DOMPER TABLET 10MG

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

DOMPERIDONE

MAH:

Y.S.P. INDUSTRIES (M) SDN BHD

INN:

DOMPERIDONE

units_in_package:

100Tablet Tablets; 1,000Tablet Tablets; 500 Tablet Tablets

manufactured_by:

Y.S.P. INDUSTRIES (M) SDN BHD

PIL

_Consumer Medication Information Leaflet (RiMUP) _
1 | P a g e
DOMPER
® TABLET
Domperidone 10mg
WHAT IS IN THIS LEAFLET
This leaflet contains information below:
•
What DOMPER® TABLET is used for
•
How DOMPER® TABLET works
•
Instructions before you use DOMPER®
TABLET
•
How to take DOMPER® TABLET
•
Instructions
while
you
are
using
DOMPER® TABLET
•
Side effects
•
Storage
and
disposal
of
DOMPER®
TABLET
•
Product description
•
MAL No.
•
Address of Manufacturer
•
Address of Product Registration Holder
WHAT DOMPER® TABLET
IS USED FOR
DOMPER® TABLET is indicated for the
symptomatic
relief
of
nausea
and
vomiting.
HOW DOMPER® TABLET
WORKS
DOMPER® TABLET is an antiemetic and a
prokinetic medicine. It works by blocking the
action of a chemical messenger in the brain
which
causes
the
feeling
of
nausea
and
vomiting, as well as increasing the movement
or contractions of the stomach and intestines,
allowing food to move more easily through
the stomach.
BEFORE YOU USE DOMPER® TABLET
_When you must not take it _
Do not take DOMPER® TABLET if you:
•
are allergic to DOMPER® TABLET
and
other
medicines
containing
domperidone
•
are allergic to any of the ingredients
listed under the Ingredients section
of this leaflet
•
have
moderate
to
severe
liver
impairment
•
have a tumour of the pituitary gland
known as prolactinoma
•
have a pre-existing heart condition.
•
have gastrointestinal hemorrhage or
mechanical obstruction.
_Before you start to take it _
Please inform your healthcare professional
regarding the following:
•
You are pregnant or planning to become
pregnant.
•
Your baby is under 1 year of age.
•
You are breast feeding or wish to
breastfeed. (It is not advisable to
take DOMPER® TABLET in
pregnancy because domperidone is
found in the breast milk but at very
low levels)
•
You have or have ever had liver or
kidney disease.
•
You are not able to digest lactose
which is a sugar found in milk and
milk products.
Your doctor will advise you whether
DOMPER®
TABLET
is
suitable
fo

SPC

INGREDIENT(S):
Each tablet contains:
Domperidone
.................................................................................................................................
10mg
PHARMACOLOGY :
PHARMACODYNAMICS:
Domperidone is a dopamine antagonist (blocking both D1 & D2 receptors)
which is structurally related
to the benzimidazole. Domperidone is a potent gastrokinetic agent.
Domperidone facilitates
gastrointestinal smooth muscle activity by inhibiting dopamine at the
D1 receptors and inhibiting the
release of neural acetylcholine by blocking D2 receptors.
Domperidone binds with high affinity to the dopamine receptor. It does
not cross the blood brain
barrier or the placental barrier but exerts its effects at peripheral
sites: the chemoreceptor trigger
zone (in the brainstem) and the gastrointestinal tract. Domperidone
inhibits dopamine-induced
gastric relaxaton and the inhibitory effects of secretin, whose
actions may be mediated by
dopamine release. Finally, it stimulates phasic activity in the
gastro-duodenal area and improves
gastro-duodenal coordination.
PHARMACOKINETICS:
Absorption
Although absorption is rapid, the systemic bioavailability of
domperidone is only about 13% to 17% in
fasting subjects given an oral dose; this is increased when
domperidone is given after food. The low
bioavailability is thought to be due to first-pass hepatic and
intestinal metabolism. Peak plasma
concentrations are achieved 30 minutes after an oral dose.
Distribution
Domperidone is 91 - 93% bound to plasma proteins. Domperidone does not
readily cross the
blood-brain barrier .In humans, the apparent volume of distribution is
440 L .Small amounts of
domperidone are distributed into breast milk; concentrations are 10 to
50% of those in maternal serum.
Metabolism
It undergoes rapid and extensive hepatic metabolism. The main
metabolic pathways are N-dealkylation
by cytochrome P450 isoenzyme CYP3A4, and aromatic hydroxylation by
CYP3A4, CYP1A2, and
CYP2E1.
Excretion
Urinary and faecal excretions amount to 31 and 66% of the ora