repaglinide tablets

This product is a non-sulfonylurea insulin secretagogue. It specifically binds to the 36KDA protein on the ATP-dependent potassium ion channel outside the pancreatic beta cell membrane, closing the potassium channel, depolarizing the beta cell, opening the calcium channel, and causing calcium ions to flow in, thus promoting insulin secretion. It works faster than sulfonylureas, so it has a faster effect in lowering blood sugar after a meal.

Repaglinide. Its chemical name is: S () -2-ethoxy-4-{2-[(3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino]-2-oxoethyl}benzoic acid.

This product is white or off-white tablets.

It is used for patients with type 2 diabetes (non-insulin-dependent) whose high blood sugar cannot be effectively controlled by diet control and exercise. Repaglinide tablets can be used together with metformin. Compared with the use of each alone, the combination of the two has a synergistic effect on controlling blood sugar.

1. Repaglinide tablets should be taken before the main meal (i.e. before meals). The insulin secretion response occurs within 30 minutes of oral administration of repaglinide tablets. This drug is usually taken within 15 minutes before meals. The time of taking the drug can also be controlled within 0 to 30 minutes before meals. 2. Please take repaglinide tablets 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 (1 tablet), which can be adjusted weekly or every two weeks if necessary. Patients receiving other oral hypoglycemic drugs can be directly switched to repaglinide tablets for treatment. The recommended starting dose is 0.5 mg (1 tablet). 3. The maximum recommended single dose is 4 mg (8 tablets), taken with meals. However, the maximum daily dose should not exceed 16 mg (32 tablets). For patients with weakness and malnutrition, the dose should be adjusted with caution. If used in combination with metformin, the dose of repaglinide tablets should be reduced. Although repaglinide is mainly excreted by bile, patients with renal insufficiency should still use it with caution.

1. Hypoglycemia These reactions are usually mild and can be easily corrected by giving carbohydrates. If they are more severe, glucose can be infused. 2. Visual abnormalities Changes in blood sugar levels are known to cause temporary visual abnormalities, especially at the beginning of treatment. Only very few cases have reported the above-mentioned visual abnormalities at the beginning of treatment with repaglinide tablets, but there have been no cases of discontinuation of repaglinide tablets in clinical trials. 3. Gastrointestinal tract Gastrointestinal reactions such as abdominal pain, diarrhea, nausea, vomiting and constipation have been reported in clinical trials. Compared with other oral hypoglycemic drugs, the frequency and severity of these symptoms are no different. 4. Liver enzyme system Individual cases reported elevated liver enzyme indicators during treatment with repaglinide tablets. Most cases were mild and temporary, and very few patients stopped treatment due to elevated enzyme indicators. 5. Allergic reactions Skin allergic reactions such as itching, redness, and urticaria may occur. Due to the different chemical structures, there is no reason to suspect that cross-allergic reactions with sulfonylurea drugs may occur.

1. Patients with known hypersensitivity to repaglinide or any excipients in this product. 2. Patients with type 2 diabetes (insulin-dependent, IDDM). 3. Patients with diabetic ketoacidosis with or without coma. 4. Pregnant or lactating women. Children under 58 years old. 6. Patients with severe renal or hepatic insufficiency. 7. When combined with CYP3A4 inhibitors or inducers.

Precautions for children: Repaglinide has not been studied in patients under 18 years of age. Precautions for pregnancy and lactation: It has not been studied in pregnant or lactating women. Therefore, the safety of using repaglinide in pregnant women cannot be evaluated. Repaglinide has not been found to be teratogenic in animal studies. In high-dose exposure studies on rats in late pregnancy and lactation, non-teratogenic abnormal limb growth of fetuses and pups was observed. 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 has not been studied in patients over 75 years old.

1 The following drugs can enhance the hypoglycemic effect of repaglinide tablets: monoamine oxidase inhibitors (MAOI), non-selective beta-receptor blockers, ACE inhibitors, nonsteroidal anti-inflammatory drugs, salicylates, octreotide, alcohol, and anabolic hormones. Beta-receptor blockers may mask the symptoms of hypoglycemia. Alcohol may aggravate or prolong the symptoms of hypoglycemia caused by repaglinide tablets. 2 The following drugs can weaken the hypoglycemic effect of repaglinide tablets: oral contraceptives, thiazides, corticosteroids, danazol, thyroid hormones and sympathomimetics. 3 Repaglinide tablets do not affect the pharmacokinetic properties of digoxin, theophylline and warfarin, and cimetixidine does not affect the pharmacokinetic properties of repaglinide tablets. 4 In vitro study results show that repaglinide tablets are mainly metabolized by P450 (CYP3A4) inducers. Therefore, CYP3A4 inhibitors such as ketoconazole, itraconazole, erythromycin, fluconazole, and mibifadil may increase the plasma level of repaglinide tablets. Compounds that can induce CYP3A4, such as rifampicin or phenytoin, may reduce the plasma level of repaglinide tablets. Because the degree of induction or inhibition is unknown, the above drugs should not be used in combination with repaglinide tablets.

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

0.5 mg

60 months.

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

• Founded in:

  1995-07-26

• Address:

  Lianyungang Economic and Technological Development Zone, Jiangsu Province

• Tax NO.:

  913207006083959289

• Registered Funds:

  1,000,000,000 Yuan

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