Casodex
Loading...Casodex Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Casodex Manufacturers
-
Physicians Total Care, Inc.
![Casodex (Bicalutamide) Tablet [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Casodex | Physicians Total Care, Inc.
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.
2.1. Dosage Adjustment in Renal ImpairmentNo dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)].
2.2. Dosage Adjustment in Hepatic ImpairmentNo dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary [see Use in Specific Populations (8.6)].
-
Astrazeneca Pharmaceuticals Lp
Casodex | Astrazeneca Pharmaceuticals Lp
2.1. Recommended Dose and ScheduleThe 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.
2.2. Dosage Adjustment in Renal ImpairmentNo dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)].
2.3. Dosage Adjustment in Hepatic ImpairmentNo dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary [see Use in Specific Populations (8.6)].
![Casodex (Bicalutamide) Tablet [Astrazeneca Pharmaceuticals Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=03607c0d-b772-435f-c985-ecce8ea8cafd&name=image-04.jpg)
Login To Your Free Account