart rate reduction w/ diltiazem or verapamil. 2-fold increase in exposure w/ grapefruit juice. Concomitant use w/ moderate CYP3A4 inhibitors (eg, fluconazole). May decreased exposure & activity w/ CYP3A4 inducers (eg, rifampicin, barbiturates, phenytoin, Hypericum perforatum [St John's Wort]).

Anti-Anginal Drugs

C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.

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