Product Information
Registration Status: ActiveSIN15573P
TASULOSE PROLONGED-RELEASE FILM-COATED TABLET 400MCG is approved to be sold in Singapore with effective from 2018-11-01. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN15573P.
This product contains Tamsulosin 0.4mg in the form of TABLET, FILM COATED, EXTENDED RELEASE. It is approved for ORAL use.
This product is manufactured by Lek Pharmaceuticals d.d. (Ljubljana) in SLOVENIA.
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
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.