"By Peter Russell
WebMD Health News
Reviewed by Arefa Cassoobhoy, MD, MPH
They say the research could lead to better treatment, because doctors would be able to know which tumors are more likely to grow and spread."...
One case of massive overdosage has been published. A 79-year-old man attempted suicide by ingesting 13 g of nilutamide (i.e., 43 times the maximum recommended dose). Despite immediate gastric lavage and oral administration of activated charcoal, plasma nilutamide levels peaked at 6 times the normal range 2 hours after ingestion. There were no clinical signs or symptoms or changes in parameters such as transaminases or chest X-ray. Maintenance treatment (150 mg/day) was resumed 30 days later.
In repeated-dose tolerance studies, doses of 600 mg/day and 900 mg/day were administered to 9 and 4 patients, respectively. The ingestion of these doses was associated with gastrointestinal disorders, including nausea and vomiting, malaise, headache, and dizziness. In addition, a transient elevation in hepatic enzyme levels was noted in one patient.
Since nilutamide is protein bound, dialysis may not be useful as treatment for overdose. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.
NILANDRON (nilutamide) tablets are contraindicated:
- in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment)
- in patients with severe respiratory insufficiency
- in patients with hypersensitivity to nilutamide or any component of this preparation.
Last reviewed on RxList: 10/14/2008
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