Flecainide — uses, dosing, side effects & the brands that sell it · pharmaranks
Flecainide: uses, dosing, side effects & brands
Flecainide is an antiarrhythmic sold in the U.S. under 2 brand and generic names, for atrial fibrillation, supraventricular tachycardia and ventricular tachycardia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Antiarrhythmic
Treats
Atrial Fibrillation, Supraventricular Tachycardia and Ventricular Tachycardia
From the FDA label for Flecainide Acetate (application ANDA076030). Other flecainide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For patients with sustained VT, no matter what their cardiac status, Flecainide Acetate Tablets, USP like other antiarrhythmics, should be initiated in-hospital with rhythm monitoring. Flecainide has a long half-life (12 to 27 hours in patients). Steady-state plasma levels, in patients with normal renal and hepatic function, may not be achieved until the patient has received 3 to 5 days of therapy at a given dose. Therefore, increases in dosage should be made no more frequently than once every four days , since during the first 2 to 3 days of therapy the optimal effect of a given dose may not be achieved. For patients with PSVT and patients with PAF the recommended starting dose is 50 mg every 12 hours. Flecainide Acetate Tablets, USP doses may be increased in increments of 50 mg bid every four days until efficacy is achieved. For PAF patients, a substantial increase in efficacy without a substantial increase in discontinuations for adverse experiences may be achieved by increasing the Flecainide Acetate Tablets, USP dose from 50 mg to 100 mg bid. The maximum recommended dose for patients with paroxysmal supraventricular arrhythmias is 300 mg/day. For sustained VT the recommended starting dose is 100 mg every 12 hours. This dose may be increased in increments of 50 mg bid every four days until efficacy is achieved. Most patients with sustained VT do not require more than 150…
Flecainide side effects
In post-myocardial infarction patients with asymptomatic PVCs and non-sustained ventricular tachycardia, flecainide acetate therapy was found to be associated with a 5.1% rate of death and non-fatal cardiac arrest, compared with a 2.3% rate in a matched placebo group. (See WARNINGS .) Adverse effects reported for flecainide acetate, described in detail in the WARNINGS section, were new or worsened arrhythmias which occurred in 1% of 108 patients with PSVT and in 7% of 117 patients with PAF; and new or exacerbated ventricular arrhythmias which occurred in 7% of 1,330 patients with PVCs, non-sustained or sustained VT. In patients treated with flecainide acetate for sustained VT, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy. 198 patients with sustained VT experienced a 13% incidence of new or exacerbated ventricular arrhythmias when dosage was initiated at 200 mg/day with slow upward titration, and did not exceed 300 mg/day in most patients. In some patients, flecainide acetate treatment has been associated with episodes of unresuscitatable VT or ventricular fibrillation (cardiac arrest). (See WARNINGS .) New or worsened CHF occurred in 6.3% of 1,046 patients with PVCs, non-sustained or sustained VT. Of 297 patients with sustained VT, 9.1% experienced new or worsened CHF. New or worsened CHF was reported in 0.4% of 225 patients with…
Every flecainide product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Flecainide pill imprints
Imprint
Strength
Colour
Shape
Maker
YH;777
50 mg
white
round
—
YH;717
100 mg
white
round
—
YH;711
150 mg
white
capsule
—
BPL026
100 mg
white
round
—
BPL025
50 mg
white
round
—
BPL026
100 mg
Frequently asked questions
What is flecainide?
Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate USP for oral administration. Flecainide acetate USP is benzamide, N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below. Flecainide acetate USP is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. Flecainide Acetate Tablets, USP also contain: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Flecainide Acetate Tablets, USP meets USP Dissolution Test 2.
What kind of drug is flecainide?
The FDA classifies flecainide as an antiarrhythmic. Antiarrhythmics steady an irregular heartbeat by controlling the flow of sodium, potassium, or calcium ions through heart-cell channels (or blunting adrenaline's effect), which slows or normalizes the heart's electrical signals so it beats in a more regular rhythm. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take flecainide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run flecainide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is flecainide sold under?
We track 2 flecainide-containing products in the U.S.: Flecainide Acetate and Tambocor. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does flecainide come in?
Across the brands we track, flecainide is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take flecainide
Flecainide Acetate Tablets are contraindicated in patients with pre-existing second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur. Flecainide Acetate Tablets are also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.
Flecainide drug interactions
Flecainide acetate has been administered to patients receiving digitalis preparations or beta-adrenergic blocking agents without adverse effects. During administration of multiple oral doses of flecainide acetate to healthy subjects stabilized on a maintenance dose of digoxin , a 13% to 19% increase in plasma digoxin levels occurred at six hours postdose. In a study involving healthy subjects receiving flecainide acetate and propranolol concurrently, plasma flecainide levels were increased about 20% and propranolol levels were increased about 30% compared to control values. In this formal interaction study, flecainide acetate and propranolol were each found to have negative inotropic effects; when the drugs were administered together, the effects were additive. The effects of concomitant administration of flecainide acetate and propranolol on the PR interval were less than additive. In flecainide acetate clinical trials, patients who were receiving beta blockers concurrently did not experience an increased incidence of side effects. Nevertheless, the possibility of additive negative inotropic effects of beta blockers and flecainide should be recognized. Flecainide is not extensively bound to plasma proteins. In vitro studies with several drugs which may be administered concomitantly showed that the extent of flecainide binding to human plasma proteins is…
Yes. Our catalog lists 1 generic flecainide product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.