Vildagliptin

No formal drug interaction studies have been conducted for this product. The following is the drug interaction information for each active ingredient in this product. Vildagliptin Vildagliptin has a low chance of interacting with other drugs. Because vildagliptin is not a substrate for the cytochrome P (CYP) 450 enzyme system and has no inducing or inhibitory effects on CYP450 enzymes, this product is unlikely to interact with drugs whose active ingredients are substrates, inhibitors or inducers of these enzymes. Co-administration with pioglitazone, metformin and glibenclamide: The results of clinical trials showed that no clinically significant pharmacokinetic interactions were found when vildagliptin was used concomitantly with the above oral antidiabetic drugs. Digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate): The results of drug-drug interaction studies conducted in healthy subjects showed that no clinically significant pharmacokinetic interactions occurred. However, it is not yet certain in the target population. Co-administration with amlodipine, ramipril, valsartan and simvastatin: Drug interaction studies of vildagliptin with amlodipine, ramipril, valsartan and simvastatin have also been conducted in healthy subjects. In these studies, no clinically significant pharmacokinetic interactions were observed after the above drugs were used concomitantly with vildagliptin. Similar to other oral hypoglycemic agents, the hypoglycemic effect of vildagliptin may be weakened by certain specific drugs, including thiazide diuretics, corticosteroids, thyroid products and sympathomimetics. Drugs not recommended for co-administration with metformin In the case of acute alcohol intoxication (especially in fasting, malnourished or hepatic insufficiency patients), the metformin component of this product increases the risk of lactic acidosis. Avoid alcohol and alcohol-containing drugs (see [Precautions]). Cationic drugs eliminated by renal tubular secretion (such as cimetidine) may interact with metformin by competing for the common renal tubular transport system, resulting in prolonged elimination of metformin and increased risk of lactic acidosis. Studies in healthy volunteers have shown that cimetidine 400 mg twice daily increases the systemic exposure (AUC) of metformin by 50%. Therefore, during the treatment of diabetes, when combined treatment with cationic drugs that are eliminated by renal tubular secretion is required, blood sugar control should be closely monitored and the dose should be adjusted as recommended. Patients who have received intravascular injection of iodinated contrast agents should suspend metformin-containing products (such as this product) for at least 48 hours before or during the examination. This product can be resumed for treatment if re-evaluation of renal function determines that it is stable (see [Dosage and Administration] and [Precautions]). Drugs that need to be used with caution Certain drugs have adverse effects on renal function, which may increase the risk of lactic acidosis, such as NSAIDs, including selective cyclooxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. When starting to use such drugs or such drugs in combination with metformin-containing products (such as this product), renal function needs to be closely monitored. Certain drug treatments often produce hyperglycemia and may lead to failure of blood sugar control. Such drugs include thiazides and other diuretics, corticosteroids, phenothiazines, thyroid drugs, estrogens, oral contraceptives, phenytoin, niacin, adrenergic receptor agonists, calcium channel blockers, and isoniazid. Patients should be informed and their blood sugar should be monitored regularly, especially when starting treatment. If necessary, the dose of this product should be adjusted or treatment should be discontinued during combined treatment. Angiotensin-converting enzyme (ACE) inhibitors have a blood sugar-lowering effect. If necessary, the dose of antihyperglycemic drugs should be adjusted or treatment should be discontinued during combined treatment with other drugs.

Vildagliptin.

Results of clinical trials have shown that no clinically significant pharmacokinetic interactions were observed when vildagliptin was used concomitantly with the oral antidiabetic drugs pioglitazone, metformin, and glibenclamide. Digoxin (P-glycoprotein substrate), warfarin (CYP2C9 substrate): Results of clinical studies conducted in healthy subjects have shown that no clinically significant pharmacokinetic interactions occurred after co-administration of vildagliptin with these two drugs. However, this study has not yet been conducted in the target population. Co-administration with amlodipine, ramipril, valsartan, and simvastatin: Drug-drug interaction studies of vildagliptin with amlodipine, ramipril, valsartan, and simvastatin were also conducted in healthy subjects. In these studies, no clinically significant pharmacokinetic interactions were observed after the above drugs were used concomitantly with vildagliptin.