"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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In the presence of life-threatening arrhythmias, underdosing with bretylium (bretylium tosylate injection ) probably presents a greater risk to the patient than potential overdosage. However, one case of accidental overdose has been reported in which a rapidly injected intravenous bolus of 30 mg/kg was given instead of an intended 10 mg/kg dose during an episode of ventricular tachycardia. Marked hypertension resulted, followed by protracted refractory hypotension. The patient expired 18 hours later in asystole, complicated by renal failure and aspiration pneumonitis. Bretylium (bretylium tosylate injection ) serum levels were 8000 ng/mL.
The exaggerated hemodynamic response was attributed to the rapid injection of a very large dose while some effective circulation was still present. Neither the total dose nor the serum levels observed in this patient are in themselves associated with toxicity. Total doses of 30 mg/kg are not unusual and do not cause toxicity when given incrementally during cardiopulmonary resuscitation procedures. Similarly, patients maintained on chronic Bretylium (bretylium tosylate injection ) Tosylate Injection therapy have had documented serum levels of 12,000 ng/mL. These levels were achieved after sequential dosage increases over time with no apparent ill effects.
If Bretylium (bretylium tosylate injection ) Tosylate Injection is overdosed and symptoms of toxicity develop, administration of nitroprusside or another short acting intravenous antihypertensive agent should be considered for the treatment of the hypertensive response. Long acting drugs that might potentiate the subsequent hypotensive effects of Bretylium (bretylium tosylate injection ) Tosylate Injection should not be used. Hypotension should be treated with appropriate fluid therapy and pressor agents such as dopamine or norepinephrine. Dialysis is probably not useful in the treatment of Bretylium (bretylium tosylate injection ) Tosylate Injection overdose.
Last reviewed on RxList: 12/8/2004
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