Symptomatic treatment of chronic stable angina pectoris in CAD adults w/ normal sinus rhythm & heart rate ≥70 bpm. In adults who are unable to tolerate or contraindicated to β-blockers, or in combination w/ β-blockers in patients inadequately controlled w/ an optimal β-blocker dose. CHF.
Dosage/Direction for Use
CAD Initially 5 mg bid, may be increased to 7.5 mg bid after 3-4 wk if well tolerated & resting heart remains >60 bpm. Titrate dose downward if heart rate is <50 bpm persist or bradycardia occurs. CHF Initially 5 mg bid; adjust dose based on heart rate after 2 wk. If >60 bpm Increase dose by 2.5 mg bid, 50-60 bpm Continue current dose, <50 bpm or signs or symptoms of bradycardia Decrease by 2.5 mg bid. Max: 7.5 mg bid.
Administration
Should be taken with food: Avoid excessive consumption of grapefruit juice.
Contraindications
Acute decompensated heart failure. Clinically significant HTN & bradycardia. Concomitant use w/ strong CYP3A4 inhibitors. Pacemaker dependent. Severe hepatic impairment. Sick-sinus syndrome, SA block, or 3rd-degree AV block, except in presence of functioning demand pacemaker.
Special Precautions
Avoid use w/ 2nd-degree AV block in patients w/o functioning demand pacemaker. Patients w/ demand pacemakers set to ≥60 bpm is not recommended. Monitor patients due to increased risk of atrial fibrillation; sinus node dysfunction, conduction defects, ventricular dyssynchrony. Sinus arrest, bradycardia & heart block may occur. Increased risk of QT prolongation which may lead to severe ventricular arrhythmias including Torsades de Pointes. Concomitant use w/ other negative chronotrophic agents, QTc prolonging drugs. Avoid use w/ verapamil, diltiazem, CYP3A4 inducers or moderate CYP3A4 inhibitors.
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