Galvus Met - Instructions For Use, Reviews, Price, Tablet Analogs

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Galvus Met

Galvus Met: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. For violations of liver function
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Galvus Met

ATX code: A10BD08

Active ingredient: vildagliptin + metformin (vildagliptin + metformin)

Producer: Novartis Pharma Productions, GmbH (Germany), Novartis Pharma Stein, AG (Switzerland)

Description and photo update: 2019-19-08

Prices in pharmacies: from 998 rubles.

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Galvus Met is a combined drug with hypoglycemic action.

Release form and composition

The dosage form of Galvus Met is film-coated tablets: oval, with beveled edges, NVR marking on one side; 50 + 500 mg - light yellow with a slight pinkish tinge, marking on the other side of LLO; 50 + 850 mg - yellow with a slight grayish tinge, marking on the other side - SEH; 50 + 1000 mg - dark yellow with a grayish tinge, marking on the other side - FLO (in blisters of 6 or 10 pcs., In a cardboard box of 1, 3, 5, 6, 12, 18 or 36 blisters).

Active ingredients in 1 tablet:

• vildagliptin - 50 mg;
• metformin hydrochloride - 500, 850 or 1000 mg.

Auxiliary components (50 + 500 mg / 50 + 850 mg / 50 + 1000 mg): hypromellose - 12.858 / 18.58 / 20 mg; talc - 1.283 / 1.86 / 2 mg; macrogol 4000 - 1.283 / 1.86 / 2 mg; hyprolosis - 49.5 / 84.15 / 99 mg; magnesium stearate - 6.5 / 9.85 / 11 mg; titanium dioxide (E171) - 2.36 / 2.9 / 2.2 mg; iron oxide red (E172) - 0.006 / 0/0 mg; iron oxide yellow (E172) - 0.21 / 0.82 / 1.8 mg.

Pharmacological properties

Pharmacodynamics

Galvus Met contains two active components with different mechanisms of action: metformin (in the form of hydrochloride), which belongs to the category of biguanides, and vildagliptin, which is a dipeptidyl peptidase-4 (DPP-4) inhibitor. The combination of these substances contributes to a more effective control of the blood glucose concentration in patients with type 2 diabetes mellitus for 1 day.

Vildagliptin is a member of the class of stimulators of the pancreatic islet apparatus, which provides selective inhibition of the DPP-4 enzyme, which is responsible for the destruction of type 1 glucagon-like peptide (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Metformin reduces the production of glucose by the liver, reduces insulin resistance due to the capture and utilization of glucose in peripheral tissues, and inhibits the absorption of glucose in the intestine. It is also an inducer of intracellular glycogen synthesis by acting on glycogen synthetase and activates glucose transport, for which certain membrane glucose transporter proteins (GLUT-1 and GLUT-4) are responsible.

Vildagliptin

After taking vildagliptin, the activity of DPP-4 is inhibited quickly and almost completely, which leads to an increase in both stimulated food intake and the basal secretion of GIP and GLP-1, which are released from the intestine into the systemic circulation for 24 hours.

The increased concentration of GIP and GLP-1, due to the action of vildagliptin, increases the sensitivity of β-cells of the pancreas to glucose, which further improves glucose-dependent insulin production. The degree of improvement in β-cell function is determined by the degree of their initial damage. Thus, in people without diabetes mellitus (with normal plasma glucose levels), vildagliptin does not stimulate insulin production and does not reduce glucose levels.

Vildagliptin increases the concentration of endogenous GLP-1, thus increasing the sensitivity of α-cells to glucose, which helps to improve glucose-dependent regulation of glucagon production. A decrease in elevated postprandial glucagon levels in turn leads to a decrease in insulin resistance.

An increase in the insulin / glucagon ratio against the background of hyperglycemia associated with an increase in the concentration of GIP and GLP-1 causes a decrease in glucose synthesis, both during and after meals. This results in a decrease in plasma glucose.

Also, against the background of treatment with vildagliptin, a decrease in the level of lipids in the blood plasma after meals was observed, but this effect does not depend on the effect of Galvus Met on GIP or GLP-1 and the improvement in the function of islet cells localized in the pancreas. There is evidence that an increase in GLP-1 content can inhibit gastric emptying, but this effect was not observed during the use of vildagliptin.

The results of studies, which involved 5759 patients with type 2 diabetes mellitus, indicate that when taking vildagliptin as a monotherapy or in combination with insulin, metformin, thiazolidinedione or sulfonylurea derivatives for 52 weeks, patients showed a significant long-term decrease in the level of glycated hemoglobin (HbA _{1 C}) and fasting blood glucose.

Metformin

Metformin increases glucose tolerance in type 2 diabetics by lowering plasma glucose both before and after meals. This substance differs from sulfonylurea derivatives in that it does not provoke hypoglycemia either in healthy individuals (excluding special cases) or in patients with type 2 diabetes mellitus. Metformin treatment is not accompanied by the development of hyperinsulinemia. When metformin is taken, insulin production does not change, while its concentration in blood plasma before meals and throughout the day may decrease.

The use of metformin has a beneficial effect on the metabolism of lipoproteins and leads to a decrease in the content of low-density lipoprotein cholesterol, total cholesterol and triglycerides, which is not associated with the effect of the drug on blood plasma glucose levels.

Vildagliptin + Metformin

When prescribing combination therapy with metformin and vildagliptin, daily doses of which are 1500-3000 mg and 50 mg, respectively, and the frequency of administration is 2 times a day for 1 year, there is a statistically significant persistent decrease in plasma glucose (determined by a decrease in HbA _{1 C}) and an increase in the number of patients in whom the decrease in the level of HbA _{1 C} was at least 0.6-0.7% (compared with the category of patients who continued to take metformin only).

In patients who received vildagliptin in combination with metformin, there was no statistically significant change in body weight compared with the state before treatment. 24 weeks after the start of therapy in groups of patients taking vildagliptin in combination with metformin, a decrease in diastolic and systolic blood pressure was recorded in patients with arterial hypertension.

The combined use of metformin and vildagliptin as starting therapy in patients with type 2 diabetes mellitus for 24 weeks was accompanied by a dose-dependent decrease in HbA _{1 C} values compared with monotherapy with these drugs. Cases of hypoglycemia were rare in both groups of patients.

When taking vildagliptin at a dosage of 50 mg 2 times a day simultaneously with metformin (or without it) in combination with insulin (mean dose 41 VD) in patients participating in a clinical study, the HbA _{1 C} index decreased by 0.72% (initial the indicator averaged 8.8%), which is statistically significant. The incidence of hypoglycemia in patients undergoing treatment was comparable to the incidence of hypoglycemia in the placebo group. When vildagliptin was taken by patients at a dosage of 50 mg 2 times a day in combination with metformin (the dose was equal to or exceeded 1500 mg) and glimepiride (the daily dose was equal to or exceeded 4 mg), the HbA _{1 C} indicator decreased statistically significantly by 0.76% with the initial value averaged 8.8%.

Pharmacokinetics

Vildagliptin

With oral administration of Galvus Met on an empty stomach, this substance is rapidly absorbed, and its maximum concentration in the blood plasma is determined 1.75 hours after the intake of vildagliptin into the body. When the drug is taken with food, its absorption rate decreases slightly: the maximum concentration decreases by 19%, and the time to reach it increases to 2.5 hours. At the same time, food intake does not change the area under the concentration-time curve (AUC) and the degree of absorption.

The absolute bioavailability of vildagliptin after oral administration is 85%. The increase in the maximum concentration and AUC in the recommended dose range is dose-dependent (increases in direct proportion to the dose taken).

Vildagliptin binds to blood plasma proteins weakly (the degree of binding is 9.3%). The substance is characterized by a uniform distribution between erythrocytes and plasma. Presumably, this process is carried out extravascularly, with intravenous administration, the volume of distribution in equilibrium is 71 liters.

Vildagliptin is excreted mainly through participation in biotransformation processes. In the human body, approximately 69% of the drug dose is metabolized. The main metabolite is LAY151, into which about 57% of the vildagliptin dose is transferred. It does not exhibit pharmacological activity and is a product of the hydrolysis of the cyano component. Approximately 4% of the drug dose is involved in amide hydrolysis processes.

The results of experimental studies indicate a positive effect of DPP-4 on the hydrolysis of vildagliptin. The substance does not take part in the metabolic processes that occur with the participation of isoenzymes of the cytochrome P _{450 system}. The data of in vitro studies confirm that vildagliptin does not belong to substrates of P (CYP) ₄₅₀ isoenzymes and is not an inhibitor or inducer of isoenzymes of the cytochrome CYP450 system.

After oral administration of vildagliptin, approximately 85% of the dose is excreted in the urine and 15% in the faeces. The renal excretion of this substance unchanged is 23%. With intravenous administration of the drug, the half-life reaches 2 hours on average, and the renal clearance and total plasma clearance are 13 l / h and 41 l / h, respectively. When Galvus Met is taken orally, the half-life is approximately 3 hours, regardless of the dose of vildagliptin.

The pharmacokinetic parameters of vildagliptin are not influenced by ethnicity, gender and body mass index.

In patients with mild and moderate liver dysfunctions (6-10 points according to the Child-Pugh scale), after a single dose of vildagliptin, its bioavailability decreased by 8% and 20%, respectively. In patients with severe liver dysfunctions (12 points according to the Child-Pugh scale), the bioavailability of this substance increases by 22%. The bioavailability of vildagliptin is maximally changed by an average of 30% towards an increase or decrease, which is not considered clinically significant. There is no correlation between the severity of liver dysfunctions and the bioavailability of this active component of Galvus Met.

In patients with mild, moderate or severe renal dysfunction, the AUC of vildagliptin is increased by 1.4, 1.7 and 2 times, respectively, compared with healthy volunteers. The AUC of the LAY151 metabolite increases 1.6, 3.2 and 7.3 times, and that of the BQS867 metabolite - 1.4, 2.7 and 7.3 times in patients suffering from mild, moderate and severe renal dysfunctions, respectively. The data concerning patients with end-stage renal failure are limited, but suggest that the indicators in this group of patients are similar to those in patients with severe renal dysfunction. Vildagliptin is poorly excreted during hemodialysis (3% of the dose taken, provided that the procedure lasts more than 3-4 hours and is carried out 4 hours after a single dose of Galvus Met).

In patients over 70 years of age, a maximum increase in the bioavailability of vildagliptin was observed by 32% (the maximum concentration increased by 18%), which is not of particular clinical significance and does not affect DPP-4 inhibition.

The pharmacokinetic features of vildagliptin in children and adolescents under the age of 18 have not been determined.

Metformin

When taken orally, metformin in a dose of 500 mg before meals, its absolute bioavailability is 50-60%. The maximum concentration of the substance in the plasma is determined 1.81-2.69 hours after ingestion. An increase in the dose of metformin from 500 mg to 1500 mg or from 850 mg to 2250 mg when taken orally leads to a slower increase in pharmacokinetic parameters than what would be typical for a linear relationship. This effect is explained not so much by a change in the excretion of the drug as by a decrease in its absorption. When metformin is taken with food, the degree and rate of absorption of the substance also decreases slightly. So, with a single dose of Galvus Met at a dose of 850 mg with food, there is a decrease in AUC and maximum concentration by approximately 25% and 40%, and the time to reach the maximum concentration increases by 35 minutes. The clinical significance of the above facts has not yet been established.

With a single oral dose of 850 mg of metformin, its apparent volume of distribution is 654 ± 358 L. Plasma protein binding is practically absent, while the degree of binding of sulfonylurea derivatives exceeds 90%. For metformin, penetration into red blood cells is characteristic, and this process can intensify over time. When using the drug in accordance with the standard regimen (standard dose and frequency of administration), the concentration of the active substance in an equilibrium state is reached within 24–48 hours and usually does not exceed 1 μg / ml. In the course of controlled clinical trials, the maximum concentration of metformin in the blood plasma, even when it entered the body in high doses, did not exceed 5 μg / ml.

With a single intravenous administration of this active substance to healthy volunteers, it was proved that it is excreted through the kidneys in an unchanged form. At the same time, metformin does not participate in metabolic processes in the liver (no metabolites have been found in the human body) and is not excreted in the bile.

Since the renal clearance of metformin is approximately 3.5 times higher than the clearance of creatinine, the main route of excretion of the substance from the body is tubular secretion. When taken orally, about 90% of the absorbed dose of the drug is excreted in the urine during the first 24 hours. In this case, the half-life from blood plasma is approximately 6.2 hours. The half-life of the drug from whole blood is approximately 17.6 hours, which indicates the accumulation of a significant proportion of metformin in erythrocytes.

The pharmacokinetics of metformin does not change depending on the gender of the patients. In patients with hepatic insufficiency, the pharmacokinetic features of this active component have practically not been studied. In patients with renal dysfunction, the degree of which is assessed by the CC (creatinine clearance) value, the half-life of metformin from whole blood and plasma increases, and its renal clearance decreases in direct proportion to the decrease in CC.

According to the limited data obtained from pharmacokinetic studies of healthy volunteers aged 65 years and older, there is a decrease in the total plasma clearance of metformin and an increase in the half-life and maximum concentration in patients of this age group compared with younger people. These features of the pharmacokinetic parameters of metformin in patients over 65 years of age are presumably due to changes in renal function, as a result of which, in patients over 80 years of age, the use of the drug is permissible only with normal QC.

The features of the pharmacokinetics of metformin in children and adolescents under the age of 18 have not been sufficiently studied.

There is no evidence of the effect of the ethnicity of patients on the pharmacokinetic parameters of the active substance. Controlled clinical studies, in which patients with type 2 diabetes mellitus, belonging to different nations and races, participated, confirm that the hypoglycemic effect of Galvus Met was manifested in the same way in all.

Vildagliptin + Metformin

Studies have shown that the maximum concentrations and AUC of Galvus Met taken in three different doses (50 mg + 1000 mg, 50 mg + 850 mg and 50 mg + 500 mg), and metformin and vildagliptin in the form of separate tablets, taken in appropriate doses, are bioequivalent.

Food intake does not change the rate and extent of absorption of vildagliptin, which is part of the combination drug. The AUC indicator and the maximum concentration of metformin included in Galvus Met, when taken with meals, decreased by 7% and 26%, respectively. Also, against the background of food intake, the absorption of metformin decreased, which caused an increase in the half-life (from 2 to 4 hours). The same change in AUC and maximum concentration when taken simultaneously with food was also recorded in the case of using metformin in its pure form, but in the latter case, the changes were less clinically significant. The effect of food on the pharmacokinetics of metformin and vildagliptin, included in Galvus Met, is similar to that when both active ingredients are taken separately.

Indications for use

According to the instructions, Galvus Met is prescribed for the treatment of type 2 diabetes mellitus (in combination with exercise and diet therapy) in the following cases:

• insufficient effectiveness of monotherapy with metformin or vildagliptin;
• conducting previously combined therapy with metformin and vildagliptin in the form of monopreparations;
• triple combination therapy with insulin in patients who have previously received insulin therapy at a stable dose and metformin, but have not achieved adequate glycemic control;
• combined use with sulfonylurea derivatives (triple combination treatment) in patients who previously received therapy with sulfonylurea derivatives and metformin, but did not achieve adequate glycemic control;
• initial therapy in patients with type 2 diabetes mellitus with insufficient effectiveness of exercise, diet therapy and, if necessary, improve glycemic control.

Contraindications

• type 1 diabetes mellitus;
• functional disorders of the liver;
• acute myocardial infarction, acute and chronic heart failure, respiratory failure, acute cardiovascular failure (shock);
• chronic / acute metabolic acidosis (including diabetic ketoacidosis with / without coma; diabetic ketoacidosis must be corrected with insulin therapy), lactic acidosis (including indications in history);
• renal failure or impaired renal function (with serum creatinine concentration in men ≥ 1.5 mg% and in women ≥ 1.4 mg%);
• acute conditions that occur with the risk of impaired renal function: dehydration (against the background of diarrhea and vomiting), fever, severe infectious diseases, hypoxia (sepsis, shock, bronchopulmonary diseases, renal infections);
• the period before surgical operations, radioisotope, X-ray studies with the introduction of contrast agents (break before / after their conduct - 48 hours);
• acute alcohol poisoning, chronic alcoholism;
• liver disease or abnormalities in the biochemical parameters of liver function;
• adherence to a hypocaloric diet (less than 1000 kcal per day);
• age up to 18 years (the effectiveness / safety of therapy has not been established);
• pregnancy and the period of breastfeeding;
• individual intolerance to the components of Galvus Met.

Elderly patients (over 60 years old), when performing heavy physical work, should use Galvus Met with caution (associated with an increased risk of lactic acidosis).

Instructions for the use of Galvus Met: method and dosage

Galvus Met tablets are taken orally, preferably simultaneously with food intake (in order to reduce the severity of adverse reactions from the digestive system, which are characteristic of metformin).

The dosage regimen is selected by the doctor individually based on the effectiveness / tolerability of therapy. It should be borne in mind that the maximum daily dose of vildagliptin is 100 mg.

The initial dose of Galvus Met is calculated based on the duration of the course of diabetes, the level of glycemia, the patient's condition and the previously used treatment regimens with vildagliptin and / or metformin.

Recommended doses:

• starting therapy for type 2 diabetes mellitus with insufficient effectiveness of exercise and diet therapy: 1 tablet 50 + 500 mg once a day, after evaluating the effectiveness, the dose is gradually increased to 50 + 1000 mg 2 times a day;
• treatment in cases of ineffectiveness of monotherapy with vildagliptin: 2 times a day, 1 tablet 50 + 500 mg, a gradual increase in the dose is possible after evaluating the therapeutic effect;
• treatment in cases of ineffectiveness of monotherapy with metformin: 2 times a day, 1 tablet 50 + 500 mg, 50 + 850 mg or 50 + 1000 mg (depending on the dose of metformin taken);
• treatment in cases of combined therapy with metformin and vildagliptin in the form of separate tablets: select the dose that is as close as possible to the therapy being administered, and then it is corrected based on its effectiveness;
• combination therapy with Galvus Met in combination with sulfonylurea derivatives or insulin (the dose is selected from the calculation): vildagliptin - 50 mg 2 times a day; metformin - in a dose equal to that taken earlier in the form of a monopreparation.

Patients with creatinine clearance of 60–90 ml / min may require dose adjustment of Galvus Met. It is also possible to change the dosage regimen in patients over 65 years old, which is associated with the likelihood of impaired renal function (regular monitoring of indicators is required).

Side effects

The adverse reactions described below relate to the use of vildagliptin and metformin, either alone or in combination.

Estimation of the frequency of possible violations:> 10% - very often; > 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01%, including isolated messages - very rare.

With the use of vildagliptin, in rare cases, the development of hepatic dysfunction (including hepatitis) of an asymptomatic course was noted. Most often, these side effects and deviations of liver function indicators from the norm passed on their own and did not cause complications after discontinuation of the drug. In most cases, the increase in the activity of liver enzymes was asymptomatic, did not progress and was not accompanied by jaundice or cholestasis.

During combined therapy with vildagliptin and metformin, disorders of the digestive system and the nervous system (often - dizziness, headache, tremor) can be observed.

Adverse reactions when combined with insulin:

• digestive system: often - gastroesophageal reflux, nausea; infrequently - diarrhea, flatulence;
• nervous system: often - headache;
• metabolism and nutrition: often - hypoglycemia;
• general disorders: often - chills.

Adverse reactions when combined with sulfonylurea drugs:

• metabolism and nutrition: often - hypoglycemia;
• skin and subcutaneous tissues: often - hyperhidrosis;
• nervous system: often - tremor, dizziness;
• general disorders: often - fatigue.

Adverse reactions of vildagliptin (monotherapy):

• digestive system: infrequently - constipation;
• nervous system: often - dizziness; infrequently - headache;
• musculoskeletal and connective tissue: often - arthralgia;
• skin and subcutaneous tissue: infrequently - skin rash;
• general disorders: infrequently - peripheral edema.

During the period of post-marketing studies, the development of the following disorders was noted: hepatitis (reversible), pancreatitis, urticaria, exfoliative / bullous skin lesions.

Adverse reactions of metformin (monotherapy):

• digestive system: very often - nausea, flatulence, diarrhea, vomiting, abdominal pain; often - dysgeusia;
• metabolism and nutrition: very often - decreased appetite; very rarely - lactic acidosis;
• skin and subcutaneous tissues: very rarely - skin reactions (in the form of erythema, itching, urticaria);
• instrumental / laboratory data: very rarely - a decrease in the absorption of vitamin B ₁₂ (usually in patients who have been receiving Galvus Met for a long time, as a rule, it does not represent clinical significance; this violation must be taken into account in megaloblastic anemia), changes in hepatic function indicators;
• liver and biliary tract: very rarely - hepatitis.

Individual cases of hepatitis observed with the use of metformin, in most cases, are resolved after its withdrawal.

Overdose

Vildagliptin

Vildagliptin is well tolerated in daily doses not exceeding 200 mg. When taking the drug in a daily dose of 400 mg, undesirable symptoms such as pain in the muscles may occur, as well as occasionally a transient increase in lipase activity (2 times higher than the ULN), transient mild paresthesias, edema and fever. With an increase in the daily dose of vildagliptin to 600 mg, edema of the extremities is sometimes observed, accompanied by an increase in AST activity, an increase in the concentration of myoglobin, C-reactive protein and creatinine phosphokinase, as well as paresthesias. After discontinuation of the drug, all changes in laboratory parameters and signs of overdose disappear.

The elimination of vildagliptin from the body through dialysis is considered ineffective. However, its main metabolite LAY151, obtained as a result of hydrolysis, is well removed from the body during hemodialysis.

Metformin

There are reports of several cases of metformin overdose, including as a result of oral administration of this drug at a dose of more than 50 g. In this case, approximately 10% of patients had hypoglycemia (however, its relationship with metformin has not been reliably established), and 32% of patients, lactic acidosis was observed, the early symptoms of which include muscle pain, decreased body temperature, pain in the abdomen, diarrhea, nausea, vomiting. In the future, dizziness, impaired consciousness, coma, and increased breathing may develop. Metformin is excreted from the body by hemodialysis (clearance does not exceed 170 ml / min) in the absence of hemodynamic disturbances. In this regard, the hemodialysis procedure can be used to remove this substance from the blood in case of an overdose of Galvus Met.

In case of an overdose, appropriate symptomatic therapy is prescribed, based on the clinical manifestations and the patient's well-being.

special instructions

Galvus Met cannot replace insulin therapy in patients receiving insulin.

During the period of therapy, it is recommended to regularly determine the biochemical parameters of liver function, which is associated with an increase in the activity of aminotransferases when using vildagliptin. In cases of the development of this disorder, to confirm the result, it is necessary to conduct a second study, after which, until the biochemical parameters of liver function are normalized, their determination should be carried out regularly. If the activity of aspartate aminotransferase or alanine aminotransferase is 3 or more times higher than the upper limit of the norm, which is confirmed by a second study, Galvus Met is canceled.

Lactic acidosis is a very rare but severe metabolic complication that occurs when metformin accumulates in the body. Most often, its development is observed in patients with diabetes mellitus with impaired renal function in severe course. The likelihood of developing lactic acidosis increases in patients in whom diabetes mellitus is difficult to treat, as well as with prolonged fasting, ketoacidosis, prolonged alcohol abuse, liver dysfunction and diseases that cause hypoxia.

Lactic acidosis is associated with shortness of breath, abdominal pain, and hypothermia, followed by coma. The following laboratory parameters are of diagnostic value: a decrease in blood pH, a serum lactate concentration in the blood of more than 5 nmol / l, as well as an increase in the lactate / pyruvate ratio and an increased anion gap. In cases of suspicion of lactic acidosis, Galvus Met should be canceled and the patient should be immediately hospitalized.

Metformin is largely excreted by the kidneys, the likelihood of its accumulation and the development of lactic acidosis increases in proportion to the severity of renal dysfunction. During therapy, regular monitoring of renal function is required, especially in conditions that contribute to its impairment (in the initial phase of treatment with antihypertensive drugs, hypoglycemic drugs or non-steroidal anti-inflammatory drugs). Renal function should be assessed before starting therapy, and then at least once a year in patients with normal renal function and at least 2-4 times a year with creatinine clearance at the lower limit of the norm, as well as in elderly patients. At a high risk of impaired renal function, monitoring should be done more often. In cases of signs of deterioration in renal function, Galvus Met is canceled.

When carrying out X-ray studies that require intravascular administration of X-ray contrast agents containing iodine, Galvus Met is temporarily canceled (48 hours before / after their conduct). This is due to the likelihood of a sharp deterioration in renal function and an increased risk of developing lactic acidosis. Resumption of taking the drug is possible only after re-assessment of renal function.

In conditions characterized by hypoxia (acute cardiovascular failure, acute heart failure, acute myocardial infarction, etc.), prerenal acute renal failure and lactic acidosis may develop (immediate cancellation of therapy is required).

At the time of surgical interventions (except for minor operations that are not associated with restriction of fluid and food intake) Galvus Met is canceled. Resumption of therapy is possible after the restoration of oral food intake in a patient with reliably excluded renal impairment.

During the period of therapy, alcohol abuse is unacceptable, since it enhances the effect of metformin on lactate metabolism.

While taking Galvus Met, at least once a year, it is necessary to monitor the indicators of a general clinical blood test, which is associated with the likelihood of a decrease in the serum concentration of vitamin B ₁₂. If deviations of hematological parameters from the norm are detected, it is necessary to clarify the etiology of these disorders and conduct appropriate treatment. In cases of a predisposition to a decrease in the serum concentration of vitamin B ₁₂ in the blood, this indicator should be monitored at least 1 time in 2-3 years.

If the condition of patients with type 2 diabetes mellitus who previously responded to therapy, including the appearance of abnormalities in laboratory parameters from the norm, worsens, laboratory diagnostics should be carried out immediately in order to detect lactic acidosis / ketoacidosis. In cases of detection of acidosis, it is necessary to immediately stop therapy and take the measures necessary to correct the patient's condition.

The development of hypoglycemia while taking Galvus Met is most likely in the elderly, emaciated or debilitated patients, as well as against the background of hypopituitarism, alcohol intoxication or adrenal insufficiency. It should be borne in mind that the diagnosis of hypoglycemia in elderly patients and patients receiving β-blockers can be difficult.

Under stress (including fever, trauma, infection, surgery), there may be a short-term sharp decrease in the effectiveness of hypoglycemic agents. In such cases, temporary withdrawal of Galvus Met and insulin therapy may be required. You can resume using the drug after the end of the acute period.

In cases of the development of dizziness during therapy with Galvus Met, it is necessary to refrain from driving vehicles and mechanisms.

Application during pregnancy and lactation

Experimental studies on animals to which vildagliptin was administered in doses 200 times higher than the recommended ones, showed that the use of the drug did not lead to disturbances in the early development of the embryo, and no teratogenic effect was found. When vildagliptin was combined with metformin in a ratio of 1:10, there was also no teratogenic effect. However, information on the use of Galvus Met in pregnant women is limited, therefore, the appointment of the drug during pregnancy is contraindicated.

Metformin is determined in breast milk. It is not known whether vildagliptin passes into breast milk. For this reason, taking Galvus Met during lactation is not recommended.

For violations of liver function

Since in patients with liver dysfunctions, in some cases, lactic acidosis was observed, presumably being one of the side reactions to taking metformin, Galvus Met should not be prescribed to patients with abnormal liver biochemical parameters or liver diseases.

Drug interactions

With the combined use of Galvus Met with some drugs / substances, the following effects may develop:

• sulfonylurea derivatives, insulin, acarbose, salicylates: increased hypoglycemic action;
• furosemide: an increase in C _max (maximum concentration of a substance in the blood) and AUC (area under the concentration-time curve) of metformin; decrease in C _max and AUC of furosemide; there is no effect on renal clearance;
• nifedipine: increased absorption, renal excretion, C _max and AUC of metformin;
• organic cations, including trimethoprim, amiloride, morphine, digoxin, quinidine, procainamide, quinine, triamterene, ranitidine, vancomycin and others, excreted by the kidneys by tubular secretion: there is a theoretical probability of interaction with metformin (the combination requires caution);
• glibenclamide: a decrease in its C _max and AUC (the clinical significance of the interaction is unclear);
• danazol: the combination is not recommended (due to its hyperglycemic effect; in cases of the need for combined use / withdrawal, a dose adjustment of metformin and control of blood glucose concentration may be required);
• isoniazid, estrogens, sympathomimetics, thiazides and other diuretics, phenothiazines, glucocorticosteroids, thyroid hormone preparations, phenytoin, oral contraceptives, nicotinic acid, calcium antagonists: the likelihood of developing hyperglycemia, which may contribute to a decrease in the effectiveness of Galvus Met (when prescribing / canceling such drugs monitoring the effectiveness of metformin, dose adjustment may be required);
• chlorpromazine (more than 100 mg per day): increased glycemia, decreased insulin release (when treating with antipsychotics and after their cancellation, a dose adjustment of Galvus Met and control of blood glucose concentration is required);
• injectable β2-sympathomimetics: an increase in glycemia, which is associated with the stimulation of β2-adrenergic receptors (glycemic control is required; insulin may be required);
• X-ray contrast agents with iodine content: the development of lactic acidosis in patients with diabetes mellitus against the background of functional renal failure;
• alcohol, drugs containing ethyl alcohol: an increase in the likelihood of developing lactic acidosis (especially with fasting, liver failure or exhaustion).

Analogs

Galvus Met analogues are: Vildagliptin, Galvus.

Terms and conditions of storage

Store in a place protected from moisture at temperatures up to 30 ° C. Keep out of the reach of children.

Expiration date - 1 year 6 months.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Galvus Met

Most often, reviews about Galvus Met are left by patients with type 2 diabetes. However, it is mainly taken by patients who have recently been diagnosed with a similar diagnosis. Often they report that such treatment helps to improve well-being and helps prevent the development of unwanted symptoms characteristic of diabetes mellitus. Many users confirm the effectiveness of the drug, but complain about its high cost, which forces them to look for cheaper analogues. There are opinions according to which the use of Galvus Met gives the best results when used as part of a complex therapy.

Price for Galvus Met in pharmacies

The approximate price for Galvus Met with a dosage of 50 + 500 mg in pharmacy chains is 1365-1598 rubles, with a dosage of 50 + 850 mg - 1400-1695 rubles, and with a dosage of 50 + 1000 mg - 1535-1726 rubles (the package contains 30 tablets).

Galvus Met: prices in online pharmacies

Drug name Price Pharmacy

Galvus Met 50 mg + 500 mg film-coated tablets 30 pcs. 998 RUB Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!