Movogleken^® (Tablets) Instructions for Use

Marketing Authorization Holder

Zhuhai United Laboratories, Co., Ltd (China)

ATC Code

A10BB07 (Glipizide)

Active Substance

Glipizide (Rec.INN registered by WHO)

Dosage Form

Movogleken®

Tablets 5 mg: 48 pcs.

Dosage Form, Packaging, and Composition

Tablets are cylindrical, round, white in color with an engraving of “U” in a circle on one side and a score on the other side.

Excipients: lactose – 130 mg, pregelatinized starch – 30 mg, microcrystalline cellulose – 30 mg, hypromellose (hydroxypropyl methylcellulose) – 0.8 mg, stearic acid – 1.6 mg.

24 pcs. – blisters (2) – cardboard packs.

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 and increases insulin release. It increases the sensitivity of peripheral tissues to insulin. It has a hypolipidemic, fibrinolytic effect and inhibits platelet aggregation.

Pharmacokinetics

After oral administration, Glipizide is rapidly and completely absorbed from the gastrointestinal tract.

Plasma protein binding (primarily to albumin) is 98-99%.

It is metabolized in the liver. Less than 10% is excreted unchanged in the urine and feces, about 90% is excreted in the urine (80%) and feces (10%) as metabolites.

Indications

Type 2 diabetes mellitus (non-insulin-dependent) in patients with excess or normal body weight when diet therapy is ineffective.

ICD codes

Dosage Regimen

Determine the dose individually based on glycemic control.

Initiate therapy with 2.5 mg to 5 mg once daily.

Administer the dose 15 to 30 minutes before breakfast to maximize absorption.

Increase the dose gradually in increments of 2.5 mg to 5 mg at intervals of several days based on patient response.

Divide the total daily dose if it exceeds 15 mg into two administrations.

Take the second dose before the evening meal.

Do not exceed the maximum single dose of 15 mg.

Do not exceed the maximum total daily dose of 40 mg.

Monitor blood glucose regularly during dose titration.

Use a lower starting dose for elderly, debilitated, or malnourished patients.

Adjust the dose carefully in patients with impaired adrenal or pituitary function.

Adverse Reactions

From the endocrine system: rarely – hypoglycemia (especially in elderly, debilitated patients, with irregular meals, alcohol consumption, impaired liver and kidney function).

From the digestive system: nausea, diarrhea; extremely rarely – toxic hepatitis.

From the hematopoietic system: in some cases – thrombocytopenia, leukopenia, agranulocytosis.

Allergic reactions: rarely – skin rash, itching.

Other: headache.

Contraindications

Type 1 diabetes mellitus (insulin-dependent), ketoacidosis, precoma, coma, hepatic failure, renal failure (including patients on hemodialysis), pregnancy, breastfeeding period, children and adolescents under 18 years of age, hypersensitivity to glimepiride, other sulfonylurea derivatives and sulfonamides.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe liver function impairment.

Use in Renal Impairment

Contraindicated in severe renal function impairment.

Pediatric Use

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

Geriatric Use

Use with caution in elderly patients.

Special Precautions

When using glipizide after insulin or other hypoglycemic agents, the rapid entry of glipizide into the blood should be taken into account, and the dose should be controlled according to the glycemic profile during the first 4-5 days.

If hypoglycemia develops and 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.

In case of injuries, severe infections, or extensive surgical interventions, the patient should be switched to insulin therapy.

Glipizide should not be used concomitantly with miconazole.

Drug Interactions

Concomitant use with salicylates, sulfonamides, ACE inhibitors, and alcohol intake may lead to a severe hypoglycemic reaction. Concomitant use of beta-blockers may mask the manifestations of hypoglycemia.

Thiazide diuretics, synthetic progestins, corticosteroids (including topical use), and chlorpromazine weaken the effect of glipizide.

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.