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| | #REDIRECT [[Sotalol#Adult Indications and Dosage]] |
| {{Sotalol}}
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| {{CMG}}
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| ==Indications and Usage==
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| 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.
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| 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.
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| 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.
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| 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.
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| Antiarrhythmic drugs have not been shown to enhance survival in patients with [[ventricular arrhythmia]]s.
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| 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> | |
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Antiarrhythmic agents]]
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| [[Category:Beta blockers]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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