Drug interactions - summary-

CYP450 isoenzymes -
Nilutamide has shown to inhibit the activity of liver cytochrome isoenzymes and reduce metabolism

Vitamin K  antagonists/phenytoin/ theophylline -
Vitamin K and antagonists /phenytoin/ theophylline - could have a delayed elimination
and increases serumhalf life leading toxic levels
Dosages may need to be modified

Frequently occuring adverse reactions-
hot flushes, impotence and decreased libido are associated with low serum androgen levels and known to occur with medical or surgical castration

Cardiovascular -   angina 1%  herat failure 3%   syncope 1%

CNS -  dry mouth  1%  nervousness 1%   paresthesia  2%

Dermatologic -  pruritus 1%

GI -  diarrhea  1%   GI disorder 1%  GI haemorrhage  1%  melena  1%

Lab test abnormalites - increased haemoglobulin  1%  leukopenia  2% 
increased alkaline phosphatase   2%     increased blood  urea  nitrogen BUN  1% 
increased creatine  1% hyperglycemia  3%

Metabolic /Nutrional - alcohol intolerance 4%  edema 1%  weight loss 1%

Musculoskeletal - arthiritis  1%

Respiratory - increaed cough 1%   interstinal lung disease  1% lung disorder  3% 
rhinitis  1%

Special senses - cataract 1%  photophobia 1%

Miscellaneous -  malaise  1%

Severe hepatic impairment - should be evaluated prior to treatment
severe respiratory insufficiency , hypersenstivity to nilutamide or any component

Special precautions/Warnings-

Intertitial pneumonitis  - has been reported in few patients exposed to nilutamide
A routine chest X-ray should  be peformed prior to strating treatment

Use in women - nilutamide not no indication for women and should not be used in this category, particularly in non-serious or non- threatening conditions.

Hepatic function impairment -

Hepatitis - rare cases of death or hospitalization due to severe liver injury has been reported. Hepatoxiciy has generally occured within the first 3 to 4 months of treatment

Serum transaminase levels should be measured prior to  starting treatment with niltamide.
Liver  function tests should also be obtained at the first sign of symptom suggesting of liver
dysfunction eg, nausea, vomiting, abdominal pain, fatigue, anorexia

Pregnancy - nilutamide should be  given to a pregnant women only if needed.

Children-  safety and efficacy in pediatric patients have not been established

Indication-

Metastatic Prostrate Cancer

Dosage-
recommended dose is 300mg once a day for 30 days, followed by 150mg once a day .
Can be taken with or without meals

Store - at 25C ( 77F)

1. Patients should be informed that nilutamide should be started on thre day or on the day
    after surgical castration.

2. Inform patients that they should not interrupt ot stop taking the medication without
    consutling their physician

3. Patients should be told to report immediately any dyspepsia or aggrevation of prexising
    dyspnea

4. Patients should inform their doctor shoulf nausea, vommiting , abdominal pain or jaundice   occur.

5. Patients should avoid consuming alcoholic beverages, because of the possiblity of 
    getting  reactions  eg. facial flushes , malaise, hypotension

6. Patients receiving nilutamide have reported a delay in adaptation to dark, when
   passing from lighted area to a dark area. This effect somtimes does not abate
   as drug treatment is continued. Patients should be cautioned about driving at night.

Pregnancy -
Nilutamide should be  given to a pregnant women only if needed.

Children- 
Safety and efficacy in pediatric patients have not been established