"The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product appr"...
Intentional or accidental overdosage with sotalol has rarely resulted in death.
Symptoms and Treatment of Overdosage: The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2-16 grams) of sotalol the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with BETAPACE AF (sotalol hcl) should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels > 50 bpm. The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half life of 30 hours) thought to be due to a temporary reduction of renal function caused by the hypotension. In addition, if required, the following therapeutic measures are suggested:
Heart Block: (second and third degree) transvenous cardiac pacemaker.
Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful.
Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant.
Torsade DC cardioversion, transvenous cardiac pacing, de Pointes: epinephrine, magnesium sulfate.
BETAPACE AF (sotalol hcl) (sotalol hydrochloride) is contraindicated in patients with sinus bradycardia ( < 50 bpm during waking hours), sick sinus syndrome or second and third degree AV block (unless a functioning pacemaker is present), congenital or acquired long QT syndromes, baseline QT interval > 450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia ( < 4 meq/L), creatinine clearance < 40 mL/min, bronchial asthma and previous evidence of hypersensitivity to sotalol.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/29/2008
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