NOVONORM ® - Repaglinide

NOVONORM ® is a drug based on Repaglinide.

THERAPEUTIC GROUP: Oral hypoglycemic agents - Benzoic acid derivatives

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Directions NOVONORM ® - Repaglinide

NOVONORM ® is indicated in the treatment of hyperglycemia in patients with type II diabetes, in case of therapeutic failure of non-pharmacological measures such as diet and physical activity.

NOVONORM ® can be useful in the management of type II diabetic patients also in combination therapy with Metformin.

Action mechanism NOVONORM ® - Repaglinide

The repaglinide contained in NOVONORM ® can effectively modulate the glycemic levels, acting selectively on the pancreatic beta cell and promoting insulin secretion 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 on the triggering of the depolarization wave useful before the entry of calcium and then the release of insulin, persists for about 4 hours at the end of which the active principle is metabolised to the liver level and subsequently excreted mainly via the bile.

Studies carried out and clinical efficacy

1. THERAPEUTIC EFFECTIVENESS OF THE REPAGLINID

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 blood sugar from 191mg / dL to 155, bringing the values of glycosylated hemoglobin from 8.8 to 7.7%. The best glycemic control has also translated into a reduction in the quantity of meals.

2. REPAGLINIDE AND ENDOTHELIAL DYSFUNCTION

Micro and macroangiopathies are the main consequences of diabetic pathology and in most cases associated with a greater risk of nephropathy, retinopathy and ischemic events. In this study, it was shown that the post-prandial glycemic control induced by repaglinide, reducing blood glucose levels and the formation of advanced glycosylation products can significantly reduce damage and endothelial dysfunction.

3. REPAGLINIDE AND OXIDATIVE STRESS

An important study, which although still in an experimental phase, lays the foundation for an important collaglinide activity on the general health of the diabetic patient. In fact, this work demonstrates how the administration at therapeutic doses of repaglinide 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 ® tablets of 0.5, 1 and 2 mg of Repaglinide: as with all hypoglycemic drugs, the effective dose of repaglinide can be established by the doctor only after careful monitoring of the patient's glucose values and his responsive abilities.

In principle, therapy should be started with the minimum useful dose, equal to 0.5 mg from 15 to 30 minutes before the main meals, and only after two weeks of monitoring of the glycemic levels, make adjustments to the dosage up to a maximum of Total 16 mg daily.

The formulation of the correct dosage as well as predicting the glycemic levels, should also take into account the general state of health of the patient and in particular of the liver and kidneys.

Warnings NOVONORM ® - Repaglinide

The correct therapeutic management of the type II diabetic patient, should foresee before the administration of oral hypoglycemic drugs, the respect of correct dietary norms and the general improvement of the lifestyle.

Only when these non-pharmacological remedies were not effective on their own in ensuring good glycemic control could one start with drug therapy, monitoring glycemic levels especially in the first two weeks of treatment in order to avoid major metabolic disorders.

Excessive intake of NOVONORM ® may in fact be accompanied by hypoglycemia with a series of adverse and dangerous side reactions to the health of the patient.

The risk of hypoglycaemia increases when repaglinide is administered in combination with other hypoglycemic drugs, significantly reducing the patient's perceptive abilities and making the driving of vehicles and the use of machinery dangerous.

PREGNANCY AND BREASTFEEDING

The absence of studies concerning the intake of NOVONORM ® during the period of pregnancy and lactation and the presence of well-characterized, effective and safe antidiabetic drugs makes repaglinide administration almost useless as well as advised against the potential risks in this period.

Interactions

Although the hepatic metabolism of repaglinide is supported by the enzyme CYP3A4, which is easily modulated by different active ingredients, the concomitant intake of NOVONORM ® and substrates of CYP3A4 did not produce relevant changes in its pharmacokinetic properties.

Conversely, the concomitant intake of alcohol, oral antidiabetic agents, monoamine oxidase inhibitors, beta blockers, ACE inhibitors, NSAIDs, thyroid hormones, corticosteroids and oral contraceptives, could make glycemic oscillations unpredictable, preventing repaglinide from effectively controlling blood glucose concentrations .

Contraindications NOVONORM ® - Repaglinide

NOVONORM ® intake is contraindicated in patients with type I diabetes, keto acidosis and diabetic coma and in individuals with known hypersensitivity to repaglinide or one of its excipients.

Undesirable effects - Side effects

The therapeutic treatment with NOVONORM ® has proved generally well tolerated and has no clinically relevant side effects.

In most cases the adverse reactions observed were associated with the non-precise formulation of the dosage, with glycemic declines such as to cause changes in vision, but readily recovered with oral administration of sugars.

More rarely have been described affections affecting the gastro-intestinal tract, alterations in liver function and dermatological reactions on an allergic basis.