repaglinide tablets

Repaglinide is a short-acting insulin secretagogue. Repaglinide lowers blood sugar levels by promoting the release of insulin from the pancreas. This effect depends on the functional beta cells in the pancreatic islets. Repaglinide binds to receptors on beta cells to close ATP-dependent potassium channels in the beta cell membrane, depolarize the beta cells, open calcium channels, and increase the influx of calcium. This process induces beta cells to secrete insulin. When patients with type 2 diabetes take repaglinide orally, they experience an insulin secretion response within 30 minutes after a meal. This can cause a decrease in blood sugar during meals. Plasma repaglinide levels drop rapidly, and 4 hours after taking the drug, the drug concentration in the plasma of patients with type 2 diabetes is very low. Studies have shown that taking 0.5-4 mg of repaglinide for type 2 diabetes reduces blood sugar concentration in a dose-dependent manner. Clinical research results show that repaglinide should be taken before meals. This product should usually be taken within 15 minutes before a meal, and the medication time can also be controlled 0-30 minutes before a meal. Clinical safety data Based on traditional pharmacology tests, repeated dose toxicity tests, genetic toxicity tests and carcinogenicity potential tests, preclinical data did not show any special hazards to humans.

The main ingredient of this product is repaglinide. Chemical name: S(+)-2-ethoxy-4[2-[[3-methyl-1-[2-(1-piperidinyl)phenyl]-butyl]amino-2-oxyethyl]benzoic acid.

This product is white or off-white tablets.

It is used for patients with type 2 diabetes (non-insulin-dependent) whose hyperglycemia cannot be effectively controlled by diet control, weight loss and exercise. When metformin alone cannot effectively control their hyperglycemia, repaglinide can be used in combination with metformin. Treatment should start with adjuvant therapy to lower blood sugar during meals by diet control and exercise.

Repaglinide should be taken before the main meal (i.e. before meals). The insulin secretion-promoting response of repaglinide occurs within 30 minutes after oral administration. This drug is usually taken within 15 minutes before meals, and the time of taking the drug can also be controlled within 0 to 30 minutes before meals. Please take repaglinide as prescribed by your doctor. The dosage varies from person to person and depends on personal blood sugar. The recommended starting dose is 0.5 mg, and it can be adjusted weekly or every two weeks if necessary. Patients receiving other oral hypoglycemic drugs can be directly switched to repaglinide treatment. The recommended starting dose is 1 mg. The maximum recommended single dose for maintenance is 4 mg, taken with meals. However, the maximum daily dose should not exceed 16 mg. Patients switch from other oral hypoglycemic drugs (OHAs) to this product. Patients can directly switch from other oral hypoglycemic drugs to this product. However, this product is different from other oral hypoglycemic drugs.

The most common adverse reactions of repaglinide are changes in blood sugar levels, such as hypoglycemia. As with all diabetes treatments, the occurrence of these reactions depends on individual factors, such as eating habits, dosage, exercise and stress. The clinical application of repaglinide and other hypoglycemic drugs shows that the following adverse reactions may occur when taking repaglinide: according to the incidence of adverse reactions, they are defined as follows: common adverse reactions (≥1/100 to <1/10); uncommon adverse reactions (≥1/1000 to <1/100); rare adverse reactions: incidence >1/10,000, <1/1,000; very rare adverse reactions: incidence <1/10,000, unknown adverse reactions (no relevant data are shown).

1. Patients with known hypersensitivity to repaglinide or any excipients in this product. 2. Patients with type 1 diabetes (insulin-dependent, IDDM). 3. Patients with diabetic ketoacidosis with or without coma. 4. Pregnant or lactating women. 5. Children under 8 years old. 6. Patients with severe renal or hepatic insufficiency. 7. When combined with CYP3A4 inhibitors or inducers.

Precautions for children: There is a lack of data on safety and/or efficacy in children, and repaglinide is not recommended for use in children under 18 years of age. Precautions for pregnancy and lactation: No studies have been conducted in pregnant or lactating women. Therefore, the safety of repaglinide for pregnant women cannot be evaluated. Repaglinide has not been found to be teratogenic in animal studies. High-dose exposure studies were conducted on rats in late pregnancy and lactation, and non-teratogenic abnormal limb growth was observed in fetuses and pups. Repaglinide was found in the milk of experimental animals. It is recommended that pregnant and lactating women not use it. Precautions for the elderly: Repaglinide tablets have not been studied in patients over 75 years old. Therefore, patients over 75 years old should not use it.

Some drugs are known to affect glucose metabolism. Therefore, doctors should consider possible drug interactions. In vitro studies have shown that the metabolism of repaglinide is affected by CYP2C8 and CYP3A4. Clinical study data conducted in healthy volunteers showed that CYP2C8 is the enzyme that plays a major role in the metabolism of repaglinide, and the effect of strong CYP3A4 inhibitors is limited. However, if the action of CYP2C8 is inhibited, the effect of CYP3A4 will be relatively enhanced. Therefore, the metabolism and clearance of repaglinide may be changed due to the inhibition or induction of cytochrome P450. Therefore, extreme caution should be exercised when using CYP2C8 and CYP3A4 inhibitors simultaneously with repaglinide. A drug interaction study conducted in healthy volunteers showed that

Protect from light and store in a sealed container at room temperature.

0.5mg

60 months.

Beijing Foyou Pharma Co., Ltd.

• Founded in:

  1999-02-03

• Address:

  No. 8 Guangyuan East Street, Tongzhou Industrial Development Zone, Tongzhou District, Beijing

• Tax NO.:

  91110112700216160K

• Registered Funds:

  480 million yuan

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