Diabinax (Tablets) Instructions for Use

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

ATC Code

A10BB09 (Gliclazide)

Active Substance

Gliclazide (Rec.INN registered by WHO)

Dosage Forms

	Diabinax	Tablets 20 mg: 10 or 20 pcs.
		Tablets 40 mg: 10 or 20 pcs.
		Tablets 80 mg: 10, 20 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, flat, with beveled edges and a break line on one side.

Excipients: microcrystalline cellulose, starch, povidone, sodium methylparaben, colloidal silicon dioxide (aerosil), magnesium stearate, sodium starch glycolate, talc, purified water.

20 pcs. – blisters (2) – cardboard packs.
20 pcs. – blisters (3) – cardboard packs.

Tablets are white, round, flat, with beveled edges and a break line on one side.

Excipients: microcrystalline cellulose, starch, povidone, sodium methylparaben, colloidal silicon dioxide (aerosil), magnesium stearate, sodium starch glycolate, talc, purified water.

20 pcs. – blisters (2) – cardboard packs.
20 pcs. – blisters (3) – cardboard packs.

Tablets are white, round, flat, with beveled edges and a break line on one side.

Excipients: microcrystalline cellulose, starch, povidone, sodium methylparaben, colloidal silicon dioxide (aerosil), magnesium stearate, sodium starch glycolate, talc, purified water.

20 pcs. – blisters (2) – cardboard packs.
20 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Oral hypoglycemic drug

Pharmacotherapeutic Group

Hypoglycemic agent for oral administration of the second-generation sulfonylurea group

Pharmacological Action

Diabinax is a hypoglycemic drug, a second-generation sulfonylurea derivative.

It stimulates insulin secretion by the pancreas, potentiates the insulin-secretory effect of glucose, and increases the sensitivity of peripheral tissues to insulin.

It stimulates the activity of intracellular enzymes – muscle glycogen synthetase.

It reduces the time period from food intake to the onset of insulin secretion.

It restores the early peak of insulin secretion (unlike other sulfonylurea derivatives, such as glibenclamide and chlorpropamide, which act mainly during the second stage of secretion).

It reduces the peak of postprandial hyperglycemia.

In addition to its effect on carbohydrate metabolism, it affects microcirculation.

It reduces platelet adhesion and aggregation, slowing the development of a parietal thrombus.

It normalizes vascular permeability, prevents the development of microthrombosis, and restores the process of physiological parietal fibrinolysis.

It reduces vascular sensitivity to adrenaline.

It has anti-atherogenic properties, lowering the concentration of total cholesterol in the blood.

It slows the development of diabetic retinopathy at the non-proliferative stage.

In diabetic nephropathy, long-term use leads to a significant reduction in proteinuria.

It does not lead to weight gain, as it primarily affects the early peak of insulin secretion and does not cause hyperinsulinemia; it promotes weight loss in obese patients when an appropriate diet is followed.

Pharmacokinetics

When taken orally, the drug is well absorbed from the gastrointestinal tract.

C_max in blood plasma is reached approximately 4 hours after a single 80 mg dose.

Plasma protein binding is 94%.

It is metabolized in the liver to form several metabolites.

It is excreted by the kidneys – 70% as metabolites, less than 1% is excreted unchanged in the urine; in feces – 12% as metabolites.

T_1/2 is about 12 hours.

Indications

• Moderate type 2 diabetes mellitus when diet therapy is ineffective.

ICD codes

Dosage Regimen

Determine the dose individually based on the patient’s age, clinical status, and fasting and postprandial blood glucose levels.

Initiate therapy with a starting daily dose of 80 mg.

Administer the total daily dose in two divided doses, taken in the morning and evening.

Take tablets 30-60 minutes before meals to ensure optimal absorption and effect.

Adjust the dose gradually based on glycemic response; the average therapeutic daily dose is 160 mg.

Do not exceed the maximum daily dose of 320 mg.

For patients requiring dose titration, utilize the scored tablet for accurate splitting.

Perform regular monitoring of blood glucose to guide dose adjustments and assess therapeutic efficacy.

Reduce the dose during periods of increased physical activity or changes in diet to prevent hypoglycemia.

Consider temporary substitution with insulin during severe stress, trauma, surgery, or infections.

Use with caution in elderly patients and those with adrenal or pituitary insufficiency due to an increased risk of hypoglycemia.

Adverse Reactions

From the endocrine system hypoglycemia (in case of overdose and/or inadequate diet).

Allergic reactions skin rash, urticaria, itching.

From the digestive system rarely – anorexia, nausea, vomiting, diarrhea, feeling of heaviness or pain in the epigastric region.

From the hematopoietic system thrombocytopenia, leukopenia or agranulocytosis, anemia (usually reversible).

Contraindications

• Type 1 diabetes mellitus;
• Diabetic ketoacidosis;
• Diabetic precoma and coma;
• Severe impairment of liver and kidney function;
• Infectious diseases, trauma, major surgical interventions;
• Pregnancy;
• Breastfeeding period;
• Hypersensitivity to sulfonamide drugs and sulfonylurea derivatives.

Use in Pregnancy and Lactation

Contraindicated during pregnancy. If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Special Precautions

Treatment with Diabinax should be carried out in combination with a low-calorie, low-carbohydrate diet.

During treatment, fasting and postprandial blood glucose levels should be monitored regularly.

The drug should be used with caution in patients suffering from adrenal insufficiency, thyroid diseases (with impaired function), chronic pyelonephritis, and alcoholism.

In case of severe trauma, infectious diseases, or surgical interventions, the possibility of using insulin preparations should be considered.

Dose adjustment is necessary during physical and emotional stress, and changes in diet.

In case of fasting or alcohol consumption, the risk of hypoglycemia increases.

Effect on ability to drive vehicles and operate machinery

During treatment, it is not recommended to engage in activities requiring concentration and quick reactions.

Overdose

Symptoms: pale skin, tachycardia, feeling of hunger, increased sweating, tremor, in severe cases – impaired consciousness.

Treatment: if the patient is conscious, glucose or a sugar solution is administered orally.

In case of loss of consciousness, 40% glucose solution is administered intravenously or glucagon subcutaneously, intramuscularly, or intravenously.

After regaining consciousness, the patient should be given food rich in carbohydrates to prevent recurrent hypoglycemia.

Drug Interactions

Sulfonamides, salicylates, indirect anticoagulants, anabolic steroids, beta-blockers, fibrates, chloramphenicol, fenfluramine, fluoxetine, guanethidine, MAO inhibitors, pentoxifylline, theophylline, caffeine, phenylbutazone, tetracyclines, as well as ethanol-containing preparations enhance the hypoglycemic effect of gliclazide.

Concomitant use of gliclazide and acarbose shows an additive hypoglycemic effect, which requires dose adjustment of these drugs.

Cimetidine increases the concentration of gliclazide in blood plasma, which can cause severe hypoglycemia (CNS depression, impaired consciousness), so the combined use of these drugs is not recommended.

Barbiturates, chlorpromazine, glucocorticosteroids, sympathomimetics, glucagon, nicotinic acid, estrogens, progestins, oral contraceptives, diuretics, rifampicin, thyroid hormones, lithium salts weaken the hypoglycemic effect of gliclazide.

Concomitant use of gliclazide and imidazole derivatives (including miconazole) is contraindicated.

Storage Conditions

In a dry place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

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.