Glimaryl 2mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLIMEPIRIDE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

GLIMEPIRIDE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

-1-
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
GLIMARYL TABLET 2 MG
_Glimepiride Tablet 2 mg _
WHAT IS IN THIS LEAFLET?
1.
What Glimaryl Tablet 2 mg is used
for
2.
How Glimaryl Tablet 2 mg works
3.
Before you take Glimaryl Tablet 2
mg
4.
How to take Glimaryl Tablet 2 mg
5.
While you are taking Glimaryl
Tablet 2 mg
6.
Side effects
7.
Storage and disposal of Glimaryl
Tablet 2 mg
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT GLIMARYL TABLET 2 MG IS USED
FOR
Used to treat type 2 diabetes or non-
insulin
dependent
diabetes
mellitus
(NIDDM) in adults whose high blood
sugar levels cannot be lowered through
exercising or monitoring food intake.
It
is
also
used
in
combination
with
insulin.
HOW GLIMARYL TABLET 2 MG WORKS
This medicine belongs to a group called
sulphonylureas
that
lowers
the
high
blood sugar levels in the body.
It works by increasing the amount of
insulin produced by your pancreas.
BEFORE YOU USE GLIMARYL TABLET 2 MG
_When you must not take it _
_ _
Do not take this medicine if:
•
you are allergic to glimepiride or
any other of excipients
•
you are taking other anti-diabetics
•
you have Type 1 diabetes mellitus
•
you have diabetic ketoacidosis
•
you have diabetic precoma/coma
•
you have severe liver or kidney
impairment
•
you are pregnant or breastfeeding.
_Before you start to take it_
_ _
Tell your doctor if:
•
you have allergies to any other
medicines, foods, dyes or
preservatives
•
you have liver problems
•
you have kidney problems
•
you have unstable diabetes
•
you have adrenal, pituitary or
thyroid problems
•
you have glucose-6-phosphate
dehydrogenase (G6PD) deficiency
•
you drink alcohol
•
you do not eat regular meals
•
you do a lot of exercise or heavy
exercise or work
•
you are ill or feeling unwell.
_Taking other medicines _
_ _
Talk to your doctor or pharmacist if you
are taking any other medicines in any
form including any that you buy or
obtained without a prescription.
Some medicines i

Ciri produk

DESCRIPTION
Oblong, green mottled uncoated tablet, bevel-edged, flat
faces, break-bar on one face and "hovid" embossed on the
other face.
COMPOSITION
Each tablet contains:
Glimepiride Tablet 2 mg.
PHARMACODYNAMICS
Glimepiride is a sulfonylurea antidiabetic agent that is used
to reduce blood glucose in type 2 diabetes patients by
directly stimulating release of insulin from functioning beta
cells of pancreatic islet tissue. In addition, glimepiride has
extrapancreatic effects that increase the insulin sensitivity in
target tissues. However, as with other sulfonylurea, the
mechanism by which glimepiride lowers blood sugar during
long term administration has not been clearly established.
Good metabolic control over 24 hours can be achieved with
single dose of Glimaryl.
In patients with insufficient response to the maximum dose,
combination
therapy
with
oral
antidiabetic
containing
metformin or with insulin improves metabolic control.
PHARMACOKINETICS
ABSORPTION:
After oral administration, glimepiride is rapidly and well
absorbed
from
GI
tract.
Peak
drug
levels
(C
max
)
are
achieved between 2 to 3 hours. When glimepiride was given
with meals, the mean T
max
(time to reach C
max
) was slightly
elevated and mean C
max
and area under the curve (AUC)
were slightly decreased (by 8% and 9%, respectively).
DISTRIBUTION:
After intravenous (IV) dosing in normal subjects, the volume
of distribution (Vd) was 8.8L (113mL/kg), and total body
clearance
(CL)
was
47.8mL/min.
Protein
binding
was
greater than 99.5%.
METABOLISM:
Glimepiride
is
completely
metabolised
by
oxidative
biotransformation after either an IV or oral dose. The major
metabolites are the cyclohexyl hydroxy methyl derivative
(M1) and the carboxyl derivative (M2). Cytochrome P450 II
C9 has been shown to be involved in the biotransformation
of glimepiride to M1. M1 is further metabolised to M2 by one
or several cytosolic enzymes. M1, but not M2, possess
1
/
3
of the pharmacological activity as compared to its parent in
the animal model; however, whether the sugar lowe