Golda MV
Golda MV: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Golda MB
ATX code: A10BB09
Active ingredient: gliclazide (Gliclazide)
Producer: LLC "Pharmasintez-Tyumen" (Russia), JSC "Pharmasintez" (Russia)
Description and photo update: 2019-11-07
Prices in pharmacies: from 98 rubles.
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Golda MV is a hypoglycemic drug for oral administration, a II generation sulfonylurea derivative.
Release form and composition
The drug is available in the form of modified-release tablets: white or white with a yellow tinge, round, flat-cylindrical, with a bevel, on tablets with a dosage of 60 mg, a dividing line is applied (for a dosage of 30 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, 180, 200 or 300 pcs. In cans, in a cardboard box 1 can; 10 pcs. In blisters, in a cardboard box 1-10 packs; for dosage 60 mg: 10, 20, 25, 30, 40, 50, 60, 70, 75, 80, 84, 90, 100, 120, 125, 140, 150, 180, 250 or 300 pcs. in cans, in a cardboard box 1 can; in blisters: 10 pcs., In a cardboard bundle 1-10 packs; 7 pcs., In a cardboard bundle 2, 4, 6, 8 or 10 packs. Each pack also contains instructions for using Golda MV).
1 tablet contains:
- active substance: gliclazide - 30 or 60 mg;
- auxiliary components: lactose monohydrate, sodium carboxymethyl starch (type C), hypromellose 2208, colloidal silicon dioxide, magnesium stearate.
Pharmacological properties
Pharmacodynamics
Golda MV is an oral hypoglycemic drug. Its active ingredient, gliclazide, is a second generation sulfonylurea derivative with modified release. It is distinguished from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic bond. Gliclazide stimulates insulin secretion by beta cells of the islets of Langerhans, reducing the concentration of glucose in the blood. After two years of therapy, the effect of increasing the concentration of postprandial insulin and C-peptide persists.
Along with the effect on carbohydrate metabolism, it has a hemovascular effect. In type 2 diabetes mellitus, gliclazide helps to restore the early peak of insulin secretion in response to glucose intake and enhance the second phase of insulin secretion. The secretion of insulin is significantly increased against the background of stimulation due to food intake and glucose administration.
Hemovascular effects of gliclazide are manifested by a decrease in the risk of small vessel thrombosis. Partially inhibits platelet aggregation and adhesion, reduces the concentration of platelet activation factors (thromboxane B2, beta-thromboglobulin). Promotes an increase in the activity of tissue plasminogen activator, has an effect on the restoration of the fibrinolytic activity of the vascular endothelium.
In patients with a glycohemoglobin index (Hb A1c) of less than 6.5%, the use of gliclazide provides intensive glycemic control, significantly reducing micro- and macrovascular complications of type 2 diabetes mellitus.
The appointment of gliclazide for the purpose of intensive glycemic control involves increasing its dose in combination with standard therapy (or instead of it) before adding metformin, a thiazolidinedione derivative, an alpha-glucosidase inhibitor, insulin, or other hypoglycemic agent to it. The results of clinical studies have shown that against the background of the use of gliclazide in an average daily dose of 103 mg (maximum dose - 120 mg) compared with standard control therapy, a decrease in the relative risk of the combined incidence of macro- and microvascular complications is 10%.
The advantages of intensive glycemic control while taking Golda MV include a clinically significant decrease in the incidence of such pathologies as major microvascular complications (by 14%), nephropathy (by 21%), renal complications (by 11%), microalbuminuria (by 9%), macroalbuminuria (by 30%).
Pharmacokinetics
After taking Golda MV, gliclazide is completely absorbed inside, the level of its concentration in blood plasma increases gradually and reaches a plateau after 6-12 hours. Simultaneous food intake does not affect the degree of absorption, individual variability is insignificant. For gliclazide at a dose of up to 120 mg, a linear relationship is characteristic between the dose taken and AUC (area under the concentration-time pharmacokinetic curve).
Plasma protein binding - 95%.
The volume of distribution is about 30 liters. A single dose of gliclazide ensures that its effective concentration in the blood plasma remains for more than 24 hours.
Gliclazide is metabolized mainly in the liver. There are no active metabolites in blood plasma.
The half-life is 12–20 hours.
It is excreted mainly through the kidneys in the form of metabolites, unchanged - less than 1%.
In elderly patients, significant changes in pharmacokinetic parameters are not expected.
Indications for use
- treatment of type 2 diabetes mellitus - in the absence of a sufficient effect from diet therapy, physical activity and weight loss;
- prevention of complications in patients with type 2 diabetes mellitus - reducing the risk of microvascular (retinopathy, nephropathy) and macrovascular (myocardial infarction, stroke) pathologies by intensive glycemic control.
Contraindications
Absolute:
- type 1 diabetes mellitus;
- diabetic precoma, diabetic coma;
- diabetic ketoacidosis;
- severe renal failure;
- severe liver failure;
- concomitant therapy with miconazole;
- combination therapy with danazol or phenylbutazone;
- congenital lactose intolerance, galactosemia, glucose-galactose malabsorption;
- period of pregnancy;
- breast-feeding;
- age up to 18 years;
- individual intolerance to sulfonylurea derivatives, sulfonamides;
- hypersensitivity to the components of the drug.
With caution, Gold MV tablets should be used in elderly patients, with irregular and / or unbalanced nutrition, severe diseases of the cardiovascular system (severe ischemic heart disease, widespread atherosclerosis, severe form of carotid atherosclerosis), deficiency of glucose-6-phosphate dehydrogenase, renal and / or liver failure, adrenal or pituitary insufficiency, hypothyroidism, long-term glucocorticosteroid therapy (GCS), alcoholism.
Golda MV, instructions for use: method and dosage
Golda MV tablets are taken orally, swallowing whole (without chewing), preferably during breakfast.
The daily dose is taken once and should be in the range of 30 to 120 mg.
You cannot replenish the accidentally missed regular dose in the next dose, taking an increased dose.
The dose of gliclazide is selected individually, taking into account the level of glucose concentration in the blood and the Hb A1c indicator.
Recommended dosage: initial dose - 30 mg (1 tablet of Golda MV 30 mg or ½ tablet of Golda MV 60 mg). If the indicated dose provides adequate glycemic control, then it can be used as a maintenance dose. In the absence of a sufficient clinical effect after 30 days of therapy, the initial dose is gradually increased in increments of 30 mg (up to 60, 90, 120 mg). In exceptional cases, if the patient's blood glucose level has not decreased after 14 days of therapy, the dose can be increased 14 days after the start of the dose.
The maximum daily dose is 120 mg.
When switching from taking gliclazide tablets with immediate release at a dose of 80 mg, start taking modified release tablets with a dose of 30 mg, accompanying treatment with careful glycemic control.
When switching to Golda MV from other hypoglycemic drugs, a transition period is usually not required. The initial dose of gliclazide in modified release tablets should be 30 mg, followed by titration depending on the concentration of glucose in the blood.
When transferring, the dose and half-life of the previous hypoglycemic drug should be taken into account. If sulfonylurea derivatives with a long half-life are replaced, then all hypoglycemic agents can be discontinued for several days. This will avoid hypoglycemia due to the additive effect of gliclazide and sulfonylurea derivatives.
The use of Golda MV has been shown as a part of combination therapy with alpha-glucosidase inhibitors, biguanides or insulin.
Elderly patients (over 65 years of age) do not need dose adjustment.
With mild to moderate renal failure, dose adjustment is not required.
It is recommended to use the minimum dose (30 mg) of long-acting gliclazide for the treatment of patients at risk of developing hypoglycemia [irregular or unbalanced nutrition, severe or poorly compensated endocrine disorders, hypothyroidism, severe diseases of the cardiovascular system, the period after long-term use and / or intake of high doses of glucocorticosteroids (GCS)].
The use of Golda MV in addition to diet and exercise for the prevention of complications of type 2 diabetes should be started with a dose of 30 mg. To achieve intense glycemic control and target Hb A1c levels, the starting dose can be gradually increased to a maximum dose of 120 mg per day. The administration of the drug for the purpose of intensive glycemic control is indicated in combination with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative, insulin and other hypoglycemic agents.
Side effects
If you skip the next meal or systematic irregular eating, the following symptoms of hypoglycemia may appear: increased fatigue, severe hunger, headache, delayed reaction, nausea, vomiting, decreased concentration, dizziness, weakness, sleep disturbance, irritability, agitation, confusion, depression, visual and speech impairments, paresis, aphasia, tremors, loss of self-control, impaired perception, feeling of helplessness, convulsions, shallow breathing, bradycardia, delirium, drowsiness, loss of consciousness, coma (including fatal); adrenergic reactions - increased sweating, anxiety, clammy body skin, tachycardia, increased blood pressure (blood pressure), arrhythmia, palpitations, angina pectoris. The results of clinical studies indicate thatthat with the use of the drug for the purpose of intensive glycemic control, hypoglycemia occurs more often than with standard glycemic control. Most cases of hypoglycemia in the intensive glycemic control group occurred with concomitant insulin therapy.
In addition, against the background of the use of Golda MV, the following side effects may develop:
- from the gastrointestinal tract: abdominal pain, nausea, vomiting, diarrhea, constipation;
- from the lymphatic and circulatory systems: rarely - thrombocytopenia, anemia, leukopenia, granulocytopenia;
- from the hepatobiliary system: increased activity of alkaline phosphatase, ACT (aspartate aminotransferase), ALT (alanine aminotransferase), hepatitis, cholestatic jaundice;
- on the part of the organ of vision: transient visual disturbances (more often at the beginning of therapy);
- dermatological reactions: itching, rash, maculopapular rash, urticaria, erythema, Quincke's edema, bullous reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis);
- others (side effects typical for sulfonylurea derivatives): hemolytic anemia, erythrocytopenia, agranulocytosis, allergic vasculitis, pancytopenia, hyponatremia, jaundice, severe hepatic failure.
Overdose
Symptoms: in case of an overdose, symptoms characteristic of hypoglycemia develop.
Treatment: for the relief of moderate symptoms of hypoglycemia (without neurological symptoms and impaired consciousness), it is necessary to increase the intake of carbohydrates, reduce the dose of Golda MB and / or change the diet. A careful medical observation of the patient's condition is shown.
If severe hypoglycemic conditions appear (coma, seizures and other disorders of neurological origin), immediate hospitalization is required.
Ambulance for hypoglycemic coma or suspicion of it provides for intravenous (iv) jet injection of 20-30% dextrose (glucose) solution at a dose of 50 ml, followed by intravenous drip administration of 10% dextrose solution, which maintains the glucose concentration in blood above 1 g / l. Careful monitoring of the patient's condition and monitoring of blood glucose concentration should be continued for the next 48 hours.
Dialysis is ineffective.
special instructions
Golda MV should be prescribed only if the patient's diet includes breakfast and meals are regular. This is associated with a high risk of developing hypoglycemia, including severe and prolonged forms requiring hospitalization and intravenous administration of dextrose solution for several days. During the period of taking Golda MV, it is very important to ensure a sufficient intake of carbohydrates from food. An irregular diet, inadequate intake, or a diet low in carbohydrates contributes to the development of hypoglycemia. More often, the development of hypoglycemia is observed in patients following a low-calorie diet, after intense or prolonged physical exertion, alcohol consumption, or during treatment with several hypoglycemic agents at the same time. Usually, eating foods rich in carbohydrates (including sugar) can help relieve symptoms of hypoglycemia. In this case, sugar substitutes are not effective. It should be borne in mind that hypoglycemia can recur. Therefore, if hypoglycemia has a pronounced symptomatology or is prolonged, despite the effectiveness of eating carbohydrate-rich foods, you should seek emergency medical help.
When prescribing Golda MV, the doctor must inform the patient in detail about the therapy and the need for strict adherence to the dosage regimen, balanced diet and physical activity.
The reason for the development of hypoglycemia is the inability or unwillingness of the patient (especially in old age) to follow the doctor's recommendations and systematically control the blood sugar level, malnutrition, dietary changes, skipping meals or starvation, imbalance between physical activity and the amount of carbohydrates taken, severe liver failure, renal failure, drug overdose, pituitary and adrenal insufficiency and / or thyroid disease.
In addition, hypoglycemia can be potentiated by the interaction of gliclazide with concomitant therapy drugs. Therefore, the patient should agree with the doctor to take any medication.
When prescribing Golda MV, the doctor should inform the patient and his family in detail about the potential risks and benefits of the forthcoming treatment, the causes and symptoms of hypoglycemia, the importance of adhering to the recommended diet and a set of physical exercises, and the appropriateness of regular self-monitoring of blood glucose levels.
To assess glycemic control, Hb Alc should be measured regularly.
It should be borne in mind that with concomitant hepatic and / or severe renal failure, the state of hypoglycemia can be quite long and requires immediate appropriate therapy.
The achieved glycemic control can be weakened by fever, infection, injury, or major surgery. In these conditions, it is advisable to transfer the patient to insulin therapy.
The lack of efficacy of gliclazide after a long period of treatment may be due to secondary drug resistance, which is a consequence of the progression of the disease or a decrease in the clinical response to the drug. When diagnosing secondary drug resistance, it is necessary to ensure that the patient is following the prescribed diet and assess the adequacy of the dose of Golda MV taken.
With a deficiency of glucose-6-phosphate dehydrogenase, the use of sulfonylurea derivatives increases the risk of hemolytic anemia. Therefore, for the treatment of patients with glucose-6-phosphate dehydrogenase deficiency, hypoglycemic agents of another group should be preferred.
Influence on the ability to drive vehicles and complex mechanisms
During the period of application of Golda MV, especially at the beginning of therapy, patients should be careful when driving or performing work that requires a high speed of psychomotor reactions.
Application during pregnancy and lactation
The use of Golda MV is contraindicated during gestation and lactation.
When planning pregnancy or conception while taking gliclazide, it is necessary to replace taking an oral hypoglycemic drug with insulin therapy.
Pediatric use
The appointment of Golda MV is contraindicated in patients under 18 years of age, since the efficacy and safety of using gliclazide for the treatment of children and adolescents has not been established.
With impaired renal function
The appointment of Golda MV is contraindicated in patients with severe renal failure.
The drug should be taken with caution in patients with mild to moderate renal failure.
For violations of liver function
The appointment of Golda MV is contraindicated in severe liver failure.
It is recommended to use gliclazide with caution in mild to moderate hepatic insufficiency.
Use in the elderly
Patients over the age of 65 should take Golda CF with caution, strictly following all the doctor's prescriptions.
Drug interactions
- miconazole: systemic administration of miconazole or its use in the form of a gel on the oral mucosa causes an increase in the hypoglycemic effect of gliclazide, which can cause the development of hypoglycemia up to coma;
- phenylbutazone: combination with oral forms of phenylbutazone enhances the hypoglycemic effect of Golda MV, therefore, if it is impossible to prescribe another anti-inflammatory agent, it is necessary to adjust the dose of gliclazide both during the period of taking phenylbutazone and after its cancellation;
- ethanol: the use of alcoholic beverages or ethanol-containing drugs inhibits compensatory reactions, which can lead to increased hypoglycemia or the development of hypoglycemic coma;
- other hypoglycemic agents (insulin, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists), beta-blockers, fluconazole, angiotensin-converting enzyme inhibitors, H- 1 inhibitors, H-blockers, H-blockers, H-blockers sulfonamides, clarithromycin, non-steroidal anti-inflammatory drugs: the combination of these drugs with gliclazide is accompanied by an increase in the effect of Golda MV and an increased risk of hypoglycemia;
- danazol: the diabetogenic effect of danazol helps to weaken the effect of gliclazide;
- chlorpromazine: high daily doses (more than 100 mg) of chlorpromazine reduce insulin secretion, helping to increase the concentration of glucose in the blood. Therefore, with concomitant therapy with a neuroleptic, selection of a dose of gliclazide and careful glycemic control are required, including after discontinuation of chlorpromazine;
- tetracosactide, GCS for systemic and local use: reduce carbohydrate tolerance, contributing to an increase in glycemia and the risk of developing ketoacidosis. Careful monitoring of blood glucose levels is required, especially at the beginning of joint treatment, if necessary, correction of the dose of gliclazide;
- ritodrin, salbutamol, terbutaline (i / v): it should be borne in mind that beta 2 -adrenomimetics increase the level of glucose in the blood, therefore, when combined with them, patients need regular glycemic self-control, it is possible to transfer the patient to insulin therapy;
- warfarin and other anticoagulants: gliclazide may contribute to a clinically significant increase in the action of anticoagulants.
Analogs
Analogs of Golda MV are: Diabetalong, Glidiab, Gliclada, Gliclazid Canon, Gliclazide MV, Gliclazid-SZ, Gliclazid-Akos, Diabeton MB, Diabinax, Diabefarm, Diabefarm MV, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Gold MV
Reviews about Gold MV are controversial. Patients (or their relatives) indicate the rapid achievement of a sufficient sugar-reducing effect while taking the drug, while they note an increased risk of hypoglycemia and other side effects. In addition, the disadvantages include the presence of contraindications.
During the period of taking Golda MV, it is recommended to strictly follow the prescribed diet and diet, and monitor blood sugar levels daily.
The price of Golda MV in pharmacies
The price of Golda MB 30 mg can be from 164 rubles, Golda MB 60 mg - from 195 rubles. per pack containing 30 tablets.
Golda MV: prices in online pharmacies
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Drug name Price Pharmacy |
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Golda MV 30 mg modified release tablets 60 pcs. RUB 98 Buy |
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Golda MV 60 mg modified release tablets 30 pcs. 162 RUB Buy |
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Golda MV tablets with mod. release 30mg 60 pcs. Pharmsynthesis 207 r Buy |
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Golda MV tablets with mod. release 60mg 30 pcs. 217 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
