Nilutamide
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(British Approved Name, US Adopted Name, rINN)
Drug Nomenclature
International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):
Pharmacopoeias. In Europe.
European Pharmacopoeia, 6th ed., 2008 and Supplements 6.1 and 6.2 (Nilutamide). A white or almost white powder. Very slightly soluble in water; freely soluble in acetone; soluble in anhydrous ethanol. Protect from light.
Adverse Effects and Precautions
As for Flutamide. Interstitial pneumonitis has occurred in patients receiving nilutamide, and the drug is contra-indicated in those with severe respiratory insufficiency.
Effects on the eyes. Reversible visual disturbances, particularly delayed dark adaptation, have been associated with nilutamide. Although some consider such visual disturbances to be mild and generally well tolerated, others suggest that these, together with alcohol intolerance and, more seriously, effects on the lung, mean that other nonsteroidal anti-androgens should be preferred.
Interactions
Patients receiving nilutamide may exhibit intolerance to alcohol.
Pharmacokinetics
Nilutamide is rapidly and completely absorbed from the gastrointestinal tract. It is extensively metabolised although it may inhibit its own metabolism to some extent after multiple doses. About 60% of an oral dose of nilutamide is eliminated in the urine and less than 10% in the faeces, with an elimination half-life of 41 to 49 hours.
Uses and Administration
Nilutamide is a nonsteroidal anti-androgen that is used similarly to flutamide in the treatment of prostatic carcinoma. It is given orally in a dose of 300 mg daily, usually starting on the same day that the patient undergoes orchidectomy or receives treatment with a gonadorelin analogue. Dosage may be reduced to 150 mg daily after 1 month.
Single-ingredient Preparations
The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed
Argentina: Anandron; Australia: Anandron; Brazil: Anandron; Canada: Anandron; Czech Republic: Anandron; Denmark: Anandron¤; Finland: Anandron¤; France: Anandron; Greece: Anandron; Hungary: Anandron; Mexico: Anandron; Netherlands: Anandron; Norway: Anandron¤; Portugal: Anandron; Sweden: Anandron; United States: Nilandron
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