AZUKON MR Tablet 30 mg

Држава: Малезија

Језик: Енглески

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

Активни састојак:

GLICLAZIDE

Доступно од:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Међународно име):

GLICLAZIDE

Јединице у пакету:

100Tablet Tablets

Произведен од:

TORRENT PHARMACEUTICALS LTD.

Информативни летак

AZUKON MR TABLET
_ _
Gliclazide (30mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1WHAT IS IN THIS LEAFLET
1.
What is AZUKON MR used for
2.
How AZUKON MR works
3.
Before you use AZUKON MR
4.
How to use AZUKON MR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of AZUKON
MR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT AZUKON MR IS USED FOR
AZUKON MR is indicated in Therapy
of
maturity
onset
Diabetes
Mellitus
(noninsulin-dependent
or
Type
II),
where dietary management alone has
been insufficient.
HOW AZUKON MR WORKS
Gliclazide stimulates the secretion of
insulin from functioning pancreatic islet
ß-cells.
Gliclazide
reduces
blood
glucose
levels
by
stimulating
insulin
secretion from the β-cells of the islets
of Langerhans.
BEFORE YOU USE AZUKON MR
-
_When you must not use it _
Do not take TORFIL TABLETS if:
•
Hypersensitivity to sulphonylureas
or
other
ingredient
of
this
medicine.
•
Not to be used for: type 1 diabetes,
juvenile onset diabetes.
•
Diabetes complicated by ketosis or
acidosis.
•
Diabetics undergoing surgery, after
severe trauma or during infections.
•
Diabetic precoma and coma.
•
Severe renal or liver insufficiency.
•
Porphyria
(a
type
of
hereditary
metabolism
disease),
hyperthyroidism
(excessive
functional
activity of
the
thyroid
gland).
_ _
_Pregnancy and lactation _
Do not take AZUKON MR if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take AZUKON MR if you are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start use it _
AZUKON MR is susceptible to cause
episodes of hypoglycemia.
Inform
the
doctor
in
the
case
of
sweating,
intense
hunger,
trembling,
pallor, visual disturbances, feeling of
malaise,
abnormal
behaviour,
immediately
eat
sugar
or
something
containing sugar.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescrip

Карактеристике производа

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NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
AZUKON MR
Each uncoated modified release tablet contains
Gliclazide. ………….. 30mg
PRODUCT DESCRIPTION:
White to off-white coloured, capsule shaped uncoated tablets plain on
both sides.
DOSAGE FORM:
Uncoated Tablets
PHARMACODYNAMICS:
Gliclazide stimulates the secretion of insulin from functioning
pancreatic islet
β
-cells. In addition to this pancreatic action, it has been
demonstrated
that Gliclazide administration may improve the metabolic utilization
of glucose at a peripheral level.
PHARMACOKINETICS:
_ABSORPTION_
Gliclazide PR shows linear pharmacokinetics over the 15 to 120mg dose
range in patients with type 2 diabetes mellitus. The intra-individual
variability is low, at 16%. Cmax is reached at about 6 hours after
administration (tmax). Fasting Cmax in 16 healthy volunteers given a
single 30
mg dose of Gliclazide PR was 0.74 mg/L at a tmax of 7 hours, and the
area under the plasma concentration- time curve (AUC) was 16.2 mg/L
.h.
The mean absolute bioavailability of Gliclazide was 97% (range 79 to
110%) after administration of a single oral dose of Gliclazide PR 30mg
to 16
healthy volunteers.
_DISTRIBUTION_
The volume of distribution of Gliclazide in healthy and diabetic
subjects was 15.9 to 17 or 20 to 40% of body weight. Gliclazide is
highly bound to
albumin (95%).
_METABOLISM_
Gliclazide is oxidized to produce either hydroxylated metabolites or
N-oxygenated compounds, and the corresponding alcohol and carboxylic
acid.
Gliclazide is extensively metabolized, less than 20% of the dose being
excreted unchanged in the urine. However in plasma, gliclazide
represents
over 90% of all drug related material, the most important metabolite
being present at the extent of 1%. This metabolite has not
demonstrated any
hypoglycemic action but claims have been made that it possess effects
on platelet aggregation and micro thrombi formation. The other
metabolites
seen in urine are only present in trace quantity (less than 20 ng/ml)
in plasma.
_EXCRETION_
Studies