Flecainide Acetate

Registered South African indications:

• Sustained ventricular tachydysrhythmia
• AV nodal reciprocating tachycardia: Wolff-Parkinson-White syndrome and similar conditions with accessory pathway and anterograde or retrograde conduction
• Paroxysmal atrial fibrillation in patients with disabling symptoms (dysrhythmias of recent onset will respond more readily)
• Premature ventricular contractions and/or non-sustained ventricular tachycardia if these are causing disabling symptoms
• Maintenance of normal rhythm following conversion by other means

Registered South African contraindications

Controlled release capsule

• Hypersensitivity to the active ingredient or any of its excipients
• Myocardial infarction (old or acute)
• Heart failure, regardless of the type of dysrhythmia
• Complete left bundle branch block
• Bi-fascicular block
• 2nd and 3rd degree atrioventricular block
• Sinus node dysfunction
• Atrial disease, in the absence of pacing
• Patients with long-standing atrial fibrillation and haemodynamically significant valvular heart disease
• Flecainide is generally not recommended in combination with class I antidysrhythmics

Tablet and injection

• Hypersensitivity to flecainide acetate or any of the excipients
• Cardiac failure
• Recent myocardial infarction or a history of myocardial infarction in those who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia
• Safety in pregnancy and lactation has not been established
• Long standing atrial fibrillation
• Haemodynamically significant valvular heart disease
• Presence of cardiogenic shock
• Known Brugada syndrome
• Unless pacing rescue is available, flecainide acetate should not be given to patients with the following
  - Sinus node dysfunction
  - Atrial conduction defects
  - Second degree or greater atrio-ventricular block
  - Bundle branch block or distal block

Contraindications registered in other jurisdictions

• 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

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Electrolyte disturbances
• Permanent pacemakers or temporary pacing electrodes
• Patients predisposed to cardiac failure
• Pre-existing heart disease with cardiac enlargement
• History of myocardial infarction
• Arteriosclerotic heart disease
• Cardiac failure
• Post-myocardial infarction patients with asymptomatic ventricular arrhythmia
• Children <12 years
• Severe bradycardia
• Pronounced hypotension
• Structural organic heart disease
• Abnormal left ventricular function
• Acute onset of atrial fibrillation following cardiac surgery
• Switching patient to a different formulation
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab, CR cap, inj

South African registered indications and dosages

Sustained ventricular tachydysrhythmia
AV nodal reciprocating tachycardia: Wolff-Parkinson-White syndrome and similar conditions with accessory pathway and anterograde or retrograde conduction
Paroxysmal atrial fibrillation in patients with disabling symptoms (dysrhythmias of recent onset will respond more readily)
Premature ventricular contractions and/or non-sustained ventricular tachycardia if these are causing disabling symptoms
Maintenance of normal rhythm following conversion by other means

Documented supraventricular tachycardia

• Oral (CR cap): Initial: 100mg dly; A dose increase should be considered only after a period of 4-5 days in increments of 50mg/day; Optimal dose: 200mg, dly; Max: 300mg/24hrs
• Oral (tab): 50mg, twice dly and most patients will be controlled at this dose; If required, the dose may be increased to a max: 300mg/24hrs

Documented ventricular tachycardia

• Oral (CR cap): Usual dose: 200mg, dly; A dose increase should only be considered after a period of 4-5 days in increments of 50mg/day; Max: 300mg/24hrs
• Oral (tab): 100mg, twice dly; Max: 400mg/24hrs (normally reserved for patients of large build or where rapid control of the dysrhythmia is required); After 3-5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains control of the dysrhythmia. It may be possible to reduce the dosage during long-term treatment 

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Patients with a history or symptoms suggestive of heart failure: The initial dose must not exceed 100mg per 24 hours. The dose ranges from 50-100mg/24 hours depending on the patient’s state

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The dosage of flecainide acetate can be increased or decreased by increments of 50mg per day, bearing in mind that a minimum of 4 to 5 days is necessary to establish new steady-state plasma levels after each dosage change. Patients should be monitored by clinical examination and by electrocardiogram

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If a patient is switched from a tablet formulation of flecainide acetate to a CR formulation, the dose should be based on the total daily dose (e.g. 2 x 100mg tablets to flecainide 200mg CR)

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Emergency or for rapid effect

• IV: Bolus: 2mg/kg slow IV, over not less than 10min, or in divided doses; If preferred, the dose may be diluted with 5% dextrose and given as a mini-infusion; Max bolus dose: 150mg

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Continuous ECG monitoring is recommended in all patients receiving the bolus dose; The injection should be stopped when there is control of the arrhythmia

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It is recommended that flecainide IV should be administered more slowly with careful monitoring of the ECG to patients in sustained ventricular tachycardia and patients with a history of cardiac failure who may become decompensated during the administration. For these patients, it is recommended that the initial dose is given over 30mins

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When prolonged parenteral administration is required

• IV: Infusion: 2mg/kg over 30min and continued by IV infusion at the following rates: First hour: 1.5mg/kg/hr; Second and later hours: 0.1-0.25 mg/kg/hr; Max cumulative dose given in the first 24 hours should not exceed 600mg

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Infusion duration should not exceed 24hrs 

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Transition to oral dosing should be accomplished as soon as possible by stopping the infusion and administering the first required oral dose. Oral maintenance is then continued as indicated in the relevant oral dosage instructions

Not established for use for children below 18 years

Pregnancy

• Contraindicated (tab, inj)
• Caution (cr cap)

Breastfeeding

• Contraindicated (tab, inj)
• Caution (cr cap)

Renal Impairment

• Caution; dose adjustment recommended

CrCl (ml/min)	Dose
>35	Max initial dose: 100mg twice daily; Dose adjustments should be guided by plasma level monitoring; Titrate cautiously at intervals >4 days
≤35	Max initial dose:100mg daily OR 50mg twice daily; Dose adjustments should be guided by plasma level monitoring; Titrate cautiously at intervals >4 days

Hepatic Impairment

• Caution; no dose adjustment recommended
  Dose adjustments should be guided by plasma level monitoring; Titrate cautiously at intervals >4 days
  In severe hepatic impairment, regular monitoring of plasma levels is essential; if unavailable, use should be avoided

Elderly

• Caution; dose adjustment recommended
  Max initial dose: 100mg daily OR 50mg twice daily; Rate of plasma elimination may be reduced in elderly people

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Hallucination
• Depression
• Confusional state
• Anxiety
• Amnesia
• Insomnia
• Dizziness
• Paraesthesia
• Ataxia
• Hypoaesthesia
• Hyperhidrosis
• Syncope
• Tremor
• Flushing
• Somnolence
• Headache
• Peripheral neuropathy
• Seizures
• Dyskinesia
• Asthenia

Cardiovascular Disorders

• Proarrhythmia
• Dose-related increases in PR and QRS intervals
• Altered pacing threshold
• 1:1 atrioventricular conduction with tachycardia (patients with atrial flutter)
• Second-degree atrioventricular block
• Third-degree atrioventricular block
• Cardiac arrest
• Bradycardia
• Cardiac failure/congestive cardiac failure
• Chest pain
• Hypotension
• Myocardial infarction
• Palpitations
• Sinus pause or arrest
• Tachycardia or ventricular fibrillation
• Oedema
• Demasking of a pre-existing Brugada syndrome

Respiratory Disorders

• Dyspnoea
• Pneumonitis
• Pulmonary fibrosis
• Interstitial lung disease

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Abdominal pain
• Decreased appetite
• Diarrhoea
• Dyspepsia
• Flatulence

Hepatobiliary Disorders

• Hepatic enzymes increased with or without jaundice
• Hepatic dysfunction

Skin and Subcutaneous Tissue Disorders

• Allergic dermatitis
• Rash
• Alopecia
• Serious urticaria
• Photosensitivity reaction

Immune, Blood and Lymphatic System Disorders

• Antinuclear antibody increased with and without systemic inflammation
• Decreased red blood cell count
• Decreased white blood cell count
• Decreased platelet count
• Fever

Sensory Disorders

• Visual impairment
• Diplopia
• Blurred vision
• Corneal deposits
• Tinnitus
• Vertigo

• Other class I antiarrhythmics
• Cardiac glycosides
• Digoxin
• Class II antiarrhythmics
• Beta-blockers
• Verapamil
• Class III antiarrhythmics
• Amiodarone
• Class IV antiarrhythmics
• Calcium channel blockers
• CYP2D6 inhibitors
• Neuroleptics
• Propranolol
• Ritonavir
• Some antihistamines
• Mizolastine
• Terfenadine
• CYP2D6 inducers
• Phenytoin
• Phenobarbital
• Carbamazepine
• Antidepressants
• Fluoxetine
• Paroxetine
• Reboxetine
• Tricyclic antidepressants
• Diuretics
• Corticosteroids
• Laxatives
• Antipsychotics
• Clozapine
• Antimalarials
• Quinine
• Antivirals
• Lopinavir
• Indinavir
• H2 antihistamines
• Cimetidine
• Anti-epileptics
• CYP2D6 isoenzyme substrates
• Antismoking aids
• Bupropion

Other

• Dairy products
• Milk
• Infant formula
• Yoghurt

• Electrocardiogram
• Blood pressure
• Heart rate

None routine. Specific cases may require

• Periodic serum trough concentrations

Flecainide slows conduction through the heart, having its greatest effect on His Bundle conduction. It also acts selectively to increase anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be reflected in the ECG by prolongation of the PR interval and widening of the QRS complex. The effect on the JT interval is insignificant.

Tablet 100mg

• Tambocor (iNova) originator

Capsule SRC 100mg

• Tambocor cr (iNova) originator

Capsule SRC 200mg

• Tambocor cr (iNova) originator

Injection (per ml) 10mg

• Tambocor (iNova) originator