Glucoxit Tablet 500mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METFORMIN HYDROCHLORIDE

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE

Unit dalam pakej:

1000 Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA (M) SDN. BHD.

Risalah maklumat

GLUCOXIT TABLET 500 MG
Active Ingredient: Metformin Hydrochloride 500 mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Glucoxit Tablet 500mg is used
for
2.
How Glucoxit Tablet 500mg works
3.
Before
you
use
Glucoxit
Tablet
500mg
4.
How to use Glucoxit Tablet 500mg
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Glucoxit
Tablet 500mg
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT GLUCOXIT TABLET 500MG IS USED
FOR
Glucoxit
Tablet
500mg
contains
metformin hydrochloride.
Metformin hydrochloride is used in the
treatment
of
non-insulin-dependent
diabetes
mellitus
(NIDDM)
to
control
high
blood
sugar
that
cannot
be
controlled
adequately
by
diet
management,
exercise
or
weight
reduction.
The
medicine
can
be
used
alone
or
in
combination
with
other
medications.
HOW GLUCOXIT TABLET 500MG WORKS
Metformin
hydrochloride
increases
the
sensitivity
of
target
cells
to
insulin
(hormone which regulates the amount of
sugar in the blood) to reduce blood sugar
level.
Since
metformin
hydrochloride
does
not
stimulate
the
secretion
of
insulin, insulin must be present for the
medicine to work properly.
BEFORE YOU USE GLUCOXIT TABLET 500MG
_- When you must not use it _
Do not take Glucoxit Tablet 500mg:
•
If you have severely reduced kidney
function.
•
If you have lactic acidosis [too much
lactic acid in the blood (see “Risk of
lactic
acidosis”
below)]
or
ketoacidosis.
Ketoacidosis
is
a
condition in which substances called
'ketone
bodies'
accumulate
in
the
blood and which can lead to diabetic
pre-coma.
Symptoms
of
acidosis
may include stomach pain, abnormal
breathing and drowsiness (if severe).
•
You have very low kidney function
(GFR <30 mL/min)
•
You have sudden metabolic acidosis
(A
condition
when
your
body
produces too much acid or when the
kidneys
are
not
removing
enough
acid from the body)
•
You have allergy to Metformin
•
You have any medical condition that
requires close blood sugar control,
suc

Ciri produk

[DUOPHARMA (M) SDN
BHD]
1/2
[Revision Date: (29.03.2019)]
GLUCOXIT TABLET 500 MG
DESCRIPTION:
11mm, round, bi-convex, scored on one side, marked 'MET, white tablet.
COMPOSITION:
Each tablet contains Metformin Hydrochloride 500mg.
PHARMACODYNAMICS:
Metformin hydrochloride does not stimulate pancreatic beta cells of
insulin; insulin secretion must be present for metformin to work
properly. Metformin hydrochloride
may increase the
number and/or affinity of insulin receptors on cell surface membranes,
especially at peripheral receptor sites, and help to correct down
regulation of the
insulin receptor. This effect increases
the sensitivity to insulin at receptor and post receptor binding sites
and increases uptake peripherally. Insulin concentrations
remain unchanged or are slightly reduced as glucose
metabolism improves. In addition, metformin's metabolic effects
increase hepatic glycogen stores in diabetic
patients (but not in non-diabetic patients). Decrease intestinal
glucose
absorption, and reduce fatty acid oxidation and acetyl co-enzyme A
formation. Glucose uptake or
free fatty acid oxidation is effects considered to be caused by
non-insulin mediated
mechanisms.
PHARMACOKINETICS:
Metformin hydrochloride is absorbed over a period of 6 hours with
bioavailability between 50%-60% under fasting condition. Presence of
food will delay the absorption,
lowers the peak
concentration by 40% and decreases the bioavailability by 25%. Peak
serum concentration at steady state is 1 to 2 mcg/ml, achieved within
2 hours.
The main sites of concentration
without accumulation are the intestinal mucosa and the salivary
glands; also, the erythrocyte mass may be a compartment of
distribution. It has a plasma half-life of about 3 hours
and it is not bound to plasma proteins. Metformin hydrochloride does
not undergo hepatic metabolism and up to
90% of a dose of metformin is excreted unchanged in the urine. About
30% of a dose is eliminated in the feces. Haemodialysis with a
clearance of 170 ml/minute
prevents accumulation of metformin.