Sotalol Hydrochloride M S25 00378 5125 01 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Sotalol/Sotalol AF is an antiarrhythmic indicated for:• the treatment of life-threatening ventricular arrhythmias (1.1)• the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2) Limitations of Use• Sotalol has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1)• Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (1.2)
What should I know before taking it?
Sotalol/Sotalol AF is contraindicated in patients with: Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is presentCongenital or acquired long QT syndromesCardiogenic shock or decompensated heart failureSerum potassium <4 mEq/LBronchial asthma or related bronchospastic conditionsHypersensitivity to sotalol For the treatment of AFIB/AFL, Sotalol/Sotalol AF is also contraindicated in patients with: Baseline QT interval >450 msec
What important warnings are listed?
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 ]. WARNING: LIFE THREATENING PROARRHYTHMIA See full prescribing information for complete boxed warning. Sotalol/Sotalol AF can cause life-threatening.
How is this medication usually taken?
Sotalol Hydrochloride Tablets are supplied as capsule-shaped, light-blue, scored tablets: 80 mg imprinted with “B104” on one side and 80 mg on the other120 mg imprinted with “B105” on one side and 120 mg on the other60 mg imprinted with “B105” on one side and 160 mg on the other Sotalol AF is supplied as capsule-shaped white to off-white scored tablets: • 80 mg debossed ‘B107’ on one side and scored on the other side• 120 mg debossed ‘B108’ on one side and scored on the other side• 160 mg debossed ‘B109’ on one side and scored on the other side
What side effects are listed?
The most common adverse reactions (≥2%) for Sotalol Hydrochloride Tablets are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. (6) To report SUSPECTED ADVERSE REACTIONS, contact Beximco Pharmaceuticals USA Inc. at 877-372-6093 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What interactions are listed?
Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use (7.1)Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure (7.2)Dosage of insulin or antidiabetic drugs may need adjustment (7.5)Aluminum or magnesium-based antacids reduce sotalol exposure (7.7)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5962c4ee-c8f7-4e38-ab8c-4848c7644362
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.