DAONIL ® - Glibenclamide

DAONIL ® is a glibenclamide-based drug

THERAPEUTIC GROUP: Oral hypoglycemic agents - Sulfonylureas

Indications DAONIL ® - Glibenclamide

DAONIL ® is indicated as a pharmacological aid in the treatment of type II diabetes mellitus, in case of failure of non-pharmacological therapeutic measures such as a balanced diet and a healthy lifestyle.

Mechanism of action DAONIL ® - Glibenclamide

The hypoglycemic action of DAONIL ® is due to the presence of its active ingredient glibenclamide, belonging to the pharmacological class of second generation sulfonylureas.
Taken orally, it reaches its peak in 2-4 hours, and then gradually decreases and is eliminated in the form of inactive metabolites in both faeces and urine, while continuing to exert its hypoglycemic effect for about 24 hours.
The main mechanism of action is carried out at the level of pancreatic Beta cells, in which glibenclamide, penetrated through the plasma membrane, selectively inhibits the potassium channel SUR1, facilitating the depolarization of the Beta cell and the consequent release of insulin.
Although the insulin secretagogue activity is predominant, this sulfonylurea also presents a series of extrahepatic mechanisms useful for improving peripheral insulin sensitivity and at the same time reducing potentially deleterious processes for the diabetic patient such as gluconeogenesis and hepatic glycogen lysis, capable to contribute to the onset of hypoglycemia.

Studies carried out and clinical efficacy

1. GLIBENCLAMIDE AND GLUCOSE

Ter Arkh. 2010; 82: 41-4.

Correlation of HBA (1c) and postprandial glycemia during a standard breakfast test in patients with type 2 diabetes mellitus receiving glibenclamide

Dreval "AV, Cheporeva ON, Red" kin IuA, Misnikova IV.

Particularly important study from the statistical point of view which demonstrates how the assumption of glibenclamide can guarantee in 3 months of therapy, the reduction of glycosylated hemoglobin from 8.7% to 7%, guaranteeing better control of both postprandial and basal glycemia.

2. GLIBENCLAMIDE AND GESTATIONAL DIABETES

Expert Opin Drug Saf. 2011 Mar; 10: 227-38. Epub 2011 Jan 6.

Oral hypoglycemic agents for gestational diabetes mellitus?

Maymone AC, Baillargeon JP, Ménard J, Ardilouze JL.

Despite gestational diabetes, is one of those pathologies particularly dangerous for the health of the fetus and present among pregnant women with a frequency of about 3%, at the moment the only effective and safe therapeutic treatment, if well dosed, seems to be the one related to the administration of insulin. The most important limit of this type of therapeutic approach is represented by the low compliance among patients which reduces its efficacy. For this reason, the use of oral hypoglycemic agents could be particularly useful, but at the moment the studies present in the literature seem to agree on the high danger to the health of the fetus.

3.GLIBENCLAMIDE / HONEY: ANTIOXIDANT ROLE

Int J Mol Sci. 2011 Jan 21; 12: 829-43.

Comparison of antioxidant effects of honey, glibenclamide, metformin, and their combinations in the kidneys of streptozotocin-induced diabetic rats.

Erejuwa OO, Sulaiman SA, Wahab MS, Salam SK, Salleh MS, Gurtu S.

Different experimental studies have shown how the association between honey and glibenclamide can significantly increase the pull of antioxidants at the cellular level, preserving in some cases, even the beta cell from tissue damage. This important indication has been observed for the significant increase in antioxidants. endogenous such as glutathione.

Method of use and dosage

DAONIL ® Glibenclamide 5 mg tablets:
DAONIL ® therapy should begin with the lowest dose capable of providing the hypoglycemic effect, therefore equal to ½ tablet per day.
Only after having monitored the patient's glycemic levels for at least a couple of weeks, the doctor will be able to adequately correct the drug therapy, increasing the dosage up to a maximum of 2 - 3 tablets per day.
It should be preferable to take it in a single dose, better know before the main meal with a large glass of water.

DAONIL ® warnings - Glibenclamide

In order for the intake of DAONIL ® to guarantee the achievement and maintenance of the therapeutic target, it is of fundamental importance to support it with non-pharmacological therapeutic measures such as a healthy diet and a correct lifestyle.
In fact, it is important to reiterate that the management of diabetic disease cannot ignore the improvement of daily habits.
Throughout the therapeutic process it is important to constantly monitor glycemic levels to avoid the appearance of metabolic alterations, potentially dangerous for the patient's health, thus adapting both drug therapy and eating habits.
The possible occurrence of hypoglycaemia, preceded by the presence of warning symptoms, could be controlled by the rapid administration of oral glucose.
Administration of glibenclamide in patients with impaired hepatic and renal function, or with G6PD enzyme deficiency should be avoided in order to prevent the development of adverse reactions such as pronounced haemolysis.
The presence of lactose in DAONIL ® could lead to the onset of gastrointestinal diseases in patients with lactase enzyme deficiency or glucose / galactose malabsorption.
It is also essential to remember that among the manifestations of hypoglycemia there is the reduction of the patient's perceptive abilities which could make the use of machinery or driving cars dangerous.

PREGNANCY AND BREASTFEEDING

Gestational diabetes, which affects about 3% of pregnant women, is a transient pathological condition characterized by hyperglycemia that could seriously compromise the health of the fetus.
Despite the therapeutic efficacy of glibenclamide, several studies have demonstrated the toxic effects of this active principle on the health of the fetus, so much so as to severely contraindicate the administration of DAONIL ® during pregnancy.
Furthermore, the possible secretion of the active ingredient in breast milk could also expose the infant to the risk of hypoglycaemia, therefore it is not recommended to interrupt breastfeeding during this therapy or to avoid the use of glibenclamide as a hypoglycemic agent.

Interactions

Given the hepatic metabolism of glibenclamide and its numerous metabolic interrelationships, it is possible to describe numerous interactions capable of altering the normal pharmacokinetic properties of the active ingredient and its therapeutic capabilities.
More precisely, an enhancement of the hypoglycemic effect could occur following the simultaneous intake of insulin and other oral antidiabetic agents, ACE inhibitors, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, phenyramidol, fibrates, fluoxetine, ifosfamide, MAO inhibitors, miconazole, para-aminosalicylic acid, pentoxifylline (parenterally in high doses), phenylbutazone, azapropazone, oxifenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, sympatholytic drugs such as beta-blockers tetracyclines, tritoqualine, trophosphamide, thus increasing the risk of hypoglycemia.
On the contrary, the therapeutic efficacy of DAONIL ® could be reduced following the intake of acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, adrenaline and other sympathomimetic drugs, glucagon, laxatives (after prolonged use), nicotinic acid (in high doses), estrogens and progestogens, phenothiazines, phenytoin, thyroid hormones and rifampicin.
Furthermore, glibenclamide could cause an increase in plasma concentrations of cyclosporine, significantly increasing its toxicity.

Contraindications DAONIL ® - Glibenclamide

DAONIL ® is contraindicated in patients with type 1 diabetes mellitus, severe liver and kidney dysfunctions, diabetic precoma and coma, diabetic keto acidosis and in case of hypersensitivity to the active substance or to one of its excipients.
This medicine is also contraindicated during the period of pregnancy and lactation.

Undesirable Effects - Side Effects

Although therapy with sulfonylureas is well tolerated in most patients, the risk of hypoglycemia certainly represents the potentially most dangerous side effect of therapy with DAONIL ®. This condition can manifest itself with headache, nausea, vomiting, bradycardia, fatigue, dyspnoea , visual disturbances and tremors, is usually associated with incorrect dosage formulation or an inadequate diet, too low in carbohydrates.
Gatro-intestinal disorders, changes in the blood picture with diffuse cytopenia and skin reactions due to hypersensitivity to the active substance or its excipients have been observed only in rare cases, without consequently clinically relevant for the patient's health.

Note

DAONIL ® can only be sold under strict medical prescription.

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