Radiglip 50 mg Tablet

देश: बांग्लादेश

भाषा: अंग्रेज़ी

स्रोत: DGDA (Directorate General of Drug Administration)

सक्रिय संघटक:

Sitagliptin

थमां उपलब्ध:

Radiant Pharmaceuticals Ltd.

INN (इंटरनेशनल नाम):

Sitagliptin

डोज़:

50 mg

फार्मास्यूटिकल फॉर्म:

Tablet

सूचना पत्रक

RADIGLIP
TM
Sitagliptin USP
PMR5398
Version: 01
TM = Trade Mark
Manufactured by
RADIANT PHARMACEUTICALS LIMITED
B-34 & 46, BSCIC Industrial Estate
Tongi, Gazipur, Bangladesh
COMPOSITION:
Radiglip
TM
50
mg
Tablet:
Each
film
coated
tablet
contains Sitagliptin 50 mg as Sitagliptin Phosphate USP.
PHARMACOLOGY:
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor,
which is believed to exert its actions in patients with
type 2 diabetes by slowing the inactivation of 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. 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 increases insulin release and decreases
glucagon levels in the circulation in a glucose-dependent
manner.
INDICATIONS:
Radiglip
TM
is indicated as an adjunct to diet and
exercise
to
improve
glycemic
control
in
adults
with type 2 diabetes mellitus. Radiglip
TM
is indicated as
monotherapy and also indicated for use in combination
with
Metformin,
Sulfonylurea
or
Thiazolidinediones
when diet, exercise and the single agent does not
provide adequate glycemic control.
DOSAGE & ADMINISTRATION:
•
The recommended dose of Radiglip
TM
is 100 mg
once daily. Radiglip
TM can be taken with or without
food.
•
For patients with mild renal insufficiency (creatinine
clearance
[CrCl]
≥
50
mL/min)
no
dosage
adjustment for Radiglip
TM
is required.
•
For patients with moderate renal insufficiency
(creati