Interaction
It has been established that Galvus has a low drug interaction potential. Therefore, it can be taken simultaneously with substrates, inhibitors, inducers of cytochrome P450 and various enzymes.
There may be a significant interaction of this medication with drugs also prescribed for type 2 diabetes mellitus , for example: Glibenclamide, Metformin, Pioglitazone . The results of simultaneous use with drugs that have a narrow therapeutic range - Amlodipine, Digoxin, Ramipril, Simvastatin, Valsartan, Warfarin - have not been established, so such combination therapy should be carried out with caution.
Side effects
Typically, treatment with Galvus does not cause severe adverse reactions requiring discontinuation of the drug.
However, the development of allergic manifestations, especially in the form of swelling, should not be excluded. Possible dysfunction of the liver, deviations in the normal functioning of this organ. There is also a possibility of hypoglycemia, headaches, dizziness, digestive disorders and general body disorders.
Galvus
When using Galvus as monotherapy or in combination with other drugs, most adverse reactions were mild, temporary and did not require discontinuation of therapy. There was no correlation between the incidence of adverse events (AEs) and age, gender, ethnicity, duration of use, or dosage regimen.
The incidence of angioedema during treatment with Galvus was ≥1/10,000, <1/1000 (rare) and was similar to that in the control group. The most common cases of angioedema were observed when using the drug in combination with ACE inhibitors. In most cases, angioedema was of moderate severity and resolved spontaneously with continued therapy with vildagliptin.
During therapy with Galvus, asymptomatic liver dysfunction (including hepatitis) was rarely observed. In most cases, these disorders and deviations of liver function tests from normal resolved independently without complications after discontinuation of drug therapy. When using Galvus at a dose of 50 mg 1 time/day or 2 times/day, the frequency of increases in liver enzyme activity (ALT or AST ≥3×ULN) was 0.2% or 0.3%, respectively (compared to 0.2% in the control group). The increase in liver enzyme activity was in most cases asymptomatic, did not progress, and was not accompanied by cholestasis or jaundice.
Determination of the frequency of adverse events: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10,000, <1 /1000), very rarely (≤1/10,000), including isolated reports.
When using the drug Galvus as monotherapy
When using the drug Galvus at a dose of 50 mg 1 time / day or 2 times / day, the frequency of discontinuation of therapy due to the development of adverse reactions (0.2% or 0.1%, respectively) was not higher than that in the placebo group (0.6%) or the reference drug (0.5 %).
During monotherapy with Galvus at a dose of 50 mg 1 time/day or 2 times/day, the incidence of hypoglycemia without increasing the severity of the condition was 0.5% (2 out of 409 patients) or 0.3% (4 out of 1082), which is comparable with the reference drug and placebo (0.2%).
When using the drug Galvus as monotherapy, no increase in body weight was observed.
From the nervous system: often - dizziness; infrequently - headache.
From the digestive system: infrequently - constipation.
General reactions: uncommon - peripheral edema.
Long-term clinical studies of up to 2 years did not reveal any additional safety profile deviations or unexpected risks when using vildagliptin as monotherapy.
When using the drug Galvus at a dose of 50 mg 1 time / day or 2 times / day in combination with metformin
When using the drug Galvus at a dose of 50 mg/day in combination with metformin, the frequency of discontinuation of therapy due to the development of adverse reactions was 0.4%; In the vildagliptin (50 mg 2 times/day) + metformin and placebo + metformin groups, there were no cases of discontinuation of therapy due to the development of adverse reactions.
When using the drug Galvus at a dose of 50 mg 1 time / day or 2 times / day in combination with metformin, hypoglycemia was observed in 0.9% and 0.5% of cases, respectively; in the placebo+metformin group - 0.4%. There was no development of severe hypoglycemia in the Galvus group.
Combination therapy with vildagliptin + metformin did not affect the body weight of patients.
From the nervous system: often - tremor, dizziness, headache.
Long-term clinical studies of up to 2 years did not reveal any additional safety profile deviations or unexpected risks when using vildagliptin in combination with metformin.
When using the drug Galvus at a dose of 50 mg/day in combination with sulfonylurea derivatives
When using Galvus at a dose of 50 mg/day in combination with glimepiride, the rate of discontinuation of therapy due to the development of adverse reactions was 0.6% (compared to 0% in the glimepiride + placebo group).
The incidence of hypoglycemia in patients receiving Galvus at a dose of 50 mg/day along with glimepiride was 1.2% (compared to 0.6% in the placebo + glimepiride group). There was no development of severe hypoglycemia in the Galvus group.
When using the drug Galvus at the recommended dose (50 mg/day) in combination with glimepiride, there was no increase in patient weight.
From the nervous system: often - tremor, dizziness, headache.
General reactions: often - asthenia.
When using the drug Galvus at a dose of 50 mg 1 time / day or 2 times / day in combination with thiazolidinedione derivatives
When using the drug Galvus at a dose of 50 mg/day in combination with pioglitazone, the frequency of discontinuation of therapy due to the development of adverse reactions was 0.7%; In the vildagliptin (50 mg 2 times/day) + pioglitazone and placebo + pioglitazone groups, there were no cases of discontinuation of therapy due to the development of adverse reactions.
When using the drug Galvus at a dose of 50 mg/day in combination with pioglitazone at a dose of 45 mg, no hypoglycemia was observed; in the group vildagliptin (at a dose of 50 mg 2 times a day) + pioglitazone (at a dose of 45 mg), hypoglycemia was observed in 0.6% of cases, and in patients receiving placebo + pioglitazone at a dose of 45 mg, in 1.9% of cases. No severe hypoglycemia was observed in the Galvus group. The mean increase in body weight compared to placebo in patients receiving Galvus 50 mg once a day or twice a day with pioglitazone was +0.1 kg or +1.3 kg, respectively.
When Galvus was added at a dose of 50 mg once a day or twice a day to pioglitazone at a dose of 45 mg/day, the incidence of peripheral edema was 8.2% and 7%, respectively (compared to 2.5% with pioglitazone monotherapy). However, when prescribing initial combination therapy with vildagliptin at a dose of 50 mg 1 time / day or 2 times / day together with pioglitazone at a dose of 45 mg / day, the development of peripheral edema was observed in 3.5% or 6.1% of patients, respectively (compared to 9.3% with monotherapy pioglitazone at a dose of 30 mg/day).
General reactions: often - peripheral edema, weight gain.
When using the drug Galvus at a dose of 50 mg 2 times a day in combination with insulin
When the drug was prescribed in combination with insulin (in combination with metformin or without metformin), the frequency of therapy discontinuation due to the development of side effects was 0.3% in the vildagliptin therapy group; there were no cases of therapy discontinuation in the placebo group.
When using the drug in combination with insulin (in combination with/without metformin), there was no increase in the risk of hypoglycemia compared with the combination of placebo + insulin (14% in the vildagliptin group and 16.4% in the placebo group). Two patients in the vildagliptin group and 6 patients in the placebo group developed severe hypoglycemia.
At the time of completion of the study, the drug had no effect on average body weight (body weight increased by 0.6 kg compared to baseline in the vildagliptin group, and no changes were noted in the placebo group).
When using vildagliptin 50 mg 2 times a day in combination with insulin (with or without metformin)
From the nervous system: often - headache.
From the digestive system: often - nausea, gastroesophageal reflux; infrequently - diarrhea, flatulence.
Metabolism: often - hypoglycemia.
General reactions: often - chills.
When using the drug Galvus in combination with sulfonylureas and metformin
There were no cases of drug withdrawal associated with adverse events in the combination therapy group with vildagliptin, metformin and glimepiride. In the combination therapy group with placebo, metformin and glimepiride, the incidence of adverse events was 0.6%.
Hypoglycemia was observed in both groups (5.1% in the combination therapy group of vildagliptin, metformin and glimepiride and 1.9% in the combination therapy group of placebo, metformin and glimepiride). There was one episode of severe hypoglycemia in the vildagliptin group.
At the time of completion of the study, no significant effect on body weight was detected (+0.6 kg in the vildagliptin group and -0.1 kg in the placebo group).
When using vildagliptin 50 mg 2 times a day in combination with metformin and sulfonylureas
From the nervous system: often - dizziness, tremor.
Metabolism: often - hypoglycemia.
From the skin and subcutaneous tissues: often - hyperhidrosis.
General reactions: often - fatigue.
Post-marketing studies
Since the reports were obtained voluntarily from a population of unknown size, it is not possible to reliably determine the incidence of these adverse events, and therefore they are classified as frequency unknown: hepatitis (reversible with cessation of therapy), urticaria, pancreatitis, bullous and exfoliative skin lesions .
Contraindications for use
This medicine is not recommended for use if:
- sensitivity to vildagliptin and other components of the drug;
- hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption ;
- some cases of chronic heart failure;
- under 18 years of age.
Treatment is prescribed with caution to patients suffering from severe liver dysfunction and renal failure .
Overdose
As a rule, patients tolerate Galvus well when prescribed a daily dosage of up to 200 mg.
When prescribing a daily dose of 400 mg, the development of muscle pain, fever , swelling and other undesirable symptoms is possible.
Increasing the daily dose to 600 mg can cause the development of swelling of the extremities, a significant increase in the concentration of ALT, CPK, C-reactive protein and myoglobin . Usually, after stopping the medication, all symptoms of overdose disappear.
Reviews about Galvus
As reviews of Galvus on forums devoted to medical topics show, this drug is one of the first to be prescribed when diagnosing diabetes mellitus . Perhaps for this reason, patients do not know exactly how to take the medicine correctly so that the therapy is effective.
In addition, at the initial stage of the disease, not all patients take the specialist’s other recommendations seriously: following a diet , controlling body weight, and so on, so often such prescriptions are simply not followed. As a result, people begin to experience unwanted symptoms and “spikes” in sugar levels, trying to normalize all this only by taking the drug.
Those who immediately took treatment seriously note the good effectiveness of Galvus. Patients say that they had to change some habits, but this did not particularly affect their quality of life. Another problem is the high cost of the drug, which forces patients to look for a replacement.
It is known that the normal well-being of patients suffering from diabetes requires certain efforts from the person himself. Only through an integrated approach to your health can you feel good and prevent or significantly slow down the development of disorders in the functioning of the nervous and cardiovascular systems, which, unfortunately, often accompany diabetics.
Difference between Galvus and Galvus Met
An important difference between Galvus Met and Galvus is that it contains the substance metformin . Metformin and Vildagliptin tablets separately is much higher and quite convenient. In addition, patients taking the combination drug do not experience cases of severe hypoglycemia.
Galvus price, where to buy
The price of Galvus 50 mg, 28 pieces, in Moscow pharmacies varies between 720-800 rubles.
- Online pharmacies in RussiaRussia
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Instructions for Galvus (Method and dosage)
This medicine is intended for oral administration and is not dependent on food intake. The dosage of the drug is selected individually, taking into account the effectiveness and characteristics of the body.
According to the instructions for use of Galvus, when carrying out monotherapy, as well as in two-component combination therapy with thiazolidinedione, metformin or insulin , a daily dose of 50-100 mg is prescribed. In patients with severe type 2 diabetes mellitus receiving insulin , the daily dose of Galvus tablets is 100 mg.
The prescription of triple combination therapy, that is: vildagliptin + metformin + sulfonylurea derivatives, involves taking 100 mg per day. In this case, they usually take 50 mg - morning and evening.
Two-component combination therapy with sulfonylurea derivatives includes a daily dosage of Galvus of 50 mg, which is taken in the morning. It is possible to increase the daily dose to 100 mg, but this is usually not required.
If insufficient clinical effect is observed when taking the maximum daily dosage of 100 mg, then in order to further control the development of glycemia, you can take other hypoglycemic agents, for example: metformin, thiazolidinedione, sulfonylurea derivatives or insulin .
