Gliclazid Canon - Instructions For Use, Price, 60 Mg Tablets, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Gliclazide Canon

Gliclazid Canon: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Gliclazide Canon

ATX code: A10BB09

Active ingredient: gliclazide (Gliclazide)

Producer: Kanonpharma production, CJSC (Russia)

Description and photo update: 2019-05-07

Prices in pharmacies: from 90 rubles.

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Gliclazide Canon is an oral hypoglycemic drug of the second generation sulfonylurea group.

Release form and composition

Dosage form - tablets with prolonged release: almost white or white, slight marbling of the surface is permissible, round biconvex; 60 mg each - with a dividing line (Gliclazide Canon 30 mg: 10 pcs. in blister packs, in a cardboard bundle 3 or 6 packs, 30 pcs. in blister packs, in a cardboard bundle 1 or 2 packs; Gliclazid Canon 60 mg: 10 pcs. in blister packs, in a cardboard bundle 3 or 6 packs, 15 pcs. in blister packs, in a cardboard bundle 2 or 4 packs; each pack also contains instructions for the use of Gliclazide Canon).

Composition of 1 tablet:

• active substance: gliclazide - 30 or 60 mg;
• auxiliary components (30/60 mg): magnesium stearate - 1.8 / 3.6 mg; microcrystalline cellulose - 81.1 / 102.2 mg; hydrogenated vegetable oil - 3.6 / 7.2 mg; hypromellose - 50/100 mg; colloidal silicon dioxide - 3.5 / 7 mg; mannitol - 10/80 mg.

Pharmacological properties

Pharmacodynamics

Gliclazide - the active substance of Gliclazide Canon, belongs to the sulfonylurea derivatives and is a hypoglycemic agent for oral administration. It differs from similar drugs by the presence of an N-containing heterocyclic ring with an endocyclic bond.

Gliclazide helps to reduce blood glucose concentration, which is provided by stimulating insulin secretion by beta cells of the islets of Langerhans. The duration of the effect of increasing the content of postprandial insulin and C-peptide continues after 2 years of therapy. The substance, in addition to affecting carbohydrate metabolism, has hematovascular and antioxidant properties.

When using Gliclazide Canon for the treatment of type 2 diabetes mellitus, the early peak of insulin secretion is restored in response to glucose intake and the second phase of insulin secretion is enhanced. As a result of stimulation, which is due to the introduction of glucose or food intake, there is a significant increase in insulin secretion.

The action of gliclazide is aimed at reducing the risk of thrombosis of small vessels, which occurs due to the influence on the mechanisms that may be associated with the development of complications in diabetes mellitus. These include partial inhibition of platelet adhesion and aggregation, reduction of the concentration of platelet activating factor (thromboxane B ₂, beta-thromboglobulin). In addition, Gliclazide Canon affects the restoration of the fibrinolytic activity of the vascular endothelium and an increase in the intensification of tissue plasminogen activator.

Compared to standard glycemic control (based on the results of the ADVANCE study), due to enhanced glycemic control based on prolonged release gliclazide therapy [target HbAlc (glycosylated hemoglobin) <6.5%], the likelihood of macro- and microvascular complications of sugar type 2 diabetes.

Pharmacokinetics

Gliclazide is completely absorbed after oral administration. Food intake has no effect on the degree of absorption. Plasma concentration of gliclazide increases gradually, it reaches maximum values and reaches a plateau after 6–12 hours. Has relatively low individual variability. The relationship between dose and the plasma concentration curve of a substance is linear with time.

About 95% of gliclazide binds to plasma proteins. The substance is metabolized mainly in the liver and excreted mainly by the kidneys. Vd (volume of distribution) - approximately 30 liters.

When 30 mg of gliclazide is used once a day, the effective plasma concentration of the substance in the blood is maintained for more than 24 hours.

Metabolism occurs primarily in the liver. There are no active metabolites in plasma.

Excretion of gliclazide is carried out mainly by the kidneys in the form of metabolites, up to 1% is excreted unchanged. T _1/2 (half-life) is in the range of 12-20 hours (on average - 16 hours).

In elderly patients, clinically significant changes in pharmacokinetic parameters are not observed.

Indications for use

• therapy of type 2 diabetes mellitus in patients who have insufficient effectiveness of nutritional therapy, exercise and weight loss;
• prevention of exacerbation of diabetes mellitus by reducing the risk of micro- and macrovascular complications (retinopathy, nephropathy, myocardial infarction, stroke) in patients with type 2 diabetes mellitus by means of intensive glycemic control.

Contraindications

Absolute:

• type 1 diabetes mellitus;
• severe hepatic / renal impairment;
• diabetic ketoacidosis, diabetic coma, diabetic precoma;
• simultaneous use with miconazole;
• combination therapy with dibazole or phenylbutazone;
• pregnancy and lactation;
• age up to 18 years;
• individual intolerance to the components of the drug, other sulfonylurea derivatives, sulfonamides.

Relative (Gliclazid Canon tablets are used under medical supervision):

• renal / hepatic impairment;
• unbalanced and / or irregular nutrition;
• severe diseases of the cardiovascular system, including atherosclerosis, ischemic heart disease;
• hypothyroidism;
• pituitary or adrenal insufficiency;
• hypopituitarism;
• long-term use of glucocorticosteroids;
• alcoholism;
• insufficiency of glucose-6-phosphate dehydrogenase;
• elderly age.

Gliclazid Canon, instructions for use: method and dosage

Gliclazide Canon 60 mg and 30 mg tablets should be taken orally, preferably during breakfast. They should not be crushed or chewed and should be swallowed whole.

The dose is selected individually based on the concentration of blood glucose and HbAlc.

The daily dose range is from 30 to 120 mg in one dose.

If you miss one or more doses of Gliclazide Canon, you cannot increase the next dose.

In untreated patients, the recommended starting dose is 30 mg per day. It is then adjusted individually until the desired result is achieved. You can start increasing the dose no earlier than 30 days after taking Gliclazide Canon. Further dose changes can be made at intervals of at least two weeks.

When transferring a patient from another hypoglycemic agent, no transition period is required.

The maintenance daily dose of Gliclazide Canon is in the same range as the therapeutic one (maximum 120 mg per day).

The drug can be used concomitantly with biguanidines, insulin or alpha-glucosidase inhibitors.

When Gliclazide Canon is prescribed to patients with mild / moderate renal failure, medical supervision should be established for their condition.

Patients at risk of developing hypoglycemia are prescribed a minimum dose of Gliclazide Canon. This group includes patients with the following diseases / conditions:

• unbalanced / insufficient nutrition;
• poorly compensated or severe endocrine disorders, including pituitary and adrenal insufficiency, hypothyroidism;
• severe diseases of the cardiovascular system, including severe ischemic heart disease, generalized atherosclerosis, severe atherosclerosis of the carotid arteries;
• withdrawal of glucocorticosteroids after prolonged therapy and / or use in high doses.

In order to achieve intensive glycemic control, therapy can be supplemented with other hypoglycemic drugs, for example, metformin, alpha-glucosidase inhibitors, thiazolidinedione derivatives or insulin.

Side effects

In cases of irregular food intake, especially if meals are skipped, hypoglycemia may be accompanied by the following symptoms: severe hunger, vomiting, nausea, headache, sleep disturbance, increased fatigue, irritability, confusion, decreased concentration, agitation, delayed reaction, depression, convulsions, weakness, delirium, bradycardia, impaired speech and vision, impaired perception, paresis, dizziness, drowsiness, respiratory failure, tremor, aphasia, loss of consciousness with the possible development of coma, up to death.

In addition, adrenergic reactions have been reported with Gliclazide Canon, including increased sweating, clammy skin, anxiety, tachycardia, palpitations, increased blood pressure, angina pectoris, and arrhythmia.

Other possible violations from systems and organs:

• digestive system: vomiting, nausea, diarrhea, abdominal pain, constipation (when taking Gliclazide Canon with meals, there is a decrease in the severity of these symptoms);
• skin and subcutaneous tissue: maculopapular rash, rash, urticaria, pruritus, erythema, bullous reactions (including toxic epidermal necrolysis, Stevens-Johnson syndrome);
• circulatory and lymphatic systems: granulocytopenia, thrombocytopenia, anemia, leukopenia (usually, with discontinuation of therapy, these disorders are reversible);
• liver and biliary tract: increased activity of liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), hepatitis (isolated cases have been reported), cholestatic jaundice (Gliclazide Canon must be canceled);
• organ of vision: visual impairments (they are transient, their development is associated with a change in the concentration of glucose in the blood, especially at the beginning of treatment).

Common adverse reactions of sulfonylurea derivatives include hyponatremia, allergic vasculitis, agranulocytosis, erythropenia, hemolytic anemia, pancytopenia. Also, while taking other sulfonylurea derivatives, there was an increase in the activity of liver enzymes, impaired liver function (for example, with the development of jaundice and cholestasis), hepatitis. After the abolition of these drugs, the severity of these manifestations decreased over time, however, in some patients, the development of life-threatening liver failure was noted.

Overdose

The main symptom of an overdose of sulfonylurea derivatives is hypoglycemia, up to hypoglycemic coma.

Moderate manifestations of hypoglycemia, not accompanied by impaired consciousness or neurological symptoms, can be stopped by taking carbohydrates, changing the diet and / or adjusting the dose. Careful monitoring of the patient's condition is required until there is confidence that nothing threatens his health.

In severe hypoglycemic conditions, which are accompanied by convulsions, coma, or other neurological disorders, an ambulance should be provided. In this case, immediate hospitalization is indicated.

Patients with hypoglycemic coma (confirmed or suspected) are injected intravenously with 50 ml of a 40% glucose solution (dextrose). After that, a 5% dextrose solution is prescribed (intravenously drip) in order to maintain the required blood glucose concentration at about 1 g / l. Careful monitoring of blood glucose concentration and monitoring of the patient's condition is carried out for at least 48 hours. The question of the need for further monitoring of the vital functions of the patient is decided individually, based on his condition.

In case of an overdose, dialysis is ineffective, due to the pronounced binding of gliclazide to plasma proteins.

special instructions

Against the background of the use of Gliclazide Canon, hypoglycemia may develop, in some patients - in a prolonged and severe form, which requires hospitalization and intravenous administration of a dextrose solution for several days.

Gliclazide Canon should be prescribed only in cases where the patient's meals are regular and includes breakfast. It is very important that the patient maintains an adequate intake of carbohydrates from food, since the likelihood of hypoglycemia with irregular or insufficient nutrition, as well as with the use of low carbohydrate foods, increases. In most cases, hypoglycemia develops with a low-calorie diet, after vigorous or prolonged physical exercise, alcohol consumption, or while using several hypoglycemic drugs at the same time.

Symptoms of hypoglycemia usually resolve after eating carbohydrate-rich foods (such as sugar). It should be borne in mind that taking sugar substitutes does not help to eliminate hypoglycemic symptoms.

Based on the use of other sulfonylurea derivatives, it can be argued that hypoglycemia can recur despite effective initial relief of this condition.

If hypoglycemic symptoms are prolonged or pronounced, even with a temporary improvement in the condition after taking a carbohydrate-rich meal, emergency medical care is required, sometimes hospitalization is necessary.

To minimize the likelihood of hypoglycemia, the dose must be carefully selected. Also, the patient should have full information about the proposed treatment.

An increased risk of developing hypoglycemia is observed in the following cases:

• inability or refusal of the patient (especially the elderly) to control their condition and follow the doctor's prescriptions;
• discrepancy between the amount of carbohydrates taken and physical activity;
• skipping meals, irregular and inadequate nutrition, dietary changes and fasting;
• renal failure;
• severe liver failure;
• some endocrine diseases (thyroid disease, adrenal and pituitary insufficiency);
• overdose of Gliclazide Canon;
• combined use with certain drugs.

Against the background of glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia may develop, which requires caution when prescribing Gliclazide Canon to patients with glucose-6-phosphate dehydrogenase deficiency. The possibility of prescribing a hypoglycemic drug of another group should be evaluated.

In patients with severe hepatic and / or renal impairment, developing hypoglycemia can be quite prolonged, in such cases, immediate appropriate treatment is required.

Family members of the patient should be informed about the risk of hypoglycemia, its signs and conditions that contribute to its occurrence.

While taking Gliclazide Canon, glycemic control in patients may be weakened in the following cases: trauma, fever, infectious diseases or major surgical interventions. Under these conditions, it may be necessary to stop taking the drug and switch to insulin.

After prolonged treatment, the effectiveness of oral hypoglycemic agents, including gliclazide, tends to decrease in many patients. This may be due to the progression of the disease and / or a decrease in the therapeutic response to Gliclazide Canon. This phenomenon is called secondary drug resistance. It must be distinguished from the primary one, when the drug does not give the expected clinical effect initially. Before diagnosing secondary drug resistance, it is necessary to assess the adequacy of the dose selection and patient compliance with the prescribed diet.

During the period of therapy, it is advisable to regularly self-monitor the concentration of blood glucose.

Influence on the ability to drive vehicles and complex mechanisms

During the period of therapy, when driving vehicles, patients should take into account the likelihood of hypoglycemia and be able to recognize its symptoms.

Application during pregnancy and lactation

Gliclazide Canon is not prescribed during pregnancy / lactation.

There is no experience with gliclazide therapy during pregnancy; information on the use of other sulfonylurea derivatives is limited. Teratogenic effects of gliclazide have not been identified in studies on laboratory animals.

The drug of choice for diabetes mellitus in pregnant women is insulin. At the onset or planning of pregnancy, Gliclazide Canon should be replaced with insulin.

There is no information on the penetration of gliclazide into breast milk and the risk of developing neonatal hypoglycemia, and therefore breastfeeding during therapy with this hypoglycemic agent is contraindicated.

Pediatric use

Gliclazide Canon is not intended for use in children under 18 years of age.

With impaired renal function

• severe renal failure: therapy is contraindicated;
• renal impairment: Gliclazide Canon should be used under medical supervision.

For violations of liver function

• severe hepatic impairment: therapy is contraindicated;
• liver failure: Gliclazide Canon should be used under medical supervision.

Use in the elderly

Gliclazide Canon is prescribed to elderly patients in doses identical to those for adults up to 65 years of age, but caution should be exercised during treatment.

Drug interactions

Medicines that enhance the effect of gliclazide:

• miconazole (systemic therapy or the use of the drug in the form of a gel on the oral mucosa): the hypoglycemic effect of gliclazide increases; the combination is contraindicated, which is associated with a high likelihood of developing hypoglycemia up to coma;
• phenylbutazone (systemic therapy): the hypoglycemic effect is enhanced, which occurs due to the displacement of gliclazide from the bonds with plasma proteins and / or a slowdown in its excretion from the body; the combination is not recommended, it is preferable to use another anti-inflammatory agent. In cases where the use of phenylbutazone is necessary, it is necessary to control the concentration of blood glucose. If necessary, for the period of combined use, the dose of gliclazide must be adjusted;
• ethanol: hypoglycemia may increase, which occurs due to inhibition of compensatory reactions; the combination is not recommended, since hypoglycemic coma may develop. During the period of therapy, one should refrain from taking ethanol-containing drugs and drinking alcohol.

Medicines, combined use with which requires caution (due to increased hypoglycemic effect and risk of hypoglycemia):

• other hypoglycemic agents, including insulin, acarbose, biguanides;
• beta-blockers, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, fluconazole;
• angiotensin-converting enzyme inhibitors, including captopril, enalapril;
• blockers of H ₂ -histamine receptors;
• monoamine oxidase inhibitors;
• non-steroidal anti-inflammatory drugs, sulfonamides, clarithromycin.

Medicines that weaken the effects of gliclazide:

• danazol: has diabetogenic properties; combined use is not recommended. If necessary, the simultaneous use of these drugs requires careful monitoring of blood glucose levels, for the period of combination therapy, the dose of gliclazide should be adjusted;
• chlorpromazine (from 100 mg per day): the concentration of glucose in the blood increases, while the secretion of insulin decreases; the combination requires caution. Careful monitoring of blood glucose levels is required; for the period of combination therapy, the dose of gliclazide should be adjusted;
• glucocorticosteroids (systemic therapy and local use: intra-articular, rectal and external): the concentration of glucose in the blood increases with the possible development of ketoacidosis (decreased tolerance to carbohydrates); the combination requires caution. Careful monitoring of blood glucose levels is recommended, especially at the start of combination therapy. For the period of simultaneous use, the dose of gliclazide should be adjusted;
• salbutamol, ritodrin, terbutaline (intravenous administration): beta-2-adrenergic agonists increase the concentration of glucose in the blood; the combination requires caution. It is important to self-control your blood glucose levels. In some cases, it is possible to transfer the patient to insulin therapy.

It should be taken into account that with the simultaneous use of gliclazide with anticoagulants (for example, with warfarin), it is likely that the action of the latter will increase, which may require a dose adjustment.

Analogs

Analogs of Gliclazide Canon are: Diabetalong, Diabinax, Reklid, Gliclada, Glidiab, Diatica, Glucostabil, Diabeton, Predian, Diabefarm, etc.

Terms and conditions of storage

Store in manufacturer's packaging at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Gliclazide Canon

There are few reviews about Gliclazide Canon, patients and medical specialists mainly describe the action of the active component of the drug - gliclazide. Since the substance is a representative of second-generation sulfonylurea derivatives, its hypoglycemic capabilities are more pronounced in comparison with its predecessors: gliclazide has 2-5 times higher affinity for β-cell receptors, therefore, minimum doses of the drug are used for treatment. It is well tolerated, has a daily coverage, and is able to restore carbohydrate metabolism for several days, especially in patients with newly diagnosed diabetes mellitus.

Drugs containing gliclazide are considered effective and are often prescribed for the treatment of type 2 diabetes.

Price for Gliclazide Canon in pharmacies

The approximate price for Gliclazide Canon, extended-release tablets, is: 60 pcs. 30 mg each - 129 rubles; 30 pcs. 60 mg each - 171 rubles.

Gliclazide Canon: prices in online pharmacies

Drug name Price Pharmacy

Gliclazide Canon 30 mg sustained release tablets 30 pcs. RUB 90 Buy

Gliclazide Canon 30 mg sustained release tablets 60 pcs. 144 RUB Buy

Gliclazide Canon 60 mg sustained release tablets 30 pcs. 153 r Buy

Gliclazide Canon tablets with prolonged release. 30mg 60 pcs. 168 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!