Gavrila Special Precautions

Ivabradine should not be given to patients with resting heart rate below 60 beats/minute, or to patients with cardiogenic shock, severe conduction defects, acute myocardial infarction, or unstable angina. Heart failure should be controlled before Ivabradine is started; it has not been studied in severe heart failure. Ivabradine should not be used in patients with congenital QT prolongation. Ivabradine is not recommended in atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function, and regular monitoring for such arrhythmias should be performed. If resting heart rate falls below 50 beats/minute, the dose should be reduced; treatment should be stopped if this rate persists. Ivabradine is contraindicated in severe hypotension and severe hepatic impairment, and should be used with caution in severe renal impairment. If unexpected deterioration in visual function occurs, stopping treatment may be considered. Caution should be observed in patients with retinitis pigmentosa. Studies in animals have shown that Ivabradine is embryotoxic and teratogenic, and is distributed into breast milk.
Patients with Hypotension: Ivabradine is contraindicated in patients with severe hypotension (blood pressure <90/50 mmHg).
Atrial Fibrillation-Cardiac Arrhythmias: There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with Ivabradine. However, in the absence of extensive data, non-urgent DC-cardioversion should be considered 24 hrs after the last dose of Ivabradine.
Use in Patients with Congenital QT Syndrome or Treated with QT Prolonging Medicinal Products: The use of Ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided. If the combination appears necessary, close cardiac monitoring is needed. Heart rate reduction, as caused by Ivabradine, may exacerbate QT prolongation, which may give rise to severe arrhythmias, in particular Torsade de pointes.
Hypertensive Patients Requiring Blood Pressure Treatment Modifications: In the SHIFT trial, more patients experienced episodes of increased blood pressure while treated with Ivabradine. These episodes occurred most frequently shortly after blood pressure treatment was modified, were transient and did not effect the treatment effect of Ivabradine. When treatment modifications are made in chronic heart failure patients treated with Ivabradine, blood pressure should be monitored at an appropriate interval.
Use in Patients with Moderate Hepatic Insufficiency: Caution should be exercised when using Ivabradine in patients with moderate hepatic insufficiency.
Use in Patients with Severe Renal Insufficiency: Caution should be exercised when using Ivabradine in patients with severe renal insufficiency (creatinine clearance <15 ml/min).
Effects on the Ability to Drive or Operate Machinery: Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes. The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night. Ivabradine has no influence on the ability to use machines.