APO-SOTALOL 80 MG — DIN 02210428

What is APO-SOTALOL?

APO-SOTALOL 80 MG contains SOTALOL HYDROCHLORIDE : 80 MG. It is listed in the Health Canada Drug Product Database under DIN 02210428, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 26-Jul-2022. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is APO-SOTALOL used for?

APO-SOTALOL (sotalol hydrochloride) is indicated for the treatment of documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia. It may also be used for the treatment of patients with documented symptomatic ventricular arrhythmias when the symptoms are of sufficient severity to require treatment. Due to its proarrhythmic effects, its use should be reserved for patients in whom the benefit of treatment clearly outweighs the risks. For patients with sustained ventricular tachycardia, therapy should be initiated in the hospital. Hospitalization may also be required for certain other patients depending on their cardiac status and underlying cardiac disease. Its use in patients with hypertension or angina pectoris is not recommended unless they also require APO-SOTALOL for the treatment of ventricular arrhythmias.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

APO-SOTALOL (sotalol hydrochloride), when used for the treatment of documented life-threatening ventricular arrhythmias, should be initiated and dose increased in a hospital with facilities for cardiac rhythm monitoring and assessment. It should be administered only after appropriate clinical assessment, and the dosage must be individualized on the basis of therapeutic response and tolerance. The usefulness of monitoring plasma level for optimization of therapy has not been established. Proarrhythmic events can occur not only at the initiation of therapy, but also with each upward dosage adjustment. Dosage should be adjusted gradually, allowing 2 - 3 days between dosing increments to attain steady-state plasma concentrations and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the use of doses which are higher than necessary to control the arrhythmia. The recommended initial dose is 80 mg twice daily. If needed, this dose may be increased, after appropriate evaluation, to 240 or 320 mg/day. In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two divided doses. Some patients with life-threatening refractory arrhythmias may require doses as high as 480-640 mg/day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events, in particular proarrhythmias. Because of the long elimination half-life of sotalol hydrochloride, dosing on more than a twice daily regimen is not usually necessary. Patients experiencing bradycardia or hypotension on initial administration should be removed from therapy; APO-SOTALOL may be later reintroduced at a lower dose. A dose reduction may also be advisable to alleviate symptoms of weakness and dizziness in cases where blood pressure remains low after more than a month of therapy. For renal impairment, the dosing interval should be modified based on creatinine clearance: >60 mL/min: 12 hours; 30-60 mL/min: 24 hours; 10-30 mL/min: 36-48 hours; <10 mL/min: individualized. Dose increases in renal impairment should only be done after administration of at least 5 or 6 doses at appropriate intervals. When transferring patients from another antiarrhythmic drug to APO-SOTALOL or vice versa, allow at least 3 to 4 half-lives to elapse for the discontinued drug before starting the alternative drug at the usual dosage. In patients where withdrawal of a previous antiarrhythmic agent is likely to produce life-threatening arrhythmias, hospitalization should be considered.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

APO-SOTALOL (sotalol hydrochloride) is contraindicated in patients with bronchial asthma, allergic rhinitis, severe sinus node dysfunction, sinus bradycardia, second and third degree AV block (unless a functioning pacemaker is present), congenital or acquired long QT syndrome, cardiogenic shock, severe or uncontrolled congestive heart failure, hypokalemia, anesthesia with agents that produce myocardial depression and previous evidence of hypersensitivity to APO-SOTALOL.

Warnings and precautions

Mortality: The Cardiac Arrhythmia Suppression Trial (CAST) showed a significant increase in mortality and non-fatal cardiac arrest in post-myocardial infarction patients treated with encainide or flecainide. The applicability of these results to other antiarrhythmic agents is uncertain, but it is prudent to consider these results when using any antiarrhythmic agent. Proarrhythmia: APO-SOTALOL may cause new or worsen existing arrhythmias, including ventricular tachycardia, ventricular fibrillation, or torsade de pointes. Patients must be evaluated clinically and electrocardiographically prior to and during therapy. Torsades de pointes is more frequent in patients with elevated baseline QT (>430 msec), on-therapy QT of >500 msec, bradycardia (<50 bpm), hypokalemia, hypomagnesemia, and congestive heart failure. APO-SOTALOL is not recommended for asymptomatic premature contractions. The incidence of torsade de pointes is dose-related. Caution is advised if QTc is >500 msec on-therapy, and serious consideration should be given to reducing the dose or discontinuing therapy if QTc exceeds 550 msec. Proarrhythmic events can occur with initial therapy or any upward dose adjustment. Electrolyte Disturbances: Should not be used in patients with hypokalemia or hypomagnesemia prior to correction, as these conditions can exaggerate QT prolongation and increase the risk of torsade de pointes. Serum electrolytes must be monitored regularly, especially with concomitant diuretic use or prolonged diarrhea. Congestive Heart Failure: Beta-blockade can depress myocardial contractility and precipitate severe heart failure. Patients with CHF have a higher risk of torsade de pointes. Administer cautiously in patients with controlled CHF. Discontinue if cardiac failure continues despite adequate digitalization. In patients without a history of heart failure, continued depression of the myocardium can lead to cardiac failure. Conduction Disturbances: Excessive QT prolongation (>550 msec) can promote serious arrhythmias. Sinus bradycardia (<50 bpm) occurred in 13% of patients and increases the risk of torsade de pointes. Recent Myocardial Infarction: Caution is advised, especially in the first 2 weeks. Careful dose titration is important. Abrupt Cessation of Therapy: Patients should be warned against abrupt interruption. Hypersensitivity to catecholamines has been observed with beta-blocker withdrawal, with reports of severe exacerbation of angina pectoris, ventricular arrhythmias, and myocardial infarction. Discontinue APO-SOTALOL gradually over one to two weeks. Anaphylaxis: Patients with a history of anaphylactic reactions may have more severe reactions while taking beta-blockers. Epinephrine should be administered with caution. Non-Allergic Bronchospasm: Generally, beta-blockers should not be used in patients with bronchospastic diseases. If administered, use the smallest effective dose. Sick Sinus Syndrome: Use with extreme caution in patients with symptomatic sick sinus syndrome. Skin Rashes and Oculomucocutaneous Syndrome: Beta-blockers have been associated with skin rashes and conjunctival xerosis. Discontinue treatment if such reactions occur. Thyrotoxicosis: May mask clinical signs of hyperthyroidism. Avoid abrupt withdrawal.