Urso

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Ursodeoxycholic acid

Disponible depuis:

Orphan Australia Pty Ltd

classe:

Medicine Registered

Résumé des caractéristiques du produit

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PRODUCT INFORMATION 

URSO
® 
(Ursodeoxycholic Acid) 

NAME OF THE MEDICINE 

The chemical structure of ursodeoxycholic acid is as follows: 

CAS number: 128-13-2 

DESCRIPTION 

Ursodeoxycholic acid (UDCA) is a white or almost white powder.  It
is practically 
insoluble in water, readily soluble in alcohol, sparingly soluble in
acetone, in 
chloroform and in ether.  It melts at 200 - 204ºC.  The IUPAC
chemical name of 
UDCA is 3
α, 7ß-dihydroxy-5-cholan-24-oic acid.   

URSO Capsule contains UDCA 250 mg, maize starch, colloidal silicon
dioxide, 
magnesium stearate, gelatine, titanium dioxide, sodium lauryl
sulfate and purified 
water. 

PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 
The mechanism of action of UDCA in liver and cholestatic disorders
has not yet been 
explained totally.  However, UDCA alters bile acid composition,
resulting in 
increases in the concentration of UDCA and decreases in the
concentrations of the 
more hydrophobic and potentially toxic bile acids, cholic and
chenodeoxycholic acids.  
UDCA also has a choleretic effect, resulting in increased bile acid
output and bile 
flow.  There is some evidence for immunological effects, including a
reduction of 
abnormal expression of HLA Class I antigens on hepatocytes and a
suppression of 
immunoglobulin and cytokine production. 

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PHARMACOKINETIC PROPERTIES 
UDCA occurs naturally in the body.  After oral administration of a
single 500 mg 
dose of UDCA to healthy volunteers, peak plasma concentrations were
2.7 to 6.3 
μg/mL.  T
max
 occurs at 60 minutes and a second peak plasma concentration occurs
at 
180 minutes.  After oral administration of 250 mg, 500 mg, 1000 mg
and 2000 mg 
single doses, respective absorption rates were 60.3%, 47.7%, 30.7%
and 20.7% based 
on recovery from bile within 24 hours in patients with external
biliary drainage. 

In plasm