Sotalol injection indications and usage

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Sotalol
BETAPACE® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Clinical Studies
How Supplied/Storage and Handling
Labels and Packages
SOTALOL HYDROCHLORIDE®
FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Sotalol
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Indications and Usage

1.1 Substitution for Oral Sotalol Therapy

Intravenous sotalol can substitute for oral sotalol in patients who are unable to take sotalol orally.

1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter

Sotalol is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because sotalol can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol. In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients [see Clinical Studies (14.2)].

Patients with atrial fibrillation should be anticoagulated according to usual medical practice.

1.3 Documented Life-Threatening Ventricular Arrhythmia

Sotalol is indicated for the treatment of documented life-threatening ventricular arrhythmias. Because of the proarrhythmic effects of sotalol[see Warnings and Precautions (5.1)] including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. In life-threatening ventricular arrhythmias, the response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) at steady state blood levels of drug prior to continuing the patient on chronic therapy. Antiarrhythmic drugs may not enhance survival in patients with ventricular arrhythmias.[1]

References

  1. "SOTALOL HYDROCHLORIDE INJECTION [BIONICHE PHARMA USA LLC]".

Adapted from the FDA Package Insert.