Gliklada - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Gliclada

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 190 rub.

Buy

Gliklada is a hypoglycemic drug for oral administration.

Release form and composition

Dosage form - tablets of prolonged action: almost white or white, biconvex; 30 mg and 60 mg - oval, 90 mg - capsule-shaped, engraved with "G90" on one side (30 mg: 10 pcs. in a blister, in a cardboard box 3, 6 or 9 blisters; 15 pcs. in blister, in a cardboard box 2, 4 or 6 blisters; 60 mg each: 15 pcs. in a blister, in a cardboard box 2, 4, 6 or 8 blisters; 90 mg each: 10 pcs. in a blister, in a cardboard box 3, 6 or 9 blisters).

1 tablet contains:

active substance: gliclazide - 30 mg, 60 mg or 90 mg;
excipients: hypromellose (100 mPas - nominal viscosity for a 2% aqueous solution), lactose monohydrate, colloidal silicon dioxide, magnesium stearate.

In addition, in tablets of 30 mg - hypromellose (4000 mPas), calcium carbonate.

Indications for use

The use of Glykada is indicated for the treatment of type 2 diabetes mellitus in adult patients with ineffective diet therapy, exercise and weight loss.

In addition, the drug is prescribed for the prevention of complications in patients with type 2 diabetes mellitus: reducing the risk of microvascular (retinopathy, nephropathy) and macrovascular (myocardial infarction, stroke) complications.

Contraindications

type 1 diabetes mellitus;
diabetic ketoacidosis, diabetic precoma, diabetic coma;
severe renal and / or liver dysfunction;
combination with miconazole, both for systemic use and in the form of gels for the oral mucosa;
period of pregnancy;
breast-feeding;
simultaneous use of ethanol-containing products or the use of ethanol;
lactase deficiency, glucose-galactose malabsorption syndrome, lactose intolerance;
age up to 18 years;
hypersensitivity to sulfonylurea derivatives, sulfonamides and drug components.

In addition, 60 mg and 90 mg tablets are not recommended for concomitant therapy with phenylbutazone or danazol.

Care should be taken when using Gliklada in case of irregular and / or unbalanced nutrition, deficiency of glucose-6-phosphate dehydrogenase, severe cardiovascular diseases (severe stage of coronary heart disease, carotid artery disease, vascular diseases of a systemic nature), severe or uncompensated endocrine pathologies (pituitary failure, hypothyroidism, thyrotoxicosis, hypopituitarism), renal and / or hepatic failure, alcoholism, after prolonged therapy (or taking high doses) with glucocorticosteroids (GCS), in old age.

In addition, 30 mg tablets with caution are recommended to be used simultaneously with phenylbutazone, danazol.

Method of administration and dosage

The tablets are taken orally during breakfast, once a day.

The dose of Glykada is prescribed individually on the basis of indicators of the level of glycosylated hemoglobin (HbAlc) and regular monitoring of the concentration of glucose in the blood.

Recommended daily dosage: the initial dose is 30 mg, if this dose allows you to achieve the optimal clinical effect, it is taken as a maintenance. In the absence of the required glycemic control, the dose should be gradually increased (taking into account the concentration of glucose in the blood) to 60 mg, 90 mg or 120 mg per day. If a decrease in blood glucose concentration occurs within two weeks of therapy, the dose can be increased at intervals of 4 weeks or more. If, after two weeks of using the drug, the concentration of glucose in the blood does not decrease, the dose should be increased at the end of the second week of treatment.

The maximum daily dose is 120 mg.

When switching from taking immediate-release tablets containing 80 mg of gliclazide, it should be borne in mind that the effect of one such tablet is equivalent to one 30 mg tablet of Glyclada. Changing the drug should be accompanied by careful monitoring of blood glucose concentration.

The initial dose of the drug when switching from any (even the maximum) dose of the previous

hypoglycemic oral agent should be 30 mg. In this case, it is necessary to take into account the dose, effectiveness and duration of the previous agent.

If a previously taken hypoglycemic agent had a longer T _1/2 in order to prevent an additive effect and the development of hypoglycemia, a temporary (several days) cessation of treatment is possible. After the resumption of therapy, it is necessary to follow closely the patient's condition within 1-2 weeks.

The drug can be used in combination with biguanides, thiazolidinedione derivatives, alpha-glucosidase inhibitors or insulin.

It is necessary to start therapy in combination with insulin with close medical supervision.

With mild to moderate renal failure [creatinine clearance (CC) 15–80 ml / min], no dose adjustment is required in patients over 65 years of age.

To achieve the target HbAlc level, in addition to gradually increasing the dose of the drug, you must carefully follow a special diet and exercise.

Side effects

on the part of metabolism and nutrition: against the background of an irregular meal - the development of hypoglycemic reactions; in some cases - hyponatremia;
on the part of the organ of vision: transient visual impairment (more often at the beginning of use);
from the gastrointestinal tract: dyspepsia (nausea, vomiting, abdominal pain, constipation, diarrhea);
from the hepatobiliary system: in rare cases - an increase in the activity of alanine aminotransferase (ALT), aspartate aminotransferase (ACT), alkaline phosphatase; in isolated cases - hepatitis; possibly cholestatic jaundice;
on the part of the blood and lymphatic system: rarely - anemia, leukopenia, granulocytopenia, thrombocytopenia (these disorders are usually reversible after drug withdrawal);
dermatological reactions: pruritus, rash (including maculopapular rash, bullous rash), erythema, urticaria; in some cases - late cutaneous porphyria;
others: possibly - erythrocytopenia, agranulocytosis, hemolytic anemia, pancytopenia, allergic vasculitis.

special instructions

During the period of application of Glykada, the patient must observe a regular diet, necessarily including breakfast, since irregular consumption of carbohydrates, late meals or in insufficient quantities increase the risk of hypoglycemia. Symptoms of hypoglycemia: severe hunger, headache, nausea, vomiting, fatigue, aggressiveness, irritability, severe weakness, insomnia, drowsiness, agitation, visual impairment, inattention, inability to concentrate, dizziness, slow reaction, depression, tremor, aphasia, paresis, sensory disorders, loss of self-control, convulsions, delirium, bradycardia, shallow breathing, loss of consciousness, coma. In addition, the patient may experience increased sweating, anxiety, increased blood pressure, tachycardia, palpitations, angina pectoris,violation of the rhythm of the heart, sticky and cold skin.

To stop hypoglycemic reactions, it is necessary to take carbohydrates (sugar); in severe cases, urgent medical attention is required (intravenous glucose).

The use of self-monitoring of the level of glucose concentration in blood plasma allows timely recording of changes in the patient's condition.

Strict adherence to the dosage regimen - taking the drug during breakfast - reduces the likelihood of developing undesirable effects in the form of dyspepsia.

If signs of cholestatic jaundice appear, the pill should be discontinued.

Compliance with a low-calorie diet, prolonged or intense physical activity, the simultaneous use of other hypoglycemic agents, alcohol consumption or an overdose of the drug increase the risk of hypoglycemia.

Factors that increase the risk of hypoglycemia include concomitant pathologies: renal failure, severe liver failure, thyroid disease, pituitary-adrenal insufficiency, hypopituitarism. Changes in the properties of gliclazide in hepatic or severe renal failure can cause the patient to have more prolonged episodes of hypoglycemia.

The balance between the amount of carbohydrates consumed, physical activity and emotional stress should not be disturbed.

The use of other medicines is contraindicated without consulting a doctor.

A decrease in the effect of oral hypoglycemic therapy can occur with febrile syndrome, trauma, infectious diseases, extensive burns, and surgical operations. These conditions may lead to the need to transfer the patient to insulin treatment.

It should be borne in mind that the simultaneous administration of beta-blockers, reserpine, clonidine, guanethidine can mask the clinical manifestations of hypoglycemia.

With a decrease in the therapeutic effect of the drug after prolonged therapy, the doctor must make sure that the patient follows the recommendations of the dosage regimen, diet and physical activity. If the patient adheres to them carefully, then the decrease in glycemic control is due to the progression of the disease.

The use of Glykada in case of glucose-6-phosphate dehydrogenase deficiency can cause the development of hemolytic anemia.

During the period of use of the drug, patients with diabetes mellitus are advised to be careful when driving vehicles and mechanisms.

Drug interactions

With the simultaneous use of Glykada:

miconazole, phenylbutazone, danazol, ethanol cause a significant increase in the hypoglycemic effect of the drug, increase the risk of hypoglycemia, coma;
insulin, biguanides, acarbose, beta-blockers, sulfonamides, angiotensin-converting enzyme inhibitors (enalapril, captopril), fluconazole, cimetidine, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs, clarithromycin; potentiate the action;
chlorpromazine in high (more than 100 mg per day) doses increases the level of glucose concentration in the blood, reduces insulin secretion;
tetracosactide, GCS for systemic, intra-articular, external and rectal use increase the risk of developing ketoacidosis;
salbutamol, ritodrin, terbutaline increase blood glucose levels;
warfarin and other anticoagulants enhance their therapeutic effect.

Analogs

Analogs of Glykada are: tablets - Diabeton MV, Gliclazid MV, Diabefarm MV, Glidiab.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

Shelf life: 30 mg tablets - 3 years, 60 mg and 90 mg tablets - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Gliklada: prices in online pharmacies

Drug name

Price

Pharmacy

Gliklada 60 mg prolonged release tablets 30 pcs.

190 RUB

Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!