GLIBOMET ® a drug based on Metformin hydrochloride and Glibenclamide.
THERAPEUTIC GROUP: Oral hypoglycemic agents, combined therapy
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications GLIBOMET ® - Metformin + Glibenclamide
GLIBOMET ® is used as a drug therapy for second type diabetes mellitus, not adequately compensated by diet or sulfonylureas and biguanides.
Mechanism of action GLIBOMET ® - Metformin + Glibenclamide
The association in fixed doses of metformin and glibenclamide, observable in GLIBOMET ®, guarantees good glycemic control in diabetic patients who are not responsive to single therapy with sulfonylureas or biguanides, combining complementary mechanisms of action.
In fact, while glibenclamide, once absorbed at the intestinal level, is able to reach the pancreatic beta cell by inhibiting the potassium channel belonging to the SUR family and facilitating the depolarization of the plasma membrane with the consequent release of insulin, metformin acts at the level of insulin-sensitive tissues, facilitating glucose uptake on one side and inhibiting endogenous glucose synthesis on the other.
In both cases, the active ingredients taken orally and absorbed at the intestinal level, are eliminated mainly through the urine.
Studies carried out and clinical efficacy
1. COMPARISON THERAPIES
The combined metformin / glibenclamide therapy proved to be less effective than that of glimepiride / metformin in reducing the control of the glycemic profile, reducing the levels of glycosylated hemoglobin in patients with type II diabetes, not adequately compensated for by individual therapies.
2. CARDIOVASCULAR RISK AND HYPOGLYCAISTIC DRUGS
Very interesting study that tested the cardiovascular risk induced by different oral hypoglycemic drugs. The study demonstrates how insulin secretagogues such as sulfonylureas can be associated with a greater risk than, for example, that linked to metformin, thus underlining the importance of the side effects of these drugs on the heart.
3. COMBINED TREATMENT SAFETY
The treatment of type II diabetes, with fixed doses of metformin and glibenclamide, has proved to be safer than single therapies, as it can induce the same therapeutic effect with significantly lower doses of the active ingredients. This type of dosage is therefore able to reduce the incidence of some side effects.
Method of use and dosage
GLIBOMET ® tablets of 400 mg of metformin and 2.5 mg of glibenclamide or of 400 mg of metformin and 5 mg of glibenclamide:
although the recommended initial dose is two tablets a day taken during the main meals, it is necessary that the correct dosage is formulated by your doctor after a careful evaluation of the patient's physiopathological status and of his glycemic values.
Warnings GLIBOMET ® - Metformin + Glibenclamide
Treatment with oral hypoglycemic drugs should be preceded and accompanied by non-pharmacological measures such as scheduled physical activity and a balanced diet.
In order for the therapy to produce adequate results by minimizing the risk of the occurrence of side effects, periodic monitoring of glycemic levels, liver and kidney function is necessary.
In addition, the patient must be informed of the correct management of the diabetic disease, and of the potential side effects, so that it can recognize the signs early and eventually resort to the shelters.
In the case of trauma, surgery, infectious diseases and fever, it may be necessary to stop therapy with oral hypoglycemic agents, and to provide insulin.
It should be remembered that treatment with sulfonylureas could be associated with haemolytic anemia in patients with G6PD deficiency.
PREGNANCY AND BREASTFEEDING
GLIBOMET ® is contraindicated in pregnancy and lactation, given the presence of active ingredients with a low safety profile for the health of the fetus and infant.
Gestational diabetes should therefore be treated pharmacologically with more effective and safer drugs such as insulin.
Interactions
The observable interactions for GLIBOMET ® are essentially due to the presence of glibenclamide and metformin.
Therefore in the case of glibenclamide the concomitant intake of dicumarol and derivatives, MAO inhibitors, phenylbutazone and derivatives, chloramphenicol, probenecid, cyclophosphamide, salicylates, adrenaline, corticosteroids, oral contraceptives and thiazide diuretics could alter its normal pharmacokinetic properties, while the intake of acool, glucorticoids, betagonists, diuretics and ACE inhibitors could alter the therapeutic capacity of metformin.
It is also important to remember that the administration of iodinated contrast agents could reduce renal function, resulting in an accumulation of metformin potentially toxic for the health of the patient and responsible for lactic acidosis.
Contraindications GLIBOMET ® - Metformin + Glibenclamide
GLIBOMET ® contraindicated in patients hypersensitive to the active ingredient or to one of their excipients, suffering from gestational diabetes, first-type diabetes, diabetic disease, diabetic keto acidosis, reduced liver and kidney function, cardiovascular and respiratory diseases, alcoholism, gangrene and prolonged fasts or poorly balanced diets.
Undesirable effects - Side effects
Therapy with GLIBOMET ® proved to be well tolerated with the presence of clinically little relevant and transient side effects.
In most cases, in fact, the most described adverse reactions were those affecting the gastrointestinal tract, with nausea, vomiting and diarrhea, affecting the skin with dermatological hypersensitivity reactions, headache and dizziness.
More serious side effects, such as hypoglycemic crises or lactic acidosis have been observed rarely and in predisposed patients.
Note
GLIBOMET ® sold only under medical prescription.
