Bicalutamide

Bicalutamide

Bicalutamide Recall

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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

Bicalutamide tablets, USP 50 mg daily are 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.


Bicalutamide tablets, USP 150 mg daily are 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

Bicalutamide tablets contain 50 mg of bicalutamide USP, 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 molecular formulas are:
bicalutamide-structure

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.


Bicalutamide tablet 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 bicalutamide tablets are lactose monohydrate, sodium starch glycolate type A, povidone, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.


Bicalutamide Manufacturers


  • Sun Pharma Global Fze
    Bicalutamide Tablet, Film Coated [Sun Pharma Global Fze]
  • Golden State Medical Supply, Inc.
    Bicalutamide Tablet, Film Coated [Golden State Medical Supply, Inc.]
  • Dava Pharmaceuticals, Inc.
    Bicalutamide Tablet, Film Coated [Dava Pharmaceuticals, Inc.]
  • Major Pharmaceuticals
    Bicalutamide Tablet [Major Pharmaceuticals]
  • Physicians Total Care, Inc.
    Bicalutamide Tablet, Film Coated [Physicians Total Care, Inc.]
  • Synthon Pharmaceuticals, Inc.
    Bicalutamide Tablet, Film Coated [Synthon Pharmaceuticals, Inc.]
  • Breckenridge Pharmaceutical, Inc.
    Bicalutamide Tablet, Film Coated [Breckenridge Pharmaceutical, Inc.]
  • Udl Laboratories, Inc.
    Bicalutamide Tablet, Film Coated [Udl Laboratories, Inc.]
  • American Health Packaging
    Bicalutamide Tablet, Film Coated [American Health Packaging]
  • Northstar Rx Llc
    Bicalutamide Tablet, Film Coated [Northstar Rx Llc]
  • Cadila Healthcare Limited
    Bicalutamide Tablet, Film Coated [Cadila Healthcare Limited]
  • Accord Healthcare Inc
    Bicalutamide Tablet [Accord Healthcare Inc]
  • Teva Pharmaceuticals Usa Inc
    Bicalutamide Tablet, Film Coated [Teva Pharmaceuticals Usa Inc]
  • Golden State Medical Supply, Inc.
    Bicalutamide Tablet, Film Coated [Golden State Medical Supply, Inc.]
  • Apotex Corp.
    Bicalutamide Tablet [Apotex Corp.]
  • Sandoz Inc
    Bicalutamide Tablet [Sandoz Inc]
  • American Health Packaging
    Bicalutamide Tablet [American Health Packaging]
  • Remedyrepack Inc.
    Bicalutamide Tablet [Remedyrepack Inc. ]
  • Sun Pharma Global Inc.
    Bicalutamide Tablet [Sun Pharma Global Inc.]
  • Avkare, Inc.
    Bicalutamide (Bicalutamide) Tablet, Film Coated [Avkare, Inc.]
  • Zydus Pharmaceuticals (Usa) Inc.
    Bicalutamide Tablet, Film Coated [Zydus Pharmaceuticals (Usa) Inc.]
  • Bryant Ranch Prepack
    Bicalutamide Tablet [Bryant Ranch Prepack]
  • Mylan Pharmaceuticals Inc
    Bicalutamide Tablet, Film Coated [Mylan Pharmaceuticals Inc]

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