FLECAINIDE Tablets Ref.[7255] Active ingredients: Flecainide

Posology

Initiation of flecainide therapy and dose changes should be made in hospital under ECG and plasma level monitoring. The clinical decision to initiate flecainide treatment should be made in consultation with a 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 1C (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 50mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg daily.

Ventricular arrhythmias

The recommended starting dose is 100mg twice daily. The maximum daily dose is 400mg 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.

Older people

In elderly patients the maximum initial daily dosage should be 100mg daily (or 50mg 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.

Paediatric population

Not recommended for children under 12 years of age.

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 700-1000ng/ml are associated with increased likelihood of adverse experiences.

Patients with impaired renal function

In patients with significant renal impairment (creatinine clearance of 35ml/min/1.73sq.m.or less) the maximum initial dosage should be 100mg daily (or 50mg twice daily). When used in such patients, frequent plasma level monitoring is strongly recommended. Depending on the effect and tolerability the dose may then be cautiously increased. After 6-7 days the dose may be adjusted, depending on the effect and the tolerability. Some patients with severe renal failure can have a very slow clearance of flecainide and thus a prolonged half-life (60-70 hours).

Patients with impaired liver function

In patients with impaired liver function, the patient should be closely monitored and the dose should not exceed 100mg daily (or 50mg twice daily).

Patients with a permanent pacemaker in situ should be treated with caution and the dose should not exceed 100mg twice daily.

In patients concurrently receiving cimetidine or amiodarone close monitoring is required. In some patients the dose may have to be reduced and should not exceed 100mg twice daily. Patients should be monitored during initial and maintenance therapy.

Plasma level monitoring and ECG control are recommended at regular intervals (ECG control once a month and long term ECG every 3 months) during therapy. During initiation therapy and when the dose is increased, an ECG should be performed every 2-4 days.

When flecainide is used in patients with dosage restrictions, frequent ECG control (additional to the regular flecainide plasma monitoring) should be made. Dose adjustment should be made at intervals of 6-8 days. In such patients an ECG should be performed in weeks 2 and 3 to control the individual dosage.

Method of Administration

For oral use. These tablets should be swallowed whole with water. 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.

Overdosage with flecainide is a potentially life-threatening medical emergency. Increased drug susceptibility and plasma levels exceeding therapeutic levels may also result from drug interaction (see 4.5). No specific antidote is known. There is no known way to rapidly remove flecainide from the system. Neither dialysis nor haemoperfusion is effective.

Treatment should be supportive and may include removal of unabsorbed drug from the GI tract. Further measures may include inotropic agents or cardiac stimulants such as dopamine, dobutamine or isoproterenol as well as mechanical ventilation and circulatory assistance (e.g. ballon pumping). Temporarily inserting a transvenous pacemaker if there are severe conduction disturbances or the patients left ventricular function is otherwise compromised. Assuming a plasma half-life of approximately 20h, these supportive treatments may need to be continued for an extended period of time. Forced diuresis with acidification of the urine theoretically promotes drug excretion.

In one case report amiodarone was administered to a patient after a flecainide overdose for therapy resistant ventricular fibrillation. However, the efficacy and safety are not proven and amiodarone is not regarded as an antidote to the flecainide overdose.

Shelf life: 3 years.

Polypropylene and Polyethylene containers: Do not store above 25°C. Store in the original container.

Blister packs: Do not store above 25°C. Keep container in the outer carton.

The blister packs are manufactured from 250µm white rigid PVC/PVDC coated with 60gm-2 PVDC and 20µm hard temper aluminium foil with 5-7g/m² PVC/PVDC compatible heat seal lacquer. The polypropylene containers are manufactured from rigid injection moulded polypropylene with snap-on polyethylene lids. An alternative container is a polyethylene container with a snap-on polyethylene lid.

Blister: 20s, 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s.

Polypropylene container: 100s, 250s, 500s, 1000s.

Polyethylene container: 100s.

Not all pack sizes may be marketed.

No special requirements.