Siftus 5/Siftus 7.5

Ivabradine HCl

Symptomatic treatment of chronic stable angina pectoris in CAD in adults w/ normal sinus rhythm & heart rate ≥70 bpm. Adults unable to tolerate or w/ a contraindication to the use of β-blockers. In combination w/ β-blockers in patients inadequately controlled w/ an optimal β-blocker dose. CHF 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 should not exceed 5 mg bid. May be increased to the next higher dose after 3-4 wk if patient is still symptomatic, initial dose is well tolerated & resting heart rate remains >60 bpm. Maintenance dose: Do not exceed 7.5 mg bid. Titrate dose downward if heart rate is <50 bpm at rest or symptoms related to bradycardia occurs. CHF Initially 5 mg bid. After 2 wk, may increase to 7.5 mg bid if resting heart rate is persistently >60 bpm or decrease to 2.5 mg bid if resting heart rate is persistently <50 bpm or in case of symptoms related to bradycardia. Maintain dose of 5 mg bid if heart rate is between 50-60 mg. 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 bid.

Should be taken with food: Avoid 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; AV-block of 3rd degree. Combination w/ strong CYP450 3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolides (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 child-bearing potential not using appropriate contraceptive measures. Pregnancy & lactation.

For symptomatic treatment only in patients w/ chronic stable angina pectoris. Consider serial heart rate measurements, ECG or ambulatory 24-hr monitoring when determining resting heart rate before initiation of treatment & in patients on treatment titration. Not recommended in patients w/ atrial fibrillation or other cardiac arrhythmias that interfere w/ sinus node function; AV-block of 2nd degree. Closely monitor chronic heart failure patients w/ intraventricular conduction defects (bundle branch block left/right). Must not be initiated in patients w/ a pretreatment resting heart rate <70 bpm. Heart failure patients w/ NYHA functional classification IV. Not recommended immediately after a stroke. Patients w/ retinitis pigmentosa; mild to moderate hypotension. Consider non-urgent DC-cardioversion 24 hr after the last dose. Avoid use in patients w/ congenital QT syndrome or treated w/ QT prolonging medicinal products. May exacerbate QT prolongation which may give rise to severe arrhythmias, in particular Torsade de pointes. BP should be monitored at an appropriate interval when treatment modifications are made in chronic heart failure patients. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Childn <18 yr.

Luminous phenomena (phosphenes). Headache (generally during the 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 QT prolonging medicinal products (eg, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone) & non-CV QT prolonging medicinal products (eg, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, erythromycin IV). Increased risk of arrhythmia w/ K-depleting diuretics (thiazide diuretics & loop diuretics). Increased exposure w/ ketoconazole & josamycin; diltiazem or verapamil; grapefruit juice. May decrease exposure & activity w/ CYP3A4 inducers (eg, rifampicin, barbiturates, phenytoin, Hypericum perforatum (St. John's wort). Concomitant use of potent CYP3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolides (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV-PIs (nelfinavir, ritonavir) & nefazodone.

Anti-Anginal Drugs

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

Rx