NOVONORM ® - Repaglinide
NOVONORM ® is a Repaglinide-based drug.
THERAPEUTIC GROUP: Oral hypoglycemic agents - Derivatives of benzoic acid
Indications NOVONORM ® - Repaglinide
NOVONORM ® is indicated in the treatment of hyperglycaemia in patients with type II diabetes, in case of therapeutic failure of non-pharmacological measures such as diet and physical activity.
NOVONORM ® can also be useful in the management of type II diabetic patients in combination therapy with Metformin.
Mechanism of action NOVONORM ® - Repaglinide
The repaglinide contained in NOVONORM ® can effectively modulate glycemic levels, acting selectively on the pancreatic beta cell and promoting the secretion of insulin in just 30 minutes from the oral intake of the drug.
The hypoglycemic effect that occurs through the inhibition of the potassium channels present on the surface of the pancreatic beta cell and the triggering of the depolarization wave useful first for the entry of calcium and then for the release of insulin, persists for about 4 hours. at the end of which the active principle is metabolized in the liver and subsequently excreted mainly by the biliary route.
Studies carried out and clinical efficacy
1. THERAPEUTIC EFFECTIVENESS OF REPAGLINIDE
Isr Med Assoc J. 2005 Feb; 7: 75-7.
Clinical experience with repaglinide in patients with non-insulin-dependent diabetes mellitus.
Shapiro MS, Abrams Z, Lieberman N.
A study carried out on about 700 patients with type II diabetes, treated for 8 weeks with repaglinide demonstrates how this therapeutic approach can guarantee a reduction in glycaemia from 191mg / dL to 155, bringing the glycosylated hemoglobin values from 8.8 to 7.7%. improved glycemic control also resulted in a reduction in meal quantities.
2. REPAGLINIDE AND ENDOTHELIAL DYSFUNCTION
Cardiovasc Diabetol. 2006 Apr 10; 5: 9.
Effect of repaglinide on endothelial dysfunction during a glucose tolerance test in subjects with impaired glucose tolerance.
Schmoelzer I, Wascher TC.
Micro and macroangiopathies are the main consequences of diabetic pathology and in most cases associated with a greater risk of nephropathies, retinopathies and ischemic events. In this study it was shown that repaglinide-induced post-prandial glycemic control, reducing blood glucose levels and the formation of advanced glycosylation products, can significantly reduce endothelial damage and dysfunction.
3. REPAGLINIDE AND OXIDATIVE STRESS
Diabetes Res Clin Pract. 2005 May; 68: 89-95. Epub 2004 Dec 7.
Effects of repaglinide on oxidative stress in tissues of diabetic rabbits.
Important study, which although still in an experimental phase, lays the foundations of a collateral and important activity of repaglinide on the general health of the diabetic patient. In fact, this work demonstrates how the administration of repaglinide at therapeutic doses can exert a relevant and measurable antioxidant effect, which could counteract the conditions of oxidative stress that characterize the patient and the diabetic pathology.
Method of use and dosage
NOVONORM ® Repaglinide 0.5, 1 and 2 mg tablets: as for all hypoglycemic drugs, the effective dose of repaglinide can be established by the physician only after careful monitoring of the patient's glycemic values and his responsive abilities.
As a general rule, therapy should be started with the minimum useful dose, equal to 0.5 mg 15 to 30 minutes before main meals, and only after two weeks of monitoring blood glucose levels should any dose adjustments be made up to a maximum of 16 mg total daily.
The formulation of the correct dosage as well as predicting the glycemic levels, should also take into account the general health of the patient and in particular of the liver and kidneys.
NOVONORM ® warnings - Repaglinide
The correct therapeutic management of the type II diabetic patient, before the administration of oral hypoglycemic drugs, should include the respect of correct dietary rules and the general improvement of the lifestyle.
Only when these non-pharmacological remedies were not effective alone in guaranteeing good glycemic control, could drug therapy be started, monitoring glycemic levels especially in the first two weeks of treatment in order to avoid important metabolic imbalances.
Excessive intake of NOVONORM ® could in fact be accompanied by hypoglycemia with a series of adverse and dangerous side reactions for the patient's health.
The risk of hypoglycaemia increases when repaglinide is administered in combination with other hypoglycaemic drugs, significantly reducing the patient's perceptive abilities and making it dangerous to drive and use machines.
PREGNANCY AND BREASTFEEDING
The absence of studies relating to the intake of NOVONORM ® during pregnancy and lactation and the presence of well-characterized, effective and safe antidiabetic drugs makes the administration of repaglinide in this period almost useless and not recommended due to the potential risks.
Although the hepatic metabolism of repaglinide is supported by the CYP3A4 enzyme, which is easily modulated by different active ingredients, the concomitant intake of NOVONORM ® and substrates of cytochrome CYP3A4 did not produce relevant changes in its pharmacokinetic properties.
Conversely, the concomitant intake of alcohol, oral antidiabetics, monoamine oxidase inhibitors, beta blockers, ACE inhibitors, NSAIDs, thyroid hormones, corticosteroids and oral contraceptives, could make glycemic fluctuations unpredictable, preventing repaglinide from effectively controlling blood glucose concentrations. .
Contraindications NOVONORM ® - Repaglinide
NOVONORM ® is contraindicated in patients with type I diabetes, keto acidosis and diabetic coma and in individuals with known hypersensitivity to repaglinide or to one of its excipients.
Undesirable Effects - Side Effects
Therapeutic treatment with NOVONORM ® was generally well tolerated and free from clinically relevant side effects.
In most cases, the adverse reactions observed were associated with the inaccurate dosage formulation, with glycemic drops such as to cause visual changes, but promptly recovered with oral administration of sugars.
More rarely, diseases affecting the gastrointestinal tract, alterations in liver function and dermatological reactions on an allergic basis have been described.
NOVONORM ® can only be sold under medical prescription.
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