Onglyza Saxagliptin Tablets

1. Indications and Usage
Type 2 Diabetes: Saxagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination Therapy: It may be used alone or in combination with metformin, sulfonylureas, or insulin.
2. Dosage and Administration
Standard Dosage: The recommended dose is 5 mg once daily.
Renal Impairment: For patients with moderate or severe renal impairment, end-stage renal disease, or those on kidney dialysis, the dose must be reduced to 2.5 mg once daily.
Administration: Take once daily, with or without food.
3. Mechanism of Action
DPP-4 Inhibitor: Saxagliptin belongs to a class of antidiabetic agents known as dipeptidyl peptidase-4 (DPP-4) inhibitors.
Metabolic Effects: It inhibits the DPP-4 enzyme, which increases the levels of active incretin hormones (GLP-1 and GIP). This results in a glucose-dependent increase in insulin release and a decrease in glucagon secretion.
4. Safety and Warnings
Heart Failure: Dipeptidyl peptidase-4 (DPP-4) inhibitors have been associated with an increased risk of heart failure hospitalization. Patients should be monitored for signs and symptoms of heart failure.
Pancreatitis: Acute pancreatitis has been reported. If pancreatitis is suspected, saxagliptin must be discontinued immediately.
Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis, angioedema, and exfoliative skin conditions, have been reported.
Hypoglycemia: The risk increases when combined with insulin or sulfonylureas.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include upper respiratory tract infection, nasopharyngitis, headache, and hypoglycemia (when used with other antidiabetic agents).
Clinical Research: Clinical trials demonstrate that saxagliptin significantly reduces fasting plasma glucose, postprandial glucose, and HbA1c levels.
6. Drug Interactions
Strong CYP3A4/5 Inhibitors: Drugs like ketoconazole, clarithromycin, ritonavir, and itraconazole significantly increase saxagliptin plasma concentrations. The dose must be limited to 2.5 mg daily when used with these inhibitors.
Other Antidiabetics: May potentiate hypoglycemic effects when used in combination.
7. Pharmaceutical Information
Active Ingredient: Saxagliptin.
Excipients: Microcrystalline cellulose, lactose monohydrate, magnesium stearate, and other film-coating agents.
Appearance: Film-coated tablets (available in 2.5 mg and 5 mg strengths).
Storage: Store at controlled room temperature, protected from moisture.