Legal Notices and Disclaimers
As-Is Presentation. Arbor Pharmaceuticals, LLC makes no warranty or representation of any kind as to the information or materials on our website. Access to and use of our website and the content thereof is at your own risk. To the maximum extent permitted by law, Arbor Pharmaceuticals, LLC disclaims any and all warranties, express or implied, including warranties of merchantability, title, and fitness for a particular purpose. Neither Arbor Pharmaceuticals, LLC nor any party involved in creating, producing, hosting or delivering this website or its contents shall be liable for any damages, including without limitation: direct, incidental, consequential, indirect, or punitive damages arising out of access to, use of or inability to use the website, or any errors or omissions in the content thereof. This limitation includes damages arising from any viruses or other harmful code that may infect your computer equipment or from malicious persons who may make unauthorized use of the website or its contents.
Medical Information. Our website may contain general medical or healthcare information that is provided for informational purposes only and should not be used in any way for medical diagnosis or treatment. The information provided on this website should be verified by a healthcare professional for accuracy, currency, completeness, and applicability to your situation before being relied upon. You should always obtain advice provided by a doctor or other qualified healthcare professional.
Use of Ideas You Communicate. In the event and to the extent that you have any right, title, or interest in any intellectual property contained in any communication to us, including (without limitation) moral rights, you hereby grant to Arbor Pharmaceuticals, LLC a worldwide, non-exclusive, transferable, royalty-free, fully paid-up license to use, execute, perform, display, reproduce, modify, distribute, sell, have sold, make, have made, import, export, and create derivative works that Arbor Pharmaceuticals, LLC will own, and to authorize others to do any of the same, for whatever purpose that Arbor Pharmaceuticals, LLC may choose and under all rights, title, and interest that you have, including (without limitation) all intellectual property and moral rights.
Trademarks. All product names, whether or not appearing in large print or with the trademark symbol, and all product logos, are trademarks of Arbor Pharmaceuticals, LLC, its affiliates, related companies, or its licensors or joint venture partners, unless otherwise noted. Gliadel is a registered trademark of Eisai, Inc. The use or misuse of these trademarks or any other materials, except as expressly permitted herein, and strictly within the limitations of any such permission, is expressly prohibited and may be in violation of copyright law, trademark law, the law of slander and libel, the law of privacy and publicity, and communications regulations and statutes.
Copyrights. The entire contents of this website are subject to copyright protection. Copyright ©2021 Arbor Pharmaceuticals, LLC. All rights reserved. The contents of this website may not be copied other than for non-commercial individual reference with all copyright or other proprietary notices retained, and thereafter may not be recopied, reproduced or otherwise redistributed. Except as expressly provided above, you may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text or documents contained in this website or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text or documents, without the express written consent of Arbor Pharmaceuticals, LLC. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any patent or trademark of Arbor Pharmaceuticals, or any third party.
Void Where Prohibited. This website and its contents are intended to comply with the laws and regulations in the United States. While available outside the United States, the content of this website as it pertains to pharmaceutical products is intended for use only by residents of the United States. The laws and regulations of other countries may be different. Any offer for any product or service made on our website is void where prohibited by law.
IMPORTANT SAFETY INFORMATION
Please see Important Safety Information below, as well as the full Prescribing Information.
- Sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree AV block unless a functioning pacemaker is present
- Congenital or acquired long QT syndromes, baseline QT interval >450 ms
- Cardiogenic shock, uncontrolled heart failure
- Creatinine clearance <40 mL/min
- Serum potassium <4 meq/L
- Bronchial asthma or related bronchospastic conditions
- Known hypersensitivity to sotalol
WARNINGS AND PRECAUTIONS
Because of the possible life-threatening proarrhythmic effects, use of SOTYLIZE with less severe arrhythmias, even if symptomatic, is generally not recommended. Treatment of asymptomatic ventricular premature contractions should be avoided. SOTYLIZE should be reserved for patients with highly symptomatic AFIB/AFL and not for patients with paroxysmal AFIB whose AFIB/AFL is easily reversed (by Valsalva maneuver, for example).
QT Prolongation and Proarrhythmia: SOTYLIZE can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP), a polymorphic tachycardia associated with QT interval prolongation. SOTYLIZE use in conjunction with other QT prolonging drugs has not been studied and is not recommended.
Bradycardia/Heart Block Renal Impairment: There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of sotalol.
Sick Sinus Syndrome: SOTYLIZE is not recommended in patients with sick sinus syndrome associated with symptomatic arrhythmias because it may cause sinus bradycardia, pause or arrest. In AFIB and sinus node dysfunction, sotalol increases the risk of Torsade de Pointes, especially after cardioversion. Sotalol augments bradycardia following cardioversion. Patients with AFIB/AFL associated with the sick sinus syndrome may be treated with sotalol if they have an implanted pacemaker.
Hypotension: Monitor hemodynamics in patients with marginal cardiac compensation.
Recent Acute MI: Experience in the early phase of acute MI recovery is limited.
Abrupt Withdrawal: When discontinuing chronically administered sotalol, particularly with ischemic heart disease, carefully monitor and consider temporary use of an alternate beta-blocker if appropriate.
Electrolyte Disturbances: SOTYLIZE should not be used in patients with hypokalemia or hypomagnesemia prior to correction of imbalance, as these conditions increase the potential for Torsade de Pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs.
Non-Allergic Bronchospasm: Patients with bronchospastic diseases should in general not receive beta-blockers. If SOTYLIZE is to be administered, use the smallest effective dose, to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.
Diabetes: Beta-blockade may mask some important premonitory signs of acute hypoglycemia (e.g., tachycardia) in diabetic (especially labile) patients with episodic spontaneous hypoglycemia.
Thyrotoxicosis: Beta-blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Abrupt withdrawal of SOTYLIZE may exacerbate hyperthyroid symptoms, including thyroid storm.
Anaphylaxis: While taking beta-blockers, patients with a history of severe allergic reactions may have a more severe reaction on repeated challenge, whether accidental, diagnostic, or therapeutic and may be unresponsive to the usual doses of epinephrine used to treat the reaction.
The most common adverse reactions (>10%) seen with oral sotalol (dose related) are fatigue, bradycardia, dizziness, and headache.
- Digoxin increases the risk of proarrhythmic events
- Calcium-blocking drugs may have additive effects on decreasing atrioventricular conduction, ventricular function, and blood pressure
- Concomitant use of catecholamine-depleting drugs may produce hypotension, marked bradycardia, and syncope
- Dosage of insulin or antidiabetic drugs may require adjustment
- Dose of beta-2 receptor agonists may have to be increased
- Sotalol may potentiate rebound hypertension after discontinuation of clonidine
- Aluminum or magnesium-based antacids reduce sotalol exposure
You are encouraged to report side effects of prescription drugs to Arbor Pharmaceuticals, LLC Medical Information at 1-866-516-4950 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional safety information, consult the Sotylize full Prescribing Information.