Glyza 5 mg (Tablet)

Indications

• Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Pharmacology

• Inhibits dipeptidyl peptidase IV (DPP-IV) enzyme resulting in prolonged active incretin levels
• Elevates the circulating levels of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) to stimulate insulin secretion in pancreatic beta-cells
• Reduces fasting and postprandial plasma glucose concentration in patients with type 2 diabetes mellitus

Dosage

• Recommended dosage of 2.5 mg or 5 mg once daily regardless of meals
• No dosage adjustment for patients with mild renal impairment (CrCl > 50 mL/min)
• Dosage of 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (CrCl ≤ 50 mL/min)
• Dosage adjustment to 2.5 mg once daily when coadministered with strong CYP3A4/5 inhibitors
• Lower dose of insulin secretagogue or insulin may be required when used in combination with them

Administration

• May be taken with or without food

Interaction

• Increased risk of hypoglycemia with concomitant sulfonylureas; dose reduction may be necessary
• Increased serum levels with CYP3A4/5 inhibitors
• Concomitant CYP3A4 inducers may reduce the glycemic lowering effect

Contraindications

• Type 1 diabetes
• Diabetic ketoacidosis

Side Effects

• Pancreatitis
• Heart failure
• Hypoglycemia with concomitant use of sulfonylurea or insulin
• Hypersensitivity reactions
• Severe and disabling arthralgia
• Bullous pemphigoid

Pregnancy & Lactation

• Category B

Precautions & Warnings

• Moderate and severe renal impairment
• Pregnancy and lactation

Use in Special Populations

• No dosage adjustment needed for mild renal impairment
• Dosage of 2.5 mg once daily for moderate to severe renal impairment, including ESRD requiring hemodialysis
• No dosage adjustment needed for hepatic impairment

Therapeutic Class

• Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Storage Conditions

• Store between 20-25°C

Related Brands

• Sixtin 2.5 mg (Tablet) - drug-international-ltd
• Sixtin 5 mg (Tablet) - drug-international-ltd