MEXOMIDE TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METOCLOPRAMIDE HYDROCHLORIDE

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

METOCLOPRAMIDE HYDROCHLORIDE

Unit dalam pakej:

100 Tablets; 1000 Tablets

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

MEXOMIDE TABLET
Metoclopramide Hydrochloride (10mg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Mexomide Tablet is used for
2.
How Mexomide Tablet works
3.
Before you use Mexomide Tablet
4.
How to use Mexomide Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Mexomide
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What Mexomide Tablet is used for
Adult population
Mexomide Tablet is indicated in adults
for:
-
Prevention of nausea and vomiting
induced by chemotherapy and
radiotherapy
-
Symptomatic treatment of nausea and
vomiting.
Children population
Mexomide Tablet is indicated in
children (aged 9-18 years) for:
-
Prevention of delayed chemotherapy
induced nausea and vomiting as a
second line option.
How Mexomide Tablet works:
Metoclopramide increases gastric
motility and accelerates gastric
emptying. It also has an anti-vomiting
action that is due partly to its local
action on the stomach and intestinal
tract and partly to a direct action on the
central nervous system which controls
the body and mind.
Before you use Mexomide Tablet
-
When you must not use it
Do not take this medicine if you have
any of the following;
1)
Hypersensitivity to the
metoclopramide or to any of the
ingredients listed.
2)
Gastrointestinal bleeding,
obstruction or perforation.
3)
Confirmed or suspected
phaeochromocytoma (noncancerous
(benign) tumor that develops in an
adrenal gland)
4)
History of uncontrolled body
movement induced by
metoclopramide or medicines that
reduce nerve function.
5)
Epilepsy
6)
Parkinson’s disease.
7)
Taking medicine such as levodopa
or dopaminergic agonists.
8)
Known history of
methemoglobinemia (blood disorder
in which too little oxygen is
delivered to your cells).
9)
Use in children less than 1 year of
age.
Pregnancy and lactation
Do not take Mexomide Tablet if you
are pregnant, trying to get pregnant or
think you may be pregnant especially
during the first trimester of pregnancy.
Do not take M

Ciri produk

MEXOMIDE TABLET
MAL19910164AZ
DESCRIPTION:
TABLET
Colour
:
White
Shape
:
Round, Flat and Scored
CONTENT:
Each Tablet Contains:
Metoclopramide Hydrochloride .......... 10 mg
PHARMACODYNAMICS:
Metoclopramide increases gastric motility and accelerates gastric
emptying. This action is antagonised by Atropine. It also has an
anti-emetic
action that is due partly to its local action on the gastrointestinal
tract and partly to a direct action on the CNS.
PHARMACOKINETICS:
Metoclopramide is well absorbed after oral administration in animals.
In rabbits, plasma concentrations of about 90 mcg/ml are attained
after 30
to 120 min after oral dose of 200 mcg/kg. In rats and dogs, plasma
half-life are 60 to 90 min. In rabbits about 2 hours. In mice,
Metoclopramide is
widely distributed throughout the body with highest concentrations
appearing in the liver, intestinal mucosa and biliary tract, and
lesser
concentration appearing in the heart, adrenal glands, thymus, fat,
bone marrow and CNS. In animals, Metoclopramide appears to be subject
to
enterohepatic circulation; volume of distribution in rats, rabbits,
and dogs greater than 1.1 L/kg body-weight; protein binding,
moderately bound
to plasma proteins in man. In rats and dogs, metabolised by
O-demethylation, N-de-ethylation, and amide hydrolysis then conjugated
with
glucuronic acid and sulphate; in rabbits, possibly the formation of
N4-acetyl derivatives; in animals there appears to be significant
first pass
metabolism in the liver. After an oral dose of 10 mg, 50% is excreted
unchanged in 8 hours; in rats and dogs about 50% is excreted mainly as
N-
dealkyulated or O-demethylated metabolites.
INDICATION:
Adult population
MEXOMIDE 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.
Paediatric population
MEXOMIDE TABLET is indicated in children (aged 9-1