- Indications and Usage Cofrogliptin Tablets are indicated to improve glycemic control in adults with type 2 diabetes mellitus. They may be used as monotherapy or in combination with metformin or other antidiabetic agents.
- Dosage and Administration Standard Dosage: The recommended dosage is 10 mg administered orally once every two weeks (14 days). Administration: The tablets should be taken orally without restriction regarding food. Timing: After the first dose, patients should establish a fixed dosing schedule (e.g., the same day of every other week) to ensure adherence. Renal/Hepatic Impairment: No dosage adjustment is typically required for patients with renal or hepatic impairment.
- Mechanism of Action Cofrogliptin is a selective inhibitor of dipeptidyl peptidase-4 (DPP-4). By inhibiting this enzyme, it prevents the degradation of incretin hormones (GLP-1 and GIP). This leads to an increase in the concentration of active incretins, resulting in a glucose-dependent increase in insulin release and a decrease in glucagon secretion.
- Safety and Warnings Contraindications: This medication is contraindicated in patients with a history of serious hypersensitivity (e.g., anaphylaxis, angioedema) to cofrogliptin or any excipients. Pancreatitis: Acute pancreatitis has been reported with DPP-4 inhibitors. Patients should be monitored for symptoms of severe abdominal pain. Type 1 Diabetes: Cofrogliptin is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis.
- Adverse Reactions and Clinical Research Adverse Reactions: The most common adverse reactions include nasopharyngitis, upper respiratory tract infection, and headache. Clinical Research: In pivotal Phase III clinical trials, cofrogliptin demonstrated significant efficacy in reducing fasting plasma glucose and hemoglobin A1c (HbA1c) compared to placebo, with no significant increase in hypoglycemia when used as monotherapy.
- Drug Interactions CYP Enzymes: Cofrogliptin has no inducing effect on CYP1A2, CYP2B6, or CYP3A4. Other Drugs: There are no clinically significant drug-drug interactions observed with common co-administered medications, including metformin.
- Pharmaceutical Information Composition: Active ingredient is cofrogliptin. Excipients may include microcrystalline cellulose, lactose, and magnesium stearate. Appearance: White to off-white film-coated tablets. Storage: Store in a dry place. After removing from the blister pack, the tablet should be used within 10 days and protected from light.
Beichangping Cofrogliptin Tablets
Brand Name: 倍长平 ®（Beichangping®）
Generic Name: Cofrogliptin
Strength: 5 mg per tablet, 4 tablets per box
Manufacturer: Sichuan Haisco Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Haisco Pharmaceutical Group Co., Ltd.
Approval Date in China: June 18, 2024
Registration Number: 国药准字H20240024
Storage: Store tightly sealed, protected from light at room temperature. Refer to the full package insert for detailed storage specifications.
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