BioMED Pharmaceutical Industries

Sitagliform 50/500 mg ® Tablets

Description

Each Tablet contain :

  • 50 mg Sitagliptin/500 mg metformin HCl.

  • Sitagliform is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
    mellitus

Take Sitagliform orally twice daily with meals.

  • Sitagliform is contraindicated in patients with:
    • Severe renal impairment.
    • Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
    • History of a serious hypersensitivity reaction to Sitagliptin/metformin HCI, sitagliptin, or metformin, such as
    anaphylaxis or angioedema.

A box containing 30 film coated tablets.

In patients with type 2 diabetes mellitus, administration of sitagliptin led to inhibition of DPP-4 enzyme activity for
a 24-hour period. After an oral glucose load or a meal, this DPP-4 inhibition resulted in a 2- to 3-fold increase in
circulating levels of active GLP-1 and GIP, decreased glucagon concentrations, and increased responsiveness
of insulin release to glucose, resulting in higher C-peptide and insulin concentrations. The rise in insulin with the
decrease in glucagon was associated with lower fasting glucose concentrations and reduced glucose excursion
following an oral glucose load or a meal.

In studies with healthy subjects, sitagliptin did not lower blood glucose or cause hypoglycemia.
Sitagliptin and Metformin Coadministration
In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas
metformin alone increased active and total GLP-1 concentrations to similar extents. Coadministration of
sitagliptin and metformin had an additive effect on active GLP-1 concentrations. Sitagliptin, but not metformin,
increased active GIP concentrations. It is unclear what these findings mean for changes in glycemic control in
patients with type 2 diabetes mellitus.