Posted On: Oct 25, 2016
AltaThera Pharmaceuticals is a specialty pharmaceutical company focused on critical care and alternative therapeutics for the unmet medical needs of patients with severe, and often rare disorders.
CHICAGO – Intravenous and oral sotalol are as effective as amiodarone and class IA and class IC antiarrhythmic agents for the pharmacologic conversion of atrial fibrillation, a recent meta-analysis published in the journal Cardiology concludes.
The full analysis can be accessed here: Efficacy of Intravenous and Oral Sotalol in Pharmacologic Conversion of Atrial Fibrillation: A Systematic Review and Meta-Analysis
The authors, Drs. David J. Milan of Massachusetts General Hospital’s Cardiovascular Research Center, J. Philip Saul of the Department of Pediatrics at West Virginia University School of Medicine, John C. Somberg of the Department of Medicine and Pharmacology at Rush University in Chicago and Janos Molnar, of the American Institute of Therapeutics and the Department of Medicine at Chicago Medical School, Rosalind Franklin University of Medicine and Science, based their findings on an analysis of 10 publications in which sotalol’s effectiveness at converting atrial fibrillation to normal sinus rhythm could be compared to alternate therapies or to a placebo.
About AltaThera Pharmaceuticals: AltaThera Pharmaceuticals is a specialty pharmaceutical company focused on critical care and alternative therapeutics for the unmet medical needs of patients with severe, and often rare disorders for which few effective treatments are available. AltaThera is the manufacturer of Sotalol IV. Sotalol IV carries a Boxed Warning related to life-threatening proarrhythmia.
About Sotalol IV:
Sotalol IV, sotalol hydrochloride injection, 15 mg/mL 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
WARNING: LIFE THREATENING PROARRHYTHMIA
Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. Do not initiate sotalol therapy if the baseline QTc is longer than 450 ms. If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the duration of the infusion prolonged or the drug discontinued. Patient should be hospitalized in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance.
For the safety of the patient, the safety measures required of oral sotalol administration must also be applied for intravenous route.
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 hypomagnesemia prior 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.
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