APTIN

VILDAGLIPTIN

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. As monotherapy In dual combination with Metformin, a Sulphonylurea, a Thiazolidinedione, or Insulin when diet, exercise and a single antidiabetic agent do not result in adequate glycemic control.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Verapamil inhibits entry of Ca ions into the slow channels or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarisation. It relaxes coronary vascular smooth muscle and coronary vasodilation, increases myocardial oxygen delivery, and slows automaticity and AV node conduction.

The recommended dose of Vildagliptin is- 50 mg or 100 mg daily for monotherapy. 50 mg twice daily (morning and evening) when used in dual combination with Metformin or a Thiazolidinedione; 50 mg once daily in the morning when used in dual combination with a Sulphonylurea. Vildagliptin may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.

In pharmacokinetic studies, no interactions were seen with pioglitazone, metformin, glibenclamide, digoxin, warfarin, amlodipine, ramipril, valsartan or simvastatin. As with other oral antidiabetic medicinal products the glucose-lowering effect of Vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.

Vildagliptin is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis

The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. Rare case of hepatic dysfunction is seen. Clinical trials of up to and more than 2 years8 duration did not show any additional safety signals or unforeseen risks when use this drug.

Pregnancy: There are no adequate data on the use of Vildagliptin in pregnant women; hence the potential risk for human is unknown. Lactation: It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Vildagliptin should not be used during lactation.

Caution should be exercised in patients aged 75 years and older due to limited clinical experience. It is recommended that Liver Function Tests (LFTs) are monitored prior to initiation of Vildagliptin, at three monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality (ies) return(s) to normal. If AST or ALT persist at 3 x ULN, Vildagliptin treatment should be stopped. Patients who develop jaundice or other signs of liver dysfunction should discontinue Vildagliptin. Following withdrawal of treatment with Vildagliptin and LFT normalization, treatment with Vildagliptin should not be reinitiated. Due to limited clinical experience, use with caution in patients with congestive heart failure of New York Heart Association (NYHA) functional class I8II, and do not use in patients with NYHA functional class III-IV. Vildagliptin is not recommended in patients with moderate to severe renal impairment.

Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of the children.