DESCRIPTION
CASODEX® (bicalutamide) Tablets for oral administration
contain 50 mg of bicalutamide, a nonsteroidal antiandrogen
with no other known endocrine activity. The chemical name
is propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)
sulfonyl]-2-hydroxy-2-methyl-,(+-).
Bicalutamide has a following molecular formaula: C18H14N2O4F4S.
Bicalutamide has a molecular weight of 430.37. The pKa
is approximately 12. Bicalutamide is a fine white to off-white
powder which is practically insoluble in water at 37°C
(5 mg per 1000 mL), slightly soluble in chloroform and
absolute ethanol, sparingly soluble in methanol, and soluble
in acetone and tetrahydrofuran.
CASODEX is a racemate with its antiandrogenic activity
being almost exclusively exhibited by the R-enantiomer
of bicalutamide; the S-enantiomer is essentially inactive.
The inactive ingredients of CASODEX Tablets are lactose,
magnesium stearate, methylhydroxypropylcellulose, polyethylene
glycol, polyvidone, sodium starch glycollate, and titanium
dioxide.
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