TREVIA Tablet

TREVIA is indicated in patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control as:

- Monotherapy

- Dual Therapy: In combination with metformin HCl or with a sulphonylurea or with a PPARɤ agonist (i.e. thiazolidinediones) when the treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control.

- Triple Therapy: In combination with metformin HCl and a sulphonylurea or with metformin HCl and PPARɤ (i.e. thiazolidinediones) when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control.

- Combination with Insulin.

DOSAGE AND ADMINISTRATION

The recommended dose of TREVIA is 100mg once daily as monotherapy or as combination therapy with metformin HCl, a sulphonylurea, insulin (with or without metformin HCl), a PPARɤ agonist (i.e., thiazolidinediones), metformin HCl plus a sulphonylurea, or metformin HCl plus a PPARɤ agonist (i.e., thiazolidinediones).

When TREVIA is used in combination with a sulphonylurea or with insulin, a lower dose of sulphonylurea or insulin may be considered to reduce the risk of sulphonylurea r insulin-induced hypoglycemia.

Co administration of a high-fat meal with TREVIA had no effect on the pharmacokinetics, TREVIA may be administered with or without food.

If a dose of TREVIA is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

Special Populations

See the package insert about the details.

Renal Insufficiency

Elderly

- Patients with known hypersensitivity to sitagliptin or any of the components of the product.

- Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

- Children below 18 years of age.

Monotherapy

Upper respiratory-tract infections, headache and nasopharyngitis.

Sitagliptin with Metformin HCl

Common: Nausea

Uncommon: Somnolence, diarrhea, upper abdominal pain and blood glucose decreased.

Sitagliptin with Sulphonylurea

Common: Hypoglycemia.

Sitagliptin with Pioglitazone

Common: Hypoglycemia, flatulence and peripheral edema.

Sitagliptin with Sulphonylurea and Metformin HCl

Very common: Hypoglycemia.

Common: Constipation.

Sitagliptin with a Rosiglitazone and Metformin HCl

Common: Hypoglycemia, headache, diarrhea, vomiting and peripheral edema.

Sitagliptin with Insulin

Common: Influenza, hypoglycemia and headache.

Uncommon: Dry mouth and constipation.

Digoxin

Sitagliptin has a small effect on plasma digoxin concentrations. No dosage adjustment of digoxin is recommended. However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.

Pregnancy

The safety of sitagliptin in pregnant women is not known. Sitagliptin, like other oral antihyperglycemic agents, is not recommended for use in pregnancy.

Nursing Mother

It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, sitagliptin should not be administered during nursing.

- Pancreatitis

After initiation of sitagliptin, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, sitagliptin should promptly be discontinued and appropriate management should be initiated.

- Hypoglycemia

When sitagliptin is used in combination with a sulphonylurea or with insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia increases when used in combination with a sulphonylurea or with insulin. Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycemia.

Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones, including 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 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.