Sotalol

Sotalol hydrochloride tablets are 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 hydrochloride tablets have 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 ) 1.1 Life-Threatening Ventricular Arrhythmias Sotalol hydrochloride tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT) . …

• Sotalol hydrochloride 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 tablets and monitor for a minimum of 2 to 3 plasma half-lives prior to initiating sotalol hydrochloride tablets therapy if the patient's clinical condition permits [see Drug Interactions ]
• Hospitalize patients being initiated or re-initiated on sotalol for at least 3 days or until steady-state drug levels are achieved in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring
• Initiate oral sotalol therapy in the presence of personnel trained in the management of serious arrhythmias
• Perform a baseline ECG to determine the QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy
• Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval
• Monitor QTc 2 to 4 hours after each uptitration in dose
• Discharge patients on sotalol therapy from an in-patient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol prescription
• Advise patients who miss a dose to take the next dose at the usual time
• Do not double the dose or shorten the dosing interval. …

Sotalol hydrochloride tablets, USP are supplied as capsule-shaped, light-blue, scored tablets: 80 mg debossed with “841” on left side of score on one side and debossed “O” on the reverse side 120 mg debossed with “842” on left side of score on one side and debossed “O” on the reverse side 160 mg debossed with “843” on left side of score on one side and debossed “O” on the reverse side 240 mg debos …

• The safety and effectiveness of sotalol in children have not been established
• However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see Dosage and Administration and Clinical Pharmacology ]
• Associated side effects of sotalol use
• In pediatric patients are those typical of a beta-blocking agent, and lead to discontinuation of the drug in 3 to 6% of patients. …

• Advise patients to contact their health care provider in the event of syncope, pre-syncopal symptoms or cardiac palpitations
• Advise patients that their electrolytes and ECG will be monitored during treatment [see Warnings and Precautions ]
• Advise patients to contact their healthcare provider in the event of conditions that could lead to electrolyte changes such as severe diarrhea, unusual sweating, vomiting, less appetite than normal or excessive thirst [see Warnings and Precautions ]
• Advise patients not to change the sotalol hydrochloride dose prescribed by their healthcare provider. …

• Sotalol hydrochloride 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 450 msec
• For the treatment of AFIB/AFL or ventricular arrythmias Sinus bradycardia, 2 nd or 3 rd degree AV block, sick sinus syndrome Congenital or acquired long QT syndrome Serum potassium 450 msec …

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 ( 7.4 ) Aluminum- or magnesium-based antacids reduce sotalol exposure ( 7.7 ) 7.1 Antiarrhythmics and Other QT Prolonging Drugs Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. …

QT prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose or discontinue ( 5.1 ) Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue ( 5.5 ) Correct any electrolyte disturbances ( 5.1 ) Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.7 ) 5.1 QT Prolongation and Proarrhythmia Sotalol hydrochloride can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. …

The most common adverse reactions (≥2%) for sotalol hydrochloride 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 Oxford Pharmaceuticals at 844-508-1455, 8:00 am - 4:30 pm ET, Monday – Friday or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 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). In rabbits an increase in fetal death was observed at 2 times the MRHD administered as a single dose. …

Intentional or accidental over dosage with sotalol has resulted in death. Symptoms and Treatment of Overdosage The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2 to 16 grams) of sotalol the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.