Black Box Warning

WARNING: LIFE-THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosing [see Dosage and Administration ( 2.5 )] . WARNING: LIFE-THREATENING PROARRHYTHMIA See full prescribing information for complete boxed warning. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Sotalol.

Other warnings & precautions

BLACK BOX WARNING: Sotalol can cause life-threatening ventricular arrhythmias including torsades de pointes; initiation and dose increases must be performed in a facility capable of cardiac resuscitation
BLACK BOX WARNING: Betapace AF should not be substituted for Betapace due to significant differences in labeling and patient populations
QT interval prolongation increases the risk of torsades de pointes, which is dose-related and exacerbated by electrolyte abnormalities
Correct hypokalemia and hypomagnesemia before initiating therapy; maintain electrolyte balance throughout treatment
Avoid abrupt discontinuation — taper gradually to prevent rebound angina, myocardial infarction, or fatal arrhythmias
Use with extreme caution in patients with renal impairment; dose adjustment required based on creatinine clearance
Contraindicated in patients with bronchial asthma or severe chronic obstructive pulmonary disease
May mask signs and symptoms of hypoglycemia in diabetic patients
Sotalol can worsen heart failure in patients with reduced ejection fraction
Avoid use with other QT-prolonging drugs; combination substantially increases proarrhythmic risk

Other warnings & precautions

BLACK BOX WARNING: Sotalol can cause life-threatening ventricular arrhythmias including torsades de pointes; initiation and dose increases must be performed in a facility capable of cardiac resuscitation

BLACK BOX WARNING: Betapace AF should not be substituted for Betapace due to significant differences in labeling and patient populations

QT interval prolongation increases the risk of torsades de pointes, which is dose-related and exacerbated by electrolyte abnormalities

Correct hypokalemia and hypomagnesemia before initiating therapy; maintain electrolyte balance throughout treatment

Avoid abrupt discontinuation — taper gradually to prevent rebound angina, myocardial infarction, or fatal arrhythmias

Use with extreme caution in patients with renal impairment; dose adjustment required based on creatinine clearance

Contraindicated in patients with bronchial asthma or severe chronic obstructive pulmonary disease

May mask signs and symptoms of hypoglycemia in diabetic patients

Sotalol can worsen heart failure in patients with reduced ejection fraction

Avoid use with other QT-prolonging drugs; combination substantially increases proarrhythmic risk

Sotalol Black Box Warning

Black Box Warning

Other warnings & precautions

Sotalol Black Box Warning

Black Box Warning

Other warnings & precautions