nateglinide tablets

Nateglinide is an amino acid derivative and an oral antidiabetic drug. It is used to treat patients with type 2 diabetes. The effect of nateglinide depends on the function of pancreatic β cells. Nateglinide binds to the ATP-sensitive K channel receptors on the β cell membrane and closes them, causing cell depolarization, calcium channel opening, and calcium influx, thereby stimulating insulin secretion and lowering blood sugar levels. The insulin secretion-promoting effect of nateglinide depends on the blood glucose level. When the glucose level is low, the insulin secretion-promoting effect is weakened. Nateglinide has a high degree of tissue selectivity and has a low affinity for myocardial and skeletal muscles.

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

This product is white or off-white tablets.

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 with metformin, but it cannot replace metformin.

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. No study has been conducted on the use of drugs in patients with severe liver disease, 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 insufficiency (creatinine clearance 15-50ml/min/1.73m2) and patients requiring dialysis, the bioavailability and half-life of nateglinide are not clinically significant compared with healthy people.

1. Hypoglycemia Like other antidiabetic drugs, symptoms of hypoglycemia can be observed after taking nateglinide. These symptoms include sweating, shivering, dizziness, increased appetite, palpitations, nausea, fatigue and weakness. These symptoms are generally mild and easy to deal with, and carbohydrates can be eaten if necessary. Clinical research reports show that the proportion of patients with symptoms of hypoglycemia and confirmed blood sugar reduction (blood sugar <3.3mmol/L) is 2.4% to 7.69%. 2. Liver function Very few patients have increased liver enzymes, which are mild and transient and rarely lead to drug discontinuation. 3. Allergies There are very few reports of allergic reactions such as rash, itching and urticaria. 4. Other reactions Other adverse events found in clinical trials, including gastrointestinal reactions (abdominal pain, indigestion, diarrhea), headaches, and some clinical symptoms that may be associated with diabetic patients (such as respiratory tract infections), occurred in similar proportions in the nateglinide treatment group and the placebo treatment group.

Nateglinide is contraindicated in the following patients: 1. Those who are allergic to the active ingredients of the drug or any excipients; 2. Patients with type 1 diabetes (insulin-dependent diabetes); 3. Diabetic ketoacidosis; 4. Pregnancy and breastfeeding (see: Use in pregnant and lactating women); 5. Use with caution in patients with severe infection, before and after surgery, or with severe trauma.

Precautions for children: The safety and efficacy of nateglinide in pediatric patients have not been evaluated. Therefore, nateglinide is not recommended for use in children. Precautions for pregnancy and lactation: Nateglinide has no teratogenic effects on mice and rabbits. There is no experience of pregnant women taking this drug, so the safety of nateglinide during human pregnancy cannot be estimated. Like other oral antidiabetic drugs, nateglinide is not recommended for use during pregnancy. Nateglinide can be excreted from mouse milk after oral administration. Although it is not clear whether nateglinide can be excreted from human milk, the possibility of hypoglycemia in breastfed infants exists. Therefore, nateglinide should not be used in lactating women. 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.

In vitro studies have shown that nateglinide is metabolized primarily by the cytochrome P450 enzyme CYP2C9 (70%) and partially by CYP3A4 (30%). In vitro experiments have shown that it can inhibit the metabolism of tolbutamide, which indicates 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 summary, these findings indicate that the potential for clinically significant pharmacokinetic interactions between this drug and other drugs is low. Nateglinide has no effect on the pharmacokinetic characteristics of the following drugs: warfarin (a substrate for CYP3A4 and CYP2C9), diclofenac (a substrate for CYP2C9), troglitazone (a CYP3A4 inducer), and digoxin. Therefore, no dose adjustment is required for nateglinide, digoxin, warfarin, or diclofenac when used together. Likewise, there are no clinically significant pharmacokinetic interactions between nateglinide and other oral antidiabetic drugs, such as metformin or glyburide. Nateglinide is highly bound to serum proteins (98%), primarily to albumin. In vitro displacement studies with highly protein-bound drugs have shown that they have no effect on the protein binding of nateglinide. These drugs are furosemide, propranolol, captopril, nicardipine, pravastatin, glyburide, warfarin, phenytoin, acetylsalicylic acid, tolbutamide, and metformin. Likewise, nateglinide has no effect on the serum protein binding of propranolol, glyburide, nicardipine, warfarin, phenytoin, acetylsalicylic acid, and tolbutamide. Physicians should consider the interaction of some drugs that affect glucose metabolism with 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. The hypoglycemic effect of oral antidiabetic drugs can be weakened by certain drugs, including thiazides, cortisone, thyroid preparations and sympathomimetics. Patients receiving nateglinide should be closely observed for changes in blood sugar when adding or stopping the above drugs.

Sealed and stored in a dry place.

30mg

60 months.

Zhuhai United Pharmaceutical Co., Ltd. Zhongshan Branch

• Founded in:

  1997-07-28

• Address:

  No. 12, Jialian Road, Tanzhou Town, Zhongshan City, Guangdong Province

• Tax NO.:

  91442000X180811958

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