Sotaloldrug info
sotalol hydrochloride 5 MG/ML Oral Solution [Sotylize]
What it is used for
SOTYLIZE is an antiarrhythmic indicated for: The treatment of life-threatening ventricular arrhythmias The maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) Limitations of Use SOTYLIZE has not been shown to enhance survival in patients with life threatening ventricular arrhythmias Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL
1.1 Life-Threatening
Ventricular Arrhythmia SOTYLIZE is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. Limitation of Use SOTYLIZE has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias.
1.2 Delay in
Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL) SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use Because sotalol can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given SOTYLIZE.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 24, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
SOTYLIZE is an aqueous solution containing sotalol hydrochloride. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l- N -[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C 12 H 20 N 2 O 3 S HCl and is represented by the following structural formula: SOTYLIZE is a grape-flavored aqueous solution. Each mL contains 5 mg sotalol HCl. Inactive ingredients are sodium citrate, citric acid, sucralose, sodium benzoate and purified water. Chemical Structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 24, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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