Vyldahlyptyn | Galvus tablets 50 mg, 28 pcs.
Special Price
$28.13
Regular Price
$37.00
In stock
SKU
BID464779
Release form
Tablets
Tablets
Release form
Tablets
Pharmacological action
GALVUS - vildagliptin - a representative of the class of stimulants of the insular pancreatic apparatus, selectively inhibits the enzyme dipeptidyl peptidase-4 (DPP-4). Fast and complete inhibition of DPP-4 activity (> 90%) causes an increase in both basal and food-stimulated secretion of type 1 glucagon-like peptide (GLP-1) and glucose-dependent insulinotropic polypeptide (HIP) from the intestine into the systemic circulation throughout the day.
Increasing levels of GLP-1 and HIP, vildagliptin increases the sensitivity of pancreatic cells to glucose, leading to an improvement in glucose-dependent insulin secretion. When applying vildagliptin at a dose of 50-100 mg / in patients with type 2 diabetes mellitus, an improvement in the function of pancreatic -Cells is noted. The degree of improvement in the function of Cells depends on the degree of their initial damage, so in individuals not suffering from diabetes mellitus (with normal plasma glucose), vildagliptin does not stimulate insulin secretion and does not reduce glucose.
By increasing the levels of endogenous GLP-1, vildagliptin increases the sensitivity of β-cells to glucose, which leads to an improvement in glucose-dependent regulation of glucagon secretion. A decrease in the level of excess glucagon during meals, in turn, causes a decrease in insulin resistance.
An increase in the insulin / glucagon ratio against the background of hyperglycemia, due to an increase in GLP-1 and HIP, causes a decrease in glucose production by the liver both in the prandial period and after meals, which leads to a decrease in blood glucose levels.
also with the use of vildagliptin, a decrease in the level of lipids in blood plasma is noted, however, this effect is not associated with its effect on GLP-1 or HIP and an improvement in the function of pancreatic cells.
It is known that an increase in GLP-1 can slow gastric emptying, but this effect is not observed with the use of vildagliptin.
When using vildagliptin in 5795 patients with type 2 diabetes for 12 to 52 weeks as monotherapy or in combination with metformin, sulfonylureas, thiazolidinedione, or insulin, a significant long-term decrease in fasting glycated hemoglobin (HbA1c) and fasting blood glucose was observed.
Indications
Type 2 diabetes mellitus:
- as a monotherapy in combination with diet therapy and physical exercises
- as part of a two-part combination therapy with metformin, sulfonylureas, thiazolidinedione or insulin in case of non-therapeutic diets and non-therapeutic exercises.
Contraindications
Hypersensitivity to vildagliptin and any other components of the drug.
Efficacy and safety of the drug in children under 18 years of age have not been established.
Galvus tablets include lactose, the drug is not recommended for patients with rare hereditary disorders:
- galactose intolerance
- lactase deficiency
- malabsorption of glucose-galactose.
Precautions: Galvus is not recommended for use in patients with severely impaired liver function, including patients with increased activity of liver enzymes (ALT or AST> 2.5 times higher VGN). Since the experience of using Galvus in patients with moderate or severe renal impairment (including end-stage renal failure on hemodialysis) is limited, it is not recommended to prescribe the drug in this category of patients.
Use in pregnancy and lactation
In experimental studies, when prescribed in doses 200 times higher than recommended, the drug did not cause impaired fertility and early development of the embryo and did not exert a teratogenic effect on the fetus. There are no sufficient data on the use of the drug Galvus in pregnant women, and therefore the drug should not be used during pregnancy.
In cases of impaired glucose metabolism in pregnant women, there is an increased risk of developing congenital anomalies, as well as the frequency of neonatal morbidity and mortality. To normalize the concentration of blood glucose during pregnancy, insulin therapy is recommended.
Since it is not known whether vildagliptin is excreted in human milk, Galvus should not be used during lactation.
Special instructions
In rare cases, when applying vildagliptin, an increase in the activity of aminotransferases is noted (usually without clinical manifestations).
Before prescribing drugs and during the first year of treatment (1 time in 3 months), it is recommended to determine the biochemical parameters of liver function. With an increase in the activity of aminotransferases, the result should be confirmed by repeated research, and then regularly determine the biochemical parameters of liver function until they normalize. If the excess of AST or ALT activity is 3 times higher than the upper limit of the norm is confirmed by a second study, it is recommended to cancel the drug.
With the development of jaundice or others. signs of impaired liver function, the drug should be stopped immediately and not resumed after normalization of liver function indicators. If insulin therapy is required, vildagliptin is used only in combination with insulin. The drug should not be used for type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
During the treatment period (with the development of dizziness), it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
active substance:
vildagliptin 50 mg.
excipients:
MCC - 95.68 mg
lactose anhydrous - 47, 82 mg
sodium carboxymethyl starch - 4 mg
magnesium stearate - 2.5 mg
Dosage and administration of
Galvus is taken orally, regardless of food intake.
The dosage regimen of the drug should be selected individually depending on the effectiveness and tolerability.
The recommended dose of the drug during monotherapy or as part of a two-component combination therapy with metformin, thiazolidinedione or insulin is 50 mg or 100 mg per day. In patients with more severe type 2 diabetes who are receiving insulin treatment, Galvus is recommended at a dose of 100 mg /
. A dose of 50 mg / should be given in a single dose in the morning. A dose of 100 mg / should be prescribed at 50 mg 2 in the morning and evening.
When used as part of a two-component combination therapy with sulfonylureas, the recommended dose of Galvus is 50 mg 1 time / morning.
When administered in combination with sulfonylurea derivatives, the effectiveness of drug therapy at a dose of 100 mg / was similar to that at a dose of 50 mg / With insufficient clinical effect while using the maximum recommended daily dose of 100 mg to better control glycemia, additional prescription of other hypoglycemic drugs is possible: metformin derivatives of sulfonylurea, thiazolidinedione or insulin.
Side effects
Frequency: very often (1/10 or more), often (more than 1/100 and less than 1/10), infrequently (more than 1/1000 and less than 1/100), rarely (more than 1/10000 and less than 1/1000), very rarely (less than 1/10000). With monotherapy: on the part of the nervous system - often - dizziness, rarely - headache.
From the digestive system: infrequently - constipation.
From the CCC: infrequently - peripheral edema. When used in a dose of 50 mg (1-2 times a day) in combination with metformin: on the part of the nervous system - often - dizziness, headache, tremor. When used in a dose of 50 mg / day in combination with sulfonylurea derivatives: from the nervous system - often - dizziness, headache, asthenia, tremor. When used in a dose of 50 mg 1-2 times a day in combination with thiazolidinedione derivatives: from the CCC - often - peripheral edema.
Others: often - weight gain.
When used in a dose of 50 mg 2 times a day in combination with insulin: from the nervous system - often - headache.
From the digestive system: often - nausea, flatulence, gastroesophageal reflux disease.
From the side of metabolism: often - hypoglycemia. During monotherapy or in combination with other drugs, adverse reactions were mild, temporary, and did not require drug withdrawal. The incidence of angioedema (rarely - more than 1/10000 and less than 1/1000) was similar to that in the control group.
Most often, angioedema was observed in combination with ACE inhibitors, were moderately expressed and disappeared with continued therapy. Hepatic function impairment (including hepatitis) of the asymptomatic course was rarely observed, which in most cases resolved independently after terminationApia drug.
Drug Interactions
Galvus has a low drug interaction potential. Since Galvus is not a substrate of cytochrome P450 enzymes, nor does it inhibit or induce these enzymes, the interaction of Galvus with drugs that are substrates, inhibitors, or inducers of P450 is unlikely.
With the simultaneous use of vildagliptin, it also does not affect the metabolic rate of drugs that are substrates of enzymes: CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 / 5.
overdose
Symptoms: when using the drug at a dose of 400 mg / muscle pain can rarely be observed - mild and transient paresthesias, fever, edema and transient increase in lipase concentration (2 times higher than VGN).
Increasing the dose of Galvus to 600 mg / may develop limb edema with paresthesias and increase the concentration of CPK, ALT, C-reactive protein and myoglobin. All symptoms of overdose and changes in laboratory parameters disappear after discontinuation of the drug.
Treatment: removal of the drug from the body using dialysis is unlikely. However, the major hydrolytic metabolite of vildagliptin (LAY151) can be removed from the body by hemodialysis.
Storage Conditions
The product should be stored dry, out of reach of children at a temperature not exceeding 30 РC.
shelf life
2 years
The active substance
Vildagliptin
Terms and conditions
prescription
dosage form
tablets
Possible product names
GALVUS 0, 05 N28 TABLE
Galvus 50 mg No. 28 tab
Galvus 50mg Tab. X28 (R)
GALVUS 50MG. No. 28 TAB.
Galvus tab 50mg N28
Novartis Farma Stein AG, Switzerland
Tablets
Pharmacological action
GALVUS - vildagliptin - a representative of the class of stimulants of the insular pancreatic apparatus, selectively inhibits the enzyme dipeptidyl peptidase-4 (DPP-4). Fast and complete inhibition of DPP-4 activity (> 90%) causes an increase in both basal and food-stimulated secretion of type 1 glucagon-like peptide (GLP-1) and glucose-dependent insulinotropic polypeptide (HIP) from the intestine into the systemic circulation throughout the day.
Increasing levels of GLP-1 and HIP, vildagliptin increases the sensitivity of pancreatic cells to glucose, leading to an improvement in glucose-dependent insulin secretion. When applying vildagliptin at a dose of 50-100 mg / in patients with type 2 diabetes mellitus, an improvement in the function of pancreatic -Cells is noted. The degree of improvement in the function of Cells depends on the degree of their initial damage, so in individuals not suffering from diabetes mellitus (with normal plasma glucose), vildagliptin does not stimulate insulin secretion and does not reduce glucose.
By increasing the levels of endogenous GLP-1, vildagliptin increases the sensitivity of β-cells to glucose, which leads to an improvement in glucose-dependent regulation of glucagon secretion. A decrease in the level of excess glucagon during meals, in turn, causes a decrease in insulin resistance.
An increase in the insulin / glucagon ratio against the background of hyperglycemia, due to an increase in GLP-1 and HIP, causes a decrease in glucose production by the liver both in the prandial period and after meals, which leads to a decrease in blood glucose levels.
also with the use of vildagliptin, a decrease in the level of lipids in blood plasma is noted, however, this effect is not associated with its effect on GLP-1 or HIP and an improvement in the function of pancreatic cells.
It is known that an increase in GLP-1 can slow gastric emptying, but this effect is not observed with the use of vildagliptin.
When using vildagliptin in 5795 patients with type 2 diabetes for 12 to 52 weeks as monotherapy or in combination with metformin, sulfonylureas, thiazolidinedione, or insulin, a significant long-term decrease in fasting glycated hemoglobin (HbA1c) and fasting blood glucose was observed.
Indications
Type 2 diabetes mellitus:
- as a monotherapy in combination with diet therapy and physical exercises
- as part of a two-part combination therapy with metformin, sulfonylureas, thiazolidinedione or insulin in case of non-therapeutic diets and non-therapeutic exercises.
Contraindications
Hypersensitivity to vildagliptin and any other components of the drug.
Efficacy and safety of the drug in children under 18 years of age have not been established.
Galvus tablets include lactose, the drug is not recommended for patients with rare hereditary disorders:
- galactose intolerance
- lactase deficiency
- malabsorption of glucose-galactose.
Precautions: Galvus is not recommended for use in patients with severely impaired liver function, including patients with increased activity of liver enzymes (ALT or AST> 2.5 times higher VGN). Since the experience of using Galvus in patients with moderate or severe renal impairment (including end-stage renal failure on hemodialysis) is limited, it is not recommended to prescribe the drug in this category of patients.
Use in pregnancy and lactation
In experimental studies, when prescribed in doses 200 times higher than recommended, the drug did not cause impaired fertility and early development of the embryo and did not exert a teratogenic effect on the fetus. There are no sufficient data on the use of the drug Galvus in pregnant women, and therefore the drug should not be used during pregnancy.
In cases of impaired glucose metabolism in pregnant women, there is an increased risk of developing congenital anomalies, as well as the frequency of neonatal morbidity and mortality. To normalize the concentration of blood glucose during pregnancy, insulin therapy is recommended.
Since it is not known whether vildagliptin is excreted in human milk, Galvus should not be used during lactation.
Special instructions
In rare cases, when applying vildagliptin, an increase in the activity of aminotransferases is noted (usually without clinical manifestations).
Before prescribing drugs and during the first year of treatment (1 time in 3 months), it is recommended to determine the biochemical parameters of liver function. With an increase in the activity of aminotransferases, the result should be confirmed by repeated research, and then regularly determine the biochemical parameters of liver function until they normalize. If the excess of AST or ALT activity is 3 times higher than the upper limit of the norm is confirmed by a second study, it is recommended to cancel the drug.
With the development of jaundice or others. signs of impaired liver function, the drug should be stopped immediately and not resumed after normalization of liver function indicators. If insulin therapy is required, vildagliptin is used only in combination with insulin. The drug should not be used for type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
During the treatment period (with the development of dizziness), it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
active substance:
vildagliptin 50 mg.
excipients:
MCC - 95.68 mg
lactose anhydrous - 47, 82 mg
sodium carboxymethyl starch - 4 mg
magnesium stearate - 2.5 mg
Dosage and administration of
Galvus is taken orally, regardless of food intake.
The dosage regimen of the drug should be selected individually depending on the effectiveness and tolerability.
The recommended dose of the drug during monotherapy or as part of a two-component combination therapy with metformin, thiazolidinedione or insulin is 50 mg or 100 mg per day. In patients with more severe type 2 diabetes who are receiving insulin treatment, Galvus is recommended at a dose of 100 mg /
. A dose of 50 mg / should be given in a single dose in the morning. A dose of 100 mg / should be prescribed at 50 mg 2 in the morning and evening.
When used as part of a two-component combination therapy with sulfonylureas, the recommended dose of Galvus is 50 mg 1 time / morning.
When administered in combination with sulfonylurea derivatives, the effectiveness of drug therapy at a dose of 100 mg / was similar to that at a dose of 50 mg / With insufficient clinical effect while using the maximum recommended daily dose of 100 mg to better control glycemia, additional prescription of other hypoglycemic drugs is possible: metformin derivatives of sulfonylurea, thiazolidinedione or insulin.
Side effects
Frequency: very often (1/10 or more), often (more than 1/100 and less than 1/10), infrequently (more than 1/1000 and less than 1/100), rarely (more than 1/10000 and less than 1/1000), very rarely (less than 1/10000). With monotherapy: on the part of the nervous system - often - dizziness, rarely - headache.
From the digestive system: infrequently - constipation.
From the CCC: infrequently - peripheral edema. When used in a dose of 50 mg (1-2 times a day) in combination with metformin: on the part of the nervous system - often - dizziness, headache, tremor. When used in a dose of 50 mg / day in combination with sulfonylurea derivatives: from the nervous system - often - dizziness, headache, asthenia, tremor. When used in a dose of 50 mg 1-2 times a day in combination with thiazolidinedione derivatives: from the CCC - often - peripheral edema.
Others: often - weight gain.
When used in a dose of 50 mg 2 times a day in combination with insulin: from the nervous system - often - headache.
From the digestive system: often - nausea, flatulence, gastroesophageal reflux disease.
From the side of metabolism: often - hypoglycemia. During monotherapy or in combination with other drugs, adverse reactions were mild, temporary, and did not require drug withdrawal. The incidence of angioedema (rarely - more than 1/10000 and less than 1/1000) was similar to that in the control group.
Most often, angioedema was observed in combination with ACE inhibitors, were moderately expressed and disappeared with continued therapy. Hepatic function impairment (including hepatitis) of the asymptomatic course was rarely observed, which in most cases resolved independently after terminationApia drug.
Drug Interactions
Galvus has a low drug interaction potential. Since Galvus is not a substrate of cytochrome P450 enzymes, nor does it inhibit or induce these enzymes, the interaction of Galvus with drugs that are substrates, inhibitors, or inducers of P450 is unlikely.
With the simultaneous use of vildagliptin, it also does not affect the metabolic rate of drugs that are substrates of enzymes: CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 / 5.
overdose
Symptoms: when using the drug at a dose of 400 mg / muscle pain can rarely be observed - mild and transient paresthesias, fever, edema and transient increase in lipase concentration (2 times higher than VGN).
Increasing the dose of Galvus to 600 mg / may develop limb edema with paresthesias and increase the concentration of CPK, ALT, C-reactive protein and myoglobin. All symptoms of overdose and changes in laboratory parameters disappear after discontinuation of the drug.
Treatment: removal of the drug from the body using dialysis is unlikely. However, the major hydrolytic metabolite of vildagliptin (LAY151) can be removed from the body by hemodialysis.
Storage Conditions
The product should be stored dry, out of reach of children at a temperature not exceeding 30 РC.
shelf life
2 years
The active substance
Vildagliptin
Terms and conditions
prescription
dosage form
tablets
Possible product names
GALVUS 0, 05 N28 TABLE
Galvus 50 mg No. 28 tab
Galvus 50mg Tab. X28 (R)
GALVUS 50MG. No. 28 TAB.
Galvus tab 50mg N28
Novartis Farma Stein AG, Switzerland
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