Mortality. TAMBOCOR was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a longterm, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously. An excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with TAMBOCOR compared with that seen in patients assigned to a carefully matched placebo-treated group. This rate was 16/315 (5.1%) for TAMBOCOR and 7/309 (2.3%) for the matched placebo. The average duration of treatment with TAMBOCOR in this study was ten months.
The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain, but at present, it is prudent to consider the risks of Class IC agents (including TAMBOCOR), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.
Ventricular Pro-arrhythmic Effects in Patients with Atrial Fibrillation/Flutter. A review of the world literature revealed reports of 568 patients treated with oral TAMBOCOR for paroxysmal atrial fibrillation/flutter (PAF). Ventricular tachycardia was experienced in 0.4% (2/568) of these patients. Of 19 patients in the literature with chronic atrial fibrillation (CAF), 10.5% (2) experienced VT or VF. FLECAINIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH CHRONIC ATRIAL FIBRILLATION. Case reports of ventricular proarrhythmic effects in patients treated with TAMBOCOR for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death.
As with other Class I agents, patients treated with TAMBOCOR for atrial flutter have been reported with 1:1 atrioventricular conduction due to slowing the atrial rate. A paradoxical increase in the ventricular rate also may occur in patients with atrial fibrillation who receive TAMBOCOR. Concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication.
TAMBOCORTM(flecainide acetate) is an antiarrhythmic drug available in tablets of 50, 100 or 150 mg for oral administration.
In patients without structural heart disease, TAMBOCOR is indicated for the prevention of
paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms
paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms
TAMBOCOR is also indicated for the prevention of
documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.
Use of TAMBOCOR for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of TAMBOCOR is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.
Because of the proarrhythmic effects of TAMBOCOR, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.
TAMBOCOR should not be used in patients with recent myocardial infarction. (See Boxed Warnings.)
Use of TAMBOCOR in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed Warnings.)
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of TAMBOCOR favorably affects survival or the incidence of sudden death.
Published Studies Related to Tambocor (Flecainide)
Flecainide for the treatment of chronic neuropathic pain: a Phase II trial. [2007.12]
BACKGROUND: Management of neuropathic pain is challenging. Medications that interfere with sodium channel transport, such as lidocaine, mexilitene and flecainide, are promising as analgesics. OBJECTIVE: In a general population of patients with a working diagnosis of neuropathic pain, whether if flecainide produces enough of an improvement in pain to warrant further clinical study is determined... CONCLUSIONS: Flecainide produced a 30% response rate. Response in this study was defined to be highly relevant and clinically significant reduction in pain. The drug merits study in a randomized placebo-controlled trial. Palliative Medicine 2007; 21: 667-672.
Dose-response effect of flecainide in patients with symptomatic paroxysmal atrial fibrillation and/or flutter monitored with trans-telephonic electrocardiography: a multicenter, placebo-controlled, double-blind trial. [2007.03]
CONCLUSIONS: This study indicated that flecainide exerted a significant dose-dependent effect on the prevention of symptomatic PAF/PAFL recurrence and showed that there was no inter-ethnic difference in the clinical effect of flecainide in patients with PAF/PAFL.
Multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy (MADIT-CRT): design and clinical protocol. [2005.10]
The planned MADIT-CRT trial is designed to determine if CRT-D will reduce the risk of mortality and HF events by approximately 25% in subjects with ischemic (NYHA class I-II) and non-ischemic (NYHA class II) cardiomyopathy, left ventricular dysfunction (EF<or=0.30), and prolonged intraventricular conduction (QRS duration>or=130 ms)..
Absorption kinetics and pharmacodynamics of two oral dosage forms of flecainide in patients with an episode of paroxysmal atrial fibrillation. [2004.12]
OBJECTIVES: The objectives were to study the absorption kinetics and pharmacodynamics of two oral formulations of flecainide in patients with atrial fibrillation (AF) and to assess the relationship between pharmacokinetic parameters and the efficacy in restoring sinus rhythm... CONCLUSIONS: The probability of cardioversion after an oral loading dose of flecainide in patients with AF is dependent on ka. Rapid loading of the effect compartment, i.e. the atria, appears to be critical to reach cardioversion. Higher flecainide serum concentrations and a more rapid absorption does not increase interindividual variability of pharmacokinetics and pharmacodynamics, which is important when safety is considered.
Flecainide versus ibutilide for immediate cardioversion of atrial fibrillation of recent onset. [2004.08]
CONCLUSIONS: There was no significant difference in the cardioversion efficacy or in the risk of adverse events between flecainide and ibutilide in patients with AF of recent onset. In patients without contraindications to both medications, the physician's choice has to be governed by other factors.
Clinical Trials Related to Tambocor (Flecainide)
Vernakalant Versus Flecainide: Atrial Contractility [Not yet recruiting]
Atrial fibrillation (AF) is associated with decreased atrial contractility which is
associated with stroke. Decreased contractility becomes apparent after cardioversion of
atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved
contractility immediately after cardioversion may prevent arrhythmia progression. In
addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to
convert atrial fibrillation to sinus rhythm and at the same time increase atrial
contractility. The latter has not yet been shown in humans and is subject of the present
investigation. Our hypothesis is that in humans the contractility of the atria is higher
after administration of vernakalant compared to flecainide. If indeed vernakalant improves
atrial contractility after cardioversion further studies into the effect on long-term
arrhythmia progression and stroke prevention may follow.
Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia [Active, not recruiting]
The purpose of this study is to test whether the addition of oral flecainide to standard
therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard
therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation [Completed]
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation
with controlled release flecainide on patient's quality of life.
Diagnostic Value and Safety of Flecainide Infusion Test in Brugada Syndrome [Enrolling by invitation]
The study aims to use flecainide infusion test as diagnostic test to unmask concealed
Brugada Syndrome cases. It proposes to assess the safety profile of this test in US patients
and its higher sensitivity when compared to procainamide infusion (the conventional drug
used in the USA). As a substudy it proposes to apply this test to early ARVC cases in order
to evaluate if ECG changes similar to those seen in Brugada Syndrome could be unmasked by
Flecainide-Short Long Study (Flec-SL) [Completed]
Reports of Suspected Tambocor (Flecainide) Side Effects
Product Substitution Issue (2),
Sudden Death (2),
Weight Decreased (1),
Hepatic Function Abnormal (1),
Hallucination, Auditory (1),
Visual Acuity Reduced (1),
Abdominal Pain Upper (1), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Tambocor has an overall score of 8. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
Tambocor review by 58 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || tachycardia|
|Dosage & duration:|| || 50mg taken twice a day for the period of 3 years|
|Other conditions:|| || none|
|Other drugs taken:|| || HRT|
|Benefits:|| || prevented 90% of tachycardia incidents. when tachycardia did occur it was less dramatic|
|Side effects:|| || None that i have noticed|
|Comments:|| || Take twice daily as a preventative measure. If my life is very calm I have reduced it to one a day|
Page last updated: 2008-01-02