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Action/Kinetics:
Antiandrogen activity with no estrogen, progesterone, mineralocorticoid, or glucocorticoid effects. Binds to the androgen receptor, thus preventing the normal androgenic response. Rapidly and completely absorbed from the GI tract. Extensively metabolized with at least one metabolite showing significant activity. Metabolites excreted through the urine.
t
1/2, elimination: Approximately 41-49 hr.
Uses:
In combination with surgical castration for the treatment of metastatic prostate cancer (stage D
2).
Contraindications:
Severe hepatic impairment, severe respiratory insufficiency, hypersensitivity to nilutamide.
Special Concerns:
Many clients experience a delay in adaptation to the dark ranging from seconds to a few minutes. Safety and efficacy have not been determined in children.
Side Effects:
GI: Nausea, constipation, dry mouth, diarrhea, hepatitis, GI disorder,
GI hemorrhage melena.
CNS: Dizziness, paresthesia, nervousness.
CV: Hypertension,
heart failure angina, syncope.
Respiratory: Interstitial pneumonitis, dyspnea, lung disorder, increased cough, rhinitis.
Metabolic/nutritional: Edema, weight loss, intolerance to alcohol.
Ophthalmic: Cataract, photophobia, impaired adaptation to dark, abnormal vision.
Miscellaneous: Leukopenia, hot flushes, UTI, malaise, pruritus, arthritis, aplastic anemia (rare).
Laboratory Test Alterations:
AST, ALT, alkaline phosphatase, haptoglobin, BUN, creatinine. Hyperglycemia.
Drug Interactions:
-
Phenytoin /
Phenytoin metabolism
delayed elimination and
risk of toxicity
-
Theophylline /
Theophylline metabolism
delayed elimination and
risk of toxicity
-
Vitamin K antagonists /
Metabolism of vitamin K antagonists
delayed elimination and
risk of toxicity
How Supplied:
Tablet: 50 mg
Dosage
?Tablets
Metastatic prostate cancer.
300 mg (six 50-mg tablets) once daily for 30 days followed by 150 mg (three 50-mg tablets) once daily.
