Expiration date: 02/2025
Release form and composition:
Tablets, film-coated light yellow in color with a faint pinkish tinge, oval, with beveled edges on one side marking the NVR, on the other LLO.
1 tablet contains:
vildagliptin* 50 mg
Metformin hydrochloride 500 mg
Excipients: hyprolose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000, talc, iron oxide yellow (E172), iron oxide red (E172).
10 PCs. - blisters (1) - packs of cardboard.
10 PCs. - blisters (3) - packs cardboard.
10 PCs. - blisters (6) - packs cardboard.
10 PCs. - blisters (12) - packs of cardboard.
10 PCs. - blisters (18) - packs of cardboard.
10 PCs. - blisters (36) - packs of cardboard.
Tablets, film-coated yellow with a faint grayish tint, oval, with beveled edges on one side marking the NVR, on the other-SEH.
1 tablet contains:
vildagliptin* 50 mg
Metformin hydrochloride 850 mg
Excipients: hyprolose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000, talc, iron oxide yellow (E172).
10 PCs. - blisters (1) - packs of cardboard.
10 PCs. - blisters (3) - packs cardboard.
10 PCs. - blisters (6) - packs cardboard.
10 PCs. - blisters (12) - packs of cardboard.
10 PCs. - blisters (18) - packs of cardboard.
10 PCs. - blisters (36) - packs of cardboard.
Tablets, film-coated dark yellow with a grayish tint, oval, with beveled edges on one side marking the NVR, on the other - FLO.
1 tablet contains:
vildagliptin* 50 mg
Metformin hydrochloride 1 g
Excipients: hyprolose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 4000, talc, iron oxide yellow (E172).
10 PCs. - blisters (1) - packs of cardboard.
10 PCs. - blisters (3) - packs cardboard.
10 PCs. - blisters (6) - packs cardboard.
10 PCs. - blisters (12) - packs of cardboard.
10 PCs. - blisters (18) - packs of cardboard.
10 PCs. - blisters (36) - packs of cardboard.
* international nonproprietary name, the who recommended - vildagliptin.
Pharmacological action:
Combined oral hypoglycemic agents. The drug Galvus Met consists of two hypoglycemic drugs with different mechanisms of action: vildagliptin belonging to the class of dipeptidyl peptidase-4 inhibitors, and Metformin (hydrochloride), representative of the class of biguanides. The combination of these components allows you to more effectively control the level of blood glucose in patients with diabetes mellitus type 2 within 24 h
Vildagliptin
Vildagliptin - representative of the class of stimulants of islet apparatus of the pancreas, selectively inhibits the enzyme dipeptidylpeptidase-4 (DPP-4) destroying glukagonovy peptide type 1 (GLP-1) and glucosidation insulinotropic polypeptide (GIP).
Rapid and complete inhibition of the activity of DPP-4 causes an increase in both basal and meal-stimulated secretion of GLP-1 and GIP from the gut into the systemic circulation throughout the day.
By increasing the levels of GLP-1 and GIP, vildagliptin causes an increase in the sensitivity of beta-cells of the pancreas to glucose, resulting in improved glucosidation insulin secretion. Degree improve the function of beta-cells depends on their source of damage as in persons not suffering from diabetes (with a normal level of glucose in the blood plasma), vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Elevating levels of endogenous GLP-1, vildagliptin increases the sensitivity of the apha-cells to glucose, which leads to improved glucosidation the regulation of secretion of glucagon. The decrease in the level of excess glucagon during meals in turn, causes a decrease in insulin resistance.
The increase in the ratio of insulin/glucagon with hyperglycemia due to increased levels of GLP-1 and GIP, causes a decrease in hepatic glucose production during and after meals, reducing glucose levels in the blood plasma.
In addition, application of vildagliptin, a decrease in the level of lipids in blood plasma after a meal, but this effect is not associated with its effect on GLP-1 or GIP and improving the function of islet cells of the pancreas.
It is known that increasing the level of GLP-1 may lead to slower emptying of the stomach, however, against the backdrop of vildagliptin a similar effect is not observed.
When using vildagliptin at 5759 patients with diabetes type 2 diabetes for 52 weeks as monotherapy or in combination with Metformin, sulfonylureas, thiazolidinediones, or insulin there was a significant prolonged decline in the concentration of glycated hemoglobin (HbA1c) and fasting blood glucose.
Metformin
Metformin improves glucose tolerance in patients with diabetes type 2, reducing the levels of plasma glucose before and after meals. Metformin reduces glucose production by the liver, decreases the absorption of glucose in the intestines and reduces insulin resistance by increasing the capture and glucose utilization peripheral tissues. Unlike sulfonylurea derivatives, Metformin does not cause hypoglycemia nor in patients with diabetes type 2 diabetes or in healthy subjects (except in special cases). Therapy with the drug does not cause hyperinsulinemia. In the application of Metformin insulin secretion does not change, while insulin levels in blood plasma on an empty stomach and during the day can decrease
Metformin induces intracellular glycogen synthesis by acting on glikogensintetaza, and enhances glucose transport of some membrane proteins is the vector of glucose (GLUT-1 and GLUT-4).
With the use of Metformin has a favorable effect on the metabolism of lipoproteins: decreased level of total cholesterol, cholesterol of low-density lipoproteins and triglycerides that is not associated with the effects of the drug on the concentration of glucose in plasma.
Vildagliptin+ Metformin
When using combination therapy vildagliptin/Metformin in daily doses of 1500 -3000 mg of Metformin and 50 mg vildagliptin for 1 year, there was a statistically significant persistent reduction in the concentration of blood glucose (determined by the decrease in the level HbA1c) and an increase in the proportion of patients who have reduced level HbA1c compose not less than 0.6-0.7% (compared with the group of patients who continued to receive only Metformin).
Patients receiving combination vildagliptin and Metformin, statistically significant changes in body weight compared to baseline was observed. 24 weeks after start of treatment in groups of patients treated with vildagliptin in combination with Metformin, showed a significant reduction in systolic and diastolic blood pressure compared to baseline.
Pharmacokinetics:
Vildagliptin
Suction
When administered on an empty stomach vildagliptin rapidly absorbed, and Cmax achieved within 1.75 hours after administration. At simultaneous reception with food absorption rate decreases slightly vildagliptin: marked reduction in Cmax of 19% and an increase in the time it reach up to 2.5 h. However, eating does not affect the extent of absorption and AUC.
Vildagliptin is rapidly absorbed and its absolute bioavailability after oral administration is 85%. Cmax and AUC within the therapeutic range of doses increase approximately in proportion to dose.
Distribution
The degree of binding of vildagliptin with blood plasma proteins is low (9.3%). The drug is distributed evenly between plasma and erythrocytes. Distribution vildagliptin occurs presumably extravascular, Vd at steady state after the on/in the introduction is 71 HP
Metabolism
Biotransformation is the major route of excretion of vildagliptin. The human body is subjected to a conversion of 69% of the dose. The main metabolite - LAY151 (57% dose) of the pharmacologically inactive and is the hydrolysis product of the cyano-component. About 4% of the dose subjected to amide hydrolysis.
In experimental studies indicated a positive effect of DPP-4 hydrolysis of the drug. Vildagliptin not metabolized with participation of cytochrome P450 isoenzymes. According to studies in all vitr, vildagliptin is not a substrate of P450 isozymes, does not inhibit and does not induce isoenzymes of cytochrome P450
Excretion
After ingestion of the drug is about 85% of the dose is excreted in the urine and 15% in the feces, renal excretion of unchanged vildagliptin is 23%. At/in the introduction average T1/2 is 2 h, the total plasma clearance and renal clearance vildagliptin be 41 l/h 13 l/h, respectively. T1/2 after oral administration is about 3 hours regardless of the dose
Pharmacokinetics in special clinical cases
Gender, body mass index, and ethnicity have no effect on the pharmacokinetics of vildagliptin.
In patients with mild and moderate human liver (6-10 points classification'chid-Pugh) after a single application of the drug there is a decrease in bioavailability vildagliptin 8% and 20%, respectively. In patients with severe hepatic insufficiency (12 points classification'chid-Pugh) the bioavailability of vildagliptin increased by 22%. The maximum change in bioavailability vildagliptin, increase or decrease to an average of 30%, is not clinically significant. The correlation between the severity of impaired liver function and bioavailability of the drug is not revealed.
Patients with slight, moderate and severe impaired renal function and in patients with end-stage chronic renal failure on hemodialysis, a marked increase in Cmax 8-66%, and for AUC 32-134%, not correlated with the severity of the violation, as well as increase in AUC of active metabolite LAY151 1.6-6.7 times, depending on the severity of the violation. T1/2 vildagliptin not changed. The experience of long-term use vildagliptin in patients with end-stage renal disease on hemodialysis is limited.
The maximum increase in bioavailability of the drug by 32% (increase of Cmax by 18%) in people over 70 years of age is not clinically significant and does not affect the inhibition of DPP-4.
Pharmacokinetic features vildagliptin in children and adolescents under 18 years not installed.
Metformin
Suction
The absolute bioavailability of Metformin when administered at a dose of 500 mg on an empty stomach was 50-60%. Cmax achieved through 1.81-2.69 h h after administration. When increasing the dose from 500 mg to 1500 mg, or at intake in doses of 850 mg to 2250 mg was observed a slower increase in pharmacokinetic parameters (than would be expected for a linear dependence). This effect is due not so much to change drug excretion, how much slowing its absorption. On a background of reception of food degree and speed of absorption of Metformin also decreased a little. So, in single dose at a dose of 850 mg with food, a decrease in Cmax and AUC about 40% and 25%, and increase the time to reach Cmax by 35 min. the Clinical significance of these facts is not established.
Distribution
In single dose oral dose of 850 mg of Metformin apparent Vd is 654 ± 358 L. the Drug is substantially bound to plasma proteins, while the sulfonylureas are associated with them more than 90%. Metformin enters the red blood cells (probably the strengthening of this process over time). When Metformin use according to the standard scheme (standard dose and frequency of reception) Sat in the blood plasma is reached within 24-48 h and usually does not exceed 1 mcg/ml. During controlled clinical studies Cmax of Metformin in plasma did not exceed 5 mcg/ml (even when taken in high doses).
Excretion
With a single on/in the introduction of healthy volunteers Metformin is excreted by the kidneys unchanged. It does not metabolized in the liver (in humans, revealed no metabolites) and excreted in the bile. Since the renal clearance of Metformin is approximately 3.5 times greater than creatinine clearance, the main route of elimination of the drug is tubular secretion. Ingestion about 90% of the absorbed dose is excreted via the kidneys during the first 24 h, while T1/2 from plasma is about 6.2 h. T1/2 of Metformin whole blood is approximately 17.6 hours, which indicates accumulation of a significant part of the drug in erythrocytes.
Pharmacokinetics in special clinical cases
The sex of the patients has no effect on the pharmacokinetics of Metformin.
In patients with hepatic impairment a study of the pharmacokinetic characteristics of Metformin have not been conducted.
In patients with reduced renal function (estimated by creatinine clearance (CC)) T1/2 of Metformin plasma and whole blood increased, and its renal clearance is decreased in proportion to the reduction in KK.
A limited amount of data of pharmacokinetic studies in healthy people aged gt 65 years, a decrease in total plasma clearance of Metformin and increase in T1/2 and Cmax compared to young individuals. These features of the pharmacokinetics of Metformin in patients older than 65 years is likely primarily associated with changes in renal function. Therefore, in patients older than 80 years, the purpose of Galvus Met is possible only if the normal QC.
The pharmacokinetic characteristics of Metformin in children and adolescents under 18 years not installed.
There is no evidence of the influence of ethnicity of patients on the pharmacokinetic characteristics of Metformin.
In controlled clinical studies of Metformin in patients with diabetes type 2 diabetes from different ethnic groups, hypoglycemic effect of the drug was manifested to the same extent.
Vildagliptin + Metformin
The study shows bioequivalence indicators the AUC and Cmax of Galvus Met at three different dosages (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) and vildagliptin and Metformin taken in appropriate doses in individual tablets
Food does not affect the extent and rate of absorption vildagliptin in the composition of Galvus Met. The values of Cmax and AUC of Metformin in the composition of Galvus Met at simultaneous reception with food decreased by 26% and 7% respectively. In addition, on the background of the meal slowed the absorption of Metformin, leading to an increase in Tmax (2.0 to 4.0 h). This change Smahi AUC on the background of the meal was observed in the case of the use of Metformin in isolation, but in the latter case, the changes were less significant.
The impact of food on the pharmacokinetics of vildagliptin and Metformin in the composition of Galvus Met did not differ from that in both treatments separately.
Indications:
Diabetes mellitus type 2 (in combination with diet and exercise):
- in case of insufficient efficiency of monotherapy with Metformin or vildagliptin
- patients previously receiving combination therapy and Metformin vildagliptin in the form of monopreparations.
Dosing regimen:
The drug is administered orally. The dosage of Galvus Met should be selected individually depending on efficacy and tolerability. When using Galvus Met do not exceed the recommended maximum daily dose vildagliptin (100 mg).
The recommended starting dose of Galvus Met should be selected, given it is already applied in patient treatment regimens vildagliptin and/or Metformin. To reduce the severity of side-effects from the digestive system, characteristic of Metformin, Galvus Met be taken with food.
The initial dose of Galvus Met with the ineffectiveness of monotherapy vildagliptin: treatment with Galvus Met can start with one pill a dosage of 50 mg/500 mg 2 times a day, and after the evaluation of the therapeutic effect dose can be gradually increased.
The initial dose of Galvus Met with the ineffectiveness of monotherapy with Metformin: the dose-dependent are already taking Metformin, treatment with Galvus Met can start with one pill a dosage of 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg 2 times a day.
The initial dose of Galvus Met in patients previously receiving combination therapy vildagliptin and Metformin as separate tablets: depending on the doses already taken vildagliptin or Metformin, treatment with Galvus Met should start with the pills as close as possible on the dosage of the existing treatment 50 mg/500 mg, 50 mg/850 mg or 50 mg/1000 mg, and titrate to effect.
Galvus Met should not be used in patients with renal insufficiency or with impaired renal function when serum creatinine levels gt1.5 mg% (gt135 of mcmol/l) for men and gt1.4 mg% (gt110 of mcmol/l) for women.
Metformin is excreted by the kidneys. Because patients older than 65 years is often marked by a decline in renal function, these patients Galvus Met is prescribed in minimum dose, ensuring the normalization of glucose, only after the definition of KK to confirm normal kidney function. In applying the drug in patients older than 65 years should regularly monitor kidney function.
Because the safety and effectiveness of Galvus Met in children and adolescents under 18 years has not been studied, the drug is not recommended in these patients.
Side effects:
To assess the incidence of adverse events the following criteria were used: very common (gt1/10) often (gt1/100 t1/10) sometimes (gt1/1000, t1/100), rare (gt1/10 000, t1/1 000) very rare (t1/10 000), including isolated cases.
Adverse reactions, possibly associated with the use of combination therapy vildagliptin and Metformin (the incidence of which in the group vildagliptin+Metformin differed from that on the background the use of placebo and Metformin more than 2%) are shown below:
From the nervous system: often - headache, dizziness, tremor.
When using vildagliptin in combination with Metformin in different doses hypoglycemia was noted in 0.9% of cases (compared with placebo in combination with Metformin - 0.4%).
Frequency of adverse events (AES) from the digestive system on the background of combined therapy vildagliptin/Metformin was 12.9%. When Metformin use similar AES were observed in 18.1% of patients.
In the group of patients receiving Metformin in combination with vildagliptin, gastrointestinal disorders were observed with a frequency of 10-15% and in the group of patients receiving Metformin in combination with placebo, with a frequency of 18%.
When using vildagliptin as monotherapy:
From the nervous system: often - dizziness, headache.
From the digestive system: often - constipation.
Dermatological reactions: sometimes - skin rash.
From the side of musculoskeletal system: often - arthralgia.
Other: sometimes - peripheral edema
When using combination therapy vildagliptin+Metformin were not observed clinically significant increase in the frequency of the above adverse events observed in the intake of vildagliptin.
Monotherapy with Metformin or vildagliptin frequency of hypoglycemia was 0.4% (sometimes).
Vildagliptin monotherapy and combined treatment vildagliptin+Metformin had no effect on body weight of patients.
Changes in the laboratory parameters: in the application of vildagliptin at a dose of 50 mg 1 times/day or 100 mg/day (in 1 or 2 doses) for 1 year, the frequency of increasing the activity of ALT and AST more than 3 times compared to the ULN was 0.3% and 0.9%, respectively (0.3% in the placebo group). Increased activity of ALT and AST, usually asymptomatic, was not growing and was not associated with cholestasis or jaundice.
When Metformin use as monotherapy:
Metabolic disorders: very rare - reduced absorption of vitamin B12, lactic acidosis. Since reduction of absorption of vitamin B12 and reduce its serum concentrations on the background of the use of Metformin was observed very rarely in patients receiving the drug for long periods of time, this undesirable phenomenon has no clinical significance. To consider the possibility of reducing the intake of vitamin B12 should be only in patients with megaloblastic anemia.
From the digestive system: very often - nausea, vomiting, diarrhea, abdominal pain, loss of appetite often - metallic taste in the mouth.
The liver and biliary tract: very rarely - violations of biochemical indicators of liver function. Individual cases of violations of biochemical indicators of liver function or hepatitis, which was observed on the background of the use of Metformin was permitted after discontinuation of Metformin.
The skin and subcutaneous tissue: very rarely skin reactions (including erythema, itching, urticaria).
Contraindications:
- renal failure or renal dysfunction: if creatinine level of serum gt1.5 mg% (gt135 of mcmol/l) for men and gt1.4 mg% (gt110 of mcmol/l) for women
- acute conditions occurring with the risk of developing impaired renal function: dehydration (diarrhea, vomiting), fever, severe infectious diseases, the status of hypoxia (shock, sepsis, posecene infection, bronchopulmonary disease)
- acute and chronic heart failure (acute myocardial infarction, acute cardiovascular insufficiency /shock/)
- respiratory failure
- violations of the liver
- acute or chronic metabolic acidosis (including diabetic ketoacidosis in combination with coma or without it). Diabetic ketoacidosis should be corrected with insulin therapy
- lactic acidosis (incl. in anamnese).
- the drug is not prescribed for the 2 days before the surgery, radioisotope and x-ray studies with injection of a contrast medium and within 2 days after meetings
- pregnancy
- lactation
- diabetes type 1
- chronic alcoholism , acute alcohol poisoning
- adherence to a reduced-calorie diet (less than 1000 kcal/day)
- hypersensitivity to vildagliptin or Metformin or any other component of the drug.
The efficacy and safety of the drug in children under 18 years not installed.
With care: because patients with abnormal liver function in some cases lactic acidosis, possibly as one of the side effects of Metformin, Galvus Met should not be used in patients with liver disease or impaired hepatic biochemical parameters.
Drugs containing Metformin, is recommended to be used with caution in patients older than 60 years, and also when performing heavy physical work due to increased risk of lactic acidosis.
Pregnancy and lactation:
In experimental studies, in the appointment of vildagliptin in doses 200 times greater than recommended, the drug did not cause violations of fertility and early embryonic development and did not exert teratogenic effects on the fetus. In the appointment of vildagliptin in combination with Metformin in a ratio of 1:10 was not revealed teratogenic effects on the fetus.
Since adequate data on the use of Galvus Met pregnant no, the drug should not be used during pregnancy.
When glucose metabolism disorders in pregnant women increase risk of development of congenital anomalies and the frequency of neonatal morbidity and mortality. For the normalization of blood glucose level during pregnancy it is recommended that monotherapy with insulin.
Since it is not known whether it is allocated vildagliptin or Metformin in breast milk in humans, Galvus Met should not be used during lactation.
Special instructions:
In patients receiving insulin Galvus Met can not replace insulin.
Because when using vildagliptin elevation of transaminases (usually without clinical manifestations) were observed more often than in the control group, before the appointment of Galvus Met, as well as regularly during drug treatment, it is recommended to determine the biochemical indicators of liver function. If a patient has increased activity of aminotransferases, this result should be confirmed by repeated study, and then periodic determination of biochemical indicators of liver function as long as they are not normalized. If the excess activity of AST or ALT of 3 or more times the ULN confirmed by repeated study, and the drug is recommended to cancel.
Lactic acidosis is a very rare but serious metabolic complication that occurs when the accumulation of Metformin in the body. Lactic acidosis on the background of the use of Metformin was observed mainly in diabetic patients with renal insufficiency high severity. The risk of lactic acidosis increases in patients with diabetes, difficult to treat, with ketoacidosis, prolonged starvation, prolonged alcohol abuse, liver failure and diseases causing hypoxia.
With the development of lactic acidosis marked shortness of breath, abdominal pain and hypothermia followed by coma. Diagnostic value have the following laboratory parameters: decrease in blood pH, serum lactate concentration above 5 mmol/l and increased anion spacing, and increased the ratio lactate/pyruvate. If you suspect a metabolic acidosis medicinal drug should be discontinued and the patient hospitalized immediately.
Since Metformin is largely excreted by the kidneys, the risk of accumulation and development of lactic acidosis is higher, the more impaired renal function. When using Galvus Met regularly to assess renal function, especially under the following conditions that contribute to its abuse: the initial phase of treatment, antihypertensive drugs, hypoglycemic drugs or NSAIDs. As a rule, renal function should be assessed before beginning treatment Galvus Meth, and then not less than 1 time per year for patients with normal renal function and at least 2-4 times a year for patients with serum creatinine above the ULN. In patients with a high risk of renal function should be monitored more than 2-4 times a year. When signs of deterioration of renal function Galvus Met should be abolished.
When conducting x-ray studies requiring intravascular administration of iodinated Radiocontrast dye, Galvus Met should be temporarily undone (during the study or directly in front of him and within 48 hours after the study), since intravascular administration of iodinated Radiocontrast dye may lead to a sharp deterioration of renal function and increase the risk of lactic acidosis. To resume receiving Galvus Met only after reevaluation of renal function.
In acute cardiovascular failure (shock), acute heart failure, acute myocardial infarction and other conditions characterized by hypoxia, may develop lactic acidosis and prerenal acute renal failure. If you experience the above mentioned conditions, the drug should be discontinued immediately.
At the time of surgery (except minor procedures not associated with restriction of consumption of food and liquid), Galvus Met should be abolished. To resume taking the drug after the patient starts to feed himself and it will be shown that renal function had not been violated.
It is established that alcohol increases the effect of Metformin on lactate metabolism. Patients should be warned about the unacceptability of alcohol abuse on the background of the use of Galvus Met.
Established that Metformin, approximately 7% of cases is asymptomatic reduction in serum concentrations of vitamin B12. This reduction in very rare cases leads to the development of anemia. Apparently, after the abolition of Metformin and/or substitution therapy with vitamin B12 serum concentration of vitamin B12 to normal quickly. Patients receiving Galvus Met is recommended at least 1 time a year to carry out the General analysis of blood and in case of detection of any violations to determine the cause and to take appropriate measures. Apparently, some patients (e.g. patients with inadequate intake or malabsorption of vitamin B12 or calcium) there is a predisposition to decrease serum concentrations of vitamin B12. In such cases it may be recommended to determine serum concentrations of vitamin B12 at least 1 time in 2-3 years.
If the patient with diabetes mellitus type 2, previously responded to therapy, showed signs of degradation (change in laboratory values or clinical symptoms), and symptoms were not precisely defined, it is imperative to conduct tests for the detection of ketoacidosis and/or lactic acidosis. If acidosis occurs in one form or another confirmed, you should immediately cancel Galvus Met and to take appropriate action.
Typically, patients receiving only Galvus Met, hypoglycemia is not observed, but may occur due to low calorie diet (when intense physical activity is not kompensiruet calorie foods), or on the background of alcohol consumption. Hypoglycemia is most likely in elderly, debilitated or malnourished patients, as well as on the background of hypopituitarism, adrenal insufficiency, or alcohol intoxication. In elderly patients and in patients, receiving beta-adrenoblokatora, diagnosis of hypoglycemia can be difficult.
Under stress (fever, trauma, infection, surgery, etc.) occurring in a patient receiving hypoglycemic agents on a stable scheme, possible sharp decline in the effectiveness of the last for a while. In this case, you may need to cancel Galvus Met and prescribe insulin. To resume treatment Galvus Met can after the acute period
Effects on ability to drive vehicles and management mechanisms
The effect of Galvus Met on the ability to drive vehicles and operate machinery has not been studied. With the development of vertigo on the background of the drug should refrain from driving and operating mechanisms.
Overdose:
Vildagliptin
Symptoms: vildagliptin well tolerated when administered at dose up to 200 mg/day. In applying the drug in a dose of 400 mg/day may experience muscle pain, rarely light and transient paraesthesia, fever, oedema and transient increase in the concentration of lipase (above ULN in 2 times). With increasing doses vildagliptin to 600 mg/day, may develop swelling of the extremities accompanied by paresthesia, and increased concentrations of ck, AST, C-reactive protein and myoglobin.
Treatment: the symptoms of overdose, and changes in laboratory parameters disappear after drug discontinuation. Excretion of the drug from the body by dialysis unlikely. However, the main hydrolysis metabolite of vildagliptin (LAY151) can be removed from the body by hemodialysis.
Metformin
Been a few cases of overdosage of Metformin, including as a result of ingestion of the drug in quantities greater than 50 g.
Symptoms: overdose Metformin, about 10% of cases was observed hypoglycaemia (however, its relationship to drug not established) in 32% of cases were observed lactic acidosis. Early symptoms of lactic acidosis are nausea, vomiting, diarrhea, decrease in body temperature, abdominal pain, muscle pain, in the future there may be shortness of breath, dizziness, disturbance of consciousness
