CALUMEX FILM-COATED TABLETS 50MG

Approval Information

CALUMEX FILM-COATED TABLETS 50MG was registered with Health Science Authority of Singapore by PHARMAKOE PTE LTD. It is marketed with the registration number of SIN15695P with effective from 2019-05-24.

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

The medicine was manufactured by GENEPHARM S.A in GREECE

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.

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.

Pharmacokinetics

Absorption

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

Distribution

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

Clearance

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

Active Ingredient/Synonyms

Bicalutamida | Bicalutamide | Bicalutamidum | 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.

References

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

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