DOIZ 50 MG FC TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ITOPRIDE HYDROCHLORIDE

Boleh didapati daripada:

SPG PHARMA (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

ITOPRIDE HYDROCHLORIDE

Unit dalam pakej:

1 x 10's Tablets; 6 x 10's Tablets

Dikeluarkan oleh:

SIAM BHEASACH CO LTD

Risalah maklumat

_ _
_ _
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_ Consumer Medication Information Leaflet (RiMUP)_
DOIZ 50 MG FC TABLET
Itopride hydrochloride (50 mg)
1/2
WHAT IS IN THIS LEAFLET
1.
What DOIZ is used for
2.
How DOIZ works
3.
Before you use DOIZ
4.
How to use DOIZ
5.
While you are using DOIZ
6.
Side effects
7.
Storage and Disposal of DOIZ
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DOIZ IS USED FOR
DOIZ is used to treat symptoms
cause by impaired bowel
movement and delayed gastric
emptying, such as gastric fullness,
discomfort or painful pressure in
the upper abdomen, loss of
appetite, heartburn, nausea and
vomiting, indigestion (not due to
ulcer) or long-term gastric
inflammation.
HOW DOIZ WORKS
DOIZ works by improving gastric
movement and blocks the center
inside your brain which initiate
nausea and vomiting.
BEFORE YOU USE DOIZ
_When you must not use it _
Do not use DOIZ if:
▪
you are allergic to itopride or any
other ingredients in this medicine
▪
you have gastrointestinal
bleeding, obstruction or
perforation
_Before you start to use it _
_Pregnancy and breast-feeding _
If you are pregnant or breast-
feeding, think you may be pregnant
or are planning to have a baby, ask
your doctor for advice before
taking this medicine.
Your doctor will decide whether
you are suitable for DOIZ.
_Taking other medicines _
Tell your doctor or pharmacist if
you are taking or have recently
taken any medicines, including
traditional products bought without
a prescription.
Some medicines may interact with
DOIZ when used concomitantly:
▪
Anticholinergic agents
(commonly used to treat asthma,
chronic obstructive pulmonary
disease, diarrhoea, Parkinson’s
disease)
▪
DOIZ can influence absorption
of other medicines due to its
effect on digestive tract, in
particular medicines with narrow
therapeutic range, sustained
released medicines and
medicines released in intestine
HOW TO USE DOIZ
_How much to use _
The usual daily dose for adults is
one tablet (50 mg) three times a
day before meals.
The

Ciri produk

Drawing No. DOI-50-02-L-ENG-MY-A0001
Sent date 08/06/2022
PRODUCT NAME
DOIZ 50 MG FC TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each film-coated tablet contains 50 mg itopride hydrochloride
PRODUCT DESCRIPTION
A white to off-white, round biconvex film-coated tablet engraved with
“
” logo on one side and “I”
on the other side
PHARMACODYNAMICS
Pharmacotherapeutic group: gastrokinetic agent (a substituted
benzamide)
Mechanism of action
Itopride has dual mechanism of action: dopamine D2 receptor antagonism
and acetylcholinesterase inhibition.
The effect of itopride is an increase in acetylcholine concentration,
which promotes gastric motility,
increases the lower oesophageal sphincter (LOS) pressure, accelerates
gastric emptying and improves
gastroduodenal coordination.
Itopride hydrochloride also has antiemetic action through interaction
with D2 receptors located in the
chemoreceptor trigger zone. This was demonstrated by dose dependent
inhibition of apomorphine-induced
vomiting.
The action of itopride hydrochloride is highly specific for the upper
gastrointestinal tract. Itopride
hydrochloride does not affect serum gastrin levels.
PHARMACOKINETICS
Absorption
Itopride hydrochloride is rapidly and almost completely absorbed from
the gastrointestinal tract. Relative
bioavailability is calculated to be 60% due to liver first pass
metabolism. There is no effect of food on
bioavailability. Peak plasma levels (C
max
= 0.28 g/mL) are reached within 0.5 to 0.75 hours following oral
administration of 50 mg itopride hydrochloride.
Following multiple oral doses ranging from 50 mg to 200 mg TDS (three
times daily), itopride hydrochloride
and its metabolites showed linear pharmacokinetics over a treatment
period of seven days, with minimal
accumulation.
Distribution
Approximately 96% of itopride hydrochloride is bound to plasma
proteins. Albumin accounts for most of
the binding. Alpha-1-acid-glycoprotein accounts for less than 15% of
binding.
Metabolism
Itopride undergoes extensive hepatic metabolism in humans. Three
m