Adult Dosing
PVST/ PAF
- Start 50 mg PO q12 h
- Titrate: Increase by 100 mg/day q4 days. Max: 300 mg/day
Note: Therapeutic serum drug level in adults is 0.2-1 mcg/mL
Prevention of ventricular arrhythmias
- Start 100 mg PO q12 h
- Titrate: Increase by 100 mg/day q4 days. Max: 400 mg/day
Note: Therapeutic serum drug level in adults is 0.2-1 mcg/mL
Pediatric Dosing
PVST/ PAF
- <6 months: Start 50 mg/m2 PO divided bid-tid
- >6 months: Start 100 mg/m2 PO divided bid-tid
- Titrate: Increase dose q4 days to a maximum of 200 mg/m2/day
Note: Maintain plasma drug levels within 0.2-0.5 mcg/mL
Prevention of ventricular arrhythmias
- <6 months: Start 50 mg/m2 PO divided bid-tid
- Titrate: Increase dose q4 days to a maximum of 200 mg/m2/day
- >6 months: Start 100 mg/m2 PO divided bid-tid
- Titrate: Increase dose q4 days to a maximum of 200 mg/m2/day
Note: Maintain plasma drug levels within 0.2-0.5 mcg/mL
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <35 mL/min: Starting dose is 100 mg daily or 50 mg bid
- Hemodialysis: No supplement needed
Hepatic Dose Adjustment
- Severe hepatic impairment: Avoid use. Use only if benefits clearly outweigh risks. Monitor plasma drug levels
- Therapy may induce new or worsen supraventricular or ventricular arrhythmias. Ventricular proarrhythmic effects ranging from an increase in frequency of PVCs to the development of more severe ventricular tachycardia have occurred. 80% of proarrhythmic events have occurred within 14 days of the onset of therapy in patients treated with flecainide for sustained ventricular tachycardia. Exacerbations of supraventricular arrhythmias (longer duration, more rapid rate, harder to reverse) have occurred. Complex tachycardia and ventricular fibrillation have occurred in CAF patients undergoing maximal exercise tolerance testing
- It is often difficult to distinguish a spontaneous variation in the patient's underlying rhythm disorder from drug-induced worsening in patients with complex ventricular arrhythmias
- With lower initial doses, the incidence of proarrhythmic events resulting in death has decreased. Start therapy of patients with sustained VT in the hospital so that careful titration and monitoring can be carried out effectively
- This drug exhibits negative inotropic effect and may induce or worsen CHF, particularly in patients with cardiomyopathy, preexisting severe heart failure (NYHA functional class III or IV) or low ejection fractions (less than 30%). Use initial dosage no more than 100 mg bid with careful monitoring in patients who are known to have a history of CHF or myocardial dysfunction
- Give close attention for maintenance of cardiac function, including optimization of digitalis, diuretic, or other therapy
- CHF has developed or worsened few hours to several months after starting therapy. Some patients who developed evidence of reduced myocardial function while undergoing therapy can continue this drug with adjustment of digitalis or diuretics, others may require dose reduction or discontinuation of flecainide
- Monitor plasma flecainide levels
- Therapy slows cardiac conduction to produce dose-related increase in PR, QRS, and QT intervals. New first-degree AV heart block (PR interval = 0.20 seconds), new bundle branch block may occur
- Exercise caution and consider dose reduction if a PR interval increases to 0.30 seconds or more, or if QRS interval increases to 0.18 seconds or more. The QT interval may widen by about 8%. Rare occasions of torsade de pointes-type arrhythmia have occurred
- Discontinue therapy unless a temporary or implanted ventricular pacemaker is in place to ensure an adequate ventricular rate on occurrence of second- or third-degree AV block, or right bundle branch block associated with a left hemiblock
- Sinus node dysfunction such as sinus pause, sinus arrest and symptomatic bradycardia (1.2%), second-degree AV block (0.5%) and third-degree AV block (0.4%) have occurred
- Sick sinus syndrome have also occurred
- Increases endocardial pacing thresholds and suppress ventricular escape rhythms. Avoid use in patients with existing poor thresholds or nonprogrammable pacemakers unless suitable pacing rescue is available. Determine pacing threshold in patients with pacemakers prior to instituting therapy and again after one week of administration and at regular intervals thereafter
- Hypokalemia or hyperkalemia alters the effects of Class I antiarrhythmic drugs. Correct preexisting hypokalemia or hyperkalemia before administration
- Therapy is associated with cardiac arrest and sudden death in pediatric patients
- Safety and efficacy in the fetus, infant, or child have not been established in double blind trial. Initiate therapy at the hospital with careful monitoring. Organized supervision of therapy by a cardiologist skilled in the treatment of arrhythmias in children
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Structural heart disease
- Myocardial dysfunction
- CHF
- QT prolongation
- Sick sinus syndrome
- Use of pacemaker
- Electrolyte abnormalities
Pregnancy Category:C
Breastfeeding: Limited available literature indicates that maternal doses of flecainide up to 200 mg/day produce low levels in milk and are unexpected to cause any adverse effects in breastfed infants, especially if the infant is >2 months. As relatively lack of data concerning breastfeeding during maternal flecainide therapy, is available exclusively breastfed infants should be carefully monitored if this drug is used during lactation. Measure serum levels to rule out toxicity. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 3 February 2011). Flecainide is excreted in human breast milk in concentrations as high as 4 times (with average levels about 2.5 times) corresponding to plasma levels. Manufacturer advises to use this drug only if the potential benefit justifies the potential risk to the fetus.
Pricing data from www.DrugStore.com in U.S.A.
- Flecainide Acetate 100 MG TABS [Bottle] (ROXANE)
60 mg = $83.97
180 mg = $232.94 - Tambocor 150 MG TABS [Bottle] (GRACEWAY PHARMACEUTICALS)
60 mg = $310
180 mg = $886.02 - Tambocor 50 MG TABS [Bottle] (GRACEWAY PHARMACEUTICALS)
60 mg = $145.97
180 mg = $421.98 - Tambocor 100 MG TABS [Bottle] (GRACEWAY PHARMACEUTICALS)
60 mg = $229.98
180 mg = $659.99 - Flecainide Acetate 150 MG TABS [Bottle] (ROXANE)
60 mg = $119
180 mg = $331.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
