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FLECAINIDE ACETATE is a brand name for Flecainide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Flecainide acetate is indicated for use in patients with the following arrhythmias: Severe symptomatic supraventricular arrhythmia AV nodal reciprocating tachycardia. Arrhythmias associated with the Wolff-Parkinson-White syndrome and similar conditions associated with the presence of accessory pathways. Paroxysmal…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The clinical decision to initiate flecainide treatment should be made in consultation with a specialist and should be initiated in hospital. 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:
Supraventricular Arrhythmias: The recommended starting dosage 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 dosage 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 2 arrrhythmia 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.
Paediatric population:
Flecainide acetate is not recommended in children under 12, as there is insufficient evidence of its use in this age group.
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 acetate elimination from plasma may be reduced in elderly people.
Plasma levels:
Based on premature ventricular contraction (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 100 mg daily (or 50 mg twice daily). When used in such patients, frequent plasma level monitoring is strongly recommended. It is recommended that treatment with flecainide acetate should be initiated in hospital.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Uncommon: red blood cell count decreased, white blood cell count decreased and platelet count decreased. These changes are usually mild.
Immune system disorders:
Very rare: antinuclear antibody increased with and without systemic inflammation Psychiatric disorders: Rare: hallucination, depression, confusional state, anxiety, amnesia, insomnia, nervousness Nervous system disorders: Very common: giddiness, dizziness and light headedness which are usually transient Rare: During long term therapy a few cases of neuropathy peripheral, paraesthesia and ataxia have been reported.
Rare instances of dyskinesia have been reported, which have improved on withdrawal of flecainide acetate therapy. Hypoaesthesia, hyperhidrosis, syncope, tremor, somnolence, headache and convulsion.
Eye disorders:
Very common: visual impairment, such as diplopia and vision blurred. These are usually transient and disappear upon continuing or reducing the dosage.
Very rare: corneal deposits Ear and labyrinth disorders:
Rare: tinnitus, vertigo Cardiac disorders: Common: Proarrhythmia (most likely in patients with structural heart disease and/or significant left ventricular impairment).
Uncommon:
Patients with atrial flutter can develop a 1:1 AV conduction with increased heart rate. These effects are most common following the use of the injection for acute conversion. This effect is usually short lived and abates quickly following cessation of therapy.
Intravenous treatment with flecainide acetate should be initiated in hospital. Treatment for patients with other indications should continue to be initiated in hospital. Treatment with oral flecainide acetate should be under direct hospital or specialist supervision for patients with: • AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.
• Paroxysmal atrial fibrillation in patients with disabling symptoms. Continuous ECG monitoring is recommended in all patients receiving bolus injection. e. 8). 8). Flecainide acetate should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.
Flecainide has a selective effect that increases the refractory period of the anterograde, and especially, the retrograde pathways. Flecainide acetate prolongs the QT interval and widens the QRS complex by 12-20 %. The effect on the JT interval is insignificant.
Nevertheless, there have been reports of prolongation of the JT interval of up to 4%. This action is less marked than that observed with the class 1a antiarrhythmic drugs however. A Brugada syndrome may be unmasked due to flecainide acetate therapy.
In the case of development of ECG changes during treatment with flecainide acetate that may indicate Brugada syndrome, consideration to discontinue the treatment should be made. Since flecainide acetate elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide acetate should not be used in such patients unless the potential benefits clearly outweigh the risks.
Plasma level monitoring is strongly recommended in these circumstances. 73 m2) and therapeutic drug monitoring is recommended as increase of plasma levels may also result from renal impairment due to a reduced clearance of flecainide.
1. Flecainide acetate is contraindicated in cardiac failure, and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia. Further contraindications include reduced or impaired ventricular function, cardiogenic shock, severe bradycardia, severe hypotension and concomitant use with disopyramide.
3 It is also contraindicated 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 acetate should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dosage in impaired hepatic function:
In patients with impaired liver function the patient should be closely monitored and the dose should not exceed 100 mg daily or 50mg twice daily.
Dosage in patients with pacemaker:
Patients with a permanent pacemaker in situ should be treated with caution and the dose should not exceed 100mg twice daily.
Dosage with concomitant medicines:
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 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 level monitoring) should be made. Dose adjustment should be made at intervals of 6-8 days. In such patients an ECG should be performed in week 2 and 3 to control the individual dosage.
Method of administration For oral use
Not known: 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. 4). 4).
Vascular disorders Rare: flushing Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea Rare: pneumonitis Not known: pulmonary fibrosis, interstitial lung disease Gastrointestinal disorders: 8 Uncommon: nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhoea, dyspepsia, flatulence Very rare: dry mouth, taste disorders Hepatobiliary disorders: Rare: hepatic enzymes increased with and without jaundice.
So far this has always been reversible on stopping treatment.
Not known: hepatic dysfunction Skin and subcutaneous tissue disorders:
Uncommon: dermatitis allergic, including rash, alopecia Rare: serious urticaria Very rare: photosensitivity reaction Musculoskeletal and connective tissue disorders Very rare: arthralgia and myalgia Reproductive system and breast disorders Very rare: impotence 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.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
The rate of flecainide acetate elimination from plasma may be reduced in the elderly. This should be taken into consideration when making dose adjustments. g. 5 for some drugs causing electrolyte disturbances). Severe bradycardia or pronounced hypotension should be corrected before using flecainide acetate.
e. to decrease endocardial pacing sensitivity. This effect is reversible and is more marked on the acute pacing threshold than on the chronic. Flecainide acetate 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 acetate. The minor negative inotropic effect of flecainide acetate 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 acetate has been shown to increase mortality risk of post-myocardial infarction patients with asymptomatic ventricular arrhythmia. 2 fold higher incidence of mortality or non-fatal cardiac arrest as compared with its matching placebo.
In that same study, an even higher incidence of mortality was observed in flecainide acetate-treated patients with more than one myocardial infarction. Comparable placebo-controlled clinical trials have not been done to determine if flecainide acetate is associated with higher risk of mortality in other patient groups.
Dairy products (milk, infant formula and possibly yoghurt) may reduce the absorption of flecainide acetate in children and infants. Flecainide acetate is not approved for use in children below the age of 12 years, however flecainide acetate toxicity has been reported during treatment with flecainide acetate in children who reduced their intake of milk, and in infants who were switched from milk formula to dextrose feedings.
Flecainide as a narrow therapeutic index drug requires caution and close monitoring when switching a patient to a different formulation. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
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