Eucreas Metformin Hydrochloride and Vildagliptin Tablets (II)

1. Indications and Usage
Diabetes Mellitus: Treatment of adult patients with type 2 diabetes mellitus as an add-on therapy to diet and exercise.
Specific Use: It is indicated for patients who are not adequately controlled on metformin alone or who are currently taking vildagliptin and metformin as separate tablets.
2. Dosage and Administration
Dosage: The recommended dose is one tablet twice daily.
Administration: For patients previously treated with metformin and vildagliptin separately, the starting dose is one tablet of Metformin Hydrochloride and Vildagliptin Tablets(II) twice daily, with meals.
Titration: For patients previously treated with metformin alone, the starting dose should be based on their current metformin dosage.
Maximum Dosage: The maximum recommended daily dose is two tablets twice daily.
3. Mechanism of Action
Metformin Component: A biguanide that decreases hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Vildagliptin Component: A dipeptidyl peptidase-4 (DPP-4) inhibitor that increases the levels of incretin hormones, resulting in a gradual increase in the release of insulin and a decrease in the release of glucagon.
4. Safety and Warnings
Lactic Acidosis: A rare but serious complication associated with metformin accumulation; risk increases in renal impairment or hypoxic states.
Hypoglycemia: Risk may increase when combined with insulin or sulfonylureas.
Hypersensitivity: Severe allergic reactions, including angioedema, may occur.
Hepatic Impairment: Use with caution in patients with liver dysfunction.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common reactions include diarrhea, nausea, vomiting, headache, and abdominal pain.
Clinical Research: Clinical trials demonstrate that the combination therapy is effective in reducing fasting and postprandial glucose levels and HbA1c compared to monotherapy.
6. Drug Interactions
Alcohol: Potentiates the effect of metformin on lactate metabolism and increases the risk of lactic acidosis.
Cationic Drugs: Drugs like amiloride, digoxin, and morphine may interfere with metformin excretion.
Glucocorticoids and Diuretics: May increase blood glucose levels and alter glycemic control.
7. Pharmaceutical Information
Active Ingredients: Metformin hydrochloride and vildagliptin.
Excipients: Microcrystalline cellulose, povidone, and magnesium stearate.
Appearance: Film-coated tablets.
Storage: Store in a tightly sealed container, protected from moisture and light, below 30°C.