Drugs undergoing CYP450 metabolism
Sotalol is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol. Sotalol is not expected to inhibit or induce any CYP450 enzymes; therefore, it is not expected to alter the PK of drugs that are metabolized by these enzymes.
Intentional or accidental overdosage with BETAPACE (sotalol hydrochloride) 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 BETAPACE 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 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:
Bradycardia or Cardiac Asystole
: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing.
(second and third degree) transvenous cardiac pacemaker.
(depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful.
Aminophylline or aerosol beta-2-receptor stimulant.
Torsade de Pointes
DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.
BETAPACE (sotalol hydrochloride) is contraindicated in patients with bronchial asthma, sinus bradycardia, second and third degree AV block, unless a functioning pacemaker is present, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to BETAPACE.