Shanzeping Prusogliptin Tablets

1. Indications and Usage
Glycemic Control: Indicated to improve glycemic control in adults with type 2 diabetes mellitus.
Therapeutic Context: Can be used as monotherapy or in combination with metformin when diet and exercise alone are insufficient.
2. Dosage and Administration
Starting Dose: The recommended dose is 100 mg once daily, taken orally without regard to meals.
Titration: If the response is inadequate, the dose may be increased based on clinical assessment.
Missed Dose: If a dose is missed, it should be taken as soon as remembered. If it is close to the next dose, skip the missed dose.
3. Mechanism of Action
DPP-4 Inhibition: Prusogliptin is a selective inhibitor of dipeptidyl peptidase-4 (DPP-4).
Incretin Regulation: It inhibits the inactivation of incretin hormones (GLP-1 and GIP), increasing their plasma concentrations.
Glucose-Dependent Effects: Elevated incretin levels enhance glucose-dependent insulin secretion and suppress glucagon release, thereby lowering blood glucose levels.
4. Safety and Warnings
Hypersensitivity: Do not use in patients with known hypersensitivity to prusogliptin or any excipients.
Hypoglycemia: While low risk as monotherapy, caution is advised when used with insulin or sulfonylureas.
Use in Specific Populations: The safety and efficacy in patients under 18 years of age have not been established.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Hypoglycemia, hyperlipidemia, hyperuricemia, abdominal pain, nausea, and dizziness.
Hepatic Effects: Cases of liver function abnormalities, including elevations in ALT and AST, have been reported.
Other Adverse Effects: Skin rashes and other hypersensitivity reactions may occur rarely.
Clinical Findings: Clinical trials have demonstrated significant reductions in HbA1c with a favorable safety profile.
6. Drug Interactions
Hypoglycemic Agents: Concomitant use with insulin or sulfonylureas increases the risk of hypoglycemia.
GLP-1 Agonists: The safety and efficacy of combining with GLP-1 receptor agonists have not been fully established.
Insulin: The clinical efficacy and safety of combination with insulin have not been fully established.
7. Pharmaceutical Information
Active Ingredient: Prusogliptin.
Strengths: Typically available as 100 mg tablets.
Appearance: The tablets are film-coated.
Storage: Store in a tightly closed container at room temperature.