Vildaxil

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM 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, sulphonylurea, or thiazolidinedione, when diet, exercise & single antidiabetic agent do not result in adequate glycaemic control; as triple oral therapy in combination w/ sulphonylurea & metformin when diet & exercise plus dual therapy w/ these medicinal products do not provide adequate glycemic control. In combination w/ insulin (w/ or w/o metformin) when diet & exercise plus stable dose of insulin do not provide adequate glycemic control.

Individualized dosage. Adult 50 mg once daily or bid. Max daily dose: 100 mg. Monotherapy, in combination w/ metformin, thiazolidinedione, metformin & sulphonylurea, or insulin (w/ or w/o metformin) 100 mg daily, 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 administered 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.

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. Perform LFTs prior to initiation of treatment in order to know patient's baseline value. Monitor liver function during treatment at 3-mth intervals during the 1st yr & periodically thereafter. Monitor patients who develop increased transaminase levels w/ 2nd liver function evaluation to confirm finding & be followed thereafter w/ frequent LFTs until abnormalities return to normal. W/draw therapy if increase in AST or ALT of 3x ULN or greater persist. Discontinue in patients who develop jaundice or other signs suggestive of liver dysfunction; if pancreatitis is suspected. Not recommended in patients w/ NYHA class IV. Skin lesions, including blistering & ulceration; monitor skin disorders in diabetic patient. Do not restart treatment if acute pancreatitis is confirmed. Patients w/ history of acute pancreatitis. Risk of hypoglycaemia in combination w/ sulphonylurea. Patients w/ ESRD on haemodialysis. Not to be used in patients w/ hepatic impairment, including patients w/ pre-treatment ALT or AST >3x ULN. Not to be used during pregnancy & lactation. Not recommended for childn & adolescents (<18 yr).

Nasopharyngitis. URTI; dizziness, headache, tremor; blurred vision; constipation, nausea, GERD, diarrhoea, abdominal pain (including upper), vomiting; hyperhidrosis, rash, pruritus, dermatitis; arthralgia, myalgia; asthenia, peripheral oedema.

Increased risk of angioedema w/ ACE-inhibitors. Hypoglycaemic 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