Rosiglitazone Sodium Tablets

Rosiglitazone sodium is the sodium salt of rosiglitazone. The following are the effects of rosiglitazone. 1. Rosiglitazone is a thiazolidinedione antidiabetic drug that effectively controls blood sugar by increasing insulin sensitivity. This product is a highly selective and potent agonist of peroxisome proliferator-activated receptor gamma (PPAR-gamma). Human PPAR receptors are present in the main target tissues of insulin such as liver, adipose and muscle tissue. This product activates PPAR-gamma nuclear receptors and can regulate the transcription of insulin-responsive genes involved in glucose production, transport and utilization. In addition, PPAR-gamma-responsive genes are also involved in the regulation of fatty acid metabolism. 2. In the clinical study of rosiglitazone, the results of fasting blood glucose (FPG) and HbAlc showed that rosiglitazone can improve blood sugar control, accompanied by a decrease in blood insulin and C-peptide levels, and can also reduce postprandial blood sugar and insulin levels. Rosiglitazone's improvement in blood sugar control is more lasting and can last up to 52 weeks. 3. The main pathophysiological feature of type 2 diabetes is insulin resistance. The anti-diabetic effect of rosiglitazone has been shown in animal models of type 2 diabetes (hyperglycemia and/or impaired glucose tolerance due to insulin resistance in target tissues). It can effectively reduce blood sugar in ob/ob obese mice, db/db diabetic mice and Zucker obese rats, alleviate their hyperinsulinemia, and delay the development of diabetes in db/db and Zucker obese rat models. 4. Animal studies suggest that the anti-diabetic effect of this product is achieved by increasing the sensitivity of the liver, muscle and adipose tissue to insulin, and increasing the gene expression of the insulin-regulated glucose transporter GLUT-4 in adipose tissue. Rosiglitazone alone will not cause hypoglycemia in model animals of type 2 diabetes and/or impaired glucose tolerance.

Rosiglitazone sodium

This product is white tablets.

1. This product is only suitable for patients with type 2 diabetes who cannot achieve the blood sugar control target with other hypoglycemic drugs. 2. Taking this product alone, supplemented with diet control and exercise, can control the blood sugar of patients with type 2 diabetes. 3. For patients with type 2 diabetes who do not have good blood sugar control with diet control and exercise plus this product or a single anti-diabetic drug, this product can be used in combination with metformin or sulfonylurea drugs. For patients who take the maximum recommended dose of metformin or sulfonylurea drugs and have poor blood sugar control, this product cannot replace the original anti-diabetic drugs and needs to be used in combination with them. 4. Dietary control is one of the measures for the treatment of type 2 diabetes. Restricting calories, losing weight and increasing exercise can all help improve insulin sensitivity. Therefore, it is not only the basic treatment for type 2 diabetes, but also can be effective.

Oral administration, the medication is not related to meals. Diabetes treatment should be individualized. 1. Monotherapy: The initial dose can be one tablet (4 mg) a day, taken orally once or twice a day. If the response to the initial dose is not good, the dose can be gradually increased to two tablets (8 mg) a day. 2. Combination with sulfonylureas: The initial dose can be one tablet (4 mg) a day, taken orally once or twice a day. When hypoglycemia occurs, reduce the dosage of sulfonylureas. 3. Combination with metformin: The initial dose can be one tablet (4 mg) a day, taken orally once or twice a day. If fasting blood sugar control is not ideal after 12 weeks, the dose is increased to two tablets (8 mg) a day. 4. The maximum recommended dose is two tablets (8 mg) a day, taken orally once or twice a day.

1. Mild to moderate edema. Literature reports that the incidence of edema is 4.8% when used alone and 15.3% when used in combination with insulin. 2. Anemia. The incidence is about 1%. This product may cause a decrease in hemoglobin and hematocrit, which may be related to the increase in plasma volume caused by rosiglitazone. 3. Hypoglycemia reaction. There is a risk of hypoglycemia when used in combination with other hypoglycemic drugs. 4. Liver function. Clinical trials have found that the incidence of mild to moderate elevation of transaminases is 0.2%, which is comparable to the placebo group and is reversible. 5. Blood lipids. Changes in blood lipid indicators can be observed in patients after taking this product.

1. Patients who are allergic to this product or its ingredients are contraindicated; 2. Patients with a history of heart failure or risk factors for heart failure; 3. Patients with a history of heart disease, especially ischemic heart disease; 4. Patients with osteoporosis or a history of non-traumatic fractures; 5. Patients with severe dyslipidemia.

Precautions for children: The safety of the drug for children has not been determined. Precautions for pregnancy and lactation: The safety of the drug for pregnant women has not been determined. Pregnant women and women who may become pregnant should weigh the pros and cons. Animal (rat) experiments show that this product can migrate into human breast milk. Breastfeeding should be avoided while taking this product. Precautions for the elderly: Elderly patients do not need to adjust the dosage due to age when taking this product.

1. Drugs metabolized by cytochrome P450: In vitro drug metabolism tests have shown that rosiglitazone does not inhibit major P450 enzymes at clinically used doses. In vitro test data confirm that rosiglitazone is mainly metabolized by CYP2C8, and a very small part is metabolized by CYP2C9. 2. Nimodipine and oral contraceptives (ethinyl estradiol and norethindrone) are mainly metabolized by the CYP3A4 pathway, so their co-administration with this product (4 mg/time, twice a day) will not produce clinically significant pharmacokinetic effects on the above two drugs. 3. Glyburide: For diabetic patients whose condition is stable after taking glyburide, the co-administration of this product (2 mg/day, twice a day) and glyburide (3.75 mg/day to 10 mg/day) for 7 days will not change their 24-hour average steady-state blood glucose level. 4. Metformin: For healthy subjects, the co-administration of this product (2 mg/time, twice daily) and metformin (500 mg/time, twice daily) for 4 days will not change the steady-state pharmacokinetic parameters of this product and metformin. 5. Acarbose: Healthy subjects took acarbose (100 mg/time, 3 times a day) for 7 days, which had no effect on the pharmacokinetic parameters of a single oral dose of this product. 6. Digoxin: Healthy subjects took this product (8 mg/time, once a day) for 14 days, which had no effect on the steady-state pharmacokinetic parameters of digoxin (0.375 mg/time, once a day). 7. Warfarin: Continuous use of this product has no effect on the steady-state pharmacokinetic parameters of warfarin enantiomers. 8. Ethanol: Drinking a moderate amount of ethanol once does not increase the risk of acute hypoglycemia in patients with type 2 diabetes taking this product. 9. Ranitidine: Ranitidine (150 mg/time, twice daily) was administered to healthy subjects for 4 days, which did not change the pharmacokinetic parameters of rosiglitazone after single oral or intravenous administration. This result indicates that the increase in gastrointestinal pH does not affect the oral absorption of this product.

Keep sealed.

4mg (as rosiglitazone)

Tentative 24 months