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Bicalutamide

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Overview

What is CASODEX?

CASODEX® (bicalutamide) tablets contain 50 mg of bicalutamide, a non-steroidal androgen receptor inhibitor 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-,(+-). The structural and empirical formulas are:

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, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, and titanium dioxide.



What does CASODEX look like?



What are the available doses of CASODEX?

50 mg tablets

What should I talk to my health care provider before I take CASODEX?

How should I use CASODEX?

CASODEX 50 mg daily is indicated

CASODEX 150 mg daily is not approved

[see ].

The recommended dose for CASODEX therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that CASODEX be taken at the same time each day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analog. If a dose of CASODEX is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.


What interacts with CASODEX?

Sorry No Records found


What are the warnings of CASODEX?

Sorry No Records found


What are the precautions of CASODEX?

Sorry No Records found


What are the side effects of CASODEX?

Sorry No records found


What should I look out for while using CASODEX?

CASODEX is contraindicated in:

CASODEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported.

CASODEX has no indication for women, and should not be used in this population.

CASODEX can cause fetal harm when administered to a pregnant woman .


What might happen if I take too much CASODEX?

Long-term clinical trials have been conducted with dosages up to 200 mg of CASODEX daily and these dosages have been well tolerated. A single dose of CASODEX that results in symptoms of an overdose considered to be life threatening has not been established.

There is no specific antidote; treatment of an overdose should be symptomatic.

In the management of an overdose with CASODEX, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since CASODEX is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.


How should I store and handle CASODEX?

Store at 20-25° C (68-77° F); excursions permitted to 15-30° C (59-86° F).  See USP Controlled Room Temperature.  Avoid excess heat, above 40°C (104°F)White, film-coated tablets (identified on one side with "CDX50" and on the reverse with the "CASODEX logo") are supplied in unit dose bottles of 30 tablets (0310-0705-30).