Janumet XR 50mg500mg (Sitagliptin phosphateMetformin HCl extended-release) film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Unit dalam pakej:

56 Tablets; 14 Tablets; 14 Tablets; 56 Tablets

Dikeluarkan oleh:

MSD International GmbH (Puerto Rico Branch) LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
JANUMET
® XR FILM-COATED TABLETS
Sitagliptin Phosphate/ Metformin Hydrochloride (50mg/500mg,
50mg/1000mg, 100mg/1000mg)
1
WHAT IS IN THIS LEAFLET
1.
What JANUMET XR is used
for
2.
How JANUMET XR works
3.
Before you use JANUMET XR
4.
How to use JANUMET XR
5.
While you are using
JANUMET XR
6.
Side effects
7.
Storage and Disposal of
JANUMET XR
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT JANUMET XR IS USED FOR
JANUMET is a tablet that contains
two prescription medicines,
sitagliptin phosphate
(JANUVIA™) and metformin,
which lower blood sugar.
Sitagliptin, a member of a class of
medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors),
and metformin, a member of the
biguanide class of medicines, work
together to control blood sugar
levels in patients with type 2
diabetes mellitus. Type 2 diabetes
is also called non-insulin-
dependent diabetes mellitus, or
NIDDM
Your doctor has prescribed
JANUMET XR, along with diet
and exercise, to help lower your
blood sugar.
WHAT IS TYPE 2 DIABETES?
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 builds up in the
blood. This can lead to serious
medical problems.
The main goal of treating diabetes
is to lower your blood sugar to a
normal level. Lowering and
controlling blood sugar may help
prevent or delay complications of
diabetes, such as heart problems,
kidney problems, blindness, and
amputation.
High blood sugar can be lowered
by diet and exercise, and by certain
medicines.
HOW JANUMET XR WORKS
•
JANUMET XR lowers blood
sugar levels in patients with
type 2 diabetes.
•
JANUMET XR helps to
improve the levels of insulin
after a meal.
•
JANUMET XR helps the body
respond better to the insulin it
makes naturally.
•
JANUMET XR decreases the
amount of sugar made by the
body.
•
JANUMET XR is

Ciri produk

LOCAL PRODUCT CIRCULAR
LPC-MK0431A-T-052020a
JANUMET® XR
(sitagliptin phosphate/metformin
HCl
extended-release)
Film-coated Tablets
I. THERAPEUTIC CLASS
JANUMET XR
JANUMET XR
(sitagliptin
phosphate/metformin
HCl
extended-release)
combines
two
antihyperglycemic agents with complementary mechanisms of action to
improve glycemic
control in patients with type 2 diabetes: sitagliptin phosphate, a
dipeptidyl peptidase 4 (DPP-4)
inhibitor, and metformin hydrochloride, a member of the biguanide
class.
JANUMET XR contains sitagliptin phosphate and metformin hydrochloride.
JANUMET XR tablets
consist of sitagliptin and an extended-release formulation of
metformin.
Sitagliptin phosphate
Sitagliptin phosphate is an orally-active, potent, and highly
selective inhibitor of the dipeptidyl
peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes. The
DPP-4 inhibitors are a
class of agents that act as incretin enhancers. By inhibiting the
DPP-4 enzyme, sitagliptin
increases the levels of two known active incretin hormones,
glucagon-like peptide-1 (GLP-1) and
glucose-dependent insulinotropic polypeptide (GIP). 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. GLP-1 also lowers glucagon secretion from
pancreatic alpha cells, leading
to reduced hepatic glucose production. This mechanism is unlike the
mechanism seen with
sulfonylureas; sulfonylureas cause insulin release even when glucose
levels are low, which can
lead to sulfonylurea-induced hypoglycemia in patients with type 2
diabetes and in normal
subjects. Sitagliptin is a potent and highly selective inhibitor of
the enzyme DPP-4 and does not
inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic
concentrations.
Sitagliptin
differs in chemical structure and pharmacological action from GLP-1
analogues, insulin,
sulfonylureas or meglitinides, biguanides, peroxisome
pr