• Treatment of AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways, when other treatment has been ineffective.
• Treatment of severe symptomatic and life-threatening paroxysmal ventricular arrhythmia which has failed to respond to other forms of therapy or where other treatments have not been tolerated.
• Treatment of paroxysmal atrial arrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia) in patients with disabling symptoms after conversion provided that there is definite need for treatment on the basis of severity of clinical symptoms, when other treatment has been ineffective. Structural heart disease and/or impaired left ventricular function should be excluded because of the increased risk for pro-arrhythmic effects.
DOSAGE
Initiation of flecainide acetate therapy and dose changes should be made under medical supervision and monitoring of ECG and plasma level. Hospitalization could be necessary during such procedures for certain patients, especially for patients with life threatening ventricular arrhythmias. These decisions should be made under supervision of specialist.
In patients with an underlying organic cardiopathy and especially those with a history of myocardial infarction, flecainide treatment should only be started when other arrhythmic agents, other than class IC (especially amiodarone), are ineffective or not tolerated and when non-pharmacological treatment (surgery, ablation, implanted defibrillator) is not indicated. Strict medical monitoring of ECG and plasma levels during treatment is required.
Adults and adolescents (13-17 years of age):
Supraventricular arrhythmias: The recommended starting dose is 50 mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300 mg daily.
Ventricular arrhythmias: The recommended starting dose is 100 mg twice daily. The maximum daily dose is 400 mg and this is normally reserved for patients of large build or where rapid control of the arrhythmia is required. After 3-5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains control of the arrhythmia. It may be possible to reduce dosage during long term treatment.
Elderly patients:
In elderly patients the maximum initial daily dosage should be 100 mg daily (or 50 mg twice daily) as the rate of flecainide elimination from plasma may be reduced in elderly people. This should be taken into consideration when making dose adjustments. The dose for elderly patients should not exceed 300 mg per day (or 150 mg twice daily).
Children:
Flecainide acetate is not recommended for use in children younger than 12 years.
Plasma levels:
Based on PVC suppression, it appears that plasma levels of 200-1000ng/ml may be needed to obtain the maximum therapeutic effect. Plasma levels above 700-1000 ng/ml are associated with increased likelihood of adverse experiences especially cardiac.
Method of Administration
For oral use. In order to avoid the possibility of food affecting the absorption of the drug, flecainide should be taken on an empty stomach or one hour before food.
PREGNANCY AND LACTATION
If pregnant or lactating inform your physician and follow his/her directions.
SIDE EFFECTS
nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhoea, dyspepsia, flatulence, dry mouth, dysgeusia, dyspnoea
ACTIVE INGREDIENT
