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HARNAL OCAS PROLONGED RELEASE FILM-COATED TABLET 400MCG

Product Information

Registration Status: Active

SIN13696P

HARNAL OCAS PROLONGED RELEASE FILM-COATED TABLET 400MCG is approved to be sold in Singapore with effective from 2009-08-21. It is marketed by ASTELLAS PHARMA SINGAPORE PTE LTD, with the registration number of SIN13696P.

This product contains Tamsulosin 0.4mg/tablet in the form of TABLET, FILM-COATED, EXTENDED-RELEASE. It is approved for ORAL use.

This product is manufactured by Astellas Pharma Europe B.V. in NETHERLANDS.

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
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Description

Tamsulosin is a selective antagonist at alpha-1A and alpha-1B-adrenoceptors in the prostate, prostatic capsule, prostatic urethra, and bladder neck. At least three discrete alpha1-adrenoceptor subtypes have been identified: alpha-1A, alpha-1B and alpha-1D; their distribution differs between human organs and tissue. Approximately 70% of the alpha1-receptors in human prostate are of the alpha-1A subtype. Blockage of these receptors causes relaxation of smooth muscles in the bladder neck and prostate.

Indication

Used in the treatment of signs and symptoms of benign prostatic hyperplasia (reduction in urinary obstruction and relief of associated manifestations such as hesitancy, terminal dribbling of urine, interrupted or weak stream...etc.)

Mechanism of Action

Tamsulosin is a selective antagonist at alpha-1A and alpha-1B-adrenoceptors in the prostate, prostatic capsule, prostatic urethra, and bladder neck. At least three discrete alpha1-adrenoceptor subtypes have been identified: alpha-1A, alpha-1B and alpha-1D; their distribution differs between human organs and tissue. Approximately 70% of the alpha1-receptors in human prostate are of the alpha-1A subtype. Blockage of these receptors causes relaxation of smooth muscles in the bladder neck and prostate, and thus decreases urinary outflow resistance in men.

Pharmacokinetics

Absorption
Absorption of tamsulosin HCI from capsules 0.4 mg is essentially complete (>90%) following oral administration under fasting conditions.
Distribution
* 16 L [intravenous administration to ten healthy male adults]
Metabolism
Tamsulosin HCI is extensively metabolized by cytochrome P450 enzymes in the liver, however, the pharmacokinetic profile of the metabolites in humans has not been established.
Elimination

Clearance

* 2.88 L/h

Toxicity

LD50 = 650 mg/kg (in rats)

Active Ingredient/Synonyms

(R)-5-(2-((2-(2-Ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide | 5-[2-[2-(2-Ethoxyphenoxy)ethylamino]propyl]-2-methoxy-benzenesulfonamide | Tamsulosin | Tamsulosina | Tamsulosine | Tamsulosinum | Tamsulosin |


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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