Gliptus 50

Type 2 DM in adults as monotherapy in patients inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination w/ metformin in patients w/ insufficient glycemic control despite max tolerated dose of metformin monotherapy, w/ sulphonylurea in patients w/ insufficient glycemic control despite max tolerated dose of sulphonylurea & for whom metformin is inappropriate due to contraindications of intolerance, or w/ thiazolidinedione in patients w/ insufficient glycemic control & for whom use of thiazolidinedione is appropriate; as triple oral therapy in combination w/ sulphonylurea & metformin when diet & exercise + dual therapy w/ these medicinal products do not provide adequate glycemic control. In combination w/ insulin (w/ or w/o metformin) when diet & exercise + stable dose of insulin do not provide adequate glycemic control.

Adult Monotherapy, in combination w/ metformin, w/ thiazolidinedione, w/ metformin & sulphonylurea, or w/ insulin (w/ or w/o metformin) 100 mg administered as 1 dose of 50 mg in the morning & 1 dose of 50 mg in the evening. Dual combination w/ sulphonylurea 50 mg once daily in the morning. Patients w/ moderate or severe renal impairment or w/ ESRD 50 mg once daily.

May be taken with or without food.

Hypersensitivity.

W/draw therapy should AST or ALT ≥3 x ULN persist. Discontinue use in patients who develop jaundice or other signs suggestive of liver dysfunction; suspected pancreatitis. Not a substitute for insulin in insulin-requiring patients. Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Not recommended in patients w/ cardiac failure. Safety & efficacy as triple oral therapy w/ metformin & thiazolidinedione have not been established. Patients w/ history of acute pancreatitis. Perform LFTs prior to initiation of treatment. Monitor liver function at 3-mth intervals during 1st year of treatment & periodically thereafter; 2nd liver function evaluation in patients who develop increased transaminase levels & follow thereafter w/ frequent LFTs until abnormalities return to normal; for skin disorders eg, blistering or ulceration. Consider lower dose of concomitant sulphonylurea to reduce risk of hypoglycemia. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients experiencing dizziness should avoid driving vehicles or using machines. Patients w/ ESRD on haemodialysis. Not to be used in patients w/ hepatic impairment, including patients w/ pre-treatment ALT or AST >3 x ULN. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents <18 yr.

Hypoglycemia; tremor, headache, dizziness, nausea, asthenia, increased wt, peripheral edema, hyperhidrosis, decreased blood glucose, chills, GI reflux disease.

Clinically relevant pharmacokinetic interactions w/ pioglitazone, metformin & glyburide. Risk of angioedema may be increased w/ ACE inhibitors. Hypoglycemic effect may be reduced by thiazides, corticosteroids, thyroid products & sympathomimetics.

Antidiabetic Agents

A10BH02 - vildagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

Rx