Coralan心健朗

Coralan Dosage/Direction for Use

ivabradine

Manufacturer:

Servier

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Dosage/Direction for Use
Symptomatic Treatment of Chronic Stable Angina Pectoris: It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hr monitoring.
The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged <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 above 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. The maintenance dose should not exceed 7.5 mg twice daily.
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 tab twice daily). After dose reduction, heart rate should be monitored (see Precautions). Treatment must be discontinued if heart rate remains <50 bpm or symptoms of bradycardia persist despite dose reduction.
Treatment of Chronic Heart Failure: 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.
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 tab 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 (see Warnings and Precautions).
Elderly: In patients ≥75 years, a lower starting dose should be considered for these patients (2.5 mg twice daily ie, one-half 5-mg tab twice daily) before up-titration if necessary.
Renal Impairment: No dose adjustment is required in patients with renal insufficiency and creatinine clearance >15 mL/min (see 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 Pharmacokinetics under Actions).
Administration: Tablets must be taken orally twice daily ie, once in the morning and once in the evening during meals (see Pharmacokinetics under Actions).
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