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Cardiovascular: Dose-dependent PR interval prolongation has been reported in adults and further PR prolongation is possible when given with other PR-prolonging agents.
Cardiac arrhythmias (including bradycardia, AV block, and ventricular tachyarrhythmia) have been reported and have rarely resulted in asystole, cardiac arrest, and death.
Use with caution in patients with underlying proarrhythmic conditions (eg, marked first-degree AV block, second-degree or higher AV block, sick sinus syndrome without pacemaker), severe cardiac disease (such as myocardial ischemia or heart failure, or structural heart disease), and cardiac sodium channelopathies (e.g., Brugada Syndrome) and in those receiving concomitant medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval.
Atrial fibrillation and flutter have been reported; use may predispose to atrial arrhythmias, especially in patients with diabetic neuropathy and/or cardiovascular disease.
Immunologic: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS; ie, multiorgan hypersensitivity) including life-threatening cases and fatalities has been reported; discontinue use if an alternative etiology cannot be established.
Neurologic: Dose-related dizziness and ataxia have been reported.
Abrupt discontinuation of therapy may precipitate withdrawal seizure; discontinue gradually over a minimum of 1 week.
Psychiatric: Suicidal ideation and behavior have been reported; monitoring recommended.
Special populations: Use caution during dose titration for elderly patients.
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