FLECAINIDE ACETATE

Posology Adults:

Supraventricular arrhythmias: The recommended starting dosage 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 dosage 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.

Children:

Flecainide is not recommended in children under 12, as there is insufficient evidence of its use in this age group.

Elderly Patients:

The rate of flecainide elimination from plasma may be reduced in elderly people. This should be taken into consideration when making dose adjustments.

Plasma levels:

Based on PVC suppression, it appears that plasma levels of 200- 1000 ng/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. 73 sq.

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. It is recommended that intravenous treatment with flecainide acetate should be administered in hospitals.

Treatment with oral flecainide acetate should be under direct hospital or specialist supervision for patients with: a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff- Parkinson- White Syndrome and similar conditions with accessory pathways b) Paroxysmal atrial fibrillation in patients with disabling symptoms.

Treatment for patients with other indications should continue to be initiated in hospital.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); Frequency not known (cannot be estimated from the available data).

MedDRA system organ class Frequency Adverse event Blood and lymphatic system disorders Uncommon red blood cell count decreased, white blood cell count decreased and platelet count decreased Immune system disorders Very rare antinuclear antibody increased with and without systemic inflammation Psychiatric disorders Rare hallucination, depression, confusional state, anxiety, amnesia, insomnia Very common dizziness, which is usually transientNervous system disorders Rare paraesthesia, ataxia, hypoaesthesia, hyperhidrosis, syncope, tremor, flushing, somnolence, headache, neuropathy peripheral, convulsion, dyskinesia Very common visual impairment, such as diplopia and vision blurred Eye disorders Very rare Corneal deposits Ear and labyrinth disorders Rare Tinnitus, vertigo Common Proarrhythmia (most likely in patients with structural heart disease and/or significant left ventricular impairment).

4). 4). Cardiac disorders Uncommon Patients with atrial flutter can develop a 1:1 AV conduction with increased heart rate. Frequency not known (cannot be estimated from the available data) atrioventricular block-second-degree and atrioventricular block third degree, cardiac arrest, bradycardia, cardiac failure/ cardiac failure congestive, chest pain, hypotension, myocardial infarction, palpitations, sinus pause or arrest, and tachycardia (AT or VT) or ventricular fibrillation.

Demasking of a pre-existing Brugada syndrome Common Dyspnoea Rare pneumonitis Respiratory, thoracic and mediastinal disorders Frequency not known (cannot be estimated from the available data) pulmonary fibrosis, interstitial lung disease Gastrointestinal disorders Uncommon nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhoea, dyspepsia, flatulence Rare hepatic enzymes increased with and without jaundice Hepatobiliary disorders Frequency not known (cannot be estimated from the available data) Hepatic dysfunction Uncommon dermatitis allergic, including rash, alopecia Rare Serious urticaria Skin and subcutaneous tissue disorders Very rare photosensitivity reaction Musculoskeletal and connective tissue disorders: Not known Arthralgia and Myalgia General disorders and administration site conditions Common asthenia, fatigue, pyrexia, oedema Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Treatment with oral flecainide should be under direct hospital or specialist supervision for patients with: AV nodal reciprocating tachycardia; arrhythmias associated with WPW Syndrome and similar conditions with accessory pathways.

Paroxysmal atrial fibrillation in patients with disabling symptoms. g. 5 for some drugs causing electrolyte disturbances). Since flecainide elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide should not be used in such patients unless the potential benefits clearly outweigh the risks.

Plasma level monitoring is strongly recommended in these circumstances. e, to decrease endocardial pacing sensitivity. This effect is reversible and is more marked on the acute pacing threshold than on the chronic. Flecainide should thus be used with caution in all patients with permanent pacemakers or temporary pacing electrodes, and should not be administered to patients with existing poor thresholds or non- programmable pacemakers unless suitable pacing rescue is available.

Generally, a doubling of either pulse width or voltage is sufficient to regain capture, but it may be difficult to obtain ventricular thresholds less than 1 Volt at initial implantation in the presence of flecainide. The minor negative inotropic effect of flecainide may assume importance in patients predisposed to cardiac failure.

Difficulty has been experienced in defibrillating some patients. Most of the cases reported had pre-existing heart disease with cardiac enlargement, a history of myocardial infarction, arterio-sclerotic heart disease and cardiac failure.

Flecainide has been shown to increase mortality risk of post-myocardial infarction patients with asymptomatic ventricular arrhythmia. e. 8). 73 m2) and therapeutic drug monitoring is recommended. The rate of flecainide elimination from plasma may be reduced in the elderly.

Hypersensitivity to flecainide or to any of the excipients Flecainide is contra-indicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia.

Flecainide is contra-indicated in the presence of cardiogenic shock. It is also contra-indicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease.

Known Brugada syndrome. Unless pacing rescue is available, Flecainide should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrioventricular block, bundle branch block or distal block.