Instadip 50 (Sitagliptin Film Coated Tablets USP 50mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SITAGLIPTIN PHOSPHATE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SITAGLIPTIN PHOSPHATE

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
INSTADIP
SITAGLIPTIN TABLETS USP (25MG, 50MG, 100 MG)
Page 1
WHAT IS IN THIS LEAFLET
1.
What
INSTADIP
is used for
2.
How
INSTADIP
works
3.
Before you take
INSTADIP
4.
How to take
INSTADIP
5.
While you are taking
INSTADIP
6.
Side Effects
7.
Storage and Disposal of
INSTADIP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INSTADIP IS USED FOR
INSTADIP
contains
the
active
substance
sitagliptin
which
is
a
member of a class of medicines called
DPP-4 inhibitors (dipeptidyl peptidase-
4 inhibitors) that lowers blood sugar
levels
in
adult
patients
with
type
2
diabetes mellitus.
Your
doctor
has
prescribed
this
medicine
to
help
lower
your
blood
sugar, which is too high because of
your type 2 diabetes. This medicine
can be used alone or in combination
with certain other medicines (insulin,
metformin,
sulphonylureas,
or
glitazones)
that
lower
blood
sugar,
which you may already be taking for
your diabetes together with a food and
exercise plan.
HOW INSTADIP WORK
This
medicine
helps
to
increase
the
levels of insulin produced after a meal
and
decreases
the
amount
of
sugar
made by the body.
Type 2 diabetes is a condition in which
your
body
does
not
make
enough
insulin, and the insulin that your body
produces does not work as well as it
should. Your body can also make too
much sugar. When this happens, sugar
(glucose) builds up in the blood. This
can lead to serious medical problems
like
heart
disease,
kidney
disease,
blindness, and amputation.
BEFORE YOU USE INSTADIP
_ _
-
_When you must not use it _
DO NOT TAKE INSTADIP IF ANY OF THE
FOLLOWING APPLY TO YOU.

if you are allergic to Sitagliptin or
any of the other ingredients of this
medicine.
-
_Before you start to use it _
Tell your doctor if you have allergies
to
any
other
medicines,
foods,
preservatives or dyes.

Cases
of
i

Ciri produk

1
_For the use of a Registered Medical Practitioner_ _Only _
PRESCRIBING INFORMATION
INSTADIP 25 / 50 / 100
(SITAGLIPTIN FILM COATED TABLETS USP 25MG, 50MG, 100MG)
COMPOSITION
INSTADIP 25
SITAGLIPTIN TABLET USP 25MG
EACH FILM COATED TABLET CONTAINS:
Sitagliptin Phosphate USP is equivalent to Sitagliptin ......…25 mg
INSTADIP 50
SITAGLIPTIN TABLET USP 50MG
EACH FILM COATED TABLET CONTAINS:
Sitagliptin Phosphate USP is equivalent to Sitagliptin......…50 mg
INSTADIP 100
SITAGLIPTIN TABLET USP 100MG
EACH FILM COATED TABLET CONTAINS:
Sitagliptin Phosphate USP is equivalent to Sitagliptin ......…100 mg
_EXCIPIENTS:_ _ _
Microcrystalline cellulose, dibasic calcium phosphate (anhydrous),
croscarmellose sodium, sodium stearyl
fumarate, magnesium stearate, Opadry Orange 03F530010 (25mg), Opadry
Beige 03F570000 (50mg),
Opadry Beige 03F570001(100mg)
DESCRIPTION
INSTADIP 25
Orange, round, film-coated tablets plain on both sides
INSTADIP 50
Light beige, round, film coated tablets plain on both sides
INSTADIP 100
Beige, round, film coated tablets plain on both sides
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
_PHARMACODYNAMIC PROPERTIES _
Sitagliptin is a member of a class of oral anti-hyperglycemic agents
called dipeptidyl peptidase 4 (DPP-4)
inhibitors, which improve glycemic control in patients with type 2
diabetes by enhancing the levels of active
2
incretin hormones. Incretin hormones, including glucagon-like
peptide-1 (GLP-1) and glucose-dependent
insulinotropic polypeptide (GIP), are released by the intestine
throughout the day, and levels are increased in
response to a meal. The incretins are part of an endogenous system
involved in the physiologic regulation of
glucose homeostasis. When blood glucose concentrations are normal or
elevated, GLP-1 and GIP increase
insulin synthesis and release from pancreatic beta cells by
intracellular signaling pathways involving cyclic
AMP.
Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type
2 diabetes has been reported to
improve beta cell responsiveness to