JANUVIA 25 MG TABLET

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

SITAGLIPTIN

Commercializzato da:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nome Internazionale):

SITAGLIPTIN

Confezione:

28Tablet Tablets

Prodotto da:

MERCK SHARP & DOHME LTD

Foglio illustrativo

_ Consumer Medication Information Leaflet (RiMUP)_
JANUVIA
® TABLET
Sitagliptin Phosphate (25mg, 50mg, 100mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_JANUVIA_
is taken for
2.
How
_JANUVIA_
works
3.
Before you take
_JANUVIA_
4.
How to take
_JANUVIA_
5.
While you are taking
JANUVIA
6.
Side effects
7.
Storage and disposal of
JANUVIA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
Please read this information
carefully before you start to take
your medicine, even if you have
just refilled your prescription.
Some of the information may have
changed.
Remember that your doctor has
prescribed this medicine only for
you. Never give it to anyone else.
WHAT JANUVIA IS TAKEN FOR
JANUVIA (sitagliptin phosphate,
MSD) is a tablet that contains 25,
50, or 100 mg of sitagliptin
_ _
as the
active ingredient.
•
JANUVIA helps to improve
the levels of insulin after a
meal.
•
JANUVIA decreases the
amount of sugar made by the
body.
•
JANUVIA works when blood
sugar is high, especially after a
meal. This is when the body
needs the greatest amount of
help in lowering blood sugar.
JANUVIA also lowers blood
sugar between meals.
•
JANUVIA by itself is unlikely
to cause low blood sugar
(hypoglycemia) because it
does not work when your
blood sugar is low.
HOW JANUVIA WORKS
JANUVIA is a member of a class
of medicines you take by mouth
called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors)
that lowers blood sugar levels in
patients with type 2 diabetes
mellitus. Type 2 diabetes is also
called non-insulin-dependent
diabetes mellitus, or NIDDM.
WHY HAS MY DOCTOR PRESCRIBED
JANUVIA?
Your doctor has prescribed
JANUVIA to help lower your
blood sugar, which is too high
because of your type 2 diabetes.
JANUVIA can be used alone or in
combination with certain other
medicines that lower blood sugar,
along with a recommended diet
and exercise program.
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

Scheda tecnica

LOCAL PRODUCT CIRCULAR
LPC-MK0431-T-052020B
Tablet
JANUVIA®
(sitagliptin phosphate)
I. THERAPEUTIC CLASS
JANUVIA
*
(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
proliferator-activated receptor
gamma (PPAR
γ
) agonists, alpha-glucosidase inhibitors, and amylin analogues.
II. COMPOSITION
_IIA. ACTIVE INGREDIENTS _
Each film-coated tablet of JANUVIA contains 32.13, 64.25 or 128.5 mg
of sitagliptin phosphate
monohydrate, which is equivalent to 25, 50 or 100 mg, respectively, of
free base.
III. CLINICAL PHARMACOLOGY
_IIIA. MECHANISM OF ACTION_
JANUVIA 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 en