Infant Data
Results
INDICATIONS
Treatment of supraventricular arrhythmias not responsive to conventional therapies. Not recommended in patients with structurally abnormal hearts.
CONTRAINDICATIONS
Contraindicated in patients with preexisting second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock, unless a pacemaker is present. Also contraindicated in the presence of cardiogenic shock.
ADVERSE EFFECTS
Flecainide can cause new or worsened arrhythmias, including AV block, bradycardia, ventricular tachycardia, torsades de pointes. There is also a negative inotropic effect. Dizziness, blurred vision, and headache have been reported in children.
BLACK BOX WARNING
An excessive mortality or non-fatal cardiac arrest rate was seen in patients (adults) with asymptomatic non-life-threatening ventricular arrhythmias and a history of myocardial infarction treated with flecainide compared with that seen in patients assigned to a carefully matched placebo-treated group in the Cardiac Arrhythmia Suppression Trial (CAST). It is prudent to consider the risks of Class IC agents (including flecainide), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without lifethreatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs. Flecainide is not recommended for use in patients with chronic atrial fibrillation. Case reports of ventricular proarrhythmic effects in patients treated with flecainide for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death.
ADMINISTRATION
Infant formulas and milk may decrease absorption. If milk is removed from the infant’s diet, a reduction in dose should be considered.
MONITORING
Continuous EKG during initiation of therapy, as this is the most common time to see druginduced arrhythmias. Follow trough serum concentrations closely at initiation, 3 to 5 days after any dose change, and with any significant change in clinical status or diet. Therapeutic trough levels are 200 to 800 nanograms/mL.