Galvus

Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance, or in combination w/ other medicinal products for the treatment of diabetes (including insulin) when these do not provide adequate glycaemic control.

Adult Monotherapy, in combination w/ metformin, in combination w/ thiazolidinedione, in combination w/ metformin & sulphonylurea, or in combination w/ insulin (w/ or w/o metformin) 100 mg daily (50 mg in the morning & 50 mg in the evening). Dual combination w/ sulphonylurea 50 mg once daily in the morning. Patient 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. Do not use in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Perform LFTs prior to treatment initiation. Monitor liver function during treatment at 3-mth intervals during the 1st yr & periodically thereafter. Discontinue treatment if AST or ALT ≥3x ULN persists or if jaundice or other signs suggestive of liver dysfunction develop. Limited experience in patients w/ diabetic skin complications. Post-marketing reports of bullous & exfoliative skin lesions. Monitor for skin disorders eg, blistering or ulceration. Risk of developing acute pancreatitis. Discontinue treatment if pancreatitis is suspected. Do not restart treatment if acute pancreatitis is confirmed. Caution in patients w/ history of acute pancreatitis. Consider lower dose of sulphonylurea to reduce risk of hypoglycaemia when used in combination w/ sulphonylurea. Doses >100 mg are not recommended. Safety & efficacy as triple oral therapy in combination w/ metformin & thiazolidinedione have not been established. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Limited clinical experience in patients w/ NYHA functional class III. Not recommended in patients w/ NYHA functional class IV. Caution in patients w/ ESRD on haemodialysis. Do not use in patients w/ hepatic impairment, including those w/ pre-treatment ALT or AST >3x ULN. Do not use during pregnancy & breast-feeding. Not recommended for use in childn & adolescents <18 yr.

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

Increased risk of angioedema w/ ACE inhibitors. Reduced hypoglycaemic effect w/ certain active substances, including 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.

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