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Valheart

Valheart

ivabradine

Manufacturer:

KRKA

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Ivabradine HCl
Indications/Uses
Symptomatic treatment of chronic stable angina pectoris in CAD adults w/ normal sinus rhythm & heart rate ≥70 bpm, 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. Stable chronic heart failure NYHA II-IV class w/ systolic dysfunction, in adults who are in sinus rhythm w/ heart rate ≥75 bpm, in combination w/ standard therapy including β-blocker therapy or when β-blocker therapy is contraindicated or not tolerated.
Dosage/Direction for Use
Individualized dosage. Chronic stable angina Initially 5 mg bid, may be increased to next higher dose if patient is still symptomatic, if initial dose is well tolerated & if resting heart rate remains >60 bpm after 3-4 wk. Titrate dose downward if heart rate decreases <50 bpm at rest or symptoms related to bradycardia are experienced. Maintenance dose: Not to exceed 7.5 mg bid. Chronic heart failure Initially 5 mg bid, increased by 2.5 mg bid (max: 7.5 mg bid) if heart rate is >60 bpm or decreased by 2.5 mg bid if heart rate is <50 bpm or in signs & symptoms of bradycardia. Elderly ≥75 yr Consider initial dose of 2.5 mg bid before increasing if necessary.
Administration
Should be taken with food.
Contraindications
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 dependence; unstable angina; 3rd degree AV block. Patients w/ existing prolonged QT interval eg, congenital long QT syndrome. Concomitant use w/ strong CYP3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolides (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV PIs (nelfinavir, ritonavir) & nefazodone; moderate CYP3A4 inhibitors w/ heart-reducing properties eg, verapamil or diltiazem. Severe hepatic impairment. Pregnancy & lactation.
Special Precautions
Discontinue use if atrial fibrillation develops. Not recommended in patients w/ atrial fibrillation or other cardiac arrhythmias that interfere w/ sinus node function; to be used immediately after a stroke. Avoid use in patients w/ 2nd-degree AV block unless a functioning demand pacemaker is present. Indicated only for symptomatic treatment of chronic stable angina pectoris & has no benefits on CV outcomes eg, MI or CV death. Bradycardia, sinus arrest, & heart block. Patients w/ retinitis pigmentosa; implantable cardioverter defibrillator or cardiac resynchronization therapy. Consider serial heart rate measurements, ECG or ambulatory 24-hr monitoring when determining heart rate prior to initiation of & during treatment when titration is considered. Closely monitor chronic heart failure patients w/ intraventricular conduction defects (bundle branch block left & right) & ventricular dyssynchrony. Regularly monitor BP in hypertensive patients. Avoid concurrent use w/ verapamil or diltiazem. May cause transient luminous phenomena which should be taken into account when driving or using machines. Mild or moderate hepatic impairment. Severe renal impairment (CrCl <15 mL/min). Childn <18 yr.
Adverse Reactions
Luminous phenomena (phosphenes) & bradycardia.
Drug Interactions
Increased exposure & risk of excessive bradycardia w/ potent CYP3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolides (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV PIs (nelfinavir, ritonavir), & nefazodone. Increased exposure & additive effects on heart rate w/ moderate CYP3A4 inhibitors w/ heart rate-reducing properties ie, diltiazem or verapamil. Exposure may be decreased w/ CYP3A4 inducers eg, St. John's wort, rifampicin, barbiturates, phenytoin. May exacerbate QT prolongation w/ CV QT (eg, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone) & non-CV (eg, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, IV erythromycin) QT prolonging agents. Increased risk of bradycardia w/ drugs that slow heart rate eg, digoxin, β-blockers. Onset of severe arrhythmias w/ K-depleting diuretics eg, furosemide, hydrochlorothiazide, indapamide. Increased exposure w/ grapefruit juice.
MIMS Class
Anti-Anginal Drugs
ATC Classification
C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Valheart FC tab 5 mg
Packing/Price
56's (P23.58/film-coated tab)
Form
Valheart FC tab 7.5 mg
Packing/Price
56's (P24.53/film-coated tab)
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