Viglita 50 mg Tablet

Viglita 50 mg is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus as monotherapy and 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

Viglita 50 mg is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. 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, Viglita 50 mg increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

The recommended dose of Viglita 50 mg 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. Viglita 50 mg may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.

The recommended dose of Viglita 50 mg 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. Viglita 50 mg may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.Pediatric use: Viglita 50 mg is not recommended in patients 18 years of age.

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 Viglita 50 mg may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.

Viglita 50 mg is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients Patients with moderate to severe renalImpairment Patients with Hepatic Impairment: patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotrasferase (AST) >3 times the upper limit of normal (ULN). Patients with type 1 diabetes

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

Pregnancy: There are no adequate data on the use of Viglita 50 mg in pregnant women; hence the potential risk for human is unknown.Lactation: It is not known whether Viglita 50 mg is excreted in human milk. Due to lack of human data, Viglita 50 mg 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 LFTs are monitored prior to initiation of Viglita 50 mg, 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 returns to normal. If AST or ALT persists at 3xULN, Viglita 50 mg treatment should be stopped. Patients who develop jaundice or other signs of liver dysfunction should discontinue Viglita 50 mg. Following the withdrawal of treatment with Viglita 50 mg and LFT normalization, treatment with Viglita 50 mg 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 I-II, and do not use in patients with NYHA functional class III IV.

Store below 30°C temperature & keep away from light & moisture. Keep out of reach of children.

Paediatric use: Viglita 50 mg is not recommended in patients 18 years of age

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Viglita 50 mg is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by the enzyme, DPP-4. 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, Viglita 50 mg increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

Viglita 50 mg should not be used in pregnancy. Viglita 50 mg should not be used during lactation.