EUGLUCON ® - Glibenclamide

EUGLUCON ® is a glibenclamide-based drug

THERAPEUTIC GROUP: Oral hypoglycemic agents - Sulfonylureas

Indications EUGLUCON ® - Glibenclamide

EUGLUCON ® is a drug indicated in the treatment of type II diabetes mellitus in the absence of satisfactory results obtained through non-pharmacological therapies.
EUGLUCON ® can be used both as monotherapy and in combination therapy with insulin or other oral hypoglycemic agents.

Mechanism of action EUGLUCON ® - Glibenclamide

Glibenclamide, the active ingredient of EUGLUCON ®, is an oral hypoglycemic agent belonging to the pharmaceutical category of sulfonylureas and one of the oral hypoglycemic drugs.
Its therapeutic action is associated with two main mechanisms capable of guaranteeing better control of both post-prandial and basal glycaemia.
The first mechanism is carried out at the pancreatic level, where this active principle can act on the beta cell, inhibiting the potassium channels of the SUR family, thus facilitating "the depolarization of the cell membrane and the consequent release of insulin, while the second, decidedly more complex and coordinated, it seems to correlate with the ability of glibenclamide to increase the sensitivity of insulin receptors to insulin, enhancing the metabolic effects of this hormone at the peripheral level.
The hypoglycemic action is carried out for about 24 hours from its intake, thus allowing with the simple administration of one tablet a day, good glycemic control in 24 hours.
The drug, metabolised in the liver, is subsequently excreted in the form of inactive metabolites in almost equal quantities in faeces and urine.

Studies carried out and clinical efficacy

1. EFFECTIVENESS OF GLIBENCLAMIDE

Diabetes Metab Res Rev. 2004 May-Jun; 20: 225-31.

Effects of glipizide GITS and glibenclamide on metabolic control, hepatic glucose production, and insulin secretion in patients with type 2 diabetes.

Go EH, Kyriakidou-Himonas M, Berelowitz M.

Glibenclamide has proved particularly effective not only in ensuring better insulin secretion, useful for glycemic control, but also in reducing hepatic secretion of glucose. This statistically significant study conducted on patients with type II diabetes supports the hypothesis of an extrapancreatic mechanism of action of glibenclamide.

2. GLIBENCLAMIDE AND KIDNEY PATHOLOGY

Clin J Am Soc Nephrol. 2011 Mar 31.

Renal Function in Type 2 Diabetes with Rosiglitazone, Metformin, and Glyburide Monotherapy.

Lachin JM, Viberti G, Zinman B, Haffner SM, Aftring RP, Paul G, Kravitz BG, Herman WH, Holman RR, Kahn SE; ADOPT.

One of the most important consequences of diabetic disease is the onset of nephropathy and renal failure. This study evaluates the contribution that drug therapy offers to the onset of this condition. Specifically, glibenclamide, like rosiglitazone, has been shown to be safer for kidney disease, compared to metformin, for example, which has been recorded in 5 years. more cases of kidney failure.

3. THE DANGER OF HYPOGLYCEMIA

Klin Padiatr. 1990 Mar-Apr; 202: 103-5.

Fatal iatrogenically-induced hyperglycemia following accidental glibenclamide ingestion

Lemke R.

One of the most important risks associated with glibenclamide therapy is that of hypoglycemia, due to its important systemic effects. In this case report, the death of a patient from hypoglycemia following ingestion of excessive doses of glibenclamide is reported. The intent of this work is to reiterate the importance of correct dosage formulation and periodic control of glycemic levels, in order to avoid unpleasant consequences.

Method of use and dosage

EUGLUCON ® Glibenclamide 5 mg tablets: after monitoring glycemic levels and adjusting the meal plan, the first administration of EUGLUCON ® should not exceed ½ tablet daily.
In the event that the initial portion of the drug is not capable of producing the expected therapeutic results, the doctor may increase the dosage up to a maximum of 2-3 tablets per day.
Given the long-lasting efficacy of glibenclamide, EUGLUCON ® should be taken once a day at the main meal.

Warnings EUGLUCON ® - Glibenclamide

The correct therapeutic approach to diabetic pathology should primarily include the adoption of non-pharmacological measures such as diet and lifestyle, accompanied in case of poor therapeutic results by drug therapy.
Before starting treatment and during therapy, it is of fundamental importance to periodically monitor the glycemic levels, both to evaluate the efficacy of the therapy and to correctly adjust the dose of the drug, thus avoiding glycemic imbalances.
It is indeed important to remember that hypoglycemic crises are accompanied by severe symptoms, such as to seriously compromise the patient's state of health.
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.
EUGLUCON ® contains lactose, therefore its intake could be followed by annoying side effects concentrated in the gastrointestinal tract 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

The high risk for the health of the fetus, documented by several studies in the literature that tested the efficacy and safety of glibenclamide in pregnant women, and the possibility of using more effective and characterized therapeutic protocols, severely contraindicating the use of EUGLUCON ® during the period of pregnancy.
The contraindication to use also extends to the lactation period, given the secretion of the active ingredient in breast milk, which could cause hypoglycemia in the infant.

Interactions

As described for the other sulfonylureas, glibenclamide can also interact with numerous other active ingredients, also significantly varying its pharmacokinetic and therapeutic properties.
In fact, the concomitant administration of insulin and other oral antidiabetics, ACE inhibitors, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, phenyramidol, fibrates, fluoxetine, ifosfamide, MAO inhibitors, miconazole, para- aminosalicylic, pentoxifylline (parenterally in high doses), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, sympatholytic drugs such as beta-blockers and guanethidine, may increase tritophylline, clarithromycin, tetracycline, tetracycline effect blood glucose lowering agent of EUGLUCON ® increasing the risk of hypoglycemia.
On the contrary, the concomitant intake of acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, adrenaline and other sympathomimetic drugs, glucagon, laxatives (after prolonged use), nicotinic acid (in high doses), estrogens and progestin, phenothiazines, phenytoin, thyroid hormones and rifampicin could reduce the therapeutic efficacy of the drug thus leading to impaired and ineffective glycemic control.
Furthermore, glibenclamide could cause an increase in plasma concentrations of cyclosporine, significantly increasing its toxicity.

Contraindications EUGLUCON ® - Glibenclamide

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

Undesirable Effects - Side Effects

Various clinical trials and careful post-marketing monitoring seem to agree on the good tolerability of glibenclamide if taken in the appropriate doses and modalities.
In fact, the main side effects were observed following the formulation of excessive dosages, and materialized in the appearance of hypoglycemic episodes, easily reversible with the oral intake of simple sugars.
On the other hand, adverse reactions affecting the gastrointestinal and haematological system were rarer, promptly regressed once the therapy was suspended.
Dermatological affections such as rash and urticaria have been observed in patients hypersensitive to the drug or to one of its components.

Note

EUGLUCON ® can only be sold under strict medical prescription

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