AXCEL METOCLOPRAMIDE TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METOCLOPRAMIDE HYDROCHLORIDE

Boleh didapati daripada:

KOTRA PHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

METOCLOPRAMIDE HYDROCHLORIDE

Unit dalam pakej:

1000 Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

KOTRA PHARMA (M) SDN. BHD.

Risalah maklumat

AXCEL METOCLOPRAMIDE TABLET
Metoclopramide Hydrochloride (10mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Metoclopramide
Tablet is used for.
2.
How
Axcel
Metoclopramide
Tablet works.
3.
Before
you
use
Axcel
Metoclopramide Tablet.
4.
How to use Axcel Metoclopramide
Tablet.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Metoclopramide Tablet.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT AXCEL METOCLOPRAMIDE TABLET
IS USED FOR
Axcel Metoclopramide Tablet are used
for:
Adult population:
•
Prevention
of
delayed
chemotherapy induced nausea and
vomiting (CINV).
•
Prevention
of
radiotherapy
induced
nausea
and
vomiting
(RINV).
•
Symptomatic treatment of nausea
and
vomiting,
including
acute
migraine
induced
nausea
and
vomiting.
Age 9-18 years population:
•
Prevention
of
delayed
chemotherapy induced nausea and
vomiting (CINV) as a second line
option.
HOW AXCEL METOCLOPRAMIDE TABLET
WORKS
Metoclopramide
HCl
promotes
involuntary constriction and dilation of
the
muscle
in
the
oesophagus
(food
pipe) and stomach, increases the tone
of the muscular ring in between the
stomach and oesophagus to prevent the
backflow of stomach content and tends
to speed gastric emptying.
BEFORE
YOU
USE
AXCEL
METOCLOPRAMIDE TABLET_ _
_-When you must not use it _
Do
not
take
Axcel
Metoclopramide
Tablet if:
•
You
are
hypersensitive
to
Metoclopramide or to any of the
ingredients listed.
•
You
have
stomach
and
intestine
bleeding, obstruction or tear.
•
You
are
confirmed
or
suspected
pheochromocytoma (tumor of the
adrenal glands), due to the risk of
severe high blood pressure.
•
You have history of transquilizer
use
or
metoclopramide-induced
tardive
dyskinesia
(involuntary,
repetitive body movements).
•
You
have
seizures
or
parkinson
(movement disorder).
•
It
is
combination
with
medicine
such as levodopa or dopaminergic
agonists.
•
You
have
known
history
of
methaemoglobinaemia
(abnormal
blood
pigm

Ciri produk

METOCLOPRAMIDE
TABLETS
MAL19921470AZ
KOTRA PHARMA (M) SDN. BHD.
No.1, 2 & 3, Jalan TTC 12,
Cheng Industrial Estate,
75250 Melaka, Malaysia.
(90082-V)
COMPOSITION:
Each tablet contains
Metoclopramide HCL equivalent to
Anhydrous Metoclopramide HCL 10mg
PRESENTATION:
Light yellow, round, flat tablet, 7.1mm in diameter with a single
score line
on one side and marked KOTRA logo on the other side.
INDICATION:
_Adult population:_
Axcel Metoclopramide Tablet is indicated in adults for :
- Prevention of delayed chemotherapy induced nausea and vomiting
(CINV).
- Prevention of radiotherapy induced nausea and vomiting (RINV).
- Symptomatic treatment of nausea and vomiting, including acute
migraine induced nausea and vomiting.
_Age 9-18 years patient:_
Axcel Metoclopramide Tablet is indicated in patient (aged 9-18 years)
for :
Prevention of delayed chemotherapy induced nausea and vomiting
(CINV) as a second line option.
PHARMACOLOGY:
_Mechanism of Action:_
The action of metoclopramide is closely associated with
parasympathetic
nervous control of the upper gastro-intestinal tract where it has the
effect
of encouraging normal peristaltic action. This provides for a
fundamental
approach
to
the
control
of
those
conditions
where
disturbed
gastrointestinal motility is a common underlying factor.
_Pharmacokinetics:_
Metoclopramide is metabolised in the liver and the predominant route
of
elimination of metoclopramide and its metabolites is via the kidney.
_Renal impairment:_
The clearance of metoclopramide is reduced by up to 70% in patients
with
severe
renal
impairment,
while
the
plasma
elimination
half-life
is
increased (approximately 10 hours for a creatinine clearance of 10-50
mL/minute and 15 hours for a creatinine clearance <10 mL/minute).
_Hepatic impairment:_
In patients with cirrhosis of the liver, accumulation of
metoclopramide has
been observed, associated with a 50% reduction in plasma clearance.
DOSAGE AND ADMINISTRATION:
Total daily dose of metoclopramide, especially for children and young
adults, should not normally ex