Drugplain

Flecainide Acetate 50 mg/1

Flecainide Acetate · TABLET · AvPAK

2 Recalls on Record
Plain English

Flecainide Acetate is a tablet containing flecainide acetate at 50 mg/1, taken oral. Manufactured by AvPAK.

Key Facts

Brand Name
Flecainide Acetate
Generic Name
Flecainide Acetate
NDC Code (Product)
50268-320
Manufacturer
AvPAK
Strength
50 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA075442
Marketing Start
02/12/2015

Recall History

2 Recalls on Record
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: FLECAINIDE ACETATE, Tablet, 100 mg may be potentially mislabeled as the following drug: COLESTIPOL HCL MICRONIZED, Tablet, 1 g, NDC 59762045001, Pedigree: AD56847_1, EXP: 5/21/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; FLECAINIDE ACETATE Tablet, 50 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD46419_7, EXP: 5/16/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

atrial fibrillation344 reports
fatigue283 reports
dyspnoea275 reports
dizziness262 reports
nausea247 reports
drug ineffective220 reports
headache215 reports
diarrhoea214 reports
asthenia202 reports
fall184 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE In patients without structural heart disease, flecainide acetate tablets, USP are 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 Flecainide acetate tablets, USP are 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 flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate tablets, USP are not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide a…

Dosage & Administration

DOSAGE AND ADMINISTRATION For patients with sustained VT, no matter what their cardiac status, flecainide acetate tablets, 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 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 dose from 50 to 100 mg bid. The maximum recommended dose for patients with paroxysmal supraventricular arrhythmias is 300 mg/day. For sustained VT the recom…

Contraindications

CONTRAINDICATIONS Flecainide acetate tablets are contraindicated in patients with preexisting 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.

Drug Interactions

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…

Adverse Reactions

ADVERSE REACTIONS 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 1330 patients with PVCs, non-sustained or sustained VT. In patients treated with flecainide 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 …

Frequently Asked Questions

What is Flecainide Acetate used for?

Flecainide Acetate contains Flecainide Acetate. It is a tablet taken oral. Consult your doctor for specific uses.

Is Flecainide Acetate a controlled substance?

Flecainide Acetate is not classified as a controlled substance by the DEA.

What is the generic name for Flecainide Acetate?

The generic name for Flecainide Acetate is Flecainide Acetate. There are no other listed brand versions of Flecainide Acetate.

What is the NDC code for Flecainide Acetate 50 mg/1?

The NDC (National Drug Code) for Flecainide Acetate 50 mg/1 is 50268-320, listed by AvPAK.

Product NDC

50268-320

Package NDC

50268-320-15

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)