Bicalutamide Tablets USP 50mg Technical Specification:

Product Name:Bicalutamide Tablets USP 50mg
Brand Name:Bicalutamide
Strength:50mg, 150mg
Dosage Form:Film-coated Tablet
Packing:10s, 28s, 30s, 50s
Route of Administration:For Oral Use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).
Storage:Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bicalutamide Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bicalutamide Tablets USP 50mg
    Each film-coated tablet contains:
    Bicalutamide USP……………..50mg
    Excipients…………………………q.s.
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.

Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.

Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.

Keep out of reach and sight of children.

Keep container tightly closed.

Dispense in original container.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Bicalutamide Tablets USP 50mg
b) Bicalutamide Tablets USP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Bicalutamide Tablets USP 50mg
Each film-coated tablet contains:
Bicalutamide USP……………..50mg
Excipients…………………………q.s.
Colours: Titanium Dioxide USP


b) Bicalutamide Tablets USP 150mg
Each film-coated tablet contains:
Bicalutamide USP……………150mg
Excipients……………………….q.s.
Colours: Iron Oxide Red

THERAPEUTIC INDICATIONS:

Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analogue to treat stage D2 metastatic prostate cancer (cancer that has spread in men).

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
Warning: Cytotoxic: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Keep out of reach and sight of children.
Keep container tightly closed.
Dispense in original container.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C. Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.