GLY-50 TABLETS (Each tablet contains Vildaglipton 50mg

Indications

• Type 2 diabetes mellitus
• Inadequate glycemic control with diet and exercise alone
• Combination therapy with other antidiabetic agents

Dosage

Adults: Refer to prescribing information for specific adult dosing guidelines based on individual patient needs and combination

Mechanism of action

Vildagliptin works by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4). This inhibition leads to increased levels of incretin hormones, such as GLP-1 (glucagon-like peptide-1) and GIP (gastric inhibitory polypeptide). These hormones enhance insulin secretion in response to meals and suppress glucagon secretion, which in turn helps reduce hepatic glucose production. The overall effect is a decrease in blood glucose levels, particularly after meals.

Pharmacodynamics

The pharmacodynamic effects of vildagliptin include increased insulin secretion and decreased glucagon levels in the circulation, which leads to improved postprandial (after meal) glucose control. It also has a low risk of causing hypoglycemia when used alone, as its mechanism of action is glucose-dependent. Additionally, vildagliptin may have beneficial effects on beta-cell function and may help preserve pancreatic function over time in patients with type 2 diabetes.

Pharmacokinetics

Vildagliptin is well absorbed after oral administration, with a bioavailability of approximately 85%. It reaches peak plasma concentrations within 1-2 hours. The drug is primarily excreted via the kidneys, with about 80% of an administered dose eliminated in the urine, primarily as unchanged drug. The half-life of vildagliptin is approximately 2 hours, and it is not significantly metabolized by the liver. Renal impairment can affect its clearance, necessitating dose adjustment in patients with moderate to severe renal impairment.

Contra-indications

• Hypersensitivity to vildagliptin or any of its excipients
• Severe renal impairment (eGFR < 30 mL/min)
• Type 1 diabetes mellitus
• Diabetic ketoacidosis

Adverse effects

• Headache
• Nausea
• Diarrhea
• Hypoglycemia (especially in combination with other antidiabetic agents)
• Pancreatitis
• Skin reactions (e.g., rash)

Interactions

• Concurrent use with insulin or sulfonylureas may increase the risk of hypoglycemia
• Caution advised when used with other medications that affect renal function
• May interact with CYP3A4 inhibitors or inducers

Precautions

• Monitor renal function prior to and during treatment
• Use caution in patients with a history of pancreatitis
• Assess for signs of hypersensitivity reactions
• Consider potential for hypoglycemia when used with other antidiabetic medications

Pregnancy

There is limited data on the use of vildagliptin in pregnant women. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether vildagliptin is excreted in human milk. Caution should be exercised when administering to nursing women.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

• Tablets: 50 mg