Diabefarm MB modified-release pills 30mg, 60pcs

Composition

1 tablet contains:

• Active ingredient: gliclazide -30 mg;

excipients:

• hypromellose,
• microcrystalline cellulose,
• colloidal silicon dioxide (aerosil),
• magnesium stearate.

Pharmacological action

Pharmacotherapeutic group hypoglycemic agent for oral use of the second generation sulfonylurea group. ATX code: A 10 BB 09 Pharmacological action of DIABEFARM®MV is an oral hypoglycemic drug derived from a second-generation sulfonylurea. It stimulates the secretion of insulin by pancreatic cells, enhances the insulin-secretory action of glucose, and increases the sensitivity of peripheral tissues to insulin. It stimulates the activity of intracellular enzymes-muscle glycogen synthetase. Reduces the interval from the moment of food intake to the beginning of insulin secretion. Restores the early peak of insulin secretion (unlike other sulfonylurea derivatives, which have an effect mainly during the second stage of secretion). Reduces postprandial increase in glucose levels. In addition to its effect on carbohydrate metabolism, it improves microcirculation:   reduces platelet adhesion and aggregation, normalizes vascular permeability, prevents the development of microthrombosis and atherosclerosis, and restores the process of physiological parietal fibrinolysis. Reduces the sensitivity of vascular receptors to cadrenaline. Slows down the development of diabetic retinopathy in the non-proliferative stage. In diabetic nephropathy, long-term use causes a significant decrease in the severity of proteinuria. It does not lead to an increase in body weight, since it has a predominant effect on the early peak of insulin secretion and does not cause hyperinsulinemia; it contributes to weight loss in obese patients with an appropriate diet. Pharmacokinetics: It is almost completely absorbed from the gastrointestinal tract (GIT) after oral use. The concentration of the Active ingredient in plasma increases gradually, reaching a maximum in 6-12 hours after taking the drug. Food intake does not affect absorption. The binding to plasma proteins is approximately 95%. It is metabolized in the liver to form inactive metabolites. The half-life is approximately 16 hours. It is mainly excreted by the kidneys in the form of metabolites and about 1% of the drug is excreted by the kidneys in an unchanged form. No significant clinical changes in pharmacokinetics are observed in the elderly. Due to the peculiarities of the dosage form, daily use of a single dose of the drug provides an effective therapeutic concentration of gliclazide in the plasma for 24 hours.

Indications

Type 2 diabetes mellitus combined with diet therapy and moderate physical exertion when the latter are ineffective.

Use during pregnancy and lactation

Contraindicated in pregnancy. Breast-feeding should be discontinued for the duration of treatment.

Contraindications

• Hypersensitivity to the drug;
• diabetea 1 diabetes;
• diabetic ketoacidosis, diabetic precoma, diabetic coma;
• hyperosmolarity;
• severe hepatic and/or renal failure;
• major surgery, extensive burns, trauma, and other conditions, requiring insulin;
• intestinal obstruction, paresis of the stomach;
• conditions associated with malabsorption of food, the development of hypoglycemia (infectious diseases);
• leukopenia;
• pregnancy, lactation;
• children up to age 18 years.

With caution (the need for more careful monitoring and dose selection), Diabefarm®MV is prescribed for febrile syndrome, alcoholism and thyroid diseases (with impaired thyroid function), the elderly.

Side effects

Hypoglycemia (in case of violation of the dosage regimen and inadequate diet): headache, feeling tired, feeling hungry, sweating, sudden weakness, aggressiveness, anxiety, irritability, inattention, inability to concentrate and slow reaction, depression, visual impairment, aphasia, tremor, feeling helpless, sensory disorders, dizziness, loss of self-control, delirium, convulsions, hypersomnia, loss of consciousness, shallow breathing, bradycardia. From the digestive system: dyspepsia (nausea, diarrhea, a feeling of heaviness in the epigastrium); anorexia-the severity decreases when taken with food; liver function disorders (cholestatic jaundice, increased activity of “liver” transaminases). Hematopoietic disorders: anemia, thrombocytopenia, leukopenia. Allergic reactions: pruritus, urticaria, maculopapular rash.

Interaction

Enhance the hypoglycemic effect of Diabepharma®MB angiotensin-converting enzyme inhibitors (captopril, enalapril), H2-histamine receptor blockers (cimetidine), antifungal drugs (miconazole, fluconazole), nonsteroidal anti-inflammatory drugs (phenylbutazone, Indometacin, diclofenac, azapropazone, oxyphenbutazone), tetracycline, fibrates (clofibrate, bezafibrate), anti-tuberculosis drugs (ethionamide), salicylates, coumarin-type indirect anticoagulants, anabolic steroids, beta-blockers, cyclophosphamide, chloramphenicol, monoamine oxidase inhibitors, long-acting sulfonamides, fenfluramine, fluoxetine, pentoxifylline, guanethidine, theophylline, drugs that block tubular secretion, reserpine, bromocriptine, disopyramide, pyridoxine, allopurinol, ethanol and ethanol-containing drugs, as well as other hypoglycemic drugs (acarbose, biguanides, insulin). Weaken the hypoglycemic effect  Diabepharma MB barbiturates, glucocorticosteroids, sympathomimetics (epinephrine, clonidine, ritodrin, salbutamol, terbutaline), phenytoin, slow calcium channel blockers, carbonic anhydrase inhibitors (acetazolamide), thiazide diuretics, chlortalidone, furosemide, triamtaren, asparaginase, baclofen, danazol, diazoxide, isoniazid, morphine, glucagon, rifampicin, thyroid hormones, lithium salts, in high doses – nicotinic acid, chlorpromazine, estrogens and oral contraceptives containing them. When interacting with ethanol, a disulfiram-like reaction can develop. Gliclazide increases the risk of ventricular extrasystole when taking cardiac glycosides. Beta-blockers, clonidine, reserpine, and guanethidine may mask the clinical manifestations of hypoglycemia. When used concomitantly with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.

How to take, course of use and dosage

The dose of the drug should be selected individually, depending on the clinical manifestations of the disease, fasting glucose levels and 2 hours after meals. Usually the initial daily dose (including for the elderly over 65 years of age)It is 30 mg (1 tablet), then, if necessary, the dose of the drug is increased at intervals of at least 2 weeks. The maximum daily dose is 120 mg (4 tablets). The drug is taken orally 1 time a day in the morning, during breakfast. Diabefarm ® MV can replace Diabefarm in doses from 1 to 4 tablets per day. It can be used in combination with other hypoglycemic agents: biguanides, alpha-glucosidase inhibitors or insulin. In patients with mild to moderate renal impairment (creatinine clearance from 15 to 80 ml / min), the drug is prescribed in the same doses.

Overdose

In case of overdose, hypoglycemia is possible, up to the development of hypoglycemic coma. Treatment: if the patient is conscious –take easily digestible carbohydrates (sugar) inside, if he loses consciousness-intravenously inject 40% dextrose (glucose) solution,1-2 mg of glucagon intramuscularly. After regaining consciousness, the patient should be given food rich in easily digestible carbohydrates in order to avoid the re-development of hypoglycemia.

Special instructions

Diabepharm®Treatment MB is performed in combination with a low-calorie diet with a low carbohydrate content. It is necessary to regularly monitor the level of glucose in the blood on an empty stomach and after meals. In the case of surgical interventions or decompensation of diabetes, the possibility of using insulin preparations should be considered. Patients should be warned about the increased risk of hypoglycemia when taking ethanol, nonsteroidal anti-inflammatory drugs, and fasting. If you take ethanol, you may also develop a disulfiram-like syndrome (abdominal pain, nausea, vomiting, headache). It is necessary to adjust the dose of the drug in case of physical or emotional overstrain, changing the diet. Particularly sensitive to the effects of hypoglycemic drugs are elderly people; patients who do not receive a balanced diet; weakened patients; patients suffering from pituitary-adrenal insufficiency.At the beginning of treatment, during the selection of the dose, patients who are prone to developing hypoglycemia are not recommended to engage in activities that require increased attention and speed of psychomotor reactions.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Gliclazide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes