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 glucosedependent
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.
INDICATION & USAGE
Siglitaâ„¢ is indicated as an adjunct to diet and exercise to improve glycemic control in
patients with type 2 diabetes mellitus. It is also indicated for use in combination with
Metformin, Sulfonylurea or Thiazolidinediones when diet and exercise plus the single
agent does not provide adequate glycemic control.
DOSAGE AND ADMINISTRATION
The recommended dose of Siglitaâ„¢ is 100 mg once daily. Siglitaâ„¢ can be
taken with or without food.
For patients with mild renal insufficiency (creatinine clearance [CrCl] 50
mL/min) no dosage adjustment for Siglitaâ„¢ is required.
For patients with moderate renal insufficiency (CrCl 30 to <50 mL/min),
the dose of Siglitaâ„¢ is 50 mg once daily.
For patients with severe renal insufficiency (CrCl <30 mL/min) or with endstage
renal disease (ESRD) requiring hemodialysis or peritoneal dialysis,
the dose of Siglitaâ„¢ is 25 mg once daily. Siglitaâ„¢ may be administered
without regard to the timing of hemodialysis.
ADVERSE REACTIONS
The most common adverse reactions are; upper respiratory tract infection,
nasopharyngitis and headache. Hypoglycemia may occur in patients treated with the
combination of Sitagliptin and sulfonylurea and add-on to insulin.
PRECAUTION
Dosage adjustment is recommended in patients with moderate or severe renal
insufficiency and in patients with ESRD
PEDIATRIC USE
Safety and effectiveness of Sitagliptin in pediatric patients under 18 years of age have
not been established.
CONTRAINDICATION
History of a serious hypersensitivity reaction to Sitagliptin, such as anaphylaxis or
angioedema.
DRUG INTERACTIONS
Co-administration of Digoxin and Sitagliptin may slightly increase the mean peak
drug concentration of Digoxin. But no dosage adjustment of Digoxin or Sitagliptin is
recommended.
STORAGE
Store in cool and dry place. Protect from light and moisture.
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Siglita 50mg 10pcs
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