- Instructions for use Diabeton mr 60 mg
- Composition of the drug Diabeton mr 60 mg
- Indications for the drug Diabeton mr 60 mg
- Storage conditions for the drug Diabeton mr 60 mg
- Shelf life of the drug Diabeton mr 60 mg
ATX code: Digestive tract and metabolism (A) > Drugs for the treatment of diabetes mellitus (A10) > Oral hypoglycemic drugs (A10B) > Sulfonylurea derivatives (A10BB) > Gliclazide (A10BB09)
Release form, composition and packaging
Reg. No.: 9715/11 from 06/30/2011 - Expired
Excipients:
Reg. No.: 9510/10 from 11/30/2010 - Replaced
Modified release tablets white, oblong, with a division line and the sign "DIA 60" embossed on both sides; The tablet can be divided into two equal parts.
Excipients: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, colloidal anhydrous silica.
15 pcs. - contour cell packaging (2) - cardboard packs.
15 pcs. - contour cell packaging (4) - cardboard packs.
15 pcs. - contour cell packaging (6) - cardboard packs.
15 pcs. - contour cell packaging (8) - cardboard packs.
Description of the drug DIABETON MR 60 mg based on officially approved instructions for use of the drug and made in 2015. Update date: 03/23/2015
An oral hypoglycemic drug from the group of sulfonylurea derivatives, which differs from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic linkage.
Gliclazide reduces blood glucose levels by stimulating insulin secretion by β-cells of the islets of Langerhans. Increases in postprandial insulin and C-peptide levels persist after 2 years of therapy.
In addition to its effect on carbohydrate metabolism, gliclazide improves microcirculation.
Effect on insulin secretion
In type 2 diabetes mellitus, gliclazide restores the early peak of insulin secretion in response to glucose and enhances the second phase of insulin secretion. A significant increase in insulin secretion is observed in response to stimulation caused by glucose administration or food intake.
Hemovascular effects
Gliclazide reduces the risk of developing small vessel thrombosis by influencing two mechanisms that may be involved in the development of complications in diabetes mellitus:
- partially inhibits platelet aggregation and adhesion and reduces the concentration of platelet activating factors (β-thromboglobulin, thromboxane B 2), and also restores the fibrinolytic activity of the vascular endothelium and increases the activity of tissue plasminogen activator.
Suction
After taking the drug orally, gliclazide is completely absorbed from the gastrointestinal tract. The concentration of gliclazide in the blood plasma gradually increases over 6 hours, reaching a plateau, which persists from the 6th to the 12th hour after administration. Individual variability is low.
Food intake does not affect the rate and extent of absorption.
Distribution
Plasma protein binding is 95%. V d - about 30 l. One daily dose of Diabeton MR 60 mg provides an effective plasma concentration of gliclazide for 24 hours.
There is a linear relationship between the dose taken (up to 120 mg) and AUC.
Metabolism
Gliclazide is metabolized primarily in the liver. The resulting metabolites do not have pharmacological activity.
Removal
T1/2 varies from 12 to 20 hours. It is excreted mainly in the urine in the form of metabolites, less than 1% - unchanged.
Pharmacokinetics in special groups of patients
In elderly patients, no clinically significant changes in pharmacokinetic parameters were detected.
- type 2 diabetes mellitus (non-insulin-dependent) in adults in cases where diet therapy, exercise and weight loss are not effective enough to adequately control blood glucose levels.
The daily dose of the drug can vary from 30 to 120 mg (from 1/2 to 2 tablets). The drug is taken orally 1 time/day during breakfast. It is recommended to swallow the tablets whole without chewing. If you miss a dose, do not increase the dose the next day.
1 modified release tablet Diabeton MR 60 mg is equivalent to 2 tablets modified release Diabeton MR 30 mg. Diabeton MR 60 mg modified release tablet is easily split, allowing the dose to be tailored.
The dose should be selected in accordance with the blood glucose level and the level of glycated hemoglobin.
The recommended starting dose is 30 mg (1/2 tablet). With effective control of blood glucose levels, the drug at this dose can be used for maintenance therapy. If effectiveness is insufficient, the dose can be gradually increased to 60, 90 or 120 mg/day. The interval between each dose increase should be at least 1 month, unless after 2 weeks of therapy the blood glucose level does not decrease. In such cases, the dose can be increased at the end of the 2nd week of treatment. The maximum daily dose is 120 mg.
Switching from Diabeton 80 mg tablets to Diabeton MR 60 mg modified release tablets
1 tablet of Diabeton 80 mg is comparable to 1 tablet of 30 mg modified release (i.e. 1/2 tablet of Diabeton MR 60 mg), so the transition can be carried out under strict control of blood glucose concentrations.
Switching from taking another hypoglycemic drug to Diabeton MR 60 mg
Diabeton MR 60 mg can be used to replace another hypoglycemic agent for oral administration. When switching to Diabeton MR 60 mg, the dose and T1/2 of the previous hypoglycemic drug should be taken into account. As a rule, no transition period is required. Reception should begin with a dose of 30 mg/day, and then, if necessary, adjust the dose depending on the glucose level in the blood, as described above.
When switching from hypoglycemic drugs of sulfonylurea derivatives with a long half-life, in order to avoid hypoglycemia caused by the additive effect of two hypoglycemic drugs, you can stop taking them for several days. The initial dose of Diabeton MR is also 30 mg and, if necessary, can be gradually increased in the future, as described above.
Use in combination with other hypoglycemic drugs
Diabeton MR 60 mg can be prescribed in combination with biguanides, alpha-glucosidase inhibitors or insulin.
Patients whose blood glucose levels are not sufficiently controlled when using Diabeton MR 60 mg can be prescribed insulin under strict medical supervision.
U elderly patients (over 65 years old) No adjustment of the dosage regimen for Diabeton MR is required.
Patients with an increased risk of developing hypoglycemia(in case of insufficient or improper nutrition, in case of severe or poorly compensated endocrine disorders /hypopituitarism, hypothyroidism, ACTH deficiency/, after discontinuation of previous long-term and/or high-dose therapy with GCS, in severe forms of coronary artery disease, severe stenosis of the carotid artery, diffuse vascular disorders) it is recommended to start treatment with a minimum daily dose of 30 mg.
There are no data from clinical studies on the use of the drug in children. Safety and effectiveness of the drug in children and teenagers not installed.
Hypoglycemia
Like other sulfonylureas, Diabeton MR 60 mg can cause hypoglycemia if meals are not taken regularly and especially if meals are missed. Possible symptoms of hypoglycemia:
- headache, severe hunger, nausea, vomiting, increased fatigue, sleep disturbance, agitation, aggressiveness, decreased concentration, slow reaction, depression, confusion, visual and speech impairment, aphasia, tremors, paresis, loss of self-control, delirium, convulsions , shallow breathing, bradycardia, drowsiness, loss of consciousness with the possible development of coma, even death.
Signs of andrenergic counterregulation may also be observed:
- increased sweating, “sticky” skin, anxiety, tachycardia, increased blood pressure, palpitations, arrhythmia and angina.
As a rule, the symptoms of hypoglycemia are relieved by taking carbohydrates (sugar). Taking sweeteners is ineffective. Experience with the use of other sulfonylurea derivatives indicates the possibility of relapse of hypoglycemia, even after its successful relief.
Severe or prolonged hypoglycemia, even with the benefit of carbohydrate intake, requires emergency medical attention, possibly including hospitalization.
Other side effects
From the digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation. Taking the drug during breakfast can avoid or minimize these symptoms.
The following side effects are less common.
From the skin and subcutaneous tissue: rash, pruritus, urticaria, angioedema, erythema, maculopapular rash, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis).
From the hematopoietic system: hematological disorders (anemia, leukopenia, thrombocytopenia, granulocytopenia) rarely develop. As a rule, these phenomena are reversible if therapy is discontinued.
From the liver and biliary tract: increased activity of liver enzymes (AST, ALT, alkaline phosphatase);
These effects are usually reversible if therapy is discontinued.
From the side of the organ of vision: Transient visual disturbances may occur due to changes in blood glucose levels, especially at the beginning of therapy.
Side effects inherent in sulfonylurea derivatives: as with the use of other sulfonylurea derivatives, erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis, and hyponatremia were noted. Increased activity of liver enzymes, impaired liver function (for example, with the development of cholestasis and jaundice) and hepatitis were noted. These manifestations decreased after discontinuation of sulfonylurea drugs, but in some cases led to life-threatening liver failure.
Use during pregnancy and breastfeeding
There is no experience with the use of gliclazide during pregnancy. There is some data on the use of other sulfonylureas during pregnancy.
IN experimental studies teratogenic effects of gliclazide have not been detected in laboratory animals.
Optimal control of diabetes mellitus is necessary to reduce the risk of developing birth defects. Oral hypoglycemic drugs are not used during pregnancy. Insulin is the drug of choice for the treatment of diabetes mellitus in pregnant women. It is recommended to replace the use of oral hypoglycemic drugs with insulin therapy both in the case of a planned pregnancy and if pregnancy occurs while using the drug.
It is not known whether gliclazide is excreted in breast milk. Given the risk of hypoglycemia in a newborn, breastfeeding is contraindicated during drug therapy.
Patients with renal failure mild to moderate the drug is prescribed in the same doses as for patients with normal renal function. Such recommendations have been confirmed by clinical studies.
Patients with severe renal failure the use of the drug is contraindicated (the use of insulin is recommended).
There are no data from clinical studies on the use of the drug in children. Safety and effectiveness of the drug in children and teenagers not installed.
The drug should be prescribed only to those patients whose meals are regular and include breakfast. It is very important to maintain a sufficient intake of carbohydrates from food, because... The risk of developing hypoglycemia increases with irregular or insufficient nutrition, as well as with consumption of foods low in carbohydrates. The risk of developing hypoglycemia increases with a low-calorie diet, after prolonged or excessive exercise, after drinking alcohol, or when using several hypoglycemic drugs in combination.
Hypoglycemia can develop after taking sulfonylurea drugs, sometimes it is severe and protracted and requires hospitalization of the patient and administration of dextrose (glucose) for several days.
To reduce the risk of hypoglycemia, careful individual selection of drugs and dosage regimen is necessary, as well as providing the patient with clear recommendations on the use of the drug.
Factors that increase the risk of developing hypoglycemia:
- refusal or inability of the patient (especially the elderly) to follow the doctor’s instructions;
- insufficient and irregular nutrition, skipping meals, periods of fasting and changes in diet;
- imbalance of physical activity and carbohydrate consumption;
- renal failure;
- severe liver failure;
- overdose of the drug Diabeton MR 60 mg;
- some endocrine disorders (thyroid dysfunction, pituitary and adrenal insufficiency);
- simultaneous use of certain medications.
In patients with severe hepatic and/or renal insufficiency, the pharmacokinetic and/or pharmacodynamic properties of gliclazide may change. In such patients, episodes of hypoglycemia may be longer lasting, requiring immediate appropriate therapy.
It is necessary to inform the patient and his family about the risk of developing hypoglycemia, its symptoms and conditions that contribute to its development. The patient should be taught the importance of diet, the need for regular exercise, and regular monitoring of blood glucose levels.
The effectiveness of blood glucose control in patients receiving hypoglycemic agent therapy may be reduced in the following cases:
- fever, injury, infection or surgery. In some cases, insulin may be required.
The effectiveness of any oral hypoglycemic drug, incl. Gliclazide decreases over time in many patients, which may be due to progression of diabetes mellitus or a decrease in therapeutic response to the drug. This phenomenon is known as secondary drug resistance, which must be distinguished from primary resistance, in which the drug does not produce the expected clinical effect even at the first prescription. A conclusion about secondary drug resistance can be made only after adequate dose adjustment and if the patient follows the diet.
Sulfonylureas may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency. Since gliclazide is a sulfonylurea derivative, caution must be exercised when prescribing it to patients with glucose-6-phosphate dehydrogenase deficiency. The possibility of prescribing a hypoglycemic drug of another group should be assessed.
Diabeton MR 60 mg should not be prescribed to patients with hereditary lactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome.
Preclinical safety data
The results of standard toxicity and genotoxicity studies of gliclazide in repeated doses showed that there is no specific risk for humans. Carcinogenicity studies have not been conducted with long-term use. In animal studies, no teratogenic changes were found, but decreased fetal weight was observed in animals receiving gliclazide at doses 25 times the maximum recommended human dose.
Impact on the ability to drive vehicles and operate machinery
Diabeton MR 60 mg does not affect the ability to drive vehicles and operate machinery. However, patients should be informed about the symptoms of hypoglycemia and the need to exercise caution when driving or performing work requiring high psychomotor speed, especially at the beginning of therapy.
Symptoms: hypoglycemia;
Treatment: moderate symptoms of hypoglycemia (without loss of consciousness and signs of neurological disorders) are corrected by taking carbohydrates, adjusting the dose and/or changing the diet. Careful monitoring of the patient's condition must be continued until the attending physician is sure that the patient's health is not in danger.
In severe conditions, emergency medical care and immediate hospitalization are required.
If a hypoglycemic coma develops or is suspected, the patient should quickly inject 50 ml of a concentrated glucose solution (20-30%) intravenously, and then continue intravenous infusion with a glucose solution of lower concentration (10%) to maintain the blood glucose concentration more than 1 g/l. In the future, depending on the patient’s condition, the issue of the need for further monitoring of the patient’s vital functions should be decided. Dialysis is not performed in such patients due to the pronounced binding of gliclazide to plasma proteins.
Increased risk of hypoglycemia
Contraindicated combinations
Simultaneous use with miconazole (for systemic use and when using the gel on the oral mucosa) leads to increased hypoglycemic effect:
- the development of hypoglycemia up to the state of hypoglycemic coma is possible.
Phenylbutazone (for systemic use) enhances the hypoglycemic effect of sulfonylurea derivatives, because displaces them from connection with plasma proteins and/or slows down their elimination from the body. It is preferable to prescribe another anti-inflammatory drug. If taking phenylbutazone is necessary, the patient should be warned about the need to monitor blood glucose concentrations. If necessary, the dose of Diabeton MR 60 mg should be adjusted during and after phenylbutazone therapy.
Ethanol and ethanol-containing drugs increase hypoglycemia by inhibiting compensatory reactions, which can lead to the development of hypoglycemic coma. When using Diabeton MR 60 mg, you should avoid drinking alcohol and taking medications that contain ethanol.
Concomitant use of other antidiabetic drugs (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists, biguanides), beta-blockers, fluconazole, ACE inhibitors (captopril, enalapril), histamine H2 receptor blockers, inhibitors MAOI, sulfonamides, clarithromycin and NSAIDs can worsen the hypoglycemic effect of Diabeton MR and in some cases lead to hypoglycemia.
Increased risk of hyperglycemia
Danazol has a diabetogenic effect. If the use of this drug cannot be avoided, the patient is advised to carefully monitor the concentration of glucose in the blood and urine. If simultaneous use of drugs is necessary, it is recommended to adjust the dose of Diabeton MR 60 mg both during therapy with danazol and after its discontinuation.
Combinations requiring caution
The simultaneous use of Diabeton MR 60 mg with chlorpromazine in high doses (more than 100 mg/day) can lead to an increase in blood glucose due to a decrease in insulin secretion. The patient should be warned about the need to carefully monitor blood glucose concentrations. If it is necessary to use drugs together, it is recommended to select the dose of a hypoglycemic agent both during antipsychotic therapy and after its discontinuation.
When used simultaneously with gliclazide, GCS (for systemic and local use /intra-articular, cutaneous, rectal administration/) and tetracosactide increase the concentration of glucose in the blood with the possible development of ketoacidosis (decreased tolerance to carbohydrates). The patient should be warned about the need to carefully monitor blood glucose concentrations, especially at the beginning of treatment. If simultaneous use of drugs is necessary, it may be necessary to adjust the dose of gliclazide during GCS therapy and after their discontinuation.
With simultaneous use of β 2 -adrenergic agonists (ritodrine, salbutamol, terbutaline) increase the concentration of glucose in the blood. Particular attention should be paid to the importance of self-monitoring of blood glucose levels. If necessary, it is recommended to transfer the patient to insulin therapy.
Other effects
The use of sulfonylurea derivatives may lead to increased effects of indirect anticoagulants (warfarin) and require adjustment of the anticoagulant dose.
Le Laboratoire SERVIER, representative office, (France)
Representative office in the Republic of Belarus
Les Laboratoires Servier Belarus
There are many different nuances in the treatment of type 2 diabetes, and it is not always possible to immediately find a medicine that helps control glycemia 100%. Due to the variety of antidiabetic medications, it's not just diabetics who are confused.
If you have read the drug Diabeton and its instructions for use, but still do not fully understand whether it is right for you and how you can replace it, if the medicine does not help, then this article is worth spending time on.
Diabeton - a drug for type 2 diabetes
For a diabetic, one of the ways to successfully combat the disease is to normalize the so-called “fasting sugar.” But in pursuit of ideal glucometer readings, you can make a lot of mistakes, since the prescription of a medication must be justified, and this concerns Diabeton in the first place. The new-fashioned French drug is prescribed to everyone - from athletes to diabetics, but it is not useful for everyone.
To understand who really needs it, you need to figure out what type of medicine Diabeton is and on the basis of what active substance it is created. The medicine is made from sulfonylurea derivatives; they have been used successfully all over the world for a long time.
In the cardboard box, as in the photo, you can see white oval tablets with “60” and “DIA” printed on each side. In addition to the main active component gliclazide, Diabeton also contains fillers: maltodextrin, lactose monohydrate, magnesium stearate, silicon dioxide.
Diabeton is an international trade name; the official manufacturer of the drug is the French pharmacological company Servier.
The nonproprietary chemical name of the product is gliclazide, based on the name of the active component.
Many analogues of various brands are produced with gliclazide, so the pharmacy can give out, according to a preferential prescription, not the French Diabeton, but another analogue based on gliclazide, at an order of magnitude cheaper.
Analogues of Diabeton
The original medicine was and remains only Diabeton from Servier.
The shelf life of the drug is 2 years, after which it is not suitable for treatment and must be disposed of. No special conditions are required for its storage.
Instead of the drug Diabeton, the price of which ranges from 260-320 rubles, the pharmacy can offer analogues:
In addition to the regular drug, Servier also produces Diabeton MV. All other medications are generics; manufacturers did not invent them, but simply acquired the right to produce them, and the entire evidence base relates only to the original drug Diabeton.
Generics differ in the quality of the filler, sometimes this seriously affects the effectiveness of the drug. The most budget-friendly analogue option is with Indian and Chinese roots. Among domestic generics that are successfully conquering the market of Diabeton analogues, Glibiab and Gliclazide-Akos enjoy authority.
How to replace Diabeton
If your doctor has prescribed Diabeton, but you can’t take it, you can find a replacement.
When there is no suitable option among the listed analogues, you can choose:
For whatever reasons it would be necessary to select a replacement, only a specialist can change the treatment regimen. Self-diagnosis and self-prescription can only do harm to a diabetic!
Maninil or Diabeton - which is better?
Different methods of controlling type 2 diabetes have different effects on the risk of developing fatal complications. Glibenclamide, the active component of Maninil, is much stronger than gliclazide, the main ingredient of Diabeton. Whether this will be an advantage can be found out from the comments of specialists who analyzed questions about Diabetes and reviews on forums.
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Questions for diabetics |
Experts' comments |
| Diabetes helped me for 5 years, and now even with the highest dose on the glucometer it is no less than 10 units. Why? | The drug has an aggressive effect on pancreatic β-cells. On average, after 6 years they work out and you need to switch to insulin. |
| I am an experienced diabetic, my sugar levels reach 17 mmol/l, I have been reducing them with Maninil for 8 years. Now it doesn't help anymore. They replaced it with Diabeton, but to no avail. Maybe Amaryl should try it? | Your type 2 diabetes has already turned into type 1, insulin dependent. You have to inject insulin, pills are powerless in this case, and it’s not even that Diabeton is weaker than Maninil. |
| They started treating me for diabetes with Siofor at 860 mg/day. After 2 months it was replaced with Diabeton, because the sugar was still there. I didn’t feel any difference, maybe Glibomet will help? | If Diabeton did not help, then Glibomet - even more so. In advanced stages, only a low-carbohydrate diet, the abolition of useless medications and a minimum of insulin will save you if the pancreas is completely depleted. |
| Can Diabeton be taken with Reduxin for weight loss? I want to lose weight. | Diabetes increases the secretion of insulin, which transforms glucose into fat and inhibits its breakdown. The more hormone, the more difficult it is to lose weight. Reduxin is also addictive. |
| For two years, Diabeton MV helps keep sugar levels up to 6 units. Recently my vision has deteriorated and the soles of my feet have gone numb. If sugar is normal, where do complications come from? | Sugar is controlled not only on an empty stomach, but also 2 hours after eating. If you don’t check it 5 times a day, in fact, this is self-deception, for which you pay with complications. |
| In addition to Diabetes, the doctor prescribed a low-calorie diet. I eat about 2 thousand calories a day. Is this normal or should I reduce it further? | In theory, a low-calorie diet should make it easier to control sugars, but in fact, no one sticks to it. In order not to fight hunger, you need to switch to a low-carbohydrate diet and review the dosage of medications. |
How to use - instructions
A simple drug from Diabeton MV, created on the basis of a hydrophilic matrix, is distinguished by the speed of release of the active component. For a conventional analogue, the absorption time of glycoside does not exceed 2 - 3 hours.
After consuming Diabeton MV, gliclazide is released maximally during meal hours, and the rest of the time the glycemic norm is maintained due to the release of microdoses into the bloodstream during the day.
A simple analogue is produced with a dosage of 80 mg, with a prolonged effect - 30 and 60 mg. The special formula of Diabeton MV helped to reduce the dose of the medication, thanks to which it can be used only 1 time per day. Today, doctors rarely choose a simple drug, but it is still available in pharmacies.
Doctors recommend a new generation drug with prolonged capabilities, since it acts much more mildly than other sulfonylurea drugs, the risk of hypoglycemia is minimal, and the effect of one tablet lasts throughout the day.
For those who forget to take pills on time, a one-time dose is a great advantage. And the endocrinologist can safely increase the dose, achieving complete control over the patient’s glycemia. Naturally, Diabeton is prescribed in combination with a low-carbohydrate diet and muscle exercises, without which any antidiabetic pill is ineffective.
As a rule, the medication is prescribed in parallel with Metformin, which, unlike Diabeton, actively affects insulin resistance.
Mechanism of action of Diabeton
Diabeton belongs to a class of drugs that stimulate the pancreas and, in particular, the b-cells responsible for the production of insulin. The degree of activity of such stimulation in the drug is average; if we compare Maninil or Diabeton, then Maninil has a more powerful effect.
For type 2 diabetes accompanied by any degree of obesity, the drug is not indicated. It is added to the treatment regimen when all the symptoms of a decline in the functioning of the gland are present and stimulation is necessary to enhance insulin production.
The medication will restore the first phase of hormone production if it is reduced or absent in a diabetic. In addition to its main purpose (lowering glycemic levels), the drug has a positive effect on blood vessels and the circulatory system. By reducing platelet aggregation (sticking), it reduces the likelihood of blood clots in small vessels, strengthens their internal endothelium, creating angioprotective protection.
The algorithm for the effect of the drug can be presented in the following sequence:
- Stimulation of the pancreas to increase the flow of the hormone into the bloodstream;
- Imitation and restoration of the first phase of insulin production;
- Reducing platelet aggregation to prevent the appearance of clots in small vessels;
- Small antioxidant effect.
A single dose of the drug maintains the required concentration of the active component in the plasma throughout the day. The drug is metabolized in the liver and excreted by the kidneys (up to 1% in its original form). In adulthood, no significant changes in pharmacokinetic characteristics were recorded.
Parallel intake of food does not affect the speed and quality of absorption and distribution of Diabetes.
Advantages and disadvantages of the drug
If we compare Diabeton MV with analogues of the sulfonylurea class, then in terms of efficiency it is ahead of them:
Along with undeniable advantages, the medicine also has a number of disadvantages:
So that the body does not have to choose between complications from the pancreas or cardiovascular pathologies, it is worth paying attention to a low-carbohydrate diet and adequate physical activity.
Lifestyle modification will help to simultaneously normalize all heart risk factors: high sugar, blood pressure, excess weight, and cholesterol metabolism.
Indications for prescribing medication
Diabeton is designed to normalize the glycemic profile, prevent complications of diabetes, reduce the risk of heart attack, stroke, nephropathy, and retinopathy. But it is also used by athletes to increase muscle mass.
Therefore it is shown:
Diabetes is not prescribed to patients as a starting treatment regimen. It is also harmful for diabetics with signs of obesity, since their pancreas already works under increased load, producing 2-3 norms of insulin to neutralize glucose. Prescribing Diabeton to this category of diabetics can provoke death from cardiovascular situations (CVS).
Significant research has been conducted on this issue to determine the relationship between the choice of medications for the initial treatment of type 2 diabetes and the likelihood of mortality. The findings are presented below.
- In volunteers with type 2 diabetes who received sulfonylurea derivatives, compared with the control group taking metformin, the risk of mortality from CV events was 2 times higher, coronary heart disease (CHD) - 4.6 times higher, and cerebrovascular accidents (CVA). ) - 3 times.
- The risk of death from ischemic heart disease and cerebrovascular disease was higher in the group receiving gliclazide, gliquidone and glibenclamide than in volunteers taking metformin.
- In volunteers who received gliclazide, compared with the group taking glibenclamide, the difference in risks was obvious: overall mortality was 20% less, from CVD - by 40%, and cerebrovascular accident - by 40%.
So, the choice of sulfonylurea derivatives (including Diabeton) as a first-line medicine provokes a 2-fold chance of death after 5 years, a 4.6-fold chance of getting a heart attack, and a 3-fold chance of a stroke. 
For newly diagnosed type 2 diabetes, there is no alternative to Metformin as a first-line drug. With long-term (at least 3 years) use of Diabeton, the risk of developing atherosclerosis is significantly reduced. Other drugs in the sulfonylurea class do not have this effect. Most likely, the anti-sclerotic effect of the drug is provided by its antioxidant capabilities, which protect cells from oxidation.
What harm can diabetes cause in type 2 diabetes - on video.
The antidiabetic medication significantly increases the sensitivity of the liver, muscles and fat to insulin. In bodybuilding, it is used as a powerful anabolic steroid, which can be easily purchased at a pharmacy or online. Diabetics use Diabeton to restore the first phase of hormone production and improve the second phase of its production.
The product should be used by bodybuilders with healthy b-cells. The medication affects fat metabolism, blood circulation, thins the blood, and has antioxidant capabilities. Diabeton is transformed into metabolites in the liver, and the medicine is completely eliminated from the body.
In sports, the medication is used to support high anabolism; as a result, the athlete actively increases muscle mass.
In terms of its influence, it can be compared to insulin injections. With this method of weight gain, you need to strictly adhere to the doses, eat nutritiously 6 times a day (proteins, carbohydrates), and monitor your well-being so as not to miss the occurrence of symptoms of hypoglycemia.
Start the course with ½ tablet, gradually doubling the dose. Take the pill in the morning with food. The course of treatment is 1-2 months, depending on how you feel and the results. You can repeat it every other year; if you use Diabeton more often than once every six months, health complications are inevitable.
When repeating the course, the dosage can be doubled (up to 2 tablets/day). You should not take Diabeton while on a starvation diet or taking other means to gain weight. The medication lasts for 10 hours and requires nutritious food during this period. At the first sign of hypoglycemia, the athlete should eat a candy bar or other sweets.
Diabetes is a serious drug that is taken for medical reasons, so bodybuilders need to carefully experiment with their health.
The video shows the use of Diabeton for weight gain - reviews.
Contraindications for use
All medications have contraindications; before using Diabeton, it is important to pay attention to the following warnings:
How does taking two drugs together affect the outcome of treatment? Miconazole enhances the glucose-lowering capabilities of Diabeton. If you do not monitor your glycemic profile in a timely manner, there is a risk of developing hypoglycemia. If there is no alternative to Miconazole, the doctor should reduce the dose of Diabeton.
The medicine should be taken with caution when combined with:
Diabetes can increase alcohol intolerance. This is manifested by shortness of breath, headache, tachycardia, abdominal cramps, and other dyspeptic disorders. If diabetes provoked hypoglycemia, then alcohol will reliably mask its symptoms. Since the signs of intoxication are similar to glycemic ones, the risk of diabetic coma increases if help is untimely.
The optimal dose of alcohol for a diabetic is a glass of dry red wine on occasion. And if you have a choice, it is better not to drink alcohol at all.
Side effects
The main adverse event is hypoglycemia - a drop in glucose levels below the target range, accompanied by the following clinical symptoms:
In mild cases of hypoglycemia, the victim is given carbohydrates; in severe cases, urgent hospitalization is required.
In addition to hypoglycemia, there are other side effects:
All consequences are reversible and go away without drug intervention after discontinuation of Diabeton. If the drug is prescribed instead of an alternative antidiabetic agent, then glycemia should be monitored for 10 days to avoid effects that are dangerous due to hypoglycemia.
When choosing Diabeton, the doctor must inform the diabetic about possible side effects and symptoms of overdose.
Regimen of administration and dosage of Diabeton
In the pharmacy chain, the medicine is presented in two varieties:
- Diabeton with a dosage of 80 mg;
- Diabeton MV weighing 30 and 60 mg.
For ordinary Diabetes, the starting norm is 80 mg/day, over time it is increased to 2-3 pieces per day, distributed over several doses. You can take a maximum of 4 tablets per day.
For modified Diabeton, the starting dose is 30 mg/day; if necessary, the dose is gradually adjusted. Diabeton MV is consumed 1 r./day, maximum – up to 120 mg. Even if the maximum dose is prescribed, it still needs to be taken at one time in the morning.
Like all medications of the sulfonylurea class, Diabeton should be taken half an hour before meals. By drinking it at the exact time indicated in the instructions, the diabetic allows the medication to be absorbed and show its activity with the first spoon of food.
The effectiveness of the chosen dosage can be assessed at home using a glucometer.
Its indicators are checked before and after meals (after 2 hours). The appropriate dose is calculated individually: according to the glycemic profile and laboratory tests for glycosylated hemoglobin HbA1C. You can combine the use of Diabeton with antidiabetic drugs with a different mechanism of action.
Overdose
Since treatment with Diabeton is dangerous for the development of hypoglycemia, a deliberately increased dose of the medication increases its symptoms several times.
The exact lethal dose of the drug has not been established, but if the symptoms are not eliminated in time, any dose will be fatal.
If you attempt suicide or accidentally overdose, you must:
Comprehensive treatment of type 2 diabetes
Diabeton is often used not only as a single drug, but also in complex therapy. It is compatible with all antidiabetic drugs, except for medications of the mulfonylurea class (they have a similar mechanism of action), as well as new norm: it also activates the synthesis of the hormone, but in a different way.
Diabeton works great in combination with Metformin. In this regard, Russian manufacturers have even developed a combination medicine, Glimekomb, containing 40 g of gliclazide and 500 mg of metformin.
The use of such a medicine is characterized by a good increase in compliance (compliance by a diabetic with the prescribed medication regimen). Glimecomb is taken in the morning and evening immediately before or after meals. Side effects of the drug are also common to metformin and gliclazide.
Drug interactions
There are many medications that increase the risk of hypoglycemia when used in parallel with Diabeton. The doctor should be especially careful when prescribing acarbose, metformin, thiazolidinediones, DPP-4 inhibitors, GLP-1 agonists, and insulin with Diabeton.
Many medications that are prescribed to hypertensive patients also enhance the potential of diabetes. The doctor should remember beta-blockers, ACE and MAO inhibitors, fluconazole, sulfonamides, histamine H2 receptor blockers, clarithromycin.
A complete list of drugs that enhance or weaken the activity of the main ingredient of the formula can be found in the original instructions. Even before prescribing Diabeton, it is important for a diabetic to inform his doctor about the medications, dietary supplements, and herbal teas that he is taking.
It is worthwhile to understand the intricacies of your illness and its treatment yourself, since conscious motivation in such cases is a great thing.
What do diabetics think about Diabetes?
Reviews from diabetics about Diabeton are mixed: it helps control sugar, but many could not avoid undesirable consequences. Gliclazide modified-release tablets are more easily tolerated. And side effects are more often observed in diabetics who regularly take Diabeton for several years.
Dmitry, 64 years old. I didn’t know that it was necessary to take into account the interaction of the medication with anticoagulants, since they enhance each other’s capabilities. For now I’m taking Diabeton MV half a tablet, and my sugar levels have been within the normal range for three years.
Lisa, 44 years old. Taking Diabeton increased my digestive problems: heartburn, a feeling of a full stomach and a bloated abdomen. I try to control the glycemic index of foods, as I am very afraid of hypoglycemia.
To treat symptoms of hypoglycemia, which are expressed in moderate symptoms of the disease, it is necessary:
- increase consumption;
- reduce the initially taken dose of the drug;
- change your diet;
- consult a specialist.
In severe conditions of hypoglycemia, the patient experiences:
- muscle cramps;
- other neurological disorders.
In severe cases of hypoglycemia, emergency medical care followed by hospitalization is required.
Side effects
The use of medication with simultaneous irregular nutrition, as well as skipping meals, can provoke the occurrence of hypoglycemia, which is expressed in the following symptoms:
- headache;
- pronounced feeling of hunger;
- fatigue;
- urge to vomit;
- nausea;
- excitation;
- decreased concentration;
- lack of sleep;
- irritable state;
- slower reaction;
- loss of self-control;
- depression;
- visual impairment;
- speech disorders;
- paresis;
- aphasia;
- tremor;
- lack of self-control;
- helplessness;
- dizziness;
- drowsiness;
- muscle cramps;
- weakness;
- bradycardia;
- rave;
- state of drowsiness;
- loss of consciousness;
- andrenergic reactions;
- coma with possible death.
Symptoms inherent in hypoglycemia are eliminated by taking. Severe or long-term cases of such conditions require hospitalization.
Other side effects in the body systems are also noted:
- digestive;
- subcutaneous tissue and skin;
- hematopoiesis;
- biliary tract and;
- organs of vision.
As a rule, side effects disappear when drug therapy is stopped or the daily dose taken is reduced.
Contraindications for use
The drug Diabeton MV 60 mg has the following contraindications:
- diabetic manifestations in the form of coma, precoma;
- severe cases of liver or kidney failure (insulin therapy is recommended);
- simultaneous use with Miconazole;
- breastfeeding period;
- age less than 18 years;
- hypersensitivity to the components of the drug;
- intolerance to lactose-containing substances;
- manifestations of galactosemia, galactose/glucose malabsorption syndrome;
- combined use with Danazol, Phenylbutazone.
Caution should be exercised when taking the medicine in the following cases:
- with an unbalanced, irregular diet;
- diseases of the heart, blood vessels, liver, kidneys;
- long-term therapy with GCS;
- manifestations of alcoholism;
- in old age.
The drug may interact with other medications and also cause undesirable effects.
It is contraindicated to use with substances that enhance the effect of the gliclazide component, as hypoglycemia may develop.
The drug should not be used in conjunction with Miconazole, Phenylbutazone, Ethanol, or other medications containing alcohol, and it is also necessary to completely avoid alcohol consumption. Use the product with caution in combination with hypoglycemic drugs (Insulin, Enalapril).
Video on the topic
Instructions for using the drug Diabeton in the video:
In any case, it is necessary to take a serious approach to glycemic control when taking the drug. It is important to carry out this procedure regularly, including on your own. If necessary, the patient should receive immediate insulin therapy.
Catad_pgroup Oral hypoglycemic agents
Diabeton MV 30 - instructions for use
INSTRUCTIONS
ON THE MEDICAL USE OF THE DRUG
Registration number:
Trade name: Diabeton ® MV International nonproprietary name:
Gliclazide. Dosage form:
modified release tablets.
Composition:
One tablet contains:
Active substance: Gliclazide – 30.0 mg.
Excipients: calcium hydrogen phosphate dihydrate 83.64 mg, hypromellose 100 cP 18.0 mg, hypromellose 4000 cP 16.0 mg, magnesium stearate 0.8 mg, maltodextrin 11.24 mg, colloidal anhydrous silicon dioxide 0.32 mg.
Description
White, biconvex oval tablets engraved with “DIA 30” on one side and the company logo on the other.
Pharmacotherapeutic group:
hypoglycemic agent for oral use of the sulfonylurea group of the second generation.
ATX code: A10ВВ09
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Gliclazide is a sulfonylurea derivative, a hypoglycemic drug for oral administration, which differs from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic bond.
Gliclazide reduces blood glucose concentrations by stimulating insulin secretion by b-cells of the islets of Langerhans. Increases in postprandial insulin and C-peptide concentrations persist after 2 years of therapy.
In addition to its effect on carbohydrate metabolism, gliclazide has hemovascular effects.
Effect on insulin secretion
In type 2 diabetes mellitus, the drug restores the early peak of insulin secretion in response to glucose and enhances the second phase of insulin secretion. A significant increase in insulin secretion is observed in response to stimulation caused by food intake or glucose administration.
Hemovascular effects
Gliclazide reduces the risk of thrombosis of small vessels by influencing the mechanisms that can cause the development of complications in diabetes mellitus: partial inhibition of platelet aggregation and adhesion and a decrease in the concentration of platelet activating factors (beta-thromboglobulin, thromboxane B2), as well as restoration of fibrinolytic activity of the vascular endothelium and increased activity of tissue plasminogen activator.
Intensive glycemic control based on the use of Diabeton® MB (HbA1c) The intensive glycemic control strategy involved prescribing Diabeton® MB and increasing its dose against the background (or instead of) standard therapy before adding another hypoglycemic drug (for example, metformin, an alpha-glucosidase inhibitor , a thiazolidinedione derivative or insulin). The average daily dose of Diabeton® MB in patients in the intensive control group was 103 mg, the maximum daily dose was 120 mg.
During the use of the drug Diabeton ® MB in the intensive glycemic control group (average follow-up duration 4.8 years, average HbA1c level 6.5%) compared to the standard control group (average HbA1c level 7.3%) a significant decrease of 10% was shown relative risk of combined incidence of macro- and microvascular complications
The benefit was achieved due to a significant reduction in the relative risk of: major microvascular complications by 14%, the occurrence and progression of nephropathy by 21%, the occurrence of microalbuminuria by 9%, macroalbuminuria by 30% and the development of renal complications by 11%.
The benefits of intensive glycemic control while taking Diabeton® MB did not depend on the benefits achieved with antihypertensive therapy.
Pharmacokinetics
After oral administration, gliclazide is completely absorbed. The concentration of gliclazide in plasma increases gradually, reaching a plateau after 6-12 hours. Individual variability is low.
Eating does not affect the degree of absorption of the drug. The relationship between the dose taken (up to 120 mg) and the area under the concentration-time pharmacokinetic curve is linear. Approximately 95% of the drug is bound to plasma proteins. Gliclazide is metabolized primarily in the liver and excreted mainly by the kidneys: excretion is carried out in the form of metabolites, less than 1% is excreted unchanged by the kidneys. There are no active metabolites in plasma.
The half-life of gliclazide averages from 12 to 20 hours. The distribution volume is approximately 30 l.
In elderly people, no significant changes in pharmacokinetic parameters are observed.
Taking the drug Diabeton ® MV at a dose of 30 mg once a day ensures the maintenance of an effective concentration of gliclazide in the blood plasma for more than 24 hours.
INDICATIONS FOR USE
Type 2 diabetes mellitus with insufficient effectiveness of diet therapy, physical activity and weight loss.
Prevention of diabetes complications: reducing the risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke) in patients with type 2 diabetes through intensive glycemic control.
CONTRAINDICATIONS
- hypersensitivity to gliclazide, other sulfonylurea derivatives, sulfonamides or excipients included in the drug;
- diabetes mellitus type 1;
- diabetic ketoacidosis, diabetic precoma, diabetic coma;
- severe renal or liver failure (in these cases, insulin is recommended)
- concomitant therapy with miconazole (see section “Interaction with other drugs”);
- pregnancy and breastfeeding (see section “Pregnancy and breastfeeding”);
- age up to 18 years.
With caution:
Old age, irregular and/or unbalanced diet, glucose-6-phosphate dehydrogenase deficiency, severe diseases of the cardiovascular system, hypothyroidism, adrenal or pituitary insufficiency, renal and/or liver failure, long-term therapy with glucocorticosteroids (GCS), alcoholism.
PREGNANCY AND BREASTFEEDING
Pregnancy
There is no experience with the use of gliclazide during pregnancy. Data on the use of other sulfonylureas during pregnancy are limited.
In studies on laboratory animals, no teratogenic effects of gliclazide were identified.
To reduce the risk of developing congenital defects, optimal control (appropriate therapy) of diabetes mellitus is necessary.
Oral hypoglycemic drugs are not used during pregnancy.
Insulin is the drug of choice for the treatment of diabetes mellitus in pregnant women.
It is recommended to replace the intake of oral hypoglycemic drugs with insulin therapy both in the case of a planned pregnancy and if pregnancy occurs while taking the drug.
Breastfeeding
Taking into account the lack of data on the passage of gliclazide into breast milk and the risk of hypoglycemia in a breastfed child, breastfeeding is contraindicated during therapy with this drug.
METHOD OF APPLICATION AND DOSES
THE DRUG IS INTENDED FOR TREATMENT OF ADULTS ONLY.
The recommended dose of the drug (1-4 tablets, 30-120 mg) should be taken orally, 1 time per day, preferably during breakfast.
It is recommended to swallow the tablet whole, without chewing or crushing.
If you miss one or more doses of the drug, you should not take a higher dose at the next dose; the missed dose should be taken the next day.
As with other hypoglycemic drugs, the dose of the drug in each case must be selected individually, depending on the concentration of blood glucose and glycosylated hemoglobin (HbA1c).
Initial dose
The initial recommended dose (including for elderly patients, ≥ 65 years) is 30 mg per day.
If adequately controlled, the drug at this dose can be used for maintenance therapy. In case of inadequate glycemic control, the daily dose of the drug can be sequentially increased to 60, 90 or 120 mg.
An increase in the dose is possible no earlier than after 1 month of drug therapy at the previously prescribed dose. The exception is patients whose blood glucose concentrations have not decreased after 2 weeks of therapy. In such cases, the dose of the drug can be increased 2 weeks after starting treatment.
The maximum recommended daily dose of the drug is 120 mg.
Switching from taking the drug Diabeton
® tablets 80 mg for the drug Diabeton
®
1 tablet of Diabeton ® 80 mg can be replaced by 1 modified-release tablet Diabeton ® MV 30 mg. When transferring patients from Diabeton ® 80 mg to Diabeton ® MV, careful glycemic control is recommended.
Switching from taking another hypoglycemic drug to Diabeton
® MB modified release tablets 30 mg
The drug Diabeton ® MV modified release tablets 30 mg can be used instead of another hypoglycemic drug for oral administration. When switching to Diabeton ® MB in patients receiving other oral hypoglycemic drugs, their dose and half-life should be taken into account. As a rule, no transition period is required.
The initial dose should be 30 mg and then titrated according to blood glucose concentrations.
When replacing Diabeton ® MB with sulfonylurea derivatives with a long half-life, you can stop taking them for several days to avoid hypoglycemia caused by the additive effect of two hypoglycemic agents. The initial dose of Diabeton ® MB is also 30 mg and, if necessary, can be increased further, as described above.
Combined use with another hypoglycemic drug
Diabeton ® MB can be used in combination with biguanides, alpha-glucosidase inhibitors or insulin.
If glycemic control is inadequate, additional insulin therapy should be prescribed with close medical supervision.
Elderly patients
No dose adjustment is required for patients over 65 years of age.
Patients with kidney failure
The results of clinical studies have shown that dose adjustment of the drug is not required in patients with mild to moderate renal failure. Close medical monitoring is recommended.
Patients at risk of developing hypoglycemia
In patients at risk of developing hypoglycemia (insufficient or unbalanced nutrition; severe or poorly compensated endocrine disorders - pituitary and adrenal insufficiency, hypothyroidism; withdrawal of glucocorticosteroids (GCS) after their long-term use and/or use in high doses; severe cardiovascular diseases vascular system - severe coronary heart disease, severe atherosclerosis of the carotid arteries, widespread atherosclerosis), it is recommended to use the minimum dose (30 mg) of the drug Diabeton ® MB.
Prevention of diabetes complications
To achieve intensive glycemic control, you can gradually increase the dose of Diabeton ® MB up to 120 mg/day in addition to diet and exercise until the target HbA1c level is achieved. The risk of hypoglycemia should be remembered. In addition, other hypoglycemic drugs, such as metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative or insulin, can be added to therapy.
Children and adolescents under 18 years of age.
There are no data on the effectiveness and safety of the drug in children and adolescents under 18 years of age.
SIDE EFFECTS
Given the experience with the use of gliclazide and other sulfonylurea derivatives, one should be aware of the possibility of developing the following side effects.
Hypoglycemia
Like other drugs of the sulfonylurea group, Diabeton ® MB can cause hypoglycemia in case of irregular meals and especially if meals are skipped. Possible symptoms of hypoglycemia: headache, severe hunger, nausea, vomiting, fatigue, sleep disturbance, irritability, agitation, decreased concentration, slow reaction, depression, confusion, blurred vision and speech, aphasia, tremor, paresis, impaired perception , dizziness, weakness, convulsions, bradycardia, delirium, respiratory failure, drowsiness, loss of consciousness with the possible development of coma, even death.
Andrenergic reactions may also occur: increased sweating, clammy skin, anxiety, tachycardia, increased blood pressure, palpitations, arrhythmia and angina.
As a rule, the symptoms of hypoglycemia are relieved by taking carbohydrates (sugar).
Taking sweeteners is ineffective. Against the background of other sulfonylurea derivatives, relapses of hypoglycemia were observed after its successful relief.
For severe or prolonged hypoglycemia, emergency medical attention, possibly hospitalization, is indicated, even if carbohydrate intake is effective.
Other side effects
- From the gastrointestinal tract: abdominal pain, nausea, vomiting, diarrhea, constipation. Taking the drug during breakfast can avoid or minimize these symptoms.
The following side effects are less common:
- From the skin and subcutaneous tissue: rash, itching, urticaria, erythema, maculopapular rash, bullous rash.
- From the circulatory and lymphatic system: hematological disorders (anemia, leukopenia, thrombocytopenia, granulocytopenia) rarely develop. As a rule, these phenomena are reversible if therapy is discontinued.
- From the liver and biliary tract: increased activity of liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase), hepatitis (isolated cases). If cholestatic jaundice appears, therapy should be discontinued.
- From the side of the organ of vision: Transient visual disturbances may occur due to changes in blood glucose concentrations, especially at the beginning of therapy.
- Side effects inherent in sulfonylurea derivatives: The following side effects were observed when taking other sulfonylurea derivatives: erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis and hyponatremia. There was an increase in the activity of “liver” enzymes, impaired liver function (for example, with the development of cholestasis and jaundice) and hepatitis; manifestations decreased over time after discontinuation of sulfonylurea drugs, but in some cases led to life-threatening liver failure.
In the ADVANCE study, there was little difference in the incidence of various serious adverse events between the two groups of patients. No new safety data were obtained. A small number of patients experienced severe hypoglycemia, but the overall incidence of hypoglycemia was low. The incidence of hypoglycemia in the intensive glycemic control group was higher than in the standard glycemic control group. Most episodes of hypoglycemia in the intensive glycemic control group were observed during concomitant insulin therapy.
OVERDOSE
In case of overdose with sulfonylurea derivatives, hypoglycemia may develop.
If moderate symptoms of hypoglycemia occur without impairment of consciousness or neurological symptoms, the intake of carbohydrates from food should be increased, the dose of the drug should be reduced and/or the diet should be changed. Close medical monitoring of the patient's condition should continue until it is certain that his health is not in danger.
Severe hypoglycemic conditions may develop, accompanied by coma, seizures or other neurological disorders. If such symptoms appear, emergency medical care and immediate hospitalization are necessary.
In the case of hypoglycemic coma or if it is suspected, the patient is injected intravenously with 50 ml of a 20-30% dextrose (glucose) solution. Then a 10% dextrose solution is administered intravenously to maintain the blood glucose concentration above 1 g/l. Careful monitoring of blood glucose concentrations and monitoring of the patient should be carried out for at least the next 48 hours.
After this period of time, depending on the patient’s condition, the attending physician decides on the need for further observation. Dialysis is ineffective due to the pronounced binding of gliclazide to plasma proteins.
INTERACTION WITH OTHER MEDICINES
1) Drugs that increase the risk of hypoglycemia:
(enhancing the effect of gliclazide)
Contraindicated combinations
- Miconazole(with systemic administration and when using the gel on the oral mucosa): enhances the hypoglycemic effect of gliclazide (possible development of hypoglycemia up to a coma).
Not recommended combinations
- Phenylbutazone(systemic administration): enhances the hypoglycemic effect of sulfonylurea derivatives (displaces them from association with plasma proteins and/or slows down their elimination from the body).
It is preferable to use another anti-inflammatory drug. If taking phenylbutazone is necessary, the patient should be warned about the need for glycemic control. If necessary, the dose of Diabeton ® MB should be adjusted while taking phenylbutazone and after its termination.
- Ethanol: enhances hypoglycemia by inhibiting compensatory reactions and may contribute to the development of hypoglycemic coma. It is necessary to stop taking medications that contain ethanol and drinking alcohol.
Taking gliclazide in combination with certain drugs (for example, other hypoglycemic agents - insulin, alpha-glucosidase inhibitor, biguanides; beta-blockers, fluconazole; angiotensin-converting enzyme inhibitors - captopril, enalapril; H2-histamine receptor blockers; monoamine oxidase inhibitors; sulfonamides and non-steroidal anti-inflammatory drugs) is accompanied by an increased hypoglycemic effect and the risk of hypoglycemia.
2) Drugs that increase blood glucose levels:
(weakening the effect of gliclazide)
Not recommended combinations
- Danazol: has a diabetogenic effect. If taking this drug is necessary, careful glycemic control is recommended to the patient. If it is necessary to take drugs together, it is recommended to select the dose of a hypoglycemic agent both while taking danazol and after its discontinuation.
Combinations requiring precautions
- Chlorpromazine (antipsychotic): in high doses (more than 100 mg per day) increases the concentration of glucose in the blood, reducing insulin secretion.
Careful glycemic control is recommended. If it is necessary to take drugs together, it is recommended to select the dose of a hypoglycemic agent, both while taking the antipsychotic and after its withdrawal.
- GKS(systemic and local use: intra-articular, skin, rectal administration): increase blood glucose concentrations with the possible development of ketoacidosis (decreased tolerance to carbohydrates). Careful glycemic control is recommended, especially at the beginning of treatment. If it is necessary to take drugs together, it may be necessary to adjust the dose of the hypoglycemic agent both while taking GCS and after their withdrawal.
- Ritodrine, salbutamol, terbutaline(intravenous administration): beta-2 adrenergic agonists increase blood glucose concentrations.
Particular attention should be paid to the importance of self-glycemic control. If necessary, it is recommended to transfer the patient to insulin therapy.
3) Combinations that must be taken into account
- Anticoagulants(eg warfarin)
Sulfonylurea derivatives may enhance the effect of anticoagulants when taken together. Anticoagulant dose adjustment may be required.
SPECIAL INSTRUCTIONS
Hypoglycemia
When taking sulfonylurea derivatives, including gliclazide, hypoglycemia may develop, in some cases in a severe and prolonged form, requiring hospitalization and intravenous administration of a dextrose solution for several days (see section “Side Effects”).
The drug can be prescribed only to those patients whose meals are regular and include breakfast. It is very important to maintain a sufficient intake of carbohydrates from food, since the risk of developing hypoglycemia increases with irregular or insufficient nutrition, as well as when consuming foods low in carbohydrates.
Hypoglycemia is more likely to occur during a low-calorie diet, after prolonged or vigorous exercise, after taking ethanol or ethanol-containing drugs, or when taking several hypoglycemic drugs at the same time.
Typically, symptoms of hypoglycemia go away after eating a meal rich in carbohydrates (such as sugar). It should be borne in mind that taking sweeteners does not help eliminate hypoglycemic symptoms. Experience with other sulfonylureas suggests that hypoglycemia may recur despite initial effective management of the condition. If hypoglycemic symptoms are pronounced or prolonged, even if the condition improves temporarily after eating a meal rich in carbohydrates, emergency medical care is necessary, including hospitalization.
To avoid the development of hypoglycemia, careful individual selection of drugs and dosage regimen is necessary, as well as providing the patient with complete information about the treatment being carried out.
An increased risk of hypoglycemia may occur in the following cases:
- refusal or inability of the patient (especially the elderly) to follow the doctor’s orders and control their condition;
- insufficient and irregular nutrition, skipping meals, fasting and changes in diet;
- imbalance between physical activity and the amount of carbohydrates taken;
- renal failure;
- severe liver failure;
- overdose of the drug Diabeton ® MV;
- some endocrine disorders: thyroid diseases, pituitary and adrenal insufficiency;
- simultaneous use of certain medications (see section “Interaction with other medications”). Clinical manifestations of hypoglycemia can be masked when taking beta-blockers, clonidine, reserpine, guanethidine.
In patients with hepatic and/or severe renal impairment, the pharmacokinetic and/or pharmacodynamic properties of gliclazide may be altered.
The state of hypoglycemia that develops in such patients can be quite long-lasting; in such cases, immediate appropriate therapy is necessary.
Patient Information
It is necessary to inform the patient, as well as his family members, about the risk of developing hypoglycemia, its symptoms and conditions that contribute to its development. The patient must be informed of the potential risks and benefits of the proposed treatment.
The patient must be explained the importance of diet, the need for regular exercise and monitoring blood glucose concentrations.
Poor blood glucose control
Glycemic control in patients receiving therapy with hypoglycemic agents may be weakened in the following cases: major surgical interventions and injuries, extensive burns, infectious diseases with febrile syndrome. In these conditions, it may be necessary to stop therapy with Diabeton ® MB and prescribe insulin therapy.
In some patients, the effectiveness of oral hypoglycemic agents, including gliclazide, tends to decrease after a prolonged period of treatment. This effect may be due to both progression of the disease and a decrease in the therapeutic response to the drug. This effect is known as secondary drug resistance, which must be distinguished from primary resistance, in which the drug does not produce the expected clinical effect even at the first administration. Before diagnosing secondary drug resistance in a patient, it is necessary to assess the adequacy of dose selection and the patient’s compliance with the prescribed diet.
Laboratory tests
To assess glycemic control, regular determination of fasting blood glucose concentration and glycosylated hemoglobin HbA1c level is recommended. In addition, it is advisable to regularly self-monitor blood glucose concentrations.
Sulfonylureas may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency. Since gliclazide is a sulfonylurea derivative, caution must be exercised when prescribing it to patients with glucose-6-phosphate dehydrogenase deficiency.
The possibility of prescribing a hypoglycemic drug of another group should be assessed.
INFLUENCE ON THE ABILITY TO DRIVE A CAR AND PERFORM WORK REQUIRING HIGH SPEED OF MENTAL AND PHYSICAL REACTIONS
Patients should be aware of the symptoms of hypoglycemia and should exercise caution when driving or performing work that requires high speed of physical and mental reactions, especially at the beginning of therapy.
RELEASE FORM
Modified release tablets 30 mg.
30 tablets per blister (PVC/Al), 1 or 2 blisters with instructions for medical use per cardboard box.
When packaging (packing) at the Russian enterprise Serdix LLC: 30 tablets per blister (PVC/Al), 2 blisters with instructions for use per cardboard box.
STORAGE CONDITIONS
No special storage conditions are required.
Keep out of the reach of children.
List B.
BEST BEFORE DATE
3 years. Do not use after the expiration date stated on the packaging.
VACATION CONDITIONS
According to the recipe.
The registration certificate was issued to Servier Laboratories, France
Produced by Servier Industry Laboratories, France
"Servier Industry Laboratories":
905, highway Saran, 45520 Gidie, France
905, route de Saran, 45520 Gidy, France
LLC “Serdix”:
The registration certificate was issued to Servier Laboratories, France
Manufactured by: Serdix LLC, Russia
LLC “Serdix”:
142150, Russia, Moscow region,
Podolsky district, Sofiino village, building 1/1
For any questions, please contact the Representative Office of Servier Laboratories JSC.
Representative office of JSC Servier Laboratories:
115054, Moscow, Paveletskaya sq. d.2, p.3
Antidiabetic agents are sulfonylurea derivatives.
Composition Diabeton MV
The active substance is gliclazide.
Manufacturers
Servier Industry Laboratories, packaged by Cerdix (France), Cerdix (Russia)
Pharmacological action
Pharmacological action - hypoglycemic.
Increases insulin secretion by beta cells of the pancreas and improves glucose utilization.
Stimulates the activity of muscle glycogen synthetase.
Effective in metabolic, latent diabetes mellitus, in patients with exogenous constitutional obesity.
Normalizes the glycemic profile after several days of treatment.
Reduces the period of time from the moment of food intake to the onset of insulin secretion, restores the early peak of insulin secretion and reduces hyperglycemia caused by food intake.
Improves hematological parameters, rheological properties of blood, hemostasis and microcirculation.
Prevents the development of microvasculitis, incl. lesions of the retina of the eye.
Suppresses platelet aggregation, significantly increases the relative disaggregation index, increases heparin and fibrinolytic activity, and increases heparin tolerance.
Shows antioxidant properties, improves vascularization of the conjunctiva, ensures continuous blood flow in microvessels, and eliminates signs of microstagnation.
In diabetic nephropathy, it reduces proteinuria.
Completely and quickly absorbed from the gastrointestinal tract.
In the liver it undergoes oxidation with the formation of metabolites, one of which has a pronounced effect on microcirculation.
It is excreted in the form of metabolites in the urine and through the gastrointestinal tract.
Side effects Diabeton MV
From the gastrointestinal tract:
- very rarely - dyspeptic symptoms (nausea,
- vomiting
- stomach pain,
- jaundice.
From the cardiovascular system and blood:
- reversible cytopenia,
- eosinophils,
- anemia.
From the skin:
- skin allergic reactions,
- photosensitivity.
From the side of metabolism:
- hypoglycemia.
From the nervous system and sensory organs:
- weakness,
- headache,
- dizziness,
- change in taste sensations.
Indications for use
Diabetes mellitus type 2, monotherapy and in combination with insulin or other oral hypoglycemic drugs.
Contraindications Diabeton MV
Hypersensitivity, type 1 diabetes mellitus, incl. juvenile, ketoacidosis, diabetic (with ketoacidosis) and hyperosmolar coma, extensive trauma and burns, liver failure and severe forms of renal failure, hypo- and hyperthyroidism, pregnancy, breastfeeding.
Directions for use and dosage
Modified release tablets:
- initial dose - 30 mg;
- in the future, the dose can be increased no earlier than after 2 weeks;
- the maximum daily dose is 120 mg (1 time per day with breakfast).
Overdose
Symptoms:
- hypoglycemic conditions,
- up to whom
- cerebral edema.
Treatment:
- oral glucose intake
- if necessary, intravenous administration of glucose solution (50.
- 50 ml).
Monitoring the level of glucose, urea nitrogen, electrolytes in the blood serum.
For cerebral edema - mannitol (iv), dexamethasone.
Interaction
The effect is enhanced by ACE inhibitors, anabolic steroids, beta-blockers, fibrates, biguanides, chloramphenicol, cimetidine, coumarins, fenfluramine, fluoxetine, salicylates, guanethidine, MAO inhibitors, miconazole, fluconazole, pentoxifylline, theophylline, phenylbutazone, phosphamides, tetracyclines.
Barbiturates, chlorpromazine, glucocorticoids, sympathomimetics, glucagon, saluretics, rifampicin, thyroid hormones, lithium salts, high doses of nicotinic acid, oral contraceptives and estrogens - reduce hypoglycemia.
Special instructions
During the dose selection period, especially when combined with insulin therapy, it is necessary to determine the sugar profile and glycemic dynamics; in the future, regular monitoring of blood glucose levels is indicated.
To prevent hypoglycemia, it is necessary to clearly time the drug intake with meals, avoid fasting and completely stop drinking alcohol.
Concomitant use of beta-blockers may mask the symptoms of hypoglycemia.
Use with caution while working for vehicle drivers and people whose profession involves increased concentration of attention.
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25°C.
