Zuellig Pharma
Full Prescribing Info
Flecainide acetate.
Each tablet contains flecainide acetate 100 mg.
Not applicable.
It is recommended that treatment with Tambocor should be initiated in hospital.
a) AV nodal reciprocating tachycardia, Wolff-Parkinson-White syndrome and similar conditions with accessory pathway and anterograde or retrograde conduction.
b) Paroxysmal atrial fibrillation in patients with disabling symptoms. Arrhythmias of recent onset will response more readily.
c) Symptomatic sustained ventricular tachycardia.
d) 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.
Tambocor tablets can be used for the maintenance of normal rhythm following conversion by other means.
Dosage/Direction for Use
Adults: 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 3000 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 of 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. If may be possible to reduce dosage during long-term treatment.
Children: Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group.
Elderly patients: The rate of flecainide elimination from plasma may be reduced in elderly people. An initial dose of one tablet twice daily will usually be adequate, and it may well be possible to reduce this dose for maintenance therapy after one week.
Not applicable.
Tambocor is contra-indicated in cardiac failure, and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics of 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 heamodynamically 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 atrioventricular block, bundle branch block or distal block.
Not applicable.
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– ie. 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 current 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, arteriosclerotic heart disease and cardiac failure. 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 the 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.
Use in Pregnancy: Not applicable.
Use in Lactation: Not applicable.
Use in Children: Not applicable.
Use In Pregnancy & Lactation
Not applicable.
Adverse Reactions
Most commonly giddiness, dizziness and light-headedness. Visual disturbance, such as double vision and blurring of vision, may occur. More rarely nausea and vomiting have been reported. These effects are usually transient and disappear upon continuing or reducing the dosage. Pro-arrhythmic effects occur but are most likely in patients with structural heart disease and/or significant left ventricular impairment. A number of cases of elevated liver enzymes and jaundice have been reported in association with Tambocor. So far this has always been reversible on stopping treatment.
Drug Interactions
Other drugs: Digoxin: During multiple oral dosage of Tambocor to healthy subjects stabilized on a maintenance dose of digoxin, a 13% ± 19% increase in plasma digoxin levels occurred at six hours postdose. These small changes in digoxin levels should be of no clinical consequence for patients receiving chronic digitalis preparation without adverse effects.
Propranolol: During coadministration of Tambocor and propranolol, plasma Tambocor levels are about 20% higher and propranolol levels are about 30% higher, in comparison to control values. These small changes should be of no clinical consequence. In a formal interaction study conducted in healthy males, Tambocor and propranolol were each found to have slight negative inotropic effects on cardiac function; when administered together these effects were never any more than additive. The effects of concomitant administration of Tambocor and propranolol on the PR Interval were less than additive. While these effects were of little clinical consequence in the healthy subjects in this study, the possibility of exaggerated effects from this combination in patients with reduced left ventricular function should be borne in mind. Experience in patients receiving concomitant beta-blockers has not revealed any adverse effects.
Disopyramide, Verapamil: There has been no experience with the coadministration of Tambocor and either disopyramide or verapamil. Because both of these drugs have negative inotropic properties and the effects of coadministration with Tambocor are unknown, neither disopyramide nor verapamil should be administered concurrently with Tambocor unless, in the judgement of the physician, the benefit of this combination outweighs the risks.
Other drugs: Although formal interaction studies have not been conducted with Tambocor and other drugs. Tambocor is not extensively bound to plasma proteins and consequently interactions with other drugs which are highly protein bound (e.g. Anticoagulants) would not be expected. Tambocor has been used.
Protect from light. Store below 30°C.
MIMS Class
ATC Classification
C01BC04 - flecainide ; Belongs to class Ic antiarrhythmics.
Tab 100 mg (white, circular, biconvex, 8.5 mm, in diameter marked "3M" on one side and "TR 100" with a break-line on the other) x 60's.
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