Maniglid (Tablets) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

ATC Code

A10BB01 (Glibenclamide)

Active Substance

Glibenclamide (Rec.INN registered by WHO)

Dosage Form

Maniglid

Tablets 5 mg: 20, 40, 50, 100, 120, or 150 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
100 pcs. – bottles (1) – cardboard packs.
120 pcs. – bottles (1) – cardboard packs.
150 pcs. – plastic containers (1) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
50 pcs. – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Oral hypoglycemic drug

Pharmacotherapeutic Group

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

Pharmacological Action

Oral hypoglycemic agent, a second-generation sulfonylurea derivative. It stimulates insulin secretion by pancreatic beta-cells and increases insulin release. It acts primarily during the second phase of insulin secretion.

It increases the sensitivity of peripheral tissues to insulin and the degree of its binding to target cells. It has a hypolipidemic effect and reduces the thrombogenic properties of blood.

Pharmacokinetics

After oral administration, Glibenclamide is rapidly and almost completely absorbed from the gastrointestinal tract. Plasma protein binding is more than 95%.

It is metabolized in the liver to form inactive metabolites. It is eliminated from the body mainly in the form of metabolites with urine – 95% and with bile. T_1/2 is about 10 hours.

Indications

Type 2 diabetes mellitus in adults when diet therapy is ineffective.

ICD codes

Dosage Regimen

The dose is set individually, depending on age, severity of diabetes, fasting blood glucose level and 2 hours after a meal.

The average dose is 2.5-15 mg/day, the frequency of administration is 1-3 times/day. It is taken 20-30 minutes before meals. Doses above 15 mg/day are used in rare cases and do not cause a significant increase in the hypoglycemic effect.

For elderly patients, the initial dose is 1 mg/day.

When switching from biguanides, the initial dose of glibenclamide is 2.5 mg/day. Biguanides should be discontinued, and the dose of glibenclamide can be increased by 2.5 mg every 5-6 days if necessary until compensation of carbohydrate metabolism disorders is achieved. If compensation is not achieved within 4-6 weeks, combination therapy with glibenclamide and biguanides should be planned.

Adverse Reactions

From the endocrine system: hypoglycemia up to coma (the likelihood of its development increases with violation of the dosing regimen and inadequate diet).

Allergic reactions: skin rash, itching.

From the digestive system: nausea, diarrhea, feeling of heaviness in the epigastric region; rarely – impaired liver function, cholestasis.

From the central and peripheral nervous system: rarely – paresis, sensory disturbances, headache, fatigue, weakness, dizziness.

From the hematopoietic system: rarely – hematopoiesis disorders up to the development of pancytopenia.

Dermatological reactions: rarely – photosensitivity.

Contraindications

Type 1 diabetes mellitus, ketoacidosis, diabetic precoma and coma, severe microcirculation disorders, infectious diseases, severe renal and/or hepatic impairment. Hypersensitivity to sulfonylurea derivatives and sulfonamide drugs. Not used during major surgical interventions.

Use in Pregnancy and Lactation

Glibenclamide is not recommended for use during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment. Use with caution in patients with liver pathology (including history).

Use in Renal Impairment

Contraindicated in severe renal impairment. Use with caution in patients with renal pathology (including history).

Geriatric Use

For elderly patients, the initial dose is 1 mg/day.

Special Precautions

Use with caution in patients with liver and kidney pathology (including history), as well as in febrile conditions, impaired adrenal function, thyroid function, and in chronic alcoholism.

During therapy, regular monitoring of blood glucose levels and daily urinary glucose excretion is necessary.

If hypoglycemia develops, if the patient is conscious, glucose (or 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.

Patients taking Glibenclamide should refrain from drinking alcohol. If alcohol is consumed, disulfiram-like reactions, as well as severe hypoglycemia, may develop.

Drug Interactions

Enhancement of the hypoglycemic effect of glibenclamide is possible with simultaneous use of beta-blockers, anabolic agents, allopurinol, cimetidine, clofibrate, cyclophosphamide, isobarin, MAO inhibitors, long-acting sulfonamides, salicylates, chloramphenicol, tetracyclines, ethanol-containing drugs.

Weakening of the effect of glibenclamide and the development of hyperglycemia is possible with simultaneous use of barbiturates, chlorpromazine, phenothiazines, phenytoin, diazoxide, acetazolamide, glucocorticoids, sympathomimetic agents, glucagon, indomethacin, high doses of nicotinates, oral contraceptives and estrogens, saluretics, thyroid hormones, lithium salts, high doses of laxatives.

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.