Product Information
Registration Status: ActiveXATRAL XL TABLET 10mg is approved to be sold in Singapore with effective from 2001-05-07. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN11579P.
This product contains Alfuzosin 10mg in the form of TABLET. It is approved for ORAL use.
This product is manufactured by SANOFI WINTHROP INDUSTRIE in FRANCE.
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.
Description
Alfuzosin (INN, provided as the hydrochloride salt) is an alpha-adrenergic blocker used to treat benign prostatic hyperplasia (BPH). It works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate.
Indication
For the reduction of urinary obstruction and relief of associated manifestations (eg. sensation of incomplete bladder emptying or straining, urgency, interrupted or weak stream) in patients with symptomatic beningn prostatic hyperplasia.
Mechanism of Action
Alfuzosin is a non-subtype specific alpha(1)-adrenergic blocking agent that exhibits selectivity for alpha(1)-adrenergic receptors in the lower urinary tract. Inhibition of these adrenoreceptors leads to the relaxation of smooth muscle in the bladder neck and prostate, resulting in the improvement in urine flow and a reduction in symptoms in benign prostate hyperplasia. Alfuzosin also inhibits the vasoconstrictor effect of circulating and locally released catecholamines (epinephrine and norepinephrine), resulting in peripheral vasodilation.
Pharmacokinetics
- Absorption
- Absorption is 50% lower under fasting conditions
- Distribution
- * 3.2 L/kg [healthy male middle-aged volunteers]
- Metabolism
- Hepatic. Alfuzosin undergoes extensive metabolism by the liver, with only 11% of the administered dose excreted unchanged in the urine. Alfuzosin is metabolized by three metabolic pathways: oxidation, O-demethylations, and N-dealkylation. The metabolites are not pharmacologically active. CYP3A4 is the principal hepatic enzyme isoform involved in its metabolism.
- Elimination
Toxicity
Side effects are dizziness (due to postural hypotension), upper respiratory tract infection, headache, and fatigue.
Active Ingredient/Synonyms
(±)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furamide | Alfuzosin | Alfuzosina | Alfuzosine | Alfuzosinum | N-[3-[(4-amino-6,7-dimethoxy-quinazolin-2-yl)- methyl-amino]propyl] tetrahydrofuran- 2-carboxamide | Alfuzosin |
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.