Product Information
Registration Status: ActiveSIN15695P
CALUMEX FILM-COATED TABLETS 50MG is approved to be sold in Singapore with effective from 2019-05-24. It is marketed by PHARMAKOE PTE LTD, with the registration number of SIN15695P.
This product contains Bicalutamide 50mg in the form of TABLET, FILM COATED. It is approved for Not Available use.
This product is manufactured by GENEPHARM S.A in GREECE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}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.