BI-EUGLUCON ® a drug based on phenformin hydrochloride and glibenclamide
THERAPEUTIC GROUP: Oral hypoglycemic agents - combined therapy
Indications BI-EUGLUCON ® - Phenformin + Glibenclamide
BI-EUGLUCON ® is used in the treatment of type 2 diabetes mellitus, in case of reduced efficacy of monotherapy with sulfonylureas and marked insulin resistance.
Mechanism of action BI-EUGLUCON ® - Phenformin + Glibenclamide
The excellent hypoglycemic efficacy of BI-EUGLUCON ® is due to the combination of two active ingredients with complementary mechanisms of action.
In fact, while glibenclamide, belonging to the pharmacological category of sulfonylureas, is able to act at the level of the pancreatic beta cell, promoting the endogenous secretion of insulin, phenformin, belonging to the category of biguanides, acts at the peripheral level, improving sensitivity to " insulin and predisposing the insulin-sensitive tissues to a better use of glucose.
The synergy between the two active ingredients allows not only an excellent glycemic control both at basal and post-prandial, but also a greater tolerability of the therapy, given the modest doses used.
In addition, the easy mode of intake significantly increases compliance, further optimizing the effectiveness of the drug.
Both active ingredients, taken orally, are absorbed in the intestine and excreted mainly through the urine.
Studies carried out and clinical efficacy
1. SULPHANILUREE AND BIGUANIDES INEFFECTIVE IN VASCULAR PROTECTION
J Diabetes Complications. 2007 Mar-Apr; 21: 108-17.
Regulation of the atherogenic properties of vascular smooth muscle proteoglycans by oral anti-hyperglycemic agents.
de Dios ST, Frontanilla KV, Nigro J, Ballinger ML, Ivey ME, Cawson EA, Little PJ.
The combined therapy between biguanides and sulfonylureas was not able to modulate the potential toxic effects of hyperglycemia on the vascular wall, showing no particular anti-atherogenic effects. The study was performed in vitro, evaluating the structural changes induced by the drug on the proteoglycans of vascular muscle cells involved in the development of atheroma.
2. MONITORING OF COMBINED THERAPY
Diabetes Metab Res Rev. 2004 Jan-Feb; 20: 44-7.
All-cause mortality in diabetic patients treated with combinations of sulfonylureas and biguanides.
Mannucci E, Monami M, Masotti G, Marchionni N.
Italian work that emphasizes the study of the potential causes of death of patients treated with combined therapy between sulfonylureas and biguanides, in order to exclude possible roles of the active ingredients in these episodes. The absence of statistically significant studies increases the need for controlled clinical trials.
3. GLIBENCLAMIDE AND PHENFORMIN, EFFECTIVE THERAPEUTIC
Horm Metab Res. 1996 Feb; 28: 89-94.
Therapeutic effect of glibenclamide in a fixed combination with metformin or phenformin in NIDDM patients.
Raptis AE, Tountas NB, Yalouris AG, Halvatsiotis PG, Raptis SA.
Treatment of type 2 diabetic patients with glibenclamide and phenformin ensured good glycemic control and a more intense reduction in glycosylated hemoglobin concentrations than single therapies. However, the association between glibenclamide and metformin produced the best results
Method of use and dosage
BI-EUGLUCON ® 25 mg tablets of phenformin and 2.5 mg of glibenclamide:
treatment with this medicine should start from the lowest effective dose, equal to ½ tablet per day, to be increased up to a maximum of 3 tablets per day, in case of reduced therapeutic success.
The dosage should be formulated by the doctor in an appropriate manner to the patient's metabolic and glucose profile in order to avoid the appearance of unpleasant side effects.
Warnings BI-EUGLUCON ® - Phenformin + Glibenclamide
It is important that BI-EUGLUCON ® therapy is preceded and accompanied by non-pharmacological therapeutic measures such as a balanced diet and constant physical exercise.
All therapy must always be accompanied by periodic monitoring of glycemic levels, renal and hepatic function, in order to avoid the onset of unpleasant side effects.
For the same reason, the patient must be informed of the possible risks related to the assumption of high quantities of the drug, alcohol, unbalanced diets so that he can recognize the signs of hypoglycemia or keto acidosis and immediately seek repairs.
Treatment with BI-EUGLUCON ® should be suspended in favor of insulin, during surgery, infectious and febrile diseases or trauma in order to always ensure good glycemic control.
BI-EUGLUCON ® contains lactose, therefore it could be associated with the occurrence of unpleasant side effects in patients with lactase deficiency, lactose intolerance or galactose / glucose malabsorption.
PREGNANCY AND BREASTFEEDING
The use of BI-EUGLUCON ® is contraindicated in pregnancy and breastfeeding given the possible side effects on the health of the unborn child and the infant linked to the intake of both active ingredients.
It is therefore preferred to treat gestational diabetes with safer drugs, whose therapeutic activity is well defined
Interactions
The possible interactions must essentially refer to the single active ingredients contained in BI-EUGLUCON ®
In fact, while the therapeutic action of glibenclamide could be altered by the concomitant intake of dicumarol and derivatives, MAO inhibitors, phenylbutazone and derivatives, chloramphenicol, probenecid, cyclophosphamide, salicylates, adrenals, corticosteroids, oral contraceptives and thiazide diuretics, it could be that of phenformin altered by the intake of alcohol, glucorticoids, beta-agonists, diuretics and ACE inhibitors.
It is also important to remember that the administration of iodinated contrast media could reduce renal function, resulting in an accumulation of phenformin potentially toxic to the patient's health.
Contraindications BI-EUGLUCON ® - Phenformin + Glibenclamide
BI-EUGLUCON ® is contraindicated in patients with ketoacidosis diabetes, coma or diabetic precoma, impaired liver and kidney function, respiratory, cardiovascular, dystrophic diseases, acute bleeding, gangrene and alcoholism.
Undesirable Effects - Side Effects
BI-EUGLUCON ® therapy was generally well tolerated with the onset of clinically insignificant side effects such as nausea, anorexia, gastralgia, vomiting, diarrhea, dermatological reactions, headache and dizziness.
More clinically relevant side effects have been observed in predisposed patients, such as patients with reduced renal function, where the accumulation of active ingredients could determine the onset of lactacidosis and a severe prognosis.
Cases of hypoglycemia have also been described in debilitated patients, the elderly, alcoholics, or in case of incorrect dosages.
Note
BI-EUGLUCON ® can only be sold under medical prescription.
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