"Nevro Corp has received an "approvable" letter from the US Food and Drug Administration (FDA) for its spinal cord stimulation (SCS) system for treatment of chronic pain.
The Senza SCS system delivers Nevro's proprietary HF10"...
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 1g. Adverse reactions associated with XENAZINE overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
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.
XENAZINE is contraindicated in patients:
- Who are actively suicidal, or in patients with untreated or inadequately treated depression [see WARNINGS AND PRECAUTIONS].
- With hepatic impairment [see Use in Specific Populations, CLINICAL PHARMACOLOGY].
- 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 DRUG INTERACTIONS].
Taking reserpine. At least 20 days should elapse after stopping reserpine before starting XENAZINE [see DRUG INTERACTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/19/2015
Additional Xenazine Information
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