Nilandron (Nilutamide) Drug Information: Overdosage and Contraindications

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May 27, 2012

Nilandron

Prostate Cancer »

What is the prostate gland?

The prostate gland is an organ that is located at the base or outlet (neck) of the urinary bladder. (See the diagram that follows.) The gland surrounds the first part of the urethra. The urethra is the passage through which urine drains from the bladder to exit from the penis. One function of the prostate gland is to help control urination by pressing directly against the part of the urethra that it surrounds. The main function of the prostate gland is to produce some of the substances that are found in normal semen, such as minerals and sugar. Semen is the fluid that transports the sperm to assist with reproduction. A man can manage quite well, however, without his prostate gland. (See the section on surgical treatment for prostate cancer.)

In a young man, the normal prostate gland is the size of a walnut (<30g). During normal aging, however, the gland usually grows larger. This hormone-related enlargement with aging is called b...

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OVERDOSE

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.

CONTRAINDICATIONS

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
This monograph has been modified to include the generic and brand name in many instances.