Carivalan Dosage/Direction for Use

The recommended dose of Carvedilol + Ivabradine (Carivalan) is one tablet twice daily, once in the morning and once in the evening.
Carvedilol + Ivabradine (Carivalan) should only be used in patients controlled on stable doses of the individual components given concurrently when carvedilol and ivabradine are at the optimal dose.
The fixed dose combination is not suitable for initiation therapy.
If a change of posology is required, titration should be done with the individual components carvedilol and ivabradine, ensuring the patient is maintained at an optimal dose of carvedilol and ivabradine. It is recommended that the decision to titrate treatment takes place with the availability of serial heart measurements, ECG or ambulatory 24-hour monitoring.
If during treatment, heart rate decreases below 50 beats per minute at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, down titration should be done with the individual components carvedilol and ivabradine, ensuring the patient is maintained at an optimal dose of carvedilol and ivabradine. 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.
Renal impairment: No dosage adjustment is required in patients with renal insufficiency and creatinine clearance above 15 mL/min and SBP >100 mmHg.
No data are available in patients with creatinine clearance below 15 mL/min. Carvedilol + Ivabradine (Carivalan) should be used with precaution in patients with creatinine clearance below 15 mL/min.
Monitoring of renal function is recommended in chronic heart failure patients with SBP <100 mmHg.
Hepatic impairment: It may be necessary to adjust the dose in patients with mild to moderate hepatic impairment.
Caution should be exercised in patients with moderate hepatic impairment.
Carvedilol + Ivabradine (Carivalan) is contraindicated in patients with severe hepatic impairment.
Elderly: Carvedilol + Ivabradine (Carivalan) can be administered in elderly patients with caution.
Pediatric population: The safety and efficacy of Carvedilol + Ivabradine (Carivalan) in children and adolescents have not been established. No data are available with Carvedilol + Ivabradine (Carivalan). The data with ivabradine is presented in Pharmacology: Pharmacodynamics under Actions.
Method of administration: Oral use.
Carvedilol + Ivabradine (Carivalan) tablet should be taken twice daily during a meal.