Uglin (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

ATC Code

A10BB08 (Gliquidone)

Active Substance

Gliquidone (Rec.INN registered by WHO)

Dosage Form

Uglin

Tablets 30 mg: 30, 60, or 120 pcs.

Dosage Form, Packaging, and Composition

Tablets are white or almost white, round, biconvex, with a score line.

Excipients: lactose monohydrate – 134 mg, potato starch – 70 mg, sodium carboxymethyl starch – 5 mg, colloidal silicon dioxide – 0.6 mg, magnesium stearate – 0.4 mg.

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
30 pcs. – polyethylene jars^x (1) – cardboard packs.
60 pcs. – polyethylene jars^x (1) – cardboard packs.
120 pcs. – polyethylene jars^x (1) – cardboard packs.

^xwith first opening control

Clinical-Pharmacological Group

Oral hypoglycemic drug

Pharmacotherapeutic Group

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

Pharmacological Action

An oral hypoglycemic agent, a second-generation sulfonylurea derivative. It stimulates insulin secretion by pancreatic beta-cells, increases the sensitivity of peripheral tissues to insulin, and inhibits lipolysis in adipose tissue.

It is characterized by a rapid and pronounced effect. It does not cause prolonged hyperinsulinemia.

Pharmacokinetics

It is almost completely absorbed from the gastrointestinal tract. After oral administration of a 30 mg dose, the C_max in blood plasma is reached in 2-3 hours and is 500-700 ng/ml. After 0.5-1 hour, the concentration decreases by 50%. Gliquidone is completely metabolized.

About 5% of the dose is excreted in the urine as metabolites. The level of gliquidone excretion in the urine remains minimal with continuous use. The main part of the metabolites is excreted in bile and feces.

Indications

Type 2 diabetes mellitus (non-insulin-dependent) in middle-aged and elderly patients (when diet therapy is ineffective).

ICD codes

Dosage Regimen

Determine the daily dose and frequency of administration individually based on the patient’s glycemic and glucosuric profile and the severity of clinical symptoms.

Initiate therapy with a low dose and titrate upwards gradually to achieve optimal glycemic control.

Administer the total daily dose in divided doses, typically twice daily immediately before the start of a meal.

For some patients, a three times daily regimen may be necessary to control postprandial hyperglycemia.

The minimum effective daily dose is 15 mg (half a 30 mg tablet).

The maximum daily dose should not exceed 120 mg.

The average maintenance dose for most patients is 45 mg per day, administered as 15 mg before breakfast and 30 mg before the main evening meal, or according to the individual meal pattern.

Always take the tablet at the beginning of a meal to synchronize drug absorption with nutrient intake and minimize the risk of hypoglycemia.

Regularly monitor blood glucose levels, including fasting and postprandial measurements, to guide dose adjustments.

In elderly patients or those with hepatic impairment, use the lowest effective dose and monitor closely for signs of hypoglycemia.

For patients switching from other oral hypoglycemic agents, discontinue the previous medication and initiate gliquidone at a low dose, adjusting based on response.

Adverse Reactions

From the endocrine system rarely – hypoglycemia.

Allergic reactions rarely – skin rash, itching.

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).

Contraindications

Type 1 diabetes mellitus (insulin-dependent), diabetic coma and precoma, diabetes complicated by acidosis and ketoacidosis, insulinoma, severe hepatic insufficiency, children and adolescents under 18 years of age, hypersensitivity to sulfonylurea derivatives and sulfonamides.

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

In patients with impaired renal function, dose adjustment is not required.

Treatment of patients with severe renal insufficiency should be carried out under medical supervision.

Pediatric Use

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

Geriatric Use

Can be used in elderly patients.

Special Precautions

Gliquidone is used in combination with a low-calorie, low-carbohydrate diet.

During treatment, blood glucose levels should be regularly monitored on an empty stomach and after meals, as well as daily fluctuations in glucose levels.

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

The hypoglycemic effect is enhanced by physical exertion and alcohol intake.

Drug Interactions

The hypoglycemic effect is enhanced with the simultaneous use of salicylates, sulfonamides, butadione, chloramphenicol, tetracyclines, coumarin derivatives, MAO inhibitors, beta-blockers. The hypoglycemic effect is weakened with the simultaneous use of sympathomimetics, synthetic progestins, corticosteroids, thyroid hormones, nicotinic acid.

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.