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Drug Details

TAMBOCOR XL Capsules

• Drug Class Description
  Class 1 anti-arrhythmic (local anaesthetic) agent
• Generic Name
  Flecainide
• Presentation
  Prolonged release capsule hard. Size 1 hard gelatin capsule with light grey cap and opaque pink body with 3M 200 printed in black ink.
• Description
  Each capsule contains flecainide acetate 200mg
• Indications
  

  Tambocor is a potent sodium channel blocking agent for the treatment of the conditions listed below: The effect on the JT interval is insignificant at therapeutic levels. Tambocor XL capsules are indicated for:

  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 when treatment need has been established and in the absence of left ventricular dysfunction. Arrhythmias of recent onset will respond more readily. Tambocor XL capsules can be used for the maintenance of normal rhythm following conversion by other means. Tambocor XL capsules are for oral administration

• Adult Dosage
  

  The controlled-release form of flecainide acetate is administered as a once-daily dose. Tambocor XL should not be used for control of arrhythmias in acute situations. Treatment should be initiated with either Intravenous or oral Tambocor IR formulations then switched to Tambocor XL.

  Adults: Supraventricular arrhythmias: The recommended starting dosage is 50mg twice daily (IR formulation) and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg (IR formulation) daily.

  Those patients controlled on 200mg (IR) daily may be switched to one 200mg XL capsule once daily. 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.

  Plasma levels: Based on PVC suppression, it appears that plasma levels of 200 – 1000ng/ml may be needed to obtain the maximum therapeutic effect. Plasma levels above 700 – 1000ng/ml are associated with increased likelihood of adverse experiences.

  Dosage in impaired renal function: In patients with significant renal impairment (creatinine clearance of 35ml/min/1.73 sq.m. or less) the maximum initial dosage should be 100mg IR daily. When used in such patients, frequent plasma level monitoring is strongly recommended.

  It is recommended that intravenous treatment with Tambocor should be administered in hospital.

  Treatment with Tambocor XL 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.

• Child Dosage
  

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

• Elderly Dosage
  

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

• Contra Indications
  

  Tambocor 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.

  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.

  Unless pacing rescue is available, Tambocor 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.

• Special Precautions
  

  Electrolyte disturbances should be corrected before using Tambocor.

  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.

  Tambocor is known to increase endocardial pacing thresholds – i.e. to decrease endocardial pacing sensitivity. This effect is reversible and is more marked on the acute pacing threshold than on the chronic. Tambocor 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 Tambocor.

  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.

  Tambocor should be avoided in patients structural organic heart disease or abnormal left ventricular function.

  Tambocor should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.

  In a large scale, placebo-controlled clinical trial in post-myocardial infarction patients with asymptomatic ventricular arrhythmia, oral flecainide was associated with a 2.2 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-treated patients with more than one myocardial infarction. Comparable placebo-controlled clinical trials have not been done to determine if flecainide is associated with higher risk of mortality in other patient groups.

• Interactions
  

  Flecainide is a class I anti-arrhythmic and interactions are possible with other anti-arrhythmic drugs where additive effects may occur or where drugs interfere with the metabolism of flecainide. The following known categories of drugs may interact with flecainide:

  Cardiac glycosides: Flecainide can cause the plasma digoxin level to rise by about 15%, which is unlikely to be of clinical significance for patients with plasma levels in the therapeutic range. It is recommended that the digoxin plasma level in digitalised patients should be measured not less than six hours after any digoxin dose, before or after administration of flecainide.

  Class II anti-arrhythmics: the possibility of additive negative inotropic effects of beta-blockers and other cardiac depressants with flecainide should be recognised.

  Class III anti-arrhythmics: when flecainide is given in the presence of amiodarone, the usual flecainide dosage should be reduced by 50% and the patient monitored closely for adverse effects. Plasma level monitoring is strongly recommended in these circumstances.

  Class IV anti-arrhythmics: use of flecainide with other sodium channel blockers is not recommended.

  Anti-depressants: fluoxetine increases plasma flecainide concentration, increased risk of arrhythmias with tricyclics, manufacturer of reboxetine advises caution.

  Anti-epileptics: limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.

  Anti-psychotics: clozapine– increased risk of arrhythmias.

  Anti-histamines: increased risk of ventricular arrhythmias with mizolastine and terfenadine (avoid concomitant use).

  Anti-malarials: quinine increases plasma concentration of flecainide.

  Antivirals: plasma concentration increased by ritonavir, lopinavir and indinavir (increased risk of ventricular arrhythmias, avoid concomitant use).

  Diuretics: Class effect due to hypokalaemia giving rise to cardiac toxicity.

  Ulcer healing drugs: cimetidine inhibits metabolism of flecainide. In healthy subjects receiving cimetidine (1g daily) for one week, plasma flecainide levels increased by about 30% and the half-life increased by about 10%.

  Anti-smoking aids: Co-administration of bupropion with drugs that are metabolized by CYP2D6 isoenzyme including flecainide, should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving flecainide, the need to decrease the dose of the original medication should be considered.

  Treatment with Tambocor is compatible with use of oral anti-coagulants.

• Adverse Drug Reactions
  Body as a Whole:Asthenia,fatigue,fever,oedema. Cardiovascular: Pro-arrhythmic effects occur but are most likely in patients with structural heart disease and/or significant left ventricular impairment. In patients with atrial flutter the use of Tambocor has been associated with 1:1 AV conduction following initial atrial slowing with resultant ventricular acceleration. This has been seen most commonly following the use of the injection for acute conversion. This effect is usually short lived and abates quickly following cessation of therapy. The following adverse effects have also been reported. AV block-second-degree and third degree, bradycardia, cardiac failure/congestive cardiac failure, chest pain, hypotension, myocardial infarction, palpitation and sinus pause or arrest and tachycardia (AT or VT). Skin and Appendages: A range of allergic skin reactions has been reported including rashes and rare but serious reports of urticaria. There have also been isolated cases of photosensitivity. Immune System: A small number of cases of increases in anti-nuclear antibodies have been reported, with and without systemic inflammatory involvement. Haematological: Reductions in red blood cells, white blood cells and platelets have been occasionally reported. These changes are usually mild. Psychiatric: Rarely, hallucinations, depression, confusion, amnesia. Anxiety and insomnia have been reported Gastrointestinal: Occasionally nausea and vomiting. The following have also been reported: abdominal pain, anorexia, constipation, diarrhoea, dyspepsia and flatulence (bloating). Liver and Biliary System: A number of cases of elevated liver enzymes and jaundice have been reported in association with Tambocor treatment. So far this has always been reversible on stopping treatment. Hepatic dysfunction has also been reported. Neurological: Most commonly giddiness, dizziness and lightheadedness, which are usually transient. Rare instances of dyskinesia have been reported, which have improved on withdrawal of flecainide therapy. Rare instances of convulsions, and during long term therapy a few cases of peripheral neuropathy; paraesthesia and ataxia have been reported. There also have been reports of flushing, headache, hypoaesthesia, increased sweating, somnolence, syncope, tinnitus, tremor and vertigo. Ophthalmological: Visual disturbances, such as double vision and blurring of vision may occur but these are usually transient and disappear upon continuing or reducing the dosage. Extremely rare cases of corneal deposits have also been reported. Respiratory: Dyspnoea and rare cases of pneumonitis have been reported.