Bilessglu Chiglitazar Sodium Tablets

1. Indications and Usage
Monotherapy: Used in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination Therapy: In combination with metformin for adults with type 2 diabetes mellitus who are not well-controlled with metformin alone.
2. Dosage and Administration
Route of Administration: Oral administration ONLY.
Recommended Dosage:
Monotherapy: 32 mg (2 tablets) once daily. For patients requiring intensified glycemic control and tolerating 32 mg, the dose may be increased to 48 mg (3 tablets) once daily.
Combination with Metformin: 48 mg (3 tablets) once daily.
Administration Timing: Administration is not dependent on meals.
Critical Administration Instructions:
Hepatic/Renal Impairment: Moderate hepatic or renal impairment requires caution; use is not recommended in severe impairment.
Missed Dose: Avoid taking a double dose to make up for a missed one.
3. Mechanism of Action
PPAR Activation: Chiglitazar sodium is a peroxisome proliferator-activated receptor (PPAR) alpha, delta, and gamma pan-agonist.
Metabolic Regulation: It modulates the expression of genes involved in glucose homeostasis, lipid metabolism, and insulin sensitivity, thereby reducing insulin resistance and improving glycemic control.
4. Safety and Warnings
Edema and Heart Failure: Edema may occur. It should be used with caution in patients with existing heart failure or a history of heart failure.
Weight Gain: Weight increase may occur during treatment; dietary control is recommended.
Hypoglycemia: Although monotherapy rarely causes hypoglycemia, the risk increases when combined with insulin or insulin secretagogues.
Anemia and Fractures: Increases in hemoglobin occur due to plasma volume expansion, and there is an increased risk of fractures, particularly in female patients.
Contraindications: Contraindicated in type 1 diabetes mellitus and diabetic ketoacidosis.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Edema, weight increase, upper respiratory tract infection, and anemia.
Clinical Research Highlights: Phase III clinical trials demonstrated significant reductions in HbA1c with a generally manageable safety profile in both monotherapy and combination therapy settings.
6. Drug Interactions
CYP3A Inhibitors/Inducers: Co-administration with strong CYP3A inhibitors (e.g., itraconazole) or inducers (e.g., rifampin) may alter plasma concentrations and requires clinical monitoring.
Other Antidiabetic Agents: When used with insulin or sulfonylureas, the dose of the concomitant agent may need reduction to prevent hypoglycemia.
Thiazolidinediones: Concomitant use with other PPAR agonists (e.g., rosiglitazone, pioglitazone) may increase the risk of heart failure and is not recommended.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Chiglitazar Sodium.
Appearance: Yellow film-coated tablets.
Packaging: Blister packs (e.g., 12 tablets/strip).
Storage: Store at controlled room temperature (not exceeding 30°C). Protect from light and moisture.