Surgalo Plus 50/1000
Trade Name:
Surgalo Plus 50/1000
Composition
Each tablet contains:
Vildagliptin 50 mg
Metformin hydrochloride 1000 mg
Inactive ingredients:
Hypromellose, povidone, aerosil, magnesium stearate, macrogol, talc.
Properties
Combined hypoglycemic agent for oral administration.
Vildagliptin, a member of the pancreatic islet stimulant class, selectively inhibits the DPP-4 enzyme, improving glycemic control. Inhibition of DPP-4 activity causes an increase in both basal and postprandial endogenous levels of incretin hormones: glucagon-like peptide type 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Metformin reduces hepatic glucose production, decreases intestinal glucose absorption, and reduces insulin resistance by enhancing glucose uptake and utilization by peripheral tissues. Metformin induces intracellular glycogen synthesis by acting on glycogen synthetase and enhances glucose transport by several membrane glucose transport proteins (GLUT-1 and GLUT-4). Improves glucose tolerance in patients with type 2 diabetes by lowering plasma glucose levels both before and after meals. Unlike sulfonylurea derivatives, metformin does not cause hypoglycemia either in patients with type 2 diabetes mellitus or in healthy individuals (except in special cases). Metformin does not lead to the development of hyperinsulinemia. When metformin is used, insulin secretion does not change, while the concentration of insulin in the blood plasma on an empty stomach and during the day may decrease.The combination of these components allows more effective control of blood glucose concentration in patients with type 2 diabetes mellitus within 24 hours.
Indications
Type 2 diabetes mellitus (in combination with diet therapy and exercise).
Dosage and administration
The method of application and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosing regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.
When using this combination, the recommended maximum daily dose of vildagliptin 100 mg should not be exceeded.
The maximum daily dose of metformin is from 500 mg to 2000 mg per day.
Contraindications
Type 1 diabetes; severe renal failure or impaired renal function with GFR <30 ml / min; acute conditions with a risk of developing impaired renal function: dehydration (with diarrhea, vomiting), fever, severe infections
diseases, conditions of hypoxia (shock, sepsis, kidney infections, bronchopulmonary diseases); acute and chronic heart failure, acute myocardial infarction, acute cardiovascular failure (shock), respiratory failure; liver dysfunction; acute or chronic metabolic acidosis (including diabetic ketoacidosis with or without coma); lactic acidosis (including in history); should not be used 48 hours before surgery, radioisotope, x-ray studies with the introduction of contrast agents and within 48 hours after they are carried out; chronic alcoholism, acute alcohol poisoning; adherence to a low-calorie diet (less than 1000 kcal / day); pregnancy, lactation (breastfeeding); children’s age up to 18 years; hypersensitivity to vildagliptin or metformin or any other components of the drug.
Warnings and precautions:
Side effects
From the nervous system: often — headache, dizziness, tremor. When using vildagliptin in combination with metformin at various doses, hypoglycemia was observed in 0.9% of cases (for comparison, in the placebo group in combination with metformin — in 0.4%).
From the digestive system: often — nausea, gastroesophageal reflux, dysgeusia; infrequently — diarrhea, flatulence; very rarely — hepatitis.
From the side of metabolism and nutrition: very often — loss of appetite; often — hypoglycemia; very rarely — lactic acidosis.
Storage
In a dry cool place at a temperature not exceeding 30 °C.
Package:
Carton box contains 3 blisters of 10 tablets, paper leaflet.