Gliclazide (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

A10BB09 (Gliclazide)

Active Substance

Gliclazide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Oral hypoglycemic drug

Pharmacotherapeutic Group

Drugs for the treatment of diabetes mellitus; hypoglycemic drugs, except insulins; sulfonylurea derivatives

Pharmacological Action

An oral hypoglycemic agent, a second-generation sulfonylurea derivative. It stimulates insulin secretion by pancreatic beta cells. It increases the sensitivity of peripheral tissues to insulin. It appears to stimulate the activity of intracellular enzymes (in particular, muscle glycogen synthase). It reduces the time interval from food intake to the onset of insulin secretion. It restores the early peak of insulin secretion and reduces the postprandial peak of hyperglycemia.

Gliclazide reduces platelet adhesion and aggregation, slows the development of parietal thrombosis, and increases vascular fibrinolytic activity. It normalizes vascular permeability. It has anti-atherogenic properties: it lowers the concentration of total cholesterol and LDL cholesterol in the blood, increases the concentration of HDL cholesterol, and also reduces the number of free radicals. It prevents the development of microthrombosis and atherosclerosis. It improves microcirculation. It reduces vascular sensitivity to adrenaline.

In diabetic nephropathy during long-term use of gliclazide, a significant reduction in proteinuria is noted.

Pharmacokinetics

After oral administration, it is completely absorbed from the gastrointestinal tract.

When using the prolonged/modified-release dosage form, C_max in the blood is reached within 6 hours; C_ss is maintained for 6-12 hours.

Plasma protein binding is about 95%. V_d is about 19 L. It is metabolized mainly in the liver with the formation of 8 metabolites. The main metabolite does not have a hypoglycemic effect but does affect microcirculation.

T_1/2 ranges from 12 to 20 hours. It is excreted mainly by the kidneys: 70% as metabolites, less than 1% is excreted unchanged in the urine.

Indications

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

Prevention of complications of type 2 diabetes mellitus: reducing the risk of microvascular (nephropathy, retinopathy) and macrovascular complications (myocardial infarction, stroke).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
E11	Type 2 diabetes mellitus
H36.0	Diabetic retinopathy
I52.8	Other heart disorders in diseases classified elsewhere
I68.8	Other cerebrovascular disorders in diseases classified elsewhere
N08.3	Glomerular disorders in diabetes mellitus

ICD-11 code	Indication
5A11	Type 2 diabetes mellitus
8B23	Cerebrovascular anomalies
9B71.0Z	Diabetic retinopathy, unspecified
BE2Y	Other specified diseases of the circulatory system
MF83	Diabetic glomerular changes

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take tablets orally, swallowed whole with a meal. Do not crush or chew.

Initiate therapy at a starting dose of 80 mg per day, administered in two divided doses. Take before the morning and evening meals.

Titrate the dose based on individual glycemic response. Increase the dose gradually. The usual maintenance dose is 160-320 mg daily.

For doses exceeding 160 mg daily, administer in two divided doses. The maximum recommended daily dose is 320 mg.

Individualize the dosage regimen according to fasting blood glucose and postprandial glucose levels. Monitor glycemic control regularly.

Adjust the dose for elderly patients or those with renal impairment. Use a lower initial dose and titrate cautiously.

In patients at risk for hypoglycemia, use the lowest effective dose. Monitor blood glucose closely during dose escalation and when changing concomitant therapy.

For patients switching from other oral hypoglycemic agents, discontinue the previous drug and initiate gliclazide at the recommended starting dose.

Adverse Reactions

From the digestive system rarely – anorexia, nausea, vomiting, diarrhea, epigastric pain.

From the hematopoietic system in some cases – thrombocytopenia, agranulocytosis or leukopenia, anemia (usually reversible).

From the endocrine system in case of overdose – hypoglycemia.

Allergic reactions skin rash, itching.

Contraindications

Type 1 diabetes mellitus (insulin-dependent), ketoacidosis, diabetic precoma and coma, severe renal and/or hepatic insufficiency; pregnancy, breastfeeding period; children and adolescents under 18 years of age; hypersensitivity to sulfonylurea derivatives and sulfonamides. Simultaneous use of gliclazide and imidazole derivatives (including miconazole).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated for use in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated for use in severe renal insufficiency.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Gliclazide is used to treat non-insulin-dependent diabetes mellitus in combination with a low-calorie, low-carbohydrate diet.

During treatment, blood glucose levels should be regularly monitored fasting and after meals, as well as daily fluctuations in glucose levels.

In case of surgical interventions or decompensation of diabetes mellitus, the possibility of using insulin preparations should be considered.

If hypoglycemia develops, if the patient is conscious, glucose (or a sugar solution) should be administered orally. In case of loss of consciousness, glucose should be administered intravenously or glucagon subcutaneously, intramuscularly, or intravenously. After regaining consciousness, the patient should be given food rich in carbohydrates to prevent recurrent hypoglycemia.

With simultaneous use of gliclazide with verapamil, regular monitoring of blood glucose levels is necessary; with acarbose, careful monitoring and adjustment of the dosage regimen of hypoglycemic agents is required.

Simultaneous use of gliclazide with cimetidine, phenylbutazone, danazol is not recommended.

Drug Interactions

The hypoglycemic effect of gliclazide is potentiated by simultaneous use with pyrazolone derivatives, salicylates, phenylbutazone, antibacterial sulfonamide drugs, theophylline, caffeine, MAO inhibitors.

Simultaneous use with non-selective beta-blockers increases the likelihood of hypoglycemia and may also mask tachycardia and hand tremors characteristic of hypoglycemia, while sweating may increase.

With simultaneous use of gliclazide and acarbose, an additive hypoglycemic effect is observed.

Cimetidine increases the plasma concentration of gliclazide, which can cause severe hypoglycemia (CNS depression, impaired consciousness).

With simultaneous use with corticosteroids (including topical dosage forms), diuretics, barbiturates, estrogens, progestins, combined estrogen-progestin drugs, diphenyl, rifampicin, the hypoglycemic effect of gliclazide is reduced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Gliclazide MR [Atoll LLC (Russia)]
Modified-release tablets 30 mg: from 10 to 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Gliclazide MR

Modified-release tablets 30 mg: from 10 to 300 pcs.

Dosage Form, Packaging, and Composition

Modified-release tablets white or white with a creamy tint, round, biconvex; slight marbling is allowed.

	1 tab.
Gliclazide	30 mg

Excipients: hypromellose – 70 mg, microcrystalline cellulose (MCC-102) – 98 mg, colloidal silicon dioxide – 1 mg, magnesium stearate – 1 mg.

From 10 to 30 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.

Gliclazide MR [Atoll LLC (Russia)]
Modified-release tablets 60 mg: from 10 to 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Gliclazide MR

Modified-release tablets 60 mg: from 10 to 300 pcs.

Dosage Form, Packaging, and Composition

Modified-release tablets white or white with a creamy tint, round, biconvex, with a score; slight marbling is allowed.

	1 tab.
Gliclazide	60 mg

Excipients: hypromellose – 70 mg, microcrystalline cellulose (MCC-102) – 68 mg, colloidal silicon dioxide – 1 mg, magnesium stearate – 1 mg.

From 10 to 30 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
From 10 to 100 pcs. – jars with first-opening control (1) – cardboard packs.

Gliclazide [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Tablets 80 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Gliclazide

Tablets 80 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical.

	1 tab.
Gliclazide	80 mg

Excipients: microcrystalline cellulose (type 102) – 77.9 mg, magnesium stearate – 1.6 mg, colloidal silicon dioxide – 0.5 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (200) – cardboard boxes (for hospitals).
10 pcs. – contour cell blisters (400) – cardboard boxes (for hospitals).
10 pcs. – contour cell blisters (500) – cardboard boxes (for hospitals).
10 pcs. – contour cell blisters (600) – cardboard boxes (for hospitals).
10 pcs. – contour cell blisters (800) – cardboard boxes (for hospitals).
10 pcs. – contour cell blisters (1000) – cardboard boxes (for hospitals).
30 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.

Gliclazide Canon [Canonpharma Production, CJS (Russia)]
Prolonged-release tablets 30 mg: 30 or 60 pcs.
Prolonged-release tablets 60 mg: 30 or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Gliclazide Canon	Prolonged-release tablets 30 mg: 30 or 60 pcs.
		Prolonged-release tablets 60 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release tablets white or almost white, round, biconvex; slight marbling is allowed.

	1 tab.
Gliclazide	30 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) – 50 mg, colloidal silicon dioxide – 3.5 mg, mannitol – 10 mg, magnesium stearate – 1.8 mg, hydrogenated vegetable oil – 3.6 mg, microcrystalline cellulose – 81.1 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.

Prolonged-release tablets white or almost white, round, biconvex, with a score; slight marbling is allowed.

	1 tab.
Gliclazide	60 mg

Excipients: hypromellose (hydroxypropyl methylcellulose) – 100 mg, colloidal silicon dioxide – 7 mg, mannitol – 80 mg, magnesium stearate – 3.6 mg, hydrogenated vegetable oil – 7.2 mg, microcrystalline cellulose – 102.2 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.

Gliclazide MR Pharmstandart [Pharmstandard-Tomskkhimpharm OJSC (Russia)]
Prolonged-release tablets 30 mg: 30 or 60 pcs.

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Gliclazide MR Pharmstandart

Prolonged-release tablets 30 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release tablets white or almost white, biconvex, capsule-shaped with bevelled edges.

	1 tab.
Gliclazide	30 mg

Excipients: hypromellose (hypromellose 100 cPz) – 74 mg, calcium hydrogen phosphate (anhydrous calcium hydrogen phosphate) – 27.75 mg, lactose monohydrate – 22.54 mg, magnesium carbonate (basic magnesium carbonate) – 4.8 mg, colloidal silicon dioxide – 1.79 mg, magnesium stearate – 1.12 mg.

30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.

Gliclazide MR Pharmstandart [Pharmstandard-Tomskkhimpharm OJSC (Russia)]
Prolonged-release tablets 60 mg: 30 or 60 pcs.

Marketing Authorization Holder

Pharmstandard-Tomskkhimpharm OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Gliclazide MR Pharmstandart

Prolonged-release tablets 60 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release tablets white or almost white, oval, biconvex, with a score on both sides.

	1 tab.
Gliclazide	60 mg

Excipients: hypromellose (hypromellose 100 cPz) – 138.08 mg, calcium hydrogen phosphate (anhydrous calcium hydrogen phosphate) – 62.05 mg, lactose monohydrate – 45.09 mg, magnesium carbonate (basic magnesium carbonate) – 9.6 mg, colloidal silicon dioxide – 3.58 mg, magnesium stearate – 1.6 mg.

15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.

Gliclazide MV-Vertex [Vertex, JSC (Russia)]
Prolonged-release tablets 30 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Gliclazide MV-Vertex

Prolonged-release tablets 30 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release tablets white or almost white, round, flat-cylindrical, with a bevel; marbling is allowed.

	1 tab.
Gliclazide	30 mg

Excipients: microcrystalline cellulose 102, hypromellose 2208, colloidal silicon dioxide, magnesium stearate.

10 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – contour cell blisters (1) – cardboard packs.
30 pcs. – contour cell blisters (2) – cardboard packs.
30 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
90 pcs. – polyethylene jars (1) – cardboard packs.

Gliclazide MV-Vertex [Vertex, JSC (Russia)]
Prolonged-release tablets 60 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Gliclazide MB-Vertex

Prolonged-release tablets 60 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release tablets white or almost white, oblong, biconvex, with a score on each side; marbling is allowed.

	1 tab.
Gliclazide	60 mg

Excipients: microcrystalline cellulose 102, hypromellose 2208, colloidal silicon dioxide, magnesium stearate.

Gliclazide Prolong-AKOS [Aliym, JSC (Russia)]
Prolonged-release tablets 30 mg: 10, 20, 30, 60, 100 or 120 pcs.
Prolonged-release tablets 60 mg: 10, 20, 30, 60, 100 or 120 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Manufactured By

Sintez PJSC (Russia)

Dosage Forms

	Gliclazide Prolong-AKOC	Prolonged-release tablets 30 mg: 10, 20, 30, 60, 100 or 120 pcs.
		Prolonged-release tablets 60 mg: 10, 20, 30, 60, 100 or 120 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release tablets white or almost white, round, flat-cylindrical, with a bevel; marbling is allowed.

	1 tab.
Gliclazide	30 mg

Excipients: lactose monohydrate (tablettose 80) – 87 mg, hypromellose – 74 mg, talc – 6 mg, calcium stearate – 2 mg, colloidal silicon dioxide (aerosil) – 1 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.

Prolonged-release tablets white or almost white, round, flat-cylindrical, with a bevel and a score; marbling is allowed.

	1 tab.
Gliclazide	60 mg

Excipients: lactose monohydrate (tablettose 80) – 174 mg, hypromellose – 148 mg, talc – 12 mg, calcium stearate – 4 mg, colloidal silicon dioxide (aerosil) – 2 mg.

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.

Gliclazide Velpharm [Elzapharm, LLC (Russia)]
Prolonged-release tablets 30 mg: 30, 60, or 90 pcs.
Prolonged-release tablets 60 mg: 30, 60, or 90 pcs.

Marketing Authorization Holder

Elzapharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Forms

	Gliclazide Velpharm	Prolonged-release tablets 30 mg: 30, 60, or 90 pcs.
		Prolonged-release tablets 60 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release tablets white or almost white, round, flat-cylindrical, with a bevel; marbling is allowed.

	1 tab.
Gliclazide	30 mg

Excipients: calcium stearate, hypromellose, colloidal silicon dioxide (aerosil), talc, lactose monohydrate (milk sugar).

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.

Prolonged-release tablets white or almost white, round, flat-cylindrical, with a bevel and a score; marbling is allowed.

	1 tab.
Gliclazide	60 mg

Excipients: calcium stearate, hypromellose, colloidal silicon dioxide (aerosil), talc, lactose monohydrate (milk sugar).

Gliclazide-AKOS [Sintez PJSC (Russia)]
Tablets 80 mg: 20, 40, 60 or 100 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Gliclazide-AKOC

Tablets 80 mg: 20, 40, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, flat-cylindrical in shape.

	1 tab.
Gliclazide	80 mg

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.

Medixlife (Author)

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