Human Experience

Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with XENAZINE have been reported in the literature. The dose of XENAZINE in these patients ranged from 100 mg to 1 g. Adverse reactions associated with XENAZINE overdose included acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.

Management of Overdose

Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference® (PDR®).

XENAZINE is contraindicated in patients who are actively suicidal, or in patients with untreated or inadequately treated depression [see WARNINGS AND PRECAUTIONS].

• XENAZINE is contraindicated in patients with impaired hepatic function [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
• XENAZINE is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
• XENAZINE is contraindicated in patients taking reserpine. At least 20 days should elapse after stopping reserpine before starting XENAZINE [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Last reviewed on RxList: 10/29/2012
This monograph has been modified to include the generic and brand name in many instances.