SUN-DIANOX TABLET

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

ATROPINE SULPHATE; DIPHENOXYLATE HYDROCHLORIDE

Disponibil de la:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (nume internaţional):

ATROPINE SULPHATE; DIPHENOXYLATE HYDROCHLORIDE

Unități în pachet:

80 Tablet Tablets; 1000 Tablets; 1000 Tablets; 500 Tablets; 100 Tablets; 100 Tablets

Produs de:

SUNWARD PHARMACEUTICAL SDN. BHD.

Prospect

SUN-DIANOX TABLET
Diphenoxylate Hydrochloride/Atropine Sulphate (2.5mg/0.025mg) 1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Sun-Dianox Tablet is used for
2. How Sun-Dianox Tablet works
3. Before you use Sun-Dianox Tablet
4. How Sun-Dianox Tablet
5. While you are using it
6. Side effects
7. Storage and disposal of Sun-Dianox Tablet
8. Product description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT SUN-DIANOX TABLET IS USED FOR
It is used effective as additional therapy in the
management of acute and chronic diarrhea.
HOW SUN-DIANOX TABLET WORKS
The active ingredients in this medicine
are Diphenoxylate Hydrochloride and Atropine
Sulphate. Diphenoxylate Hydrochloride has a
direct effect which helps to decrease the
number and frequency of bowel movements. It
works by slowing the movement of the intes-
tines. Atropine a naturally occurring alkaloid is
an anticholinergic agent. It acts by reducing the
motor activity in the stomach, small and large
intestines to treat diarrhoea.
BEFORE YOU USE SUN-DIANOX TABLET
_- When you must not use it _
Do not use Sun-Dianox Tablet if:-

you are hypensitive to diphenoxylate or
atropine or other ingredients of this product.

you have jaundice.

you have diarrhea associated with the use of
certain antibiotics or bacterial infection.

you have intestinal obstruction, ulcers and
inflammation in the digestive tract.

your activities requiring mental alertness,
such
as
driving
or
operating
dangerous
machinery as it may produce drowsiness or
dizziness.
_- Before you start to use it _
You should check with your doctor if you
have the following :-

down’s syndrome

breast feeding

pregnant

liver disease
Appropriate
fluid
and
electrolyte
therapy
should be taken to prevent dehydration due to
diarrhoea. Oral rehydration therapy including
oral
rehydration
salts
remains
the
most
effective treatment for dehydration due
to diarrhoea. The intake of as much of these
fluids as possible is therefore imp

Caracteristicilor produsului

Each tablet contains:-
Diphenoxylate HCl 2.5mg
Atropine Sulphate 0.025mg
PHARMACOLOGY:
Diphenoxylate is rapidly and extensively metabolized in
man by ester hydrolysis to diphenoxylic acid (difenoxine),
which is biologically active and the major metabolite in the
blood. After
a
5-mg
oral
dose
of
carbon-
14
labelled
diphenoxylate hydrochloride in ethanolic solution was given
to three healthy volunteers, an average of 14% of the drug
plus its metabolites was excreted in the urine and 49% in
the feces over a four-day period. Urinary excretion of the
unmetabolized drug constituted less than 1% of the dose,
and
diphenoxylic
acid
plus
its
glucuronide
conjugate
constituted about 6% of the dose. In a 16-subject crossover
bioavailability study, a linear relationship in the dose range
of 2.5 to 10mg was found between the dose of diphenoxy-
late hydrochloride and the peak plasma concentration, the
area under the plasma concentration-time curve, and the
amount of diphenoxylic acid excreted in the urine. The
average peak plasma concentration of diphenoxylic acid
following ingestion of four 2.5mg tablets was 163ng/ml at
about 2 hours, and the elimination half-life of diphenoxylic
acid was approximately 12 to 14 hours.
Atropine is readily absorbed from the gastro-intestinal tract.
It
is
rapidly
cleared
from
the
blood
and
is
distributed
throughout the body. It crosses the blood-barrier.
It is incompletely metabolised in the liver and is excreted in
the urine as unchanged drug and metabolites. A half-life of
about 4 hours has been reported
In animal, diphenoxylate has a direct effect on circular
smooth muscle of the bowel that conceivably results in
segmentation and prolongation of gastrointestinal transit
time.
The
clinical
antidiarrheal
action
of
diphenoxylate
hydrochloride may thus be a consequence of enhanced
segmentation
that
allows
increased
contact
of
the
intraluminal contents with the intestinal mucosa.
Atropine a naturally occurring alkaloid, is an anticholinergic
agent. It acts by competitive inhibition of the actions of