SOTOLOL HYDROCHLORIDE INJECTION 15 mg/mL FOR INTRAVENOUS USE
Sotalol hydrochloride for intravenous use is an antiarrhythmic agent indicated for substitution for oral sotalol in patients who are unable to take sotalol orally.
Oral sotalol is indicated for maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter and treatment of documented life-threatening ventricular arrhythmias.
IMPORTANT SAFETY INFORMATION
As the bioavailability of oral sotalol is between 90% and 100%, the corresponding dose of intravenous sotalol is slightly less than that of the oral dose. 75 mg of intravenous sotalol is approximately equal to 80 mg of oral sotalol. Monitor the effect of the initial intravenous dose and titrate either upward or downward, if needed, based on clinical effect, QT interval or adverse reactions.
Sotalol is contraindicated in patients with sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block unless a functioning pacemaker is present; in patients with congenital or acquired long QT syndromes, QT interval >450 ms; in patients with cardiogenic shock or uncontrolled heart failure; in patients with creatinine clearance <40 mL/min; in patients with serum potassium <4 meq/L; in patients with bronchial asthma or related bronchospastic conditions; and in patients with known hypersensitivity to sotalol.
Sotalol can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia. Factors such as reduced creatinine clearance, gender (female) and larger doses increase the risk of TdP. Calculation of the creatinine clearance must precede administration of the first dose of sotalol.
The use of sotalol in conjunction with other drugs that prolong the QT interval has not been studied and is not recommended.
Sotalol may increase bradycardia in patients with supraventricular arrhythmia. Bradycardia itself increases the risk of Torsades de Pointes. Patients receiving concomitant digoxin must be carefully monitored.
Do not abruptly discontinue treatment. Occasional cases of exacerbation of angina pectoris, arrhythmias, and in some cases, myocardial infarction have been reported after abrupt discontinuation of beta-blocker therapy.
Sotalol may increase the propensity to develop serious arrhythmias in patients with left ventricular dysfunction.
Sotalol should not be used in patients with hypokalemia or hypomagnesemiaprior to correction of imbalance, as these conditions increase the potential for Torsades de Pointes. Special attention should be given to electrolyte and acid based balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.
Monitor serum glucose in diabetic patients as sotalol, like all beta-blockers in general, may mask symptoms of hypoglycemia or worsen hyperglycemia.
There is no clinical experience with intravenous sotalol. Because of the similarity in exposure between intravenous sotalol and oral sotalol, adverse reactions should be similar. The most common adverse reactions (> 10%) seen with oral sotalol (dose related) are fatigue, dizziness, lightheadedness, headache, asthenia, nausea, dyspnea, bradycardia, chest pain and palpitation.