DIABREZIDE ® a Gliclazide based drug.
THERAPEUTIC GROUP: Oral hypoglycemic agents - Sulfonylureas
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications DIABREZIDE ® - Gliclazide
DIABREZIDE ® is indicated as a pharmacological treatment of type II diabetes, in combination with adequate nutrition and a healthy lifestyle.
The particular therapeutic activities of gliclazide, make DIABREZIDE ® also useful in the prevention of vascular complications associated with diabetes.
Mechanism of action DIABREZIDE ® - Gliclazide
DIABREZIDE ® is a drug belonging to the therapeutic group of oral hypoglycemic agents, consisting of the active ingredient gliclazide, second generation sulfonylurea.
Taken orally, gliclazide is absorbed at the intestinal level, and bound to plasma proteins for about 94% of the total dose taken, reaches the pancreas where it performs part of its therapeutic action by selectively acting on beta cells and stimulating insulin secretion.
The biological action is essentially associated with the possibility of inhibiting the Potassium SUR channel, facilitating the depolarization of the cell membrane with the consequential opening of calcium channels, necessary to increase the influx of intracellular calcium and the subsequent release of insulin from the vesicles to the extracellular environment.
Another hypoglycemic action is added, particularly important for type II diabetic patients, represented by the ability to prevent the risk of thrombotic episodes by normalizing endothelial fibrinolytic activity and reducing adhesion and platelet aggregation.
The half-life of gliclazide can also reach 10 hours after which, after intense hepatic metabolism, it is eliminated as inactive metabolites, mainly in the urine.
Studies carried out and clinical efficacy
1. VASOPROTECTIVE ACTION OF GLYCLAZIDE
The development of atherosclerotic plaques is a more important and clinically relevant consequence of diabetic pathology, and more specifically of type II diabetic pathology. This interesting study has shown that gliclazide can significantly reduce the oxidation levels of LDL lipoproteins, protecting the vessel from plaque formation and damage.
2. GLYCLAZIDE AND CELLULAR SURVIVAL
Very interesting Italian study, which shows how gliclazide can reduce the rate of apoptosis of pancreatic beta cells, probably by acting on the antioxidant action, thus supporting pancreatic function. Activation of the beta cell apoptotic process is in fact one of those conditions most frequently associated with the onset of type II diabetes.
3.GLYCLAZIDE AND COMBINED THERAPY
Study demonstrating how the combined treatment of metformin and gliclazide represents one of the most effective combinations in the treatment of type II diabetes, allowing a rapid improvement of some blood chemistry parameters indicative as glycosylated hemoglobin, fasting blood glucose and lipidemic profile.
Method of use and dosage
DIABREZIDE ® Gliclazide 80 mg tablets:
usually the recommended dosage is that of two tablets a day to be taken also in two administrations, possibly 30 minutes before the main meals.
It is of fundamental importance to remember that the correct dosage should be formulated by the doctor only after careful monitoring of the patient's glycemic levels and his / her ability to respond to therapy.
Warnings DIABREZIDE ® - Gliclazide
Therapy with DIABREZIDE ® should always be accompanied by a general improvement in lifestyle and diet, as well as by periodic monitoring of glycemic levels.
This last point assumes an important meaning in the management of drug therapy, from the moment in which an adjustment of the dosage could become necessary even during therapy, in order to avoid unpleasant metabolic imbalances such as hypoglycemia.
The evaluation of glycosylated hemoglobin as well as glycemia could also represent an important parameter for assessing the patient's glycemic control.
In patients with impaired hepatic and renal function, medical supervision should be even more careful.
The condition of hypoglycemia is usually accompanied by specific warning signs that should be carefully evaluated by the patient, in order to avoid the use of machinery or the driving of vehicles or other risky activities, and immediately resort to remedies.
PREGNANCY AND BREASTFEEDING
Gestational diabetes, a fairly frequent condition in pregnancy, cannot be treated with oral hypoglycemic drugs such as gliclazide, given the presence of numerous positive studies and the availability on the market of drugs with a higher safety profile and with a well-characterized therapeutic activity .
Furthermore, the possibility of finding this active ingredient in breast milk greatly limits its use even during the breastfeeding phase, given the risk of inducing hypoglycemia in the infant.
Interactions
Concomitant administration of miconazole, phenylbutazone, alcohol, other antidiabetic agents, beta blockers, fluconazole and ACE inhibitors may potentiate the hypoglycemic effects of gliclazide, thereby increasing the risk of hypoglycaemia.
On the contrary, the concomitant intake of chlorpromazine (neuroleptic) and glucorticoids could reduce the therapeutic effect of DIABREZIDE ® by preventing good glycemic control.
It should also be remembered that gliclazide could alter the anticoagulant activity of warfarin, enhancing its therapeutic effects.
Contraindications DIABREZIDE ® - Gliclazide
DIABREZIDE ® is contraindicated in patients with type 1 diabetes mellitus, severe hepatic and renal dysfunction, diabetic precoma and coma, diabetic keto acidosis, hypersensitivity to the active substance or to one of its excipients and during pregnancy and 'feeding time
Undesirable effects - Side effects
In most cases, DIABREZIDE ® therapy, if performed correctly and combined with an equally healthy lifestyle, is rarely associated with the appearance of clinically relevant side effects.
Gastro-intestinal disorders, abnormal liver function, haematological disorders and allergic skin reactions are some of the documented but fortunately rare adverse reactions.
More frequently, especially in debilitated patients, drinkers or in the presence of reduced hepatic and renal function, it was possible to describe the onset of hypoglycemic episodes due also to pharmacological dosages of gliclazide not well formulated and accompanied by the classic symptomatology marked by headache, reduction of vigilance, mental confusion, delirium, convulsions, bradycardia, drowsiness and loss of consciousness.
In this case the intake of sugars allows a prompt regression of the aforementioned condition.
Note
DIABREZIDE ® can only be sold under strict medical prescription.
