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SOTYLIZE

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Overview

What is SOTYLIZE?

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--[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is CHNOS 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.



What does SOTYLIZE look like?



What are the available doses of SOTYLIZE?

Oral solution: 5 mg/mL, in 250 mL or 480 mL bottles.

What should I talk to my health care provider before I take SOTYLIZE?

How should I use SOTYLIZE?

SOTYLIZE (sotalol hydrochloride) is indicated for the treatment of ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening.

Upon initiation of SOTYLIZE, increasing doses, and prior to chronic outpatient use, evaluated response by a suitable method (e.g., PES or Holter monitoring) at steady-state blood levels of drug.

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on sotalol should be hospitalized for at least 3 days or until steady-state drug levels are achieved, in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Initiate oral sotalol therapy in the presence of personnel trained in the management of serious ventricular arrhythmias. Perform a baseline ECG to determine the QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy with sotalol. Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval for sotalol.

Start sotalol therapy only if the baseline QTc interval is <450 msec. During initiation and titration, monitor the QT interval after each dose. If the QTc interval prolongs to 500 msec or greater, reduce the dose, increase the interval between doses, or discontinue the drug.

Administer sotalol twice daily in patients with a creatinine clearance >60 mL/min or once daily in patients with creatinine clearance between 40 and 60 mL/min. Sotalol is not recommended in patients with a creatinine clearance <40 mL/min. The recommended initial oral dose of sotalol is 80 mg (once or twice daily) and is initiated and titrated as described below.

Patients to be discharged on SOTYLIZE therapy from an in-patient setting should have an adequate supply of SOTYLIZE, to allow uninterrupted therapy until the patient can fill a SOTYLIZE prescription.

Advise patients who miss a dose to take just the next dose at the usual time.

For patients discharged and taking compounded sotalol oral solution filled by the pharmacy, consider switching to SOTYLIZE while in an out-patient setting.

Table 1 shows the appropriate volume of SOTYLIZE solution for typical doses.


What interacts with SOTYLIZE?

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What are the warnings of SOTYLIZE?

Sorry No Records found


What are the precautions of SOTYLIZE?

Sorry No Records found


What are the side effects of SOTYLIZE?

Sorry No records found


What should I look out for while using SOTYLIZE?

Sinus bradycardia (<50 bpm), sick sinus syndrome or 2 or 3 degree AV block unless a functioning pacemaker is present ()

Congenital or acquired long QT syndromes, 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 ()

Hypersensitivity to sotalol ()

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on oral sotalol, and patients who are converted from intravenous sotalol to oral administration should be hospitalized in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance.


What might happen if I take too much SOTYLIZE?

Intentional or accidental overdosage with sotalol has resulted in death.


How should I store and handle SOTYLIZE?

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), [see USP Controlled Room Temperature]. Store in the original package until use to protect from light and moisture.SOTYLIZE (sotalol hydrochloride) is supplied as follows:


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotalol hydrochloride is a racemic mixture of two isomers, both of which have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at an oral dose of about 80 mg/day and maximal at doses between 320 and 640 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above.

In children, a Class III electrophysiological effect can be seen at daily doses of 210 mg/m body surface area (BSA). A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥90 mg/m in children.

Non-Clinical Toxicology
Sinus bradycardia (<50 bpm), sick sinus syndrome or 2 or 3 degree AV block unless a functioning pacemaker is present ()

Congenital or acquired long QT syndromes, 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 ()

Hypersensitivity to sotalol ()

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on oral sotalol, and patients who are converted from intravenous sotalol to oral administration should be hospitalized in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance.

Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

QT prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose as needed (, , , , )

Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue ()

Correct any electrolyte disturbances ()

May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; monitor ()

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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