DIABETON MV
Active material: Gliclazide
When ATH: A10BB09
CCF: Oral hypoglycemic agents
When CSF: 15.02.01.02.01
Manufacturer: Servier Laboratories (France)
Pharmaceutical form, composition and packaging
Pills Modified release white, oblong, engraved on both sides: one – company logo, another – “DIA30”.
| 1 tab. | |
| gliclazide | 30 mg |
Excipients: calcium hydrogen phosphate dihydrate, maltodextrin, gipromelloza, magnesium stearate, Colloidal anhydrous silica.
30 PC. – blisters (1) – packs cardboard.
30 PC. – blisters (2) – packs cardboard.
The modified-release tablet white, Oval, lenticular, scored and engraved “MORNING” “60” on both sides.
| 1 tab. | |
| gliclazide | 60 mg |
Excipients: lactose monohydrate, maltodextrin, gipromelloza 100 cP, magnesium stearate, Colloidal anhydrous silica.
30 PC. – blisters (1) – packs cardboard.
30 PC. – blisters (2) – packs cardboard.
DESCRIPTION OF ACTIVE SUBSTANCES.
Pharmacological action
The oral hypoglycemic agent, sulfonylurea derivative II generation. It stimulates the secretion of insulin β-cells of the pancreas. It increases the sensitivity of peripheral tissues to insulin. Apparently, It stimulates the activity of intracellular enzymes (in particular, muscle glycogen). Decreases the time interval from the time the meal before insulin secretion. Restores the early peak of insulin secretion, reduces postprandial hyperglycemia peak.
Gliclazide reduces platelet adhesion and aggregation, slows the development of mural thrombus, increases vascular fibrinolytic activity. Normalizes vascular permeability. It has anti-atherogenic properties: lowers blood concentration of total cholesterol and / LDL, increases the concentration of cholesterol / HDL, and also reduces the amount of free radicals. Prevents the development of atherosclerosis and mikrotromboza. It improves the microcirculation. It reduces the sensitivity of vessels to adrenaline.
In diabetic nephropathy in the background of the prolonged use of gliclazide was a significant decrease in proteinuria.
Pharmacokinetics
After ingestion is rapidly absorbed from the gastrointestinal tract. Cmax in the blood is approximately 4 hours after receiving a single dose of 80 mg.
Plasma protein binding is 94.2%. Vd – about 25 l (0.35 l / kg).
It is metabolized in the liver to form 8 metabolites. The major metabolite has no hypoglycemic action, but the influence on the microcirculation.
T1/2 – 12 no. Write mainly by the kidneys as metabolites, less 1% excreted in the urine as unchanged.
Testimony
NIDDM (type 2) moderate severity with the initial manifestations of diabetic microangiopathy. Prevention of violations of microcirculation (as part of combination therapy with other sulfonylureas).
Dosage regimen
The initial daily dose is 80 mg, Average daily dose 160-320 mg, frequency of administration – 2 times / day before meals. Dosage individually depending on fasting and after 2 hours after meals, as well as the clinical manifestations of the disease.
Side effect
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).
On the part of the endocrine system: in overdose – gipoglikemiâ.
Allergic reactions: skin rash, itch.
Contraindications
Insulin-dependent diabetes mellitus (type I), Ketoacidosis, diabeticheskaya coma and coma, expressed by the human kidney and liver; Hypersensitivity to sulfonylureas and sulfanilamides. The simultaneous use of gliclazide and imidazole derivatives (incl. mikonazola).
Pregnancy and lactation
Not recommended for use during pregnancy and lactation.
Cautions
Gliclazide is used to treat NIDDM in conjunction with a low calorie diet, low-carbohydrate.
During treatment should regularly monitor the level of glucose in fasting blood and postprandial, daily fluctuations of glucose.
In the case of surgical interventions or decompensated diabetes must take into account the possibility of insulin.
With the development of hypoglycemia, if the patient is conscious, glucose (or a solution of sugar) appointed interior. If unconscious administered glucose / or glucagon in n / a, w / o or w / w. After recovery of consciousness is necessary to give the patient food, rich in carbohydrates, in order to avoid a recurrence of hypoglycemia.
With simultaneous use of verapamil with gliclazide requires regular monitoring of glucose levels in the blood; with acarbose – It requires careful monitoring and correction of dosing regimen hypoglycemic agents.
The simultaneous use of gliclazide and cimetidine on recommended.
Drug Interactions
Hypoglycemic effect of gliclazide potentiated while the use of derivatives pyrazolone, salicylates, phenylbutazone, antibacterial agents sulfanilamidnymi, theophylline, caffeine, MAO inhibitors.
The simultaneous use of nonselective beta-blockers increase the likelihood of hypoglycemia, and can also mask the tachycardia and tremor of the hands, typical of hypoglycemia, sweating at the same time it can be enhanced.
With simultaneous use of gliclazide and acarbose observed additive hypoglycemic effect.
Cimetidine increases the concentration of gliclazide in plasma, which can cause severe hypoglycemia (CNS depression, disturbance of consciousness).
At simultaneous application with Valium (including dosage forms for external use), Diuretics, ʙarʙituratami, Estrogen, progestins, Combined estrogen-progestin preparations, difeninom, rifampicin reduces hypoglycemic action of gliclazide.
