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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: • 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Initiation of flecainide acetate therapy and dose changes should be made under medical supervision and monitoring of ECG and plasma level. 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, due to a lack of data on safety and efficacy.
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 especially cardiac.
Like other anti-arrhythmics flecainide can have the effect of inducing arrhythmia. The existing arrhythmia may worsen or a new arrhythmia may occur. The risk of pro arrhythmic effects is most likely in patients with a structural heart disease and/or significant left ventricular impairment.
The most commonly occurring cardiovascular adverse effects are second and third degree AV block, bradycardia, cardiac failure, chest pain, myocardial infarction, hypotension, sinus arrest, tachycardia (AT and VT) and palpitations. The most common adverse effects are dizziness and visual disturbances that occur in about 15 % of the patients receiving treatment.
These adverse effects are usually transient and disappear upon discontinuing or reducing the dosage. The following list of adverse effects are based on experiences from clinical trials and reported after marketing. 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 (≥1/1000 to <1/100), rare (≥ 1/10,000 to <1/1000) 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 Immune system disorders: very rare: antinuclear antibody increased with and without systemic inflammation Metabolism and nutrition disorders: Frequency not known:Anorexia Psychatric disorders: Uncommon: Impotence, decreased libido, depersonalization/derealisation disorder, euphoric mood, increased dream activity, apathy, stupor rare: hallucination, depression, confusional state, anxiety, amnesia, insomnia Nervous system disorders: very common: dizziness, vertigo and light-headedness which are usually transient rare: paraesthesia, ataxia, hypoaesthesia, hyperhidrosis, syncope, tremor, flushing, somnolence, headache, neuropathy peripheral, convulsion, dyskinesia, paresis and speech disorders Eye disorders: very common: visual impairment, such as diplopia and vision blurred uncommon: eye irritation, photophobia and nystagmus very rare: corneal deposits Ear and labyrinth disorders: rare: tinnitus, vertigo Cardiac disorders: common: Proarrhythmia (most likely in patients with structural heart disease).
Treatment with oral flecainide 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. Flecainide has been shown to increase mortality risk of post-myocardial infarction patients with asymptomatic ventricular arrhythmia. e. 8). 8). Flecainide should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.
Treatment for patients with other indications should continue to be initiated in hospital. An acceleration of the ventricular rate of atrial fibrillation in case of therapy failure has been reported. Flecainide has a selective effect that increases the refractory period of the anterograde, and especially, the retrograde pathways.
Flecainide 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 I antiarrhythmic drugs however.
A Brugada syndrome may be unmasked due to flecainide therapy. In the case of development of ECG changes during treatment with flecainide that may indicate Brugada syndrome, consideration to discontinue the treatment should be made. 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 outweigh the risks.
Plasma level monitoring is recommended. 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. The rate of flecainide elimination from plasma may be reduced in the elderly.
1. - Flecainide 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. - Patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm - Patients with reduced or impaired ventricular function, cardiogenic shock, severe bradycardia (less than 50 bpm), severe hypotension.
- Use in combination with Class I antiarrhythmic drugs. (Sodium channel blockers) - In patients with haemo dynamically significant valvular heart disease. - Unless pacing rescue is available, flecainide must not be given to patients with sinus node dysfunction, atrial condition defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.
- Patients with asymptomatic or mildly symptomatic ventricular arrhythmias must not be given flecainide. 4). - Known Brugada syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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).
Impaired liver function:
In patients with impaired liver function, the patient should be closely monitored and the dose should not exceed 100 mg daily (or 50 mg twice daily). Patients with a permanent pacemaker in situ should be treated with caution and the dose should not exceed 100 mg 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.
Switch over from IV to oral therapy Due to the near complete oral bioavailability of flecainide, switching from IV flecainide application to PO flecainide application is possible without a new dose adjustment. As a rule, an interval of 8 to 12 hours should elapse between the completion of IV administration and the ingestion of the first tablet.
Because flecainide has a narrow therapeutic spectrum, close follow up monitoring is required. 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.
uncommon: hypertension. 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 arrest, and tachycardia (AT or VT) or ventricular fibrillation.
Demasking of a pre-existing Brugada syndrome. 4). 4). Respiratory, thoracic and mediastinal disorders: common: dyspnoea uncommon: bronchospasm rare: pneumonitis Frequency not known (cannot be estimated from the available data): pulmonary fibrosis, insterstitial lung disease Gastrointestinal disorders: uncommon: nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhoea, dyspepsia, flatulence, dry mouth, dysgeusia.
Hepatobiliary disorders: rare: hepatic enzymes increased with and without jaundice Frequency not known (cannot be estimated from the available data): hepatic dysfunction Skin and subcutaneous tissue disorders: uncommon: itching, exfoliative dermatitis, dermatitis allergic, including rash, alopecia rare: serious urticaria very rare: photosensitivity reaction Musculoskeletal and connective tissue disorders: Not known: arthralgia, myalgia Renal and urinary disorders: Uncommon: polyuria, urinary retention General disorders and administration site conditions: common: asthenia, fatigue, pyrexia, oedema, malaise uncommon: swollen lips, tongue and mouth Although no cause and effect relationship has been established, it is advisable to discontinue flecainide administration in patients in whom unexplained jaundice or signs of liver dysfunction or blood dyscrasias occur, in order to eliminate flecainide as a possible cause.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store
This should be taken into consideration when making dose adjustments. Flecainide is not recommended in children under 12 years of age, as there is insufficient evidence of its use in this age group. g. 5 for some drugs causing electrolyte disturbances).
Severe bradycardia or pronounced hypotension should be corrected before using flecainide. 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.
Dairy products (milk, infant formula and possibly yoghurt) may reduce the absorption of flecainide in children and infants. Flecainide is not approved for use in children below the age of 12 years, however flecainide toxicity has been reported during treatment with flecainide 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. For further warnings and precautions please refer to