AETOS DOMPERIDONE TABLET 10 MG

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

DOMPERIDONE MALEATE

Tilgjengelig fra:

ABIOTIDE SDN. BHD.

INN (International Name):

DOMPERIDONE MALEATE

Enheter i pakken:

100 Tablets

Produsert av:

HOVID BERHAD

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
AETOS DOMPERIDONE TABLET 10 MG
Domperidone 10 mg
1
WHAT IS IN THIS LEAFLET
1.
What Aetos Domperidone is used
for
2.
How Aetos Domperidone works
3.
Before you use Aetos
Domperidone
4.
How to use Aetos Domperidone
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Aetos
Domperidone
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT AETOS DOMPERIDONE IS USED
FOR
Aetos Domperidone is used for the
relief of the symptoms of nausea and
vomiting from various causes
(including chemotherapy, radiotherapy
or other medicines).
HOW AETOS DOMPERIDONE WORKS
Aetos Domperidone 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 YOUR USE AETOS DOMPERIDONE
_ _
_- When you must not use it_
You should not use Aetos
Domperidone if:
•
You know you are allergic
(hypersensitive) to domperidone
and other ingredients listed at the
end of the leaflet.
•
You suffer from a tumour of the
pituitary gland called
prolactinoma.
•
Have bleeding, obstruction and
hole in the stomach and bowel
(e.g. severe stomach cramps or
persistent black stools).
•
Have moderate to severe liver
disease.
•
Have abnormal potassium level,
low magnesium level in the
blood.
•
Have or had heart problems
including heart failure or heart
rhythm disorders including a slow
or irregular heartbeat.
Do not take Aetos Domperidone if
you are taking any of the following
medications: clarithromycin
(antibiotic).
If in doubt, ask your pharmacist or
doctor for advice.
Stop taking Aetos Domperidone and
contact your doctor immediately if
you experience abnormal heartbeat.
_Pregnancy_
If you are pregnant or think you may
be, tell your doctor, who will decide if
you can take Aetos Domperidone.
_Breast-feeding_
Small amounts of Aetos Domperidon

Preparatomtale

DESCRIPTION
Round, 6.0 mm in diameter, white to off-white coated tablet with
shallow convex faces.
COMPOSITION
Each film-coated tablet contains Domperidone Maleate 12.73mg,
equivalent to Domperidone 10 mg.
PHARMACODYNAMICS
Domperidone is a dopamine antagonist with anti-emetic properties.
Domperidone does not readily cross the blood-brain barrier. In
domperidone users, especially adults, extrapyramidal side effects
are very rare, but domperidone promotes the release of prolactin
from the pituitary. Its anti-emetic effect may be due to a combination
of peripheral (gastrokinetic) effects and antagonism of dopamine
receptors in the chemoreceptor trigger zone, which lies outside the
blood-brain barrier in the area postrema.
Studies in man have shown oral domperidone to increase lower
oesophageal
pressure,
improve
antroduodenal
motility
and
accelerate gastric emptying.
There is no effect on gastric secretion.
PHARMACOKINETICS
ABSORPTION
In fasting subjects, domperidone is rapidly absorbed after oral
administration,
with
peak
plasma
concentrations
at
30
to
60
minutes. The low absolute bioavailability of oral domperidone
(approximately 15%) is due to an extensive first-pass metabolism in
the gut wall and liver. Although domperidone's bioavailability is
enhanced in normal subjects when taken after a meal, patients with
gastro-intestinal
complaints
should
take
domperidone
15-30
minutes
before
a
meal.
Reduced
gastric
acidity
impairs
the
absorption of domperidone. Oral bioavailability is decreased by
prior
concomitant
administration
of
cimetidine
and
sodium
bicarbonate. The time of peak absorption is slightly delayed and the
AUC somewhat increased when domperidone is taken after a meal.
DISTRIBUTION
Domperidone is 91 - 93% bound to plasma proteins.
METABOLISM
Domperidone undergoes rapid and extensive hepatic metabolism
by
hydroxylation
and
N-dealkylation.
In
vitro
metabolism
experiments with diagnostic inhibitors revealed that CYP3A4 is a
major form of cytochrome P-450 involved in the N-dealkylation of
domperidone,
whereas
C