"The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one.
This first-of-its-kind use is"...
Acute Experience in Animals: Acute overdose in animals results in CNS toxicity; notably, CNS depression, rapid gasping breathing, and convulsions. The intravenous median lethal dose in the rat was more than 50 mg/kg which is, on a mg/m2 basis, at least 250 times the maximum recommended human dose.
Human Experience: In the registration trials with CORVERT (ibutilide fumarate injection) Injection, four patients were unintentionally overdosed. The largest dose was 3.4 mg administered over 15 minutes. One patient (0.025 mg/kg) developed increased ventricular ectopy and monomorphic ventricular tachycardia, another patient (0.032 mg/kg) developed AV block-3rd degree and nonsustained polymorphic VT, and two patients (0.038 and 0.020 mg/kg) had no medical event reports. Based on known pharmacology, the clinical effects of an overdosage with ibutilide could exaggerate the expected prolongation of repolarization seen at usual clinical doses. Medical events (eg, proarrhythmia, AV block) that occur after the overdosage should be treated with measures appropriate for that condition.
CORVERT (ibutilide fumarate injection) Injection is contraindicated in patients who have previously demonstrated hypersensitivity to ibutilide fumarate or any of the other product components.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/25/2008
Additional Corvert Information
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