Ursosan 250 mg Hard Capsules

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

URSODEOXYCHOLIC ACID

Boleh didapati daripada:

PHARMENG TECHNOLOGY SDN. BHD.

INN (Nama Antarabangsa):

URSODEOXYCHOLIC ACID

Unit dalam pakej:

30 Capsules; 50 Capsules; 100 Capsules

Dikeluarkan oleh:

PRO.MED.CS Praha a.s.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
URSOSAN 250 MG HARD CAPSULES
Ursodeoxycholic Acid (250 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Ursosan is used for
2.
How Ursosan works
3.
Before you use Ursosan
4.
How to use Ursosan
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Ursosan
8.
Product Description
9.
Manufacturer,
Product
Registration
Holder
and
Distributor
10.
Date of revision
WHAT URSOSAN IS USED FOR
Ursosan is indicated for:
-
dissolution
of
symptomatic,
radiolucent
(transparent
to
X-
rays)
cholesterol
gallstones
in
the gallbladder less than 15 mm
in diameter. The gallstones must
be
radiolucent,
and
the
gallbladder
function
must
be
intact; dissolution of gallstones
with
or
without
preceding
extracorporeal
shock
wave
lithotripsy;
-
cholestatic
liver
disease
(e.g.
compensated
primary
biliary
cirrhosis,
cholestasis
of
pregnancy).
HOW URSOSAN WORKS
Ursodeoxycholic acid (UDCA) is
found in small amounts in human
bile.
Upon
oral
administration,
it
induces
a
decline
in
cholesterol
saturation
of
the
gall
bladder
through
blocking
of
cholesterol
resorption
in
the
intestine
and
decline in cholesterol secretion to
the gall. A gradual decomposition
of
cholesterol
gallstones
is
presumably
achieved
through
dispersion
of
cholesterol
and
forming of liquid crystals.
BEFORE YOU USE URSOSAN
-
_When you must not use it _
Do not take Ursosan if
-
you are, or have been told you
are, allergic (hypersensitive) to
bile acids like UDCA or to any
of the other ingredients of this
product.
-
your gall bladder does not work
properly.
-
your doctor has said you have
calcified
gallstones
(they
are
visible on an x-ray).
-
you have an acute inflammation
of
the
gall
bladder
or
biliary
tract.
-
you
have
a
blockage
of
the
common bile duct or cystic duct
(obstruction of the biliary tract).
-
you
have
frequent
cramp-like
pains
in
the
upper
abdomen
(biliary colic).
Please ask your doctor about any
of
the
conditions
mentioned
above. You should also ask if you
have previously had any of these
conditions
or
if
you
are
uns

Ciri produk

URSOSAN 250 MG HARD CAPSULES
Ursodeoxycholic Acid (250 mg)
DESCRIPTION
Hard capsule.
White, hard gelatin capsules containing white or almost white powder.
COMPOSITION
Each capsule contains 250 mg of ursodeoxycholic acid.
List of excipients:
Maize starch, Maize starch, pregelatinised, Silica colloidal
anhydrous, Magnesium stearate, Titanium
dioxide and Gelatin.
PHARMACODYNAMICS
Pharmacotherapeutic group: Bile and liver therapy; bile acids and
derivatives. ATC Code: A05AA02.
Ursodeoxycholic acid is found in small amounts in human bile.
Upon oral administration, it induces a decline in cholesterol
saturation of the gall bladder through blocking
of cholesterol resorption in the intestine and decline in cholesterol
secretion to the gall. A gradual
decomposition of cholesterol gallstones is presumably achieved through
dispersion of cholesterol and
forming of liquid crystals.
The effect of ursodeoxycholic acid in liver and cholestatic diseases
is, according to current knowledge,
based on relative exchange of lipophilic, detergent-type, toxic bile
acids for hydrophilic, cytoprotective,
non-toxic
ursodeoxycholic
acid,
improvement
of
the
secretory
performance
of
liver
cells
and
immunoregulative processes.
PHARMACOKINETICS
Orally administered ursodeoxycholic acid is resorbed fast in the
jejunum and upper ileum through passive,
and in terminal ileum active transport. The resorption rate generally
amounts to 60–80 %. Upon resorption
the bile acid conjugates almost completely with the glycine and
taurine amino acids in the liver and then
biliary excretion follows. The first-pass-clearance through liver
amounts up to 60 %.
Depending on the daily dose and the underlying disease or the liver
condition, the more hydrophilic
ursodeoxycholic acid accumulates in the gall. Concurrently, a relative
reduction of the other, more
lipophilic bile acids takes place.
In the intestine, a partial bacterial degradation to
7-keto-lithocholic acid and lithocholic acid takes place.
The lithocholic acid is liver-toxic and induces liver parenchyma