Nateglinide capsules

Vitamin B complex participates in the body's metabolism process. It is a necessary coenzyme for many metabolic links in the body and an important coenzyme for tissue respiration. Vitamin B1 is an important component of coenzymes required for carbohydrate metabolism. Vitamin B2 is an important coenzyme component required for tissue respiration. Vitamin B6 is a cofactor for many enzymes and participates in the metabolism of amino acids and fats. Nicotinamide is a component of coenzymes I and II, which is necessary for lipid metabolism, oxidation of tissue respiration and glycogenolysis. Sodium pantothenate is a precursor of coenzyme A and participates in the metabolism of carbohydrates, fats and proteins.

The main ingredient of this product is nateglinide, chemical name: N-(trans-4-isopropylcyclohexyl-1-formyl)-D-phenylalanine.

This product is a hard capsule, and the contents are white or off-white granules or powder.

This product can be used alone for patients with type 2 diabetes who cannot effectively control hyperglycemia through diet and exercise. It can also be used in combination with metformin for patients with type 2 diabetes who cannot effectively control hyperglycemia, but it cannot replace metformin. Nateglinide is not suitable for patients with type 2 diabetes who are not ideal for sulfonylurea hypoglycemic treatment.

Oral. Usually adults take 60-120 mg (2-4 tablets) three times a day, within 1-15 minutes before meals. It is recommended to start with a small dose and adjust the dose according to the results of regular HbAlc or blood glucose tests 1-2 hours after meals. Dosage for patients with liver damage No adjustment is required for patients with mild to moderate liver disease. The bioavailability and half-life of nateglinide in patients with type 2 diabetes with mild to moderate liver dysfunction are not clinically significant compared with healthy people. The use of the drug in patients with severe liver disease has not been studied, so patients with severe liver disease should use nateglinide with caution. Dosage for patients with renal impairment No dose adjustment is required for patients with renal impairment. In diabetic patients with moderate to severe renal impairment (creatinine clearance 15-50ml/min/l.73m2) and patients requiring dialysis, the bioavailability and half-life of nateglinide are not clinically significant compared with healthy people.

1. Hypoglycemia: This product can cause hypoglycemia, and the frequency of its occurrence is related to the severity of diabetes, the level of blood sugar control, and other relevant conditions of the patient. Elderly patients, malnourished patients, and patients with adrenal or pituitary insufficiency are more sensitive to hypoglycemic drugs and are prone to hypoglycemia. The risk of hypoglycemia increases with strenuous exercise, drinking, diarrhea and vomiting, reduced food intake, or combined use of other antidiabetic drugs. It is difficult to recognize hypoglycemia in patients with autonomic neuropathy or combined use of beta-receptor blockers. Nateglinide must be taken orally before meals to reduce the risk of hypoglycemia. Nateglinide should not be taken when the patient is not ready to eat. 2. Use with caution in patients with moderate to severe liver damage. 3. Abnormal blood sugar control: When the patient is accompanied by fever, infection, trauma or surgery, blood sugar may rise temporarily. At this time, insulin should be used instead of nateglinide. After a period of use, nateglinide may fail or its efficacy weakens. Use with caution in patients with severe infection, before and after surgery, or with severe trauma. 4. This product has the effect of rapidly promoting insulin secretion. The point of action is the same as that of sulfonylurea preparations. However, the clinical effect and safety of the additive and multiplicative effects of this product and sulfonylurea preparations have not been confirmed, so it cannot be used in combination with sulfonylurea preparations. 5. Combination with other oral antidiabetic drugs may increase the risk of hypoglycemia. 6. Patients should be reminded to take precautions to avoid hypoglycemia when driving or operating machinery.

1. Allergy to nateglinide or any excipients; 2. Type 1 diabetes (insulin-dependent diabetes mellitus); 3. Diabetic ketoacidosis.

Precautions for children: The safety and efficacy of nateglinide in children have not been evaluated. Therefore, nateglinide is not recommended for children. Precautions for pregnancy and lactation: Use with caution in pregnant women; large amounts of use by pregnant women may cause teratogenicity. Precautions for the elderly: No differences in drug safety and efficacy were observed between elderly patients and the general population. In addition, age does not affect the pharmacokinetic characteristics of nateglinide. Therefore, there is no need to adjust the dose for elderly patients.

1. In vitro studies have shown that nateglinide is mainly metabolized by cytochrome P450 enzyme CYP2C9 (70%) and partially metabolized by CYP3A4 (30%). In vitro experiments have found that it can inhibit the metabolism of tolbutamide, based on which it is judged that nateglinide is a potential inhibitor of CYP2C9 in vivo. In vitro experiments have shown that the drug has no inhibitory effect on the metabolic reaction of CYP3A4. In short, these findings indicate that the potential for clinically significant pharmacokinetic interactions between the drug and other drugs is low. 2. Nateglinide has no effect on the pharmacokinetic characteristics of the following drugs: warfarin (substrate of CYP3A4 and CYP2C9), diclofenac (substrate of CYP2C9), troglitazone (CYP3A4 inducer) and digoxin. Therefore, when used in combination, no dosage adjustment is required for nateglinide, digoxin, warfarin or diclofenac. Similarly, there are no clinically significant pharmacokinetic interactions between nateglinide and other oral antidiabetic drugs, such as metformin or glibenclamide. 3. Nateglinide has a high binding rate to serum proteins (98%), mainly to albumin. In vitro replacement experiments with drugs with high protein binding rates found that they had no effect on the protein binding of nateglinide. These drugs are furosemide, propranolol, captopril, nicardipine, pravastatin, glibenclamide, warfarin, phenytoin sodium, acetylsalicylic acid, tolbutamide and metformin. Similarly, nateglinide has no effect on the serum protein binding of propranolol, glibenclamide, nicardipine, warfarin, phenytoin sodium, acetylsalicylic acid and tolbutamide. 4. Physicians should consider the interaction between some drugs that affect glucose metabolism and nateglinide: The hypoglycemic effect of oral antidiabetic drugs can be enhanced by certain drugs, including nonsteroidal anti-inflammatory drugs, salicylates, monoamine oxidase inhibitors and non-selective beta-adrenergic blockers. 5. The hypoglycemic effect of oral antidiabetic drugs can be weakened by certain drugs, including thiazides, cortisone, thyroid preparations and sympathomimetics. Patients receiving nateglinide should closely observe changes in blood sugar when adding or stopping the above drugs.

Sealed, store in a dry place below 25℃.

30mg

24 months

Shi Huida Pharmaceutical Group (Jilin) Co., Ltd.

• Founded in:

  2000-01-13

• Address:

  No. 999, High-tech Industrial Park, Baishan City, Jilin Province

• Tax NO.:

  91220601702302177B

• Registered Funds:

  20 million yuan

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