Sotalol Hydrochloride

What it is and how it works

Mechanism of Action Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The two isomers of sotalol have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity.

Indications

Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) Limitations of Use Sotalol hydrochloride has not been shown to enhance survival in patients with life threatening ventricular arrhythmias Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL Life-Threatening Ventricular Arrhythmias Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride/Sotalol hydrochloride AF has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias.

Dosage and administration (summary)

Sotalol hydrochloride/Sotalol hydrochloride AF tablets: Initial dosage in adults is 80 mg twice daily. Increase the dose as needed in increments of 80 mg/day, every 3 days to a maximum 320 mg total daily dose Pediatrics: Dosage depends on age General Safety Measures for Initiation of Oral Sotalol Therapy Withdraw other antiarrhythmic therapy before starting sotalol hydrochloride/sotalol hydrochloride AF tablets and monitor for a minimum of 2 to 3 plasma half-lives prior to initiating sotalol hydrochloride/sotalol hydrochloride AF tablets therapy if the patient's clinical condition permits .

Contraindications

Sotalol hydrochloride/Sotalol hydrochloride (AF) tablets are contraindicated in patients with: Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronchospastic conditions Hypersensitivity to sotalol For the treatment of AFIB/AFL, sotalol hydrochloride/sotalol hydrochloride AF tablets are al…

Warnings and precautions

prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose or discontinue Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue Correct any electrolyte disturbances Diabetes: May mask symptoms of hypoglycemia and alter glucose levels.

Pregnancy

Pregnancy Risk Summary Both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see Clinical Considerations) . In animal reproduction studies in rats, early resorptions were increased at 15 times the maximum recommended human dose (MRHD).

Storage and supply

Sotalol hydrochloride tablets, USP are available as follows: 80 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SO” bisect “80” on the other side.

Source: Sotalol Hydrochloride (Sotalol Hydrochloride) — US FDA prescribing information, 2024-08-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.