Coralan

Ivabradine

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. 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.

Symptomatic treatment of chronic stable angina pectoris Patients <75 yr Max starting dose: 5 mg bid. May be increased to 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 decreases to <50 bpm at rest or symptoms of bradycardia occur. Max maintenance dose: 7.5 mg bid. CHF Recommended starting dose: 5 mg bid. May be increased to 7.5 mg bid after 2 wk if resting heart rate is persistently >60 bpm, or decreased to 2.5 mg bid if resting heart rate is persistently <50 bpm or symptoms of bradycardia occur. Elderly ≥75 yr Initially 2.5 mg bid before necessary up-titration.

Should be taken with food: Avoid excessive 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 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 (nelfinavir, ritonavir) & nefazodone; 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. Consider treatment cessation if any unexpected deterioration in visual function occurs. 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. Patients w/ CHF NYHA class IV; retinitis pigmentosa; mild to moderate hypotension. 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; CHF 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 CHF patients. Consider non-urgent direct current-cardioversion 24 hr after the last dose. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ heart rate reducing Ca channel blockers eg, verapamil, diltiazem. 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, 1st degree AV block (prolonged PQ interval in ECG), ventricular extrasystoles, atrial fibrillation; uncontrolled BP.

Exacerbated QT prolongation by heart rate reduction w/ CV (quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone) & non-CV (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. 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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