MOLAX-M FILM COATED TABLET

国: マレーシア

言語: 英語

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

有効成分:

DOMPERIDONE

から入手可能:

SPG PHARMA (MALAYSIA) SDN BHD

INN（国際名）:

DOMPERIDONE

パッケージ内のユニット:

10 blister packs x 10 Tablets

製:

SIAM BHEASACH CO LTD

情報リーフレット

_ _
_ _
_ _
_ Consumer Medication Information Leaflet (RiMUP)_
MOLAX-M FILM-COATED TABLET
Domperidone Maleate (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Molax-M is used for
2.
How Molax-M works
3.
Before you use Molax-M
4.
How to use Molax-M
5.
While you are using Molax-M
6.
Side effects
7.
Storage and Disposal of Molax-M
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT MOLAX-M IS USED FOR
Molax-M is used for the relief of the
symptoms of nausea and vomiting
from various causes (including
chemotherapy, radiotherapy or other
medicines).
HOW MOLAX-M WORKS
Molax-M 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 MOLAX-M
_When you must not use it _
Do not use Molax-M if you:
▪
are allergic to domperidone
maleate, or any other ingredients
listed at the end of this leaflet
▪
suffer from a tumor 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, heart rhythm
disorders such as a slow or irregular
heartbeat
Stop taking Molax-M and contact
your doctor immediately if you
experience abnormal heartbeat.
_ _
_Pregnancy _
If you are, or think you may be
pregnant, tell your doctor, who will
decide if you can take Molax-M.
_Breast-feeding _
Small amounts of Molax-M can end
up in the mother's milk. Breast-
feeding is not recommended for
mothers who are taking Molax-M.
Talk to your doctor if you have any
questions.
_Before you start to use it _
Talk to your doctor before using
Molax-M if you:
▪
have allergies to any medicines,
foods, preservatives or dyes
▪
have severe kidn

製品の特徴

PRODUCT NAME
MOLAX-M FILM COATED TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each film-coated tablet contains 10 mg Domperidone Maleate
PRODUCT DESCRIPTION
White, round and biconvex film coated tablet with “M” on
one side and SIAM logo on the other
PHARMACODYNAMICS
Domperidone is a dopamine antagonist with anti-emetic
properties. It does not readily cross the blood-brain barrier.
In domperidone users, especially in 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. Animal studies, together with the low
concentrations found in the brain, indicate a predominantly
peripheral effect of domperidone on dopamine receptors.
Studies in human 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
Domperidone is rapidly absorbed after oral administration with
peak plasma concentrations at approximately 1 hr after dosing.
The C
max
and AUC values of domperidone increased
proportionally with dose in the 10 mg to 20 mg dose range.
A 2- to 3-fold accumulation of domperidone AUC was observed
with repeated four times daily (every 5 hr) dosing of
domperidone for 4 days. 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 gastrointestinal
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 absorpt