Surgalo Plus 50/1000 mg 30 tablets

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:

Preparations containing metformin are recommended to be used with caution in patients older than 60 years of age when performing heavy physical work, due to an increased risk of developing lactic acidosis in them.

In patients receiving insulin treatment, this combination cannot replace insulin therapy.

Regularly during treatment with the drug, it is recommended to determine the biochemical parameters of liver function. If an increase in the activity of aminotransferases is detected, a second study should be carried out in order to confirm the result, and then regularly determine the biochemical parameters of liver function until they normalize. If the excess of AST or ALT activity is 3 or more times higher than the upper limit of the norm, it is recommended to cancel the treatment.

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.

Infectious and parasitic diseases: very rarely – infections of the upper respiratory tract, nasopharyngitis.

General disorders and disorders at the injection site: often – chills.

From the skin and subcutaneous tissues: often – hyperhidrosis; very rarely – skin reactions (in particular, erythema, itching, urticaria).

From the musculoskeletal and connective tissue: often – arthralgia.

From the side of the vessels: infrequently – peripheral edema.

Storage:

In a dry cool place at a temperature not exceeding 30 °C.

Package:

Carton box contains 3 blisters of 10 tablets, paper leaflet.