Tablets contain active substance vildagliptin – 50 mg.
Additional components: MCC, lactose anhydrous, carboxymethyl starch sodium, magnesium stearate.
Form of issue
Galvus is produced in the form of round smooth light-colored tablets with the marks “NVR” and “FB”.
Packed tablets in blisters for 7 or 14 pieces, 2, 4, 8, 12 blisters in the package.
The drug has hypoglycemic effect.
Pharmacodynamics and pharmacokinetics
The substance vildagliptin is a stimulator of the islet apparatus of the pancreas, capable of selectively inhibiting the enzyme dipeptidyl peptidase-4. The full value of this process increases the basal and food-stimulated secretion of the glucagon-like peptide of type 1 and the glucose-dependent insulinotropic polypeptide from the intestine to the systemic bloodstream. This increases the concentration of these components and the sensitivity of β-cells of the pancreas to glucose, improving the glucose-dependent secretion of insulin.
An elevated level of glucagon-like peptide type 1 may cause a slowdown in gastric emptying, but this effect has not been observed with vildagliptin.
Galvus monotherapy or combined treatment with metformin, thiazolidinedione, sulfonylurea derivatives or insulin for a long time lowers the concentration of glycated hemoglobin and blood glucose. Also, such treatment minimizes the occurrence of hypoglycemia.
When ingested, the absorption of vildagliptin occurs fairly quickly. Absolute bioavailability of the substance is 85%. The concentration of the active ingredient in the plasma depends on the intended dosage.
After taking the drug on an empty stomach, its presence in the blood plasma is found after 1 hour and 45 minutes. Food intake has a slight effect on the effect of the drug. Inside the body, the main part of Galvus is converted into metabolites, the excretion of which is mainly carried out with the help of kidneys.
Indications for use
The main indication for the appointment of Galvus is the treatment of type 2 diabetes mellitus in mono- or various forms of combination therapy, for example, with Metformin, Thiazolidinedione sulfonylurea derivatives or insulin in the variations established by the attending physician.
Contraindications for use
This medication should not be taken with:
sensitivity to vildagliptin and other components of the drug;
hereditary intolerance to galactose, insufficiency of lactase of glucose-galactose malabsorption;
some cases of chronic heart failure;
age to 18 years.
Precautions are prescribed for patients suffering from severe impairment of liver function and renal failure.
Usually, Galvus treatment does not cause serious undesirable reactions that require the drug to be discontinued.
However, one should not rule out the development of allergic manifestations, especially in the form of puffiness. Possible violations of the liver, deviations in the indicators of normal activity of this body. Also, there is a possibility of hypoglycemia, headaches, dizziness, digestive disorders and general disorders of the body.
Instructions for Galvus (Method and Dosage)
This medicine is intended for ingestion and does not depend on eating. Dosage of the drug is selected individually, taking into account the effectiveness and characteristics of the body.
According to the instruction for the use of Galvus, monotherapy, as well as in a two-component combination therapy with thiazolidinedione, metformin or insulin, is prescribed a daily dose of 50-100 mg. In patients with severe diabetes mellitus type 2 receiving insulin, the daily dose of Galvus tablets is 100 mg.
The appointment of a triple combination therapy, that is: vildagliptin + metformin + sulfonylurea derivatives presupposes the intake of 100 mg per day. In this case, usually take 50 mg – in the morning and in the evening.
Two-component combination therapy with sulfonylurea derivatives includes a daily Galvus dosage of 50 mg, which is taken in the morning. It is possible to increase the daily dose to 100 mg, but usually this is not required.
If there is an insufficient clinical effect when taking the maximum daily dosage of 100 mg, then to control the development of glycemia in addition, you can take other hypoglycemic agents, for example: metformin, thiazolidinedione, sulfonylurea derivatives or insulin.
As a rule, patients tolerate Galvus well with a daily dosage of up to 200 mg.
With the appointment of a daily dose of 400 mg, it is possible to develop muscle pain, fever, swelling and other undesirable symptoms.
An increase in the daily dose to 600 mg can cause the development of swelling of the extremities, a significant increase in the concentration of ALT, CK, C-reactive protein and myoglobin. Usually, after stopping the medication, all symptoms of an overdose are eliminated.
It was found that Galvus has a low potential for drug interaction. Therefore, it can be taken simultaneously by substrates, inhibitors, cytochrome P450 inducers and various enzymes.
Perhaps significant interaction of this drug with drugs also prescribed for type 2 diabetes mellitus, for example: Glibenclamide, Metformin, Pioglitazone. The results of concomitant use with drugs having a narrow therapeutic range – Amlodipine, Digoxin, Ramipril, Simvastatin, Valsartan, Warfarin, have not been established, so this combination therapy should be conducted with caution.
To store Galvus, a dry place, not accessible to children, at a temperature of up to 30 ° C.
Shelf life – 3 years.