Gavrila

Symptomatic treatment of chronic stable angina pectoris in CAD adults w/ normal sinus rhythm & heart rate ≥70 bpm. Indicated in adults 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. Treatment of chronic heart failure NYHA class II-IV w/ systolic dysfunction in adults w/ sinus rhythm & whose heart rate is ≥75 bpm, in combination w/ standard therapy including β-blocker therapy or when β-blocker is contraindicated or not tolerated.

Symptomatic treatment of chronic stable angina pectoris Patient <75 yr Initially 5 mg bid. May be increased to the next higher dose if patient is still symptomatic & w/ heart rate >60 bpm after 3-4 wk. Maintenance: 7.5 mg bid. Treatment of chronic heart failure Initially 5 mg bid. Can 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 in case of symptoms related to bradycardia eg, dizziness, fatigue or hypotension. Maintain dose at 5 mg bid if heart rate is between 50 & 60 bpm.

Should be taken with food: Intake of tab during meals is recommended. Avoid grapefruit juice.

Hypersensitivity. Resting heart rate of <70 bpm prior to treatment; cardiogenic shock; acute MI; severe hypotension (<90/50 mmHg); sick sinus syndrome; SA block; pacemaker-dependent; unstable angina; AV block of 3rd degree, heart failure which has recently become worse. Combination w/ strong CYP3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV PIs (nelfinavir, ritonavir) & nefazodone. Combination w/ verapamil or diltiazem. Severe hepatic insufficiency. Pregnancy & lactation.

May exacerbate QT prolongation. Avoid use in patients w/ congenital QT syndrome or treated w/ QT prolonging products. Not recommended in patients w/ atrial fibrillation or other cardiac arrhythmias that interfere w/ sinus node function; patients w/ AV-block of 2nd degree; immediately after stroke. May influence retinal function. Caution in patients w/ retinitis pigmentosa. Monitor BP at an appropriate interval when BP treatment modifications are made in chronic heart failure patients. Discontinue treatment if resting heart rate <50 bpm or symptoms of bradycardia persist after dose reduction. Consider serial heart rate measurements, ECG or ambulatory 24-hr monitoring when determining resting heart rate before treatment initiation & when dose is titrated. In case of DC cardioversion, consider initiation 24 hr after last ivabradine dose. Contains lactose; patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Possible occurrence of transient luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur. Caution in patients w/ moderate hepatic insufficiency or severe renal insufficiency (CrCl <15 mL/min). Women of childbearing potential should use appropriate contraceptive measures during treatment.

Luminous phenomena in visual field (phosphenes). Blurred vision, bradycardia, other cardiac arrhythmias, nausea, constipation, diarrhoea, headache, dizziness, dyspnoea, & muscle cramps. Hyperuricaemia, eosinophilia & elevated blood creatinine conc.

Exacerbated QT prolongation w/ QT prolonging medical products (eg, CV QT prolonging medical products: quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone; non-CV QT prolonging medicinal products: pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, erythromycin IV). Increased risk of arrhythmia w/ K-depleting diuretics (thiazide & loop diuretics). Increased plasma conc w/ CYP3A4 inhibitors [eg, azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV PIs (nelfinavir, ritonavir), nefazodone, diltiazem, verapamil, fluconazole]. Increased 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.

Rx