Gliclazide Canon, 60 mg 30 pcs

Hypoglycemic agent for oral use of sulfonylurea group II generation.

Indications

Type 2 diabetes mellitus with insufficient effectiveness of diet therapy, physical activity and weight reduction.

Prevention of diabetes complications: reduction of risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke) in patients with type 2 diabetes by intensive glycemic control.

Active ingredient

Composition

1 tablet contains:

The active ingredient:

Glyclazide 60 mg;

Auxiliary substances:

Hypromellose (hydroxypropyl methyl cellulose) 100 mg,

Silicon dioxide colloid 7 mg,

Mannitol 80 mg,

magnesium stearate 3.6 mg,

vegetable oil hydrogenated 7.2 mg,

microcrystalline cellulose 102.2 mg.

How to take, the dosage

The drug is intended for adults only.

The recommended dose of the drug should be taken orally, once daily, preferably during breakfast.

The daily dose is 30-120 mg (1-4 tablets) at 1 sitting. It is recommended that the tablet be swallowed whole, without chewing or crushing.

If one or more doses of the drug are missed, the higher dose should be taken the next day. As with other hypoglycemic drugs, the dose of the drug should be adjusted individually in each case, depending on the blood glucose concentration and glycosylated hemoglobin (HbAlc).

The initial recommended dose in untreated adults (including elderly people > 65 years) is 30 mg/day (1 tablet), then the dose is adjusted individually until the desired effect is achieved.

There is no transition time required when replacing Gliclazide Kanon with another hypoglycemic agent. It is necessary to stop taking this medication first and only then take Gliclazide Canon.

Dose adjustment

The dose can be increased not earlier than after 1 month of therapy with the drug in the previously prescribed dose. The dose should be adjusted according to the blood glucose concentration after the start of treatment. Each subsequent dose change can be undertaken after at least a two-week period.

Supportive therapy

The maintenance daily dose is 30 to 90 to 120 mg (1 to
3 to 4 tablets), and should not exceed 120 mg. Gliclazide Canon can be used in combination with biguanidines, alpha-glucosidase inhibitors or insulin.

Patients in the elderly

The recommended doses of the drug for the elderly are identical to those for adults under 65 years of age.

Renal failure

The recommended doses of the drug for mild to moderate renal failure are identical to those for those with normal renal function. Close medical monitoring of patients is recommended.

Patients at risk for hypoglycemia

In patients at risk for hypoglycemia (insufficient or unbalanced nutrition; severe or poorly compensated endocrine disorders – pituitary and adrenal insufficiency, hypothyroidism; withdrawal of GCS after long-term use and/or when taking them in high doses; severe cardiovascular diseases (severe coronary artery disease, severe carotid atherosclerosis, widespread atherosclerosis) a minimum dose (30 mg) of the drug is recommended.

Prevention of diabetes complications

To achieve intense glycemic control, the dose of Gliclazide Canon 120 mg/day may be gradually increased in addition to diet and exercise until the target HbAlc level is achieved. The risk of hypoglycemia should be kept in mind. In addition, other hypoglycemic medications such as metformin, an alpha-glucosidase inhibitor, a thiazolidinedione derivative, or insulin may be added to therapy.

Interaction

1) Drugs that increase the effect of gliclazide (increased risk of hypoglycemia):

Contraindicated combinations

Miconazole (systemic administration or oral mucosal gel application): increases the hypoglycemic effects of gliclazide (possible development of hypoglycemia to the point of coma).

Not recommended combinations

Phenylbutazone (systemic administration) increases the hypoglycemic effect of sulfonylurea derivatives (displaces them from binding to plasma proteins and/or slows their elimination from the body). It is preferable to use another anti-inflammatory drug. If administration of phenylbutazone is necessary, the patient should be advised to monitor blood glucose concentrations. If necessary, the dose of gliclazide should be adjusted during and after administration of phenylbutazone.

Ethanol: increases hypoglycemia by inhibiting compensatory responses, may contribute to the development of hypoglycemic coma. It is necessary to avoid taking medicines containing ethanol and drinking alcohol.

Combinations requiring precautions

The use of gliclazide in combination with certain drugs, such as other hypoglycemic agents – insulin, acarbose, biguanides; beta-adrenoblockers, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, fluconazole; angiotensin-converting enzyme inhibitors – captopril, enalapril; H2-histamine receptor blockers; monoamine oxidase inhibitors; sulfonamides, clarithromycin and non-steroidal anti-inflammatory drugs, accompanied by increased hypoglycemic effect and risk of hypoglycemia.

2) Drugs that weaken the effect of gliclazide:

No recommended combinations.

Danazol: has a diabetogenic effect. The patient is advised to monitor blood glucose concentrations carefully if this medication is needed. If co-administration is necessary, it is recommended that the dose of gliklazide be adjusted both while taking danazolol and after discontinuation of the drug.

Combinations requiring precautions.

Chlorpromazine: in high doses (more than 100 mg per day) increases blood glucose concentration, reducing insulin secretion. It is recommended to monitor blood glucose concentration carefully. If co-administration is necessary, it is recommended that the dose of gliclazide be adjusted both during chlorpromazine administration and after its withdrawal.

HKS (systemic and topical use: intraarticular, external and rectal administration): increase blood glucose concentration with possible development of ketoacidosis (reduced tolerance to carbohydrates). It is recommended to monitor blood glucose concentration carefully, especially at the beginning of treatment. If coadministration of drugs is necessary, it may be necessary to adjust the dose of hypoglycemic agent both during the administration of GCS and after their withdrawal.

Ritodrine, salbutamol, terbutaline (intravenous):

Beta-2-adrenomimetics contribute to elevated blood glucose concentrations.

Particular attention should be paid to the importance of self-monitoring of blood glucose concentrations. If necessary, it is recommended that the patient be transferred to insulin therapy.

Combinations to be considered

Anticoagulants (e.g., warfarin): Sulfonylurea derivatives may increase the effect of anticoagulants when taken together. Correction of anticoagulant dose may be required.

Special Instructions

Hypoglycemia may occur when taking sulfonylurea derivatives, including gliclazide, and in some cases may be severe and prolonged, requiring hospitalization and intravenous administration of dextrose solution for several days.

The drug Gliclazide Canon can only be prescribed to patients whose diet is regular and includes breakfast. It is very important to maintain a sufficient intake of carbohydrates with food, because the risk of hypoglycemia increases with an irregular or insufficient diet, as well as with the consumption of food poor in carbohydrates. Hypoglycemia is more likely to develop with a low-calorie diet, after prolonged or vigorous exercise, after drinking alcohol or when taking several hypoglycemic drugs at the same time.

As a rule, the symptoms of hypoglycemia disappear after eating a food rich in carbohydrates (such as sugar). It should be borne in mind that taking sugar substitutes does not help to eliminate hypoglycemic symptoms. Experience of using other sulfonylurea derivatives suggests that hypoglycemia may recur, despite the effective initial control of this condition. If hypoglycemic symptoms are pronounced or prolonged, even if there is a temporary improvement after ingestion of carbohydrate-rich food, emergency medical care, up to and including hospitalization, is required.

In order to avoid hypoglycemia, careful individual choice of medication and dosing regimen is necessary, and the patient must be fully informed about the treatment offered.

An increased risk of hypoglycemia may occur in the following cases:

Contraindications

Side effects

Hypoglycemia in case of irregular meals and especially if meals are missed, may be accompanied by the following symptoms: Headache, intense hunger, nausea, vomiting, increased fatigue, sleep disturbance, irritability, agitation, reduced concentration, delayed reactions, depression, confusion, visual and speech disturbances, aphasia, tremors, paresis, perception disturbances, dizziness, weakness, seizures, bradycardia, delirium, respiratory disturbances, drowsiness, loss of consciousness with possible development of coma, up to and including death.

Andrenergic reactions may also be noted: increased sweating, “clammy” skin, anxiety, tachycardia, increased blood pressure, palpitations, arrhythmia and angina.

Other side effects

Gastrointestinal side effects: nausea, vomiting, diarrhea, abdominal pain, constipation (the severity of these symptoms is reduced when taken with meals).

Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, erythema, maculopapular rash, bullous reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis).

Hematological and lymphatic system disorders: anemia, thrombocytopenia, leukopenia, granulocytopenia. As a rule, these phenomena are reversible in case of discontinuation of therapy.

Hepatic and biliary tract disorders: increased activity of “liver” enzymes (aspartate aminotransferase (ACT), alanine aminotransferase (ALT), alkaline phosphatase), hepatitis (single cases). In case of cholestatic jaundice it is necessary to discontinue therapy.

VIight: transient visual disturbances may occur, caused by changes in blood glucose concentration, especially at the beginning of therapy.

General side effects of sulfonylurea derivatives: erythropenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis, hyponatremia. Also against the background of taking other sulfonylurea derivatives, increased activity of “liver” enzymes, hepatic dysfunction (e.g., with the development of cholestasis and jaundice) and hepatitis were observed. These manifestations decreased with time after withdrawal of sulfonylurea drugs, but in some cases led to life-threatening liver failure.

Overdose

Overdose of sulfonylurea derivatives, including gliclazide, may lead to the development of hypoglycemia, up to hypoglycemic coma.

Moderate symptoms of hypoglycemia without impaired consciousness or neurological symptoms are corrected by carbohydrate intake, dose adjustment and/or dietary changes. Careful monitoring of the patient’s condition should continue until it is certain that the patient’s health is not in danger.

The development of severe hypoglycemic states accompanied by coma, seizures or other neurological disorders is possible. If such symptoms occur, emergency medical assistance and immediate hospitalization is necessary. If hypoglycemic coma is suspected or diagnosed, the patient is injected intravenously with 50 ml of 40% dextrose (glucose) solution. Then intravenously drip 5% dextrose solution to maintain the necessary blood glucose concentration of about 1 g/l. Close monitoring of the blood glucose concentration and monitoring of the patient should be done for at least
48 subsequent hours. Subsequently, depending on the patient’s condition, the need for further monitoring of the patient’s vital functions should be decided.

Dialysis is ineffective due to significant binding of gliclazide to plasma proteins.

Similarities