Trade Names:Tambocor- Tablets 50 mg- Tablets 100 mg- Tablets 150 mgApo-Flecainide (Canada)
Produces a dose-related decrease in intracardiac conduction in all parts of the heart; also has local anesthetic activity.
About 100% absorbed. T max is 1 to 6 h.
About 40% protein bound.
There are 2 major metabolites: meta-o-dealkylated flecainide (active, but about 1/ 5 as potent) and meta-o-dealkylated lactam of flecainide (nonactive).
The t ½ is 12 to 27 h; 10% to 50% is excreted in the urine as unchanged drug.Hemodialysis
About 1% of unchanged drug is removed by hemodialysis.
The t ½ is prolonged.ChildrenAt birth
The t ½ is up to 29 h.At 3 mo of age
The t ½ is 11 to 12 h.At 1 to 12 yr of age
The t ½ is 6 to 8 h.CHF (NYHA Class III)
The t ½ is increased.
Prevention of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms; paroxysmal supraventricular tachycardias (PSVTs), including AV nodal reentrant tachycardia and AV reentrant tachycardia; prevention of documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
Preexisting second- or third-degree AV block; right bundle branch block when associated with a left hemiblock (unless a pacemaker is present); presence of cardiogenic shock; hypersensitivity to the drug.
PO 50 mg every 12 h, increasing 50 mg twice daily every 4 days until efficacy is achieved. Max, 300 mg/day.Sustained VTAdults Initial dose
PO 100 mg every 12 h, increasing 50 mg twice daily every 4 days until efficacy is achieved. Max, 400 mg/day.ChildrenYounger than 6 mo of age
PO 50 mg/m 2 divided into 2 or 3 equally spaced doses.Older than 6 mo of age
PO 100 mg/m 2 /day. The maximum recommended dose is 200 mg/m 2 /day.Renal Function Impairment
When CrCl is less than 35 mL/min, the initial dose is 100 mg once daily (or 50 mg twice daily).Administration with Amiodarone
Reduce dose of flecainide 50% when given with amiodarone.
Increased flecainide plasma levels; reduce dose of flecainide 50%.Cimetidine
Increased bioavailability and half-life of flecainide.Cisapride, disopyramide, verapamil
Has negative inotropic effects; administer with flecainide only if benefit outweighs the risks. Coadministration with flecainide is not recommended because of the increased risk of life-threatening cardiac arrhythmias.Digoxin
Increased digoxin plasma levels.Drugs that inhibit CYP2D6 (eg, quinidine, ritonavir)
Flecainide plasma concentrations may be elevated, increasing the risk of toxicity.Propranolol
Levels of either drug may be increased; additive negative inotropic effects.Smoking
Increased dosage may be required.Urinary acidifiers
Effects of flecainide may be decreased.Urinary alkalinizers
Effects of flecainide may be increased.
None well documented.
Palpitation (6%); chest pain (5%); tachycardia (1% to less than 3%); sinus bradycardia, sinus pause, sinus arrest (1%); new or worsening arrhythmia, unresuscitatable VT or ventricular fibrillation, new or worsening CHF, second- or third-degree AV block.
Dizziness including lightheadedness, faintness, unsteadiness, and near syncope (19%); headache (10%); fatigue (8%); asthenia, tremor (5%); hypoesthesia, paresthesia, paresis, ataxia, flushing, increased sweating, vertigo, syncope, somnolence, anxiety, insomnia, depression, malaise (1% to less than 3%).
Rash (1% to less than 3%).
Visual disturbances including blurred vision, difficulty focusing, spots before eyes (16%); tinnitus, diplopia (1% to less than 3%).
Nausea (9%); constipation (4%); abdominal pain (3%); vomiting, diarrhea, dyspepsia, anorexia (1% to less than 3%).
Edema (4%); fever (1% to less than 3%).
An excessive mortality or nonfatal cardiac arrest rate was observed in patients with nonlife-threatening ventricular arrhythmias who had a recent MI.
Ventricular pro-arrhythmic effects have been observed in patients with atrial fibrillation/flutter. This drug is not recommended in patients with chronic atrial fibrillation.
Category C .
Excreted in breast milk.
Safety and efficacy not established.
Do not use in patients with hepatic function impairment unless benefits outweigh risks.
Use with caution in patients with arrhythmias, CHF, cardiomyopathy, low ejection fraction, and conduction abnormalities. Use with extreme caution in patients with sick sinus syndrome, because drug may cause sinus bradycardia, sinus pause, or sinus arrest.
Flecainide slows cardiac conduction in most patients to produce a dose-related increase in PR, QRS, and QT intervals.
Flecainide increases endocardial pacing thresholds and may suppress ventricular escape rhythms in patients with pacemakers.
Effect of flecainide may be altered in patients with hypokalemia or hyperkalemia; correct condition before administering flecainide.
Nausea and vomiting, convulsions, hypotension, bradycardia, syncope, extreme widening of the QRS complex, widening of the QT interval, widening of the PR interval, VT, AV nodal block, asystole, bundle branch block, cardiac failure, cardiac arrest, death.
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