Treatment of coronary artery disease:
Usual Recommended Starting Dose: 5 mg twice daily. After 3-4 weeks of treatment, the dose may be increased to 7.5 mg twice daily depending on the therapeutic response. If, during treatment, heart rate decreases persistently <50 beats/min (bpm) at rest or the patient experiences symptoms related to bradycardia eg, dizziness, fatigue or hypotension, the dose must be titrated downward including the possible dose of 2.5 mg twice daily (½ 5-mg tab twice daily). Treatment must be discontinued if heart rate is <50 bpm or symptoms of bradycardia persist (see Warnings and Precautions).
Treatment of chronic heart failure:
The treatment has to be initiated only in patient with stable heart failure. The usual recommended starting dose of ivabradine is 5 mg twice daily. After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decrease to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related bradycardia such as dizziness, fatigue, or hypotension. If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.
Renal Insufficiency: No dose adjustment is required in patients with renal insufficiency and creatinine clearance >15 mL/min (see Pharmacology: Pharmacokinetics under Actions).
No data are available in patients with creatinine clearance <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 for use 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 Contraindications and Pharmacology: Pharmacokinetics under Actions).
Children and Adolescents: Coralan is not recommended in children and adolescents as the efficacy and safety of ivabradine have not been studied in these populations.
Elderly: Since ivabradine has been studied in a limited number of patients ≥75 years, a lower starting dose should be considered for these patients (2.5 mg twice daily ie, ½ 5-mg tab twice daily) before up-titration if necessary.
Administration: Tablets must be taken orally twice daily ie, once in the morning and once in the evening during meals (see Pharmaclogy: Pharmacokinetics under Actions).
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