SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE

País: Indonésia

Língua: indonésio

Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unidades em pacote:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Data de autorização:

2022-12-31

Características técnicas

3 Sep 2022
1
SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE
FILM COATED TABLET
COMPOSITIONS :
SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE Film coated tablet
50 mg,
each film coated tablet
contains : Sitagliptin hydrochloride monohydrate 56.687 mg equivalent
with Sitagliptin 50 mg.
SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE Film coated tablet
100 mg,
each film coated tablet
contains : Sitagliptin hydrochloride monohydrate 113.374 mg equivalent
with Sitagliptin 100 mg.
PHARMACOLOGY :
_MECHANISM OF ACTION_ :
Sitagliptin is a DPP-4 inhibitor,
which is believed to exert
its action in patients with type 2
diabetes by slowing the inactivation of incretin hormones.
Concentrations of the active intact
hormones
are increased by Sitagliptin Hydrochloride Monohydrate,
thereby increasing and
prolonging the action of these 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.
These hormones are rapidly
inactivated by the enzyme,
DPP-4.
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.
GLP-1 also lowers glucagon
secretion from pancreatic
alpha
cells,
leading to reduced hepatic
glucose
production.
By
increasing
and
prolonging
active
incretin
levels,
Sitagliptin
hydrochloride
monohydrate
increases insulin release and decreases glucagon levels in the
circulation in a glucose-dependent
manner.
Sitagliptin demonstrates selectively for DPP-4 and does not
inhibit
DPP-8 or DPP-9
activity in vitro at concentrations approximating those from
therapeutic doses.
PHARMACOKINETIC :
This study was conducted using open label,
randomized,
two-periods,
two-treatment,
crossover
study in fasting conditions with 7 (seven) days washed-out period
betwe