Flecainide acetate

CLINICAL USE

Class Ic anti-arrhythmic agent:Ventricular arrhythmias and tachycardias

DOSE IN NORMAL RENAL FUNCTION

Supraventricular arrhythmias: 100–300 mg daily in 2 divided dosesVentricular arrhythmias: 200–400 mg daily in 2 divided dosesIV bolus: 2 mg/kg over 10–30 minutes (maximum 150 mg), then

IV infusion

of 1.5 mg/kg/hour for 1 hour, subsequently 0.1–0.25 mg/kg/hour; maximum 600 mg in 24 hours

PHARMACOKINETICS

  • Molecular weight                           :474.4
  • %Protein binding                           :32–58
  • %Excreted unchanged in urine     : 42
  • Volume of distribution (L/kg)       :8.31
  • half-life – normal/ESRD (hrs)      :12–27/19–26

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

  • 20 to 50     : See ‘Other Information’
  • 10 to 20     : See ‘Other Information’
  • <10           : See ‘Other Information’

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD                :≈1% dialysed.1 Dose as in GFR <10 mL/min
  • HD                     :≈1% dialysed.1 Dose as in GFR <10 mL/min
  • HDF/high flux   :Unknown dialysability. Dose as in GFR <10 mL/min
  • CAV/VVHD      :Minimal removal. Dose as in GFR 10 to 20 mL/min

    IMPORTANT DRUG INTERACTIONS

    Potentially hazardous interactions with other drugs

  • Anti-arrhythmics: concentration increased by amiodarone – halve dose of flecainide; increased myocardial depression with other anti-arrhythmics
  • Antidepressants: concentration increased by fluoxetine; increased risk of ventricular arrhythmias with tricyclicsAntihistamines: increased risk of ventricular arrhythmias with mizolastineAntihypertensives: increased myocardial depression and bradycardia with beta-blockers; increased myocardial depression and asystole with verapamil
  • Antimalarials: concentration increased by quinine; avoid concomitant use with artemether/lumefantrine
  • Antipsychotics: increased risk of ventricular arrhythmias with antipsychotics that prolong the QT interval and phenothiazines; increased risk of arrhythmias with clozapine
  • Antivirals: concentration increased by ritonavir and possibly amprenavir increased risk of ventricular arrhythmias – avoid concomitant use
  • Diuretics: increased cardiac toxicity if hypokalaemia occurs5HT 3 antagonists: increased risk of ventricular arrhythmias with dolasetron – avoid concomitant use; use tropisetron with caution

    ADMINISTRATION

    Reconstition

    –

    Route

    Oral, IV bolus,

    IV infusion

    Rate of Administration

    See ‘Other Information’

    Comments

    Infusion: Dilute with 5% glucose infusion; if chloride containing solutions are used the injection should be added to a volume of not less than 500 mL, otherwise a precipitate will formPlasma levels of 200–1000 nanograms/mL may be needed to obtain the maximum therapeutic effect. Plasma levels above Flecainide acetate.FLECAinidE ACETATE 309700–1000 nanograms/mL are associated with increased likelihood of adverse events

    OTHER INFORMATION

    Product information recommendation: patients with severe renal impairment (defined as being a creatinine clearance <35 mL/minute), reduce each dose recommended for

    IV infusion

    by halfProduct information recommendation: patients with severe renal impairment as defined above, that the maximum initial oral dosage should be 100 mg daily (or 50 mg twice daily) with frequent plasma level monitoring strongly recommendedElectrolyte disturbances should be corrected before using flecainidePlasma levels quoted in product information are trough levels. Sample prior to dose

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