flecainide

Therapeutic Classification: antiarrhythmics (class IC)

REMS

Life-threatening ventricular arrhythmias, including ventricular tachycardia.
Supraventricular tachyarrhythmias including:
- Paroxysmal supraventricular tachycardia,
- Paroxysmal atrial fibrillation/flutter.

Unlabeled Use:

Single dose treatment of atrial fibrillation.

Slows conduction in cardiac tissue by altering transport of ions across cell membranes.

Therapeutic effects:

Suppression of arrhythmias.

Absorption: Well absorbed from the GI tract following oral administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Mostly metabolized by liver; 30% excreted unchanged by kidneys.

Half-Life: 11–14 hr.

(antiarrhythmic effects)

ROUTE	ONSET	PEAK	DURATION
PO	days	days–weeks	12 hr

Contraindicated in:

Hypersensitivity;
Cardiogenic shock.

Use Cautiously in:

HF (dose ↓ may be required);
Pre-existing sinus node dysfunction or 2nd- or 3rd-degree heart block (without a pacemaker);
Renal impairment (↓ dose);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk.

CV: ARRHYTHMIAS, HF, chest pain

EENT: blurred vision, visual disturbances

GI: anorexia, constipation, drug-induced hepatitis, nausea, stomach pain, vomiting

Derm: rash

Neuro: dizziness, anxiety, depression, fatigue, headache, tremor

Drug-drug:

↑risk of arrhythmias with other antiarrhythmics, including calcium channel blockers.
Disopyramide, beta blockers, or verapamil may have ↑ myocardial depressant effects; combination use should be undertaken cautiously.
Amiodarone doubles flecainide levels (↓ flecainide dose by 50%).
May ↑ digoxin levels.
Concurrent beta blocker therapy may cause ↑ levels of beta blocker and flecainide.
Alkalinizing agents promote reabsorption, ↑ levels, and may cause toxicity.
Acidifying agents↑ renal elimination and may ↓ effectiveness of flecainide (if urine pH <5).

Foods that ↑ urine pH to >7 result in ↑ levels (strict vegetarian diet).
Foods or beverages that ↓ urine pH to <5 ↑ renal elimination and may ↓ effectiveness of flecainide (acidic juices).

Ventricular Tachycardia

PO (Adults ): 100 mg every 12 hr initially, ↑ by 50 mg twice daily until response is obtained or maximum total daily dose of 400 mg is reached. Some patients may require every 8 hr dosing.

Renal Impairment

PO (Adults ): CCr <35 mL/min: 100 mg once a day or 50 mg every 12 hr initially; further dosing on the basis of frequent blood level monitoring.

Paroxysmal Supraventricular Tachycardia/Paroxysmal Atrial Fibrillation/Flutter

PO (Adults ): 50 mg every 12 hr initially, ↑ by 50 mg twice daily until response is obtained or maximum total daily dose of 300 mg is reached. Some patients may require every 8 hr dosing.

Atrial Fibrillation Conversion (unlabeled)

PO (Adults ): 200-mg or 300-mg single dose.

(Generic available)

Tablets: 50 mg; 100 mg; 150 mg

Monitor ECG or Holter monitor prior to and periodically during therapy. May cause QRS widening, PR prolongation, and QT prolongation.
Monitor BP and pulse periodically during therapy.
Monitor intake and output ratios and daily weight. Assess patient for signs of HF (peripheral edema, rales/crackles, dyspnea, weight gain, jugular venous distention).

Lab Test Considerations:

Evaluate renal, pulmonary, and hepatic function and CBC periodically on patients receiving long-term therapy. Discontinue flecainide if bone marrow depression occurs.
- May cause ↑ in serum alkaline phosphatase during prolonged therapy.

Toxicity and Overdose:

Therapeutic blood levels range from 0.2 to 1.0 mcg/mL. Monitor plasma trough levels frequently during dose adjustment in patients with severe renal or hepatic impairment or in patients with HF and moderate renal impairment.

Previous antiarrhythmic therapy (except lidocaine) should be withdrawn 2–4 half-lives before starting flecainide.
- Start therapy in a hospital setting to monitor for increase in arrhythmias.
- Make dose adjustments at least 4 days apart because of the long half-life of flecainide.
PO: May be administered with meals if GI irritation becomes a problem.

Instruct patient to take medication around the clock as directed at evenly spaced intervals, even if feeling better. Take missed doses as soon as remembered if within 6 hr; omit if remembered later. Gradual dose reduction may be necessary.
May cause dizziness or visual disturbances. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
Instruct patient to notify health care professional if chest pain, shortness of breath, or diaphoresis occurs.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Advise patient to carry identification describing disease process and medication regimen at all times.
Emphasize the importance of follow-up exams to monitor progress.

Decrease in frequency of life-threatening ventricular arrhythmias.
Decrease in supraventricular tachyarrhythmias.

NDC Code

0054- West-Ward Pharmaceuticals Corp.
- 0054-0010- Flecainide Acetate
  - 0054-0010-20- 100 BLISTER PACK in 1 CARTON (0054-0010-20) > 1 TABLET in 1 BLISTER PACK

0054- West-Ward Pharmaceuticals Corp.
- 0054-0010- Flecainide Acetate
  - 0054-0010-21- 60 TABLET in 1 BOTTLE (0054-0010-21)

0054- West-Ward Pharmaceuticals Corp.
- 0054-0010- Flecainide Acetate
  - 0054-0010-25- 100 TABLET in 1 BOTTLE (0054-0010-25)

0054- West-Ward Pharmaceuticals Corp.
- 0054-0011- Flecainide Acetate
  - 0054-0011-20- 100 BLISTER PACK in 1 CARTON (0054-0011-20) > 1 TABLET in 1 BLISTER PACK

0054- West-Ward Pharmaceuticals Corp.
- 0054-0011- Flecainide Acetate
  - 0054-0011-21- 60 TABLET in 1 BOTTLE (0054-0011-21)

0054- West-Ward Pharmaceuticals Corp.
- 0054-0011- Flecainide Acetate
  - 0054-0011-25- 100 TABLET in 1 BOTTLE (0054-0011-25)

0054- West-Ward Pharmaceuticals Corp.
- 0054-0012- Flecainide Acetate
  - 0054-0012-20- 100 BLISTER PACK in 1 CARTON (0054-0012-20) > 1 TABLET in 1 BLISTER PACK

0054- West-Ward Pharmaceuticals Corp.
- 0054-0012- Flecainide Acetate
  - 0054-0012-21- 60 TABLET in 1 BOTTLE (0054-0012-21)

0054- West-Ward Pharmaceuticals Corp.
- 0054-0012- Flecainide Acetate
  - 0054-0012-25- 100 TABLET in 1 BOTTLE (0054-0012-25)

42291- AvKARE, Inc.
- 42291-293- Flecainide Acetate
  - 42291-293-01- 100 TABLET in 1 BOTTLE (42291-293-01)

42291- AvKARE, Inc.
- 42291-294- Flecainide Acetate
  - 42291-294-01- 100 TABLET in 1 BOTTLE (42291-294-01)

42291- AvKARE, Inc.
- 42291-295- Flecainide Acetate
  - 42291-295-01- 100 TABLET in 1 BOTTLE (42291-295-01)

50090- A-S Medication Solutions
- 50090-1132- Flecainide Acetate
  - 50090-1132-0- 60 TABLET in 1 BOTTLE (50090-1132-0)

50090- A-S Medication Solutions
- 50090-1133- Flecainide Acetate
  - 50090-1133-0- 60 TABLET in 1 BOTTLE (50090-1133-0)

50090- A-S Medication Solutions
- 50090-2968- Flecainide Acetate
  - 50090-2968-0- 60 TABLET in 1 BOTTLE (50090-2968-0)

50268- AvPAK
- 50268-320- Flecainide Acetate
  - 50268-320-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-320-15) > 1 TABLET in 1 BLISTER PACK (50268-320-11)

50268- AvPAK
- 50268-321- Flecainide Acetate
  - 50268-321-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-321-15) > 1 TABLET in 1 BLISTER PACK (50268-321-11)

50268- AvPAK
- 50268-322- Flecainide Acetate
  - 50268-322-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-322-15) > 1 TABLET in 1 BLISTER PACK (50268-322-11)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-641- Flecainide Acetate
  - 53746-641-01- 100 TABLET in 1 BOTTLE (53746-641-01)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-641- Flecainide Acetate
  - 53746-641-10- 1000 TABLET in 1 BOTTLE (53746-641-10)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-642- Flecainide Acetate
  - 53746-642-01- 100 TABLET in 1 BOTTLE (53746-642-01)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-642- Flecainide Acetate
  - 53746-642-10- 1000 TABLET in 1 BOTTLE (53746-642-10)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-643- Flecainide Acetate
  - 53746-643-01- 100 TABLET in 1 BOTTLE (53746-643-01)

53746- Amneal Pharmaceuticals of New York LLC
- 53746-643- Flecainide Acetate
  - 53746-643-10- 1000 TABLET in 1 BOTTLE (53746-643-10)

57237- Rising Health, LLC
- 57237-063- Flecainide Acetate
  - 57237-063-01- 100 TABLET in 1 BOTTLE (57237-063-01)

57237- Rising Health, LLC
- 57237-064- Flecainide Acetate
  - 57237-064-01- 100 TABLET in 1 BOTTLE (57237-064-01)

57237- Rising Health, LLC
- 57237-065- Flecainide Acetate
  - 57237-065-01- 100 TABLET in 1 BOTTLE (57237-065-01)

63629- Bryant Ranch Prepack
- 63629-7979- Flecainide Acetate
  - 63629-7979-1- 30 TABLET in 1 BOTTLE (63629-7979-1)

63629- Bryant Ranch Prepack
- 63629-7979- Flecainide Acetate
  - 63629-7979-2- 60 TABLET in 1 BOTTLE (63629-7979-2)

63629- Bryant Ranch Prepack
- 63629-7982- Flecainide Acetate
  - 63629-7982-1- 30 TABLET in 1 BOTTLE (63629-7982-1)

63629- Bryant Ranch Prepack
- 63629-7982- Flecainide Acetate
  - 63629-7982-2- 60 TABLET in 1 BOTTLE (63629-7982-2)

65162- Amneal Pharmaceuticals LLC
- 65162-641- Flecainide Acetate
  - 65162-641-10- 100 TABLET in 1 BOTTLE (65162-641-10)

65162- Amneal Pharmaceuticals LLC
- 65162-641- Flecainide Acetate
  - 65162-641-11- 1000 TABLET in 1 BOTTLE (65162-641-11)

65162- Amneal Pharmaceuticals LLC
- 65162-642- Flecainide Acetate
  - 65162-642-10- 100 TABLET in 1 BOTTLE (65162-642-10)

65162- Amneal Pharmaceuticals LLC
- 65162-642- Flecainide Acetate
  - 65162-642-11- 1000 TABLET in 1 BOTTLE (65162-642-11)

65162- Amneal Pharmaceuticals LLC
- 65162-643- Flecainide Acetate
  - 65162-643-10- 100 TABLET in 1 BOTTLE (65162-643-10)

65162- Amneal Pharmaceuticals LLC
- 65162-643- Flecainide Acetate
  - 65162-643-11- 1000 TABLET in 1 BOTTLE (65162-643-11)

65862- Aurobindo Pharma Limited
- 65862-621- Flecainide Acetate
  - 65862-621-01- 100 TABLET in 1 BOTTLE (65862-621-01)

65862- Aurobindo Pharma Limited
- 65862-621- Flecainide Acetate
  - 65862-621-30- 30 TABLET in 1 BOTTLE (65862-621-30)

65862- Aurobindo Pharma Limited
- 65862-621- Flecainide Acetate
  - 65862-621-99- 1000 TABLET in 1 BOTTLE (65862-621-99)

65862- Aurobindo Pharma Limited
- 65862-622- Flecainide Acetate
  - 65862-622-01- 100 TABLET in 1 BOTTLE (65862-622-01)

65862- Aurobindo Pharma Limited
- 65862-622- Flecainide Acetate
  - 65862-622-30- 30 TABLET in 1 BOTTLE (65862-622-30)

65862- Aurobindo Pharma Limited
- 65862-622- Flecainide Acetate
  - 65862-622-99- 1000 TABLET in 1 BOTTLE (65862-622-99)

65862- Aurobindo Pharma Limited
- 65862-623- Flecainide Acetate
  - 65862-623-01- 100 TABLET in 1 BOTTLE (65862-623-01)

65862- Aurobindo Pharma Limited
- 65862-623- Flecainide Acetate
  - 65862-623-30- 30 TABLET in 1 BOTTLE (65862-623-30)

65862- Aurobindo Pharma Limited
- 65862-623- Flecainide Acetate
  - 65862-623-99- 1000 TABLET in 1 BOTTLE (65862-623-99)

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