Coralan Dosage/Direction for Use

Symptomatic Treatment of Chronic Stable Angina Pectoris: Starting Dose: 5 mg twice daily in patients <75 years. After 3-4 weeks of treatment, if the patient is still symptomatic, if the initial dose is well-tolerated and if resting heart rate remains >60 bpm, the dose may be increased to the next higher dose in patients receiving 2.5 mg twice daily or 5 mg twice daily. Maintenance Dose: 7.5 mg twice daily.
It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, electrocardiogram (ECG) or ambulatory 24-hr monitoring.
If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.
In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within 3 months.
If, during treatment, heart rate decreases <50 bpm at rest or the patient experiences symptoms related to bradycardia eg, dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one-half 5 mg tablet twice daily). After dose reduction, heart rate should be monitored. Treatment must be discontinued if heart rate remains <50 bpm or symptoms of bradycardia persist despite dose reduction.
Treatment of Chronic Heart Failure: Usual Recommended Starting Dose: 5 mg twice daily. After 2 weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently >60 bpm or decreased to 2.5 mg twice daily (one-half 5 mg tablet twice daily) if resting heart rate is persistently <50 bpm or in case of symptoms related to bradycardia eg, dizziness, fatigue or hypotension. If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.
If during treatment, heart rate decreases persistently <50 bpm at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily. If heart rate increases persistently >60 bpm at rest, the dose can be up-titrated to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
Treatment must be discontinued if heart rate remains <50 bpm or symptoms of bradycardia persist.
The treatment has to be initiated only in patient with stable heart failure. It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Renal Insufficiency: No dose adjustment is required in patients with renal insufficiency and CrCl >15 mL/min (see Pharmacokinetics under Actions). No data are available in patients with CrCl <15 mL/min. Ivabradine should therefore be used with caution in this population.
Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. Ivabradine is contraindicated in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated (see Pharmacokinetics under Actions and Contraindications).
Children and Adolescents: Coralan is not recommended in children and adolescents as the efficacy and safety of ivabradine has not been studied in these populations.
Elderly: In patients ≥75 years, a lower starting dose should be considered for these patients (2.5 mg twice daily ie, ½ 5-mg tablet twice daily) before up-titration, if necessary.
Missed Dose: If a dose is missed, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
Administration: Tablets must be taken orally twice daily ie, once in the morning and once in the evening during meals (see Pharmacokinetics under Actions).