Active Ingredient: Ivabradine
Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥70 bpm. Ivabradine is indicated:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 5 milligrams ivabradine, 2 times daily to meals, over the duration of 3 to 4 weeks. Afterwards, oral, between 2.5 milligrams ivabradine and 7.5 milligrams ivabradine, 2 times daily to meals. The maximum allowed total dose is 7.5 milligrams ivabradine daily.
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-hour monitoring.
The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years.
After three to four 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. The maintenance dose should not exceed 7.5 mg twice daily.
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 three months.
If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily. After dose reduction, heart rate should be monitored. Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.
Must be taken once in the morning and once in the evening during meals.
For:
Oral, 2.5 milligrams ivabradine, 2 times daily to meals, over the duration of 3 to 4 weeks. Afterwards, oral, between 2.5 milligrams ivabradine and 7.5 milligrams ivabradine, 2 times daily to meals. The maximum allowed total dose is 7.5 milligrams ivabradine daily.
In patients aged 75 years or more, a 2.5 mg twice daily starting dose should be considered before up-titration if necessary.
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-hour monitoring.
After three to four 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. The maintenance dose should not exceed 7.5 mg twice daily.
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 three months.
If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily. After dose reduction, heart rate should be monitored. Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.
Must be taken once in the morning and once in the evening during meals.
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