- Indications and Usage Indicated as an adjuct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It may be used as monotherapy or in combination with metformin.
- Dosage and Administration The recommended dosage for adults is 100 mg once daily or 50 mg twice daily. This medication can be taken with or without food. According to the official package of 江苏恒瑞医药股份有限公司，for patients with mild renal impairment (creatinine clearance 60-89 mL/min), no dosage adjustment is required; for moderate renal impairment (30-59 mL/min), the dose should be adjusted to 50 mg once daily; and for severe renal impairment (≤29 mL/min), use is not recommended unless renal function is closely monitored.
- Mechanism of Action Retagliptin is a highly selective and reversible inhibitor of dipeptidyl peptidase-4 (DPP-4). By inhibiting DPP-4, it increases the plasma concentrations of active incretin hormones (glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide). This activation enhances the glucose-dependent synthesis and secretion of insulin and suppresses inappropriate glucagon secretion, thereby lowering blood glucose levels.
- Safety and Warnings Pancreatitis: Acute pancreatitis has been reported in post-marketing experience with DPP-4 inhibitors. Treatment should be discontinued if pancreatitis is suspected. Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis, angioedema, and exfoliative skin conditions, have been reported. Hepatic Adverse Reactions: Abnormal liver function tests and hepatic failure have been reported; liver enzymes should be monitored in patients who develop clinical signs of liver injury. 1型糖尿病 or Ketoacidosis: This drug is not indicated for type 1 diabetes mellitus or diabetic ketoacidosis.
- Adverse Reactions and Clinical Research In clinical trials, the most common adverse reactions (occurring in ≥1%) included nasopharyngitis, headache, dizziness, and gastrointestinal disorders such as diarrhea. The overall safety profile is consistent with other agents in the DPP-4 inhibitor class.
- Drug Interactions Hypoglycemic Agents: When used with insulin or insulin secretagogues (e.g., sulfonylureas), there is an increased risk of hypoglycemia, and the dose of the concomitant agent may need reduction. Metformin: Co-administration with metformin does not significantly affect the pharmacokinetics of retagliptin and is well-tolerated. Metabolic Enzymes: Retagliptin and its metabolites are not significantly metabolized by major cytochrome P450 enzymes, making significant pharmacokinetic interactions with other CYP3A4 substrates unlikely.
- Pharmaceutical Information Active Ingredient: Retagliptin phosphate. Dosage Forms: Tablets available in strengths corresponding to 100 mg (of retagliptin). Storage: Store in a dry place; protection from light and moisture is advised.
Ruizetang Retagliptin Phosphate Tablets
Brand Name: 瑞泽唐 ®（Ruizetang®）
Generic Name: Retagliptin Phosphate
Strength: 100 mg per tablet, 7 tablets per blister, 1 blister per box
Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Marketing Authorization Holder: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Approval Date in China: 2023-01-18
Registration Number: 国药准字H20230018
Storage: Keep tightly sealed, store at a temperature below 30°C, protected from light and moisture. Refer to the full package insert for detailed storage requirements.
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