BOXED WARNING Increased mortality (death/reversed cardiac arrest) seen with Class IC antiarrhythmics in post-MI patients; avoid antiarrhythmics in non-life-threatening ventricular arrhythmias and structural heart disease.
FDA dosing
Population
Start
Target
Max
Atrial fibrillation (prolong time to recurrence)
Adults
225 mg BID
325 mg BID
425 mg BID
Titration Increase at minimum 5-day intervals
Renal Undefined
Hepatic Consider dose reduction; increased bioavailability, monitor for excessive effects
Instructions
Take with or without food
Do not crush or divide capsule contents
Avoid simultaneous use with both a CYP2D6 inhibitor and a CYP3A4 inhibitor
Consider dose reduction with hepatic impairment, marked QRS widening, or 2nd/3rd-degree AV block
Contraindications
Heart failure
Cardiogenic shock
Sinoatrial, AV, and intraventricular conduction disorders without a pacemaker (e.g., sick sinus syndrome, AV block)
Known Brugada Syndrome
Bradycardia
Marked hypotension
Bronchospastic disorders or severe obstructive pulmonary disease
Marked electrolyte imbalance
Cautions
Proarrhythmic effects (may cause new/worsened arrhythmias) — ECG before and during therapy
May unmask Brugada Syndrome — ECG after initiation
Avoid QT-prolonging drugs and Class IA/III antiarrhythmics
May provoke overt heart failure
Dose-related AV block/conduction disturbances — not for conduction defects without pacemaker
May alter pacemaker/defibrillator thresholds — monitor devices
Agranulocytosis — report signs of infection
Caution in hepatic and renal impairment
May exacerbate myasthenia gravis
Adverse reactions
Dizziness
Palpitations
Chest pain
Dyspnea
Taste disturbance
Nausea
Fatigue
Anxiety
Constipation
Upper respiratory tract infection
Edema
Influenza
Pregnancy No drug-associated risks identified from case reports/postmarketing; crosses placenta — monitor fetus/neonate for arrhythmia during and after treatment.
Lactation Present in human milk, levels likely low; weigh benefits against clinical need.
⚠ BOXED WARNING
Proarrhythmia and excess mortality after myocardial infarction