BICALUTAMIDE STADA FILM-COATED TABLET 50MG

Bicalutamide

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Bicalutamida | Bicalutamide | Bicalutamidum | Bicalutamide |

Description

Bicalutamide is an oral non-steroidal anti-androgen for prostate cancer. It is a racemic mixture consisting of equal proportions of enantiomers (R)-bicalutamide and (S)-bicalutamide. Bicalutamide binds to the androgen receptor.

Indication

For treatment (together with surgery or LHRH analogue) of advanced prostatic cancer.

Mechanism of Action

Bicalutamide competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin which stimulate the growth of normal and malignant prostatic tissue.

Pharmacodynamics

Bicalutamide is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Bicalutamide is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Bicalutamide blocks the action of androgens of adrenal and testicular origin which stimulate the growth of normal and malignant prostatic tissue. Prostate cancer is mostly androgen-dependent and can be treated with surgical or chemical castration. To date, antiandrogen monotherapy has not consistently been shown to be equivalent to castration.

Pharmacokinetics

Absorption:

Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown.

Distribution:

Not Available

Metabolism:

Bicalutamide undergoes stereo specific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation.

Elimination:

Not Available

Half-life

5.9 days

Clearance

* Apparent oral cl=0.32 L/h [Normal Males]

Toxicity

Not Available

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

BICALUTAMIDE STADA FILM-COATED TABLET 50MG was registered with Health Science Authority of Singapore by DCH AURIGA SINGAPORE. It is marketed with the registration number of SIN15134P with effective from 2016-12-12.

This product contains 50mg of Bicalutamide in the form of TABLET, FILM-COATED.

The medicine was manufactured by Kocak Farma Ilac Ve Kimya Sanyi A.S. in TURKEY

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: L02BB03

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