Sotalol tablet indications and usage: Difference between revisions

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#REDIRECT [[Sotalol#Adult Indications and Dosage]]
{{Sotalol}}
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==Indications and Usage==
 
Oral Betapace (sotalol hydrochloride) is indicated for the treatment of documented [[ventricular arrhythmia]]s, such as sustained [[ventricular tachycardia]], that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of Betapace (see WARNINGS), including a 1.5 to 2% rate of [[Torsade de Pointes]] or new [[VT]]/[[VF]] in patients with either [[NSVT]] or [[supraventricular arrhythmia]]s, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic [[ventricular premature contraction]]s should be avoided.
 
Initiation of Betapace treatment or increasing doses, as with other [[antiarrhythmic]] agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, including Betapace.
 
In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of [[ventricular tachycardia]], 90% suppression of [[nonsustained VT]], 80% suppression of paired [[VPC]]s, and 75% suppression of total [[VPC]]s in patients who had at least 10 [[VPC]]s/hour at baseline; this tentative response was confirmed if [[VT]] lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic [[VT]] lasting over 15 seconds; 2) non-sustained polymorphic [[VT]] containing more than 15 beats of monomorphic [[VT]] in patients with a history of monomorphic [[VT]]; 3) polymorphic [[VT]] or [[VF]] greater than 15 beats in patients with [[VF]] or a history of aborted sudden death without monomorphic [[VT]]; and 4) two episodes of polymorphic [[VT]] or [[VF]] of greater than 15 beats in a patient presenting with monomorphic [[VT]]. Sustained [[VT]] or [[NSVT]] producing hypotension during the final treadmill test was considered a drug failure.
 
In a multicenter open-label long-term study of Betapace in patients with life-threatening [[ventricular arrhythmia]]s which had proven refractory to other [[antiarrhythmic]] medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome.
 
Antiarrhythmic drugs have not been shown to enhance survival in patients with [[ventricular arrhythmia]]s.
 
Sotalol is also indicated for the maintenance of [[normal sinus rhythm]] [delay in time to recurrence of [[atrial fibrillation]]/[[atrial flutter]] (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed under the brand name Betapace AF. Betapace is not approved for the AFIB/AFL indication and should not be substituted for Betapace AF because only Betapace AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = BETAPACE (SOTALOL HYDROCHLORIDE) TABLET [BAYER HEALTHCARE PHARMACEUTICALS INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c4caf469-f684-4f6d-98e8-b6a2fff1de98 | publisher =  | date =  | accessdate = }}</ref>
 
==References==
{{Reflist}}
 
{{FDA}}
 
[[Category:Antiarrhythmic agents]]
[[Category:Beta blockers]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 23:47, 21 July 2014