Flecainide (acetate)

Generic name
Flecainide (acetate)
Brand name
ATC Code
C01BC04
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Flecainide (acetate)

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

T½: in neonates (when administered to the mother), the elimination half-life is extended to about 29 hours; in children up to 1 year of age, the elimination half-life is 11-12 hours; in children of 1 to 12 years, the elimination half-life is 8 hours. The therapeutic plasma concentration is 0.2-1 mg/l.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Supraventricular arrhythmias, life-threatening ventricular arrhythmias
  • Intravenous
    • Normal preparation (immediate release)
      • 1 month up to 18 years
        • Flecainide acetate: 1 - 2 mg/kg/dose in 10 min. Max: 150 mg/dose.

        • Parenteral administration of flecainide is only indicated in lidocaine resistance and if the arrhythmia has to be brought under control quickly.

          The treatment with flecainide should be given in consultation with a paediatric cardiologist. The dose should be adjusted in the clinic, monitoring the ECG and the plasma concentration.

      • Term neonate
        • Flecainide acetate: 1 - 2 mg/kg/dose in 10 min.

        • Parenteral administration of flecainide is only indicated in lidocaine resistance and if the arrhythmia has to be brought under control quickly.

          The treatment with flecainide should be given in consultation with a paediatric cardiologist. The dose should be adjusted in the clinic, monitoring the ECG and the plasma concentration.

  • Oral
    • Normal preparation (immediate release)
      • Term neonate
        • Initial dose: Flecainide acetate: 4 mg/kg/day in 2 doses.
        • Maintenance dose: if needed increase dose based on the effect and serum concentration at intervals of at least 4 days to 2 - 8 mg/kg/day in 2 doses. Max: 8 mg/kg/day.

        • The treatment with flecainide should be given in consultation with a paediatric cardiologist. The dose should be adjusted in the clinic, monitoring the ECG and the plasma concentration.

      • 1 month up to 18 years
        • Flecainide acetate: 3 - 6 mg/kg/day in 2 - 3 doses. Max: 8mg/kg/day, but not exceeding 400 mg/day.

        • The treatment with flecainide should be given in consultation with a paediatric cardiologist. The dose should be adjusted in the clinic, monitoring the ECG and the plasma concentration.

Renal impaiment in children > 3 months

The dose should be adjusted in patients with renal function disorders. There are no instructions available stating how the dose should be adjusted.

Clinical consequences

Plasma concentrations above 0.7–1.0 mg/l are associated with an increased risk of side effects occurring.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Hypotension, tingling fingers, vision problems, hair loss, extension of the QTc interval. Pro-arrhythmic effects in particular in patients with structural heart disease and/or poor left ventricular function. Bradycardia, broader QRS complex, negative inotropic effect, nausea, vomiting, perioral paraesthesia, ECG changes, loss of consciousness after effort (probably due to ventricular tachycardia). Sleepiness, psychiatric problems. Abnormal ECG and tremor have been seen at high doses.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Extended QTc interval, asymptomatic and non-serious symptomatic ventricular arrhythmia, myocardial infarction in the previous history (unless the arrhythmia is life-threatening).

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Treatment with flecainide should be adjusted in a clinical setting and dose adjustments must be implemented in the clinic, with ECG and plasma concentration monitoring.

Milk and dairy products can reduce the resorption of flecainide; administering flecainide half an hour before food or 2 hours after food is preferable. If this is not practically possible, it is recommended that flecainide should always be given at the same moment with respect to the nutrition so that the effect of any interaction is not a variable that affects the level.
Caution is needed when changing the feeding pattern in a way that lowers the intake of milk and dairy products (as this can elevate the plasma concentration of flecainide).
The dose should be adjusted in patients with hepatic or renal function disorders. Plasma concentrations above 0.7–1.0 mg/l are associated with an increased risk of side effects occurring.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIARRHYTHMICS, CLASS I AND III

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antiarrhythmics, class Ia
C01BA02
C01BA01
Antiarrhythmics, class Ic
C01BC03
Antiarrhythmics, class III
C01BD01

References

  1. Fish FA, et al., Proarrhythmia, cardiac arrest and death in young patients receiving encainide and flecainide. The Pediatric Electrophysiology Group, J Am Coll Cardiol, 1991, 18, 356-65
  2. Musto B, et al., Flecainide single oral dose for management of paroxysmal supraventricular tachycardia in children and young adults., Am Heart J, 1992, 124, 110-5
  3. Perry JC, et al., Flecainide acetate for treatment of tachyarrhythmias in children: review of world literature on efficacy, safety, and dosing., Am Heart J, 1992, 124, 1614-21
  4. Perry JC, et al., Flecainide acetate for resistant arrhythmias in the young: efficacy and pharmacokinetics., J Am Coll Cardiol, 1989, 14, 185-91
  5. Russell GA, et al., Flecainide toxicity., Arch Dis Child, 1989, 64, 860-2
  6. Schneeweiss A., New antiarrhythmic drugs. II.Flecainide, Pediatr Cardiol, 1990, 11, 143-6
  7. Zeigler V, et al, Flecainide for supraventricular and ventricular arrhythmias in children and young adults., Am J Cardiol, 1988, 62, 818-20
  8. KNMP Kennisbank, Handboek oralia VGTM, Geraadpleegd 29 dec 2014
  9. EMA, Artikel 45 procedure Flecainide, http://www.hma.eu/269.html, Geraadpleegd 21 mei 2014
  10. Chorin, E., et al., Long-term flecainide therapy in type 3 long QT syndrome., Europace, 2018, 20 (2), 370-376
  11. Liberman, L., et al., Usefulness of High-Dose Oral Flecainide for Termination of Recent-Onset Atrial Fibrillation in Children., Am J Cardiol, 2018, 121 (12), 1530-1533
  12. Ferlini M, et al, Flecainide as first-line treatment for supraventricular tachycardia in newborns., J Cardiovasc Med (Hagerstown), 2009, May;10(5), 372-5
  13. Viatris AS, SmPC Tambocor (MT-nr. 7126) 11.07.2023, www.legemiddelsok.no

Changes

Therapeutic Drug Monitoring


Overdose