Active Ingredient: Propafenone
Propafenone is indicated for the prophylaxis and treatment of ventricular arrhythmias.
Propafenone is also indicated for the prophylaxis and treatment of paroxysmal supraventricular tachyarrhythmias which include paroxysmal atrial flutter/fibrillation and paroxysmal re-entrant tachycardias involving the AV node or accessory bypass tracts, when standard therapy has failed or is contra-indicated.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
450 - 900 mg
From 450 To 900 mg once every day
450 mg
It is recommended that propafenone therapy should be initiated under hospital conditions, by a physician experienced in the treatment of arrhythmias. The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and blood pressure control. If the QRS interval is prolonged by more than 20%, the dose should be reduced or discontinued until the ECG returns to normal limits.
Initially, 150 mg three times daily increasing at a minimum of three-day intervals to 300 mg twice daily and if necessary, to a maximum of 300 mg three times daily.
Dose increases should not be attempted until the patient has been receiving treatment for three to four days. The tablets should be swallowed whole and taken with a drink. A reduction in the total daily dose is recommended for patients below 70 kg bodyweight.
No overall differences in safety or effectiveness were observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out, therefore, these patients should be carefully monitored. Treatment should be initiated gradually and with particular caution in small incremental doses.
The same applies to maintenance therapy. Any dose increases that may be required should not be undertaken until after five to eight days of therapy.
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