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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 oral solution is indicated for: 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 when treatment need has been established and in the absence of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Supraventricular arrhythmias:
The recommended starting dosage is 50 mg (10 ml of the oral solution) 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 (60 ml of the oral solution).
Ventricular arrhythmias:
The recommended starting dosage is 100 mg (20 ml of the oral solution) twice daily. The maximum daily dose is 400 mg (80 ml of the oral solution) 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. Paediatric population Flecainide oral solution is not recommended in children under 12, as there is insufficient evidence of its use in this age group.
Elderly 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. m. or less) the maximum initial dosage should be 100 mg (20 ml of the oral solution) daily (or 50 mg (10 ml of the oral solution) twice daily).
When used in such patients, frequent plasma level monitoring is strongly recommended. It is recommended that intravenous treatment with flecainide should be initiated in hospital. Treatment with Flecainide oral solution 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. Treatment for patients with other indications should continue to be initiated in hospital. Method of administration Flecainide oral solution is 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.
Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000; <1/100); rare (≥1/10,000; <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).
System Organ Class 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) Not known: (cannot be established from the available data) Blood and lymphatic system disorders Red blood cell count decreased, white blood cell count decreased, and platelet count decreased.
System Organ Class 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) Not known: (cannot be established from the available data) Immune system disorders Antinuclear antibody increased with and without systemic inflammation.
Psychiatric disorders Hallucinatio n, depression, confusional state, anxiety, amnesia, insomnia. Nervous system disorders Dizziness, which is usually transient. Paraesthesia, ataxia, hypoaesthesi a, hyperhidrosi s, syncope, tremor, flushing, somnolence, headache, neuropathy peripheral, convulsion, dyskinesia.
Local anaesthesia to the mouth* Eye disorders Visual impairment , such as diplopia and vision blurred. Corneal deposits Ear and labyrinth disorders Tinnitus, vertigo. System Organ Class 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) Not known: (cannot be established from the available data) Cardiac disorders Proarrhyth mia (most likely in patients with structural heart disease and/or significant left ventricular impairment ).
Patients with atrial flutter can develop a 1:1 AV conduction with increased heart rate. 4). 4). 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.
4 Special warnings and special precautions for use). Arrhythmias of recent onset will respond more readily. Symptomatic sustained ventricular tachycardia. Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling symptoms, where these are resistant to other therapy or when other treatment has not been tolerated.
Flecainide oral solution can be used for the maintenance of normal rhythm following conversion by other means. 2 Posology and method of administration Posology Adults Supraventricular arrhythmias: The recommended starting dosage is 50 mg (10 ml of the oral solution) 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 (60 ml of the oral solution).
Ventricular arrhythmias:
The recommended starting dosage is 100 mg (20 ml of the oral solution) twice daily. The maximum daily dose is 400 mg (80 ml of the oral solution) 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. Paediatric population Flecainide oral solution is not recommended in children under 12, as there is insufficient evidence of its use in this age group.
Elderly 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. m. or less) the maximum initial dosage should be 100 mg (20 ml of the oral solution) daily (or 50 mg (10 ml of the oral solution) twice daily).
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. Flecainide is contraindicated in the presence of cardiogenic shock.
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 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 ml and a “Press-In” Bottle Adapter (PIBA) are provided with the product. Open the bottle and at first use insert the “Press-In” Bottle Adapter (PIBA). Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.
Remove the filled syringe from the bottle in the upright position. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose. Replace the cap on the bottle (PIBA remains in place). The oral syringe must be rinsed thoroughly with water after each use by taking the two parts of syringe apart.
Allow the parts to air dry afterwards.
Demasking of a pre-existing Brugada syndrome. Respiratory, thoracic and mediastinal disorders Dyspnoea Pneumonitis Pulmonary fibrosis, interstitial lung disease. System Organ Class 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) Not known: (cannot be established from the available data) Gastrointestinal disorders Nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhoea, dyspepsia, flatulence.
Hepatobiliary disorders Hepatic enzymes increased with and without jaundice. Hepatic dysfunction Skin and subcutaneous tissue disorders Dermatitis allergic, including rash, alopecia. Serious urticaria Photosensitivity reaction Musculoskeletal and connective tissue disorders Arthralgia and Myalgia General disorders and administration site conditions Asthenia, fatigue, pyrexia, oedema.
*This adverse effect relates specifically to the liquid formulation. 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.
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When used in such patients, frequent plasma level monitoring is strongly recommended. It is recommended that intravenous treatment with flecainide should be initiated in hospital. Treatment with Flecainide oral solution 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. Treatment for patients with other indications should continue to be initiated in hospital. Method of administration Flecainide oral solution is 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.
5 ml and a “Press-In” Bottle Adapter (PIBA) are provided with the product. Open the bottle and at first use insert the “Press-In” Bottle Adapter (PIBA). Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.
Remove the filled syringe from the bottle in the upright position. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose. Replace the cap on the bottle (PIBA remains in place). The oral syringe must be rinsed thoroughly with water after each use by taking the two parts of syringe apart.
Allow the parts to air dry afterwards. 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.
Flecainide is contraindicated in the presence of cardiogenic shock. 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 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.
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.
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