OSMOLAX LACTULOSE ORAL SOLUTION USP 0.68GML

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

Lactulose

Sẵn có từ:

MEDISPEC (M) SDN.BHD

INN (Tên quốc tế):

Lactulose

Các đơn vị trong gói:

100ml mL

Sản xuất bởi:

SQUARE PHARMACEUTICALS LTD

Tờ rơi thông tin

OSMOLAX LACTULOSE
ORAL SOLUTION USP 0.68G/ML
Lactulose USP 0.68 g/ml
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Osmolax Solution_
is used for
2.
How
_Osmolax Solution_
works
3.
Before you use
_Osmolax Solution_
4.
How to use
_Osmolax Solution_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Osmolax _
_Solution_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _Osmolax Solution_
IS USED FOR
Chronic Constipation: Regulation of the
physiological rhythm of the colon.
Portal Systemic Encephalopathy (PSE):
Treatment
and
prevention
of
hepatic
coma or pre-coma.
Where
a
soft
stool
is
considered
as
medical
benefit
(haemorrhoids,
post-
colon/anal surgery)
HOW _Osmolax Solution_ WORKS
Lactulose is a disaccharide, which is not
hydrolyzed
in
the
small
intestine.
It
cannot be absorbed and is transported to
the colon with water to retain the osmotic
balance. It provides a natural substrate
for the saccharolytic bacterial flora in the
colon. In the colon, several species of
bacteria can hydrolyze Lactulose to the
monosaccharides galactose and fructose.
By
encouraging
this
normal
metabolic
activity
of
the
bacteria,
the
osmotic
pressure
of
the
colonic
contents
is
doubled and more water is drawn into the
bowel.
Further
metabolism
of
the
monosaccharides leads to the production
of
acetic
acids
and
the
subsequent
lowering
of
colonic
pH.
This
acidification of the colonic contents is
considered to be the main reason for the
effectiveness
of
Lactulose
solution.
In
chronic portal systemic encephalopathy
it may be associated with the decrease in
the
relative
concentration
of
free
ammonia, the major agent involved in
the cerebral disturbance.
BEFORE YOU USE _Osmolax Solution_
-
_When you must not use it _
-
If you are allergic to lactulose or any
of the other ingredients of Osmolax
Solution
-
If you have symptoms of stomach
ache, vomiting and fever.
-
If you are lactose intolerant.
_Pregnancy and lactation _
If
laxative
therapy
is

Đặc tính sản phẩm

PRODUCT NAME
Osmolax Solution (Lactulose USP 0.68 G/ML)
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Lactulose 97.14ml IN 100ml
EACH 5 ML CONTAINS: LACTULOSE USP 3.4 GM AS LACTULOSE CONCENTRATE USP
PRODUCT DESCRIPTION
A clear colorless to light amber syrupy liquid, lemon-orange flavored
having sweet taste, filled and sealed in amber color PET bottle with
SQUARE printed and
white color cap. Free from any visible foreign particles.
PHARMACODYNAMICS
PHARMACOLOGY: In the colon, lactulose is broken down by colonic
bacteria into low molecular organic acids. These acids lead to a
lowering of pH in the
colonic lumen and via an osmotic effect to an increase of the volume
of the colonic contents. These effects stimulate the peristalsis of
the colon and
normalize the consistency of the stools. The constipation is cleared
and the physiological rhythm of the colon is reinstated. In portal
systemic
encephalopathy (PSE) c.q. (pre) coma hepaticum, the effect has been
attributed to suppression of proteolytic bacteria by an increase of
acidophilic bacteria
(eg, lactobacillus), trapping of ammonia in the ionic form by the
acidification of the colonic contents, catharsis due to the low pH in
the colon as well as an
osmotic effect and alteration of the bacterial nitrogen metabolism by
stimulating the bacteria to utilize ammonia for bacterial protein
synthesis. Within this
context, however, it should be realized that hyperammonia alone cannot
explain the neuropsychiatric manifestations of PSE. The ammonia
however might
serve as a model compound for other nitrogenous substances.
PHARMACOKINETICS
PHARMACOKINETICS: Lactulose is scantily absorbed after oral
administration. Not being absorbed as such, it reaches the colon
unchanged. There, it is
metabolized by the colonic bacterial flora. Metabolism is complete at
doses up to 25-50 g (40-75 mL): At higher dosages, a part may be
excreted unchanged.
INDICATION
Chronic Constipation: Regulation of the physiological rhythm of the
colon. Portal Systemic Encephalopathy (PSE): Treatment and preventio