Is there a difference between Sotalol and Sotalol?

[jiraiya]

I checked on several drug databases and couldn't find any clear explanations.
Some hospitals use only sotalol for both since they are the same things (same ingredient same recipients.) But manufacturer mentions not-to-be substituted. My opinion is they are the same but the warning not-to-be substituted is for pts at home (so they won't be confused.) Am I correct? 😕😕😕 Thanks in advance for your inputs 😀

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[tussionex]

huh?

sotalol and sotalol?

 

[SpirivaSunrise]

You mean Betapace and Betapace AF?

 

[jiraiya]

sotalol and sotalol AF indeed.

 

[UofMN2010]

I checked on several drug databases and couldn't find any clear explanations.
Some hospitals use only sotalol for both since they are the same things (same ingredient same recipients.) But manufacturer mentions not-to-be substituted. My opinion is they are the same but the warning not-to-be substituted is for pts at home (so they won't be confused.) Am I correct? 😕😕😕 Thanks in advance for your inputs 😀

Sotalol is a racemic mixture. The d-isomer exhibits potassium channel-blocking (Class III) effects while the l-isomer has beta-adrenergic receptor antagonistic effects. With the trend away from Class I antiarrhythmic agents toward Class III antiarrhythmic agents, the Survival With Oral d-Sotalol (SWORD) study was designed.29 The SWORD study assessed the mortality of patients with left ventricular dysfunction following myocardial infarction assigned to d-sotalol or placebo. The study was discontinued early because of a significantly higher mortality rate in the sotalol group.29 Development of d-sotalol has not been pursued further. Betapace AF (sotalol) was recently approved. Generic sotalol cannot be substituted for Betapace AF due to different patient packaging, dosing information and labeling. An estimation of glomerular filtration should be completed for patients who receive sotalol. Eighty to 90% of sotalol is renally excreted unchanged, and dose adjustment in renal dysfunction is recommended.30 Sotalol has been shown to be less effective than quinidine in cardioversion of atrial fibrillation, although sotalol is better tolerated by patients.31,32 Betapace AF is indicated for maintenance of sinus rhythm following cardioversion from atrial fibrillation and is generally not used for acute cardioversion.33

Reference:
http://www.uspharmacist.com/oldformat.asp?url=newlook/files/Feat/Atrial.htm&pub_id=8&article_id=826

There ya go, enjoy !!

 

[Old Timer]

So there you have it. There is NO difference. Since the drug once ingested, knows it can only effect the parts of the body indicated by the package insert as approved by the FDA. Only in America....

 

[SpirivaSunrise]

Yeah...same active ingredient as you mentioned. Issue is with the indication and FDA approval when the patent for Betapace expired. Only the AF™ version is indicated for A. fib/flutter in patients who are NSR. 🙄 So since it's the same drug...of course you have the exact same chance of developing ventricular arrhytmias...but the new insert requires extra monitoring parameters, starting in a hospital, patient info, etc.

 

[Old Timer]

Yeah...same active ingredient as you mentioned. Issue is with the indication and FDA approval when the patent for Betapace expired. Only the AF™ version is indicated for A. fib/flutter in patients who are NSR. 🙄 So since it's the same drug...of course you have the exact same chance of developing ventricular arrhytmias...but the new insert requires extra monitoring parameters, starting in a hospital, patient info, etc.

So I reiterate, does Betapace/Sotalol refuse to work for a-fib because the package insert says so?

 

[SpirivaSunrise]

So I reiterate, does Betapace/Sotalol refuse to work for a-fib because the package insert says so?

Of course not! Hence the "indicated" and "🙄"