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Novonorm has a hypoglycemic effect. It blocks ATP-dependent potassium channels in the membranes of functionally active beta cells of the islet apparatus of the pancreas, causes their depolarization and the opening of calcium channels, inducing insulin incretion. The insulinotropic response to food intake develops within 30 minutes after application and is accompanied by a decrease in blood glucose levels during the meal period (insulin concentration does not increase between meals). In experiments in vivo and in animals, no mutagenic, teratogenic, carcinogenic, or fertility effects were detected. Quickly and completely absorbed from the digestive tract. The maximum concentration is reached after 1 hour and is 9.8; 18.3; 26 and 65.8 ng / ml after receiving doses of 0.5; one; 2 and 4 mg, respectively; when taken with food, the maximum concentration may be reduced by 20%. Content in plasma rapidly decreases within 4 hours. Almost completely biotransformed in the liver (oxidation and binding to glucuronic acid), forming inactive metabolites. The half-life is 1 hour. Excreted within 4-6 hours, mainly from the bile through the gastrointestinal tract (90%) and with urine (less than 8%).
Type 2 diabetes mellitus with the ineffectiveness of diet and exercise. In patients with type 2 diabetes, repaglinide can also be used in combination with metformin in cases where satisfactory glycemia control cannot be achieved using repaglinide monotherapy or metformin.
1 tablet contains:
active substance: Repaglinide 2 mg.
Excipients: poloxamer 188, povidone, meglumine, corn starch, anhydrous calcium phosphate, microcrystalline cellulose (E460), glycerol 85% (glycerol), potassium polyacrylate (potassium polyacryline), magnesium stearate
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Dosage and Administration
NovoNorm adminstered orally. Assigned as a supplement to diet and exercise to reduce blood glucose levels; drug intake should be timed to meals.
The recommended initial single dose NovoNorm before the main meal is 0.5 mg. Dose adjustment is carried out 1 time per week or 1 time in 2 weeks (at the same time they are guided by the level of glucose in the blood as an indicator of response to therapy). If the patient moves from taking another oral hypoglycemic agent to treatment with NovoNorm, the recommended initial dose before each main meal should be 1 mg.
The most frequent side effects are changes in blood glucose, i.e. hypoglycemia. The frequency of such reactions depends, as with the use of any type of therapy for diabetes mellitus, on individual factors, such as dietary habits, drug dosage, physical activity and stress. Hypersensitivity reactions such as itching, rash, urticaria can be detected. Very rarely, generalized hypersensitivity reactions or immunological reactions, such as vasculitis, may occur. Hypoglycemia. As with the use of other hypoglycemic agents, hypoglycemia may develop with repaglinide. Hypoglycemia can manifest itself with the following symptoms: anxiety, dizziness, sweating, tremor, hunger, difficulty concentrating. These reactions in most cases are not heavy and can be eliminated by carbohydrate intake. In severe reactions (hypoglycemia with loss of consciousness, hypoglycemic coma), medical care may be required, in particular, intravenous administration of dextrose (glucose). However, such reactions are extremely rare, it is impossible to determine their frequency, based on the available data. The risk of hypoglycemia may increase with the interaction of repaglinide with other drugs (see the Interaction section). Changes in blood glucose levels can lead to visual disturbances, especially at the initial stage of therapy with hypoglycemic drugs. However, usually these changes are transient in nature. Abdominal pain, diarrhea, nausea, vomiting and constipation may occur. However, the frequency and severity of these symptoms did not differ from those in the use of other oral medications that stimulate insulin secretion. Violations of the liver function - in very rare cases, severe violations of the liver function were reported, but a causal relationship with repaglinide was not established.
Hypersensitivity, diabetes mellitus type 1, diabetic ketoacidosis with or without coma, severe dysfunction of the liver and / or kidneys, pregnancy, lactation. Restrictions on the use: children's age and age over 75 years.
Beta-adrenergic blockers, chloramphenicol, indirect anticoagulants (derivatives of coumarins), NPVS, probenecid, salicylates, MAO inhibitors, sulfonamides, alcohol, anabolic steroids, calcium channel blockers, corticosteroids, diuretics (especially thiazide), of them, aspirants, calcium channel blockers, corticosteroids, diuretics (especially thiazide), of them, aspirants, calcium channel blockers, corticosteroids, diuretics (especially thiazide), of them, aspirants, calcium channel blockers, corticosteroids, diuretics (especially thiazide), of them, as well as of them, as well as calcium channel blockers, corticosteroids, diuretics (especially thiazide), of them, as well as anesthetics , phenytoin, sympathomimetics, thyroid hormones - weaken the effect. Erythromycin, ketoconazole and miconazole weaken, and barbiturates, carbamazepine and rifampicin - increase metabolism.
Pregnancy and Lactation
Studies in pregnant women and nursing mothers were not conducted. Therefore, the safety of using NovoNorm® in pregnant women has not been studied.
Animal studies have shown that the drug does not have a teratogenic effect. The drug was found in the milk of experimental animals.
Taking NovoNorm® during pregnancy and lactation is not recommended.
With caution used in patients with impaired liver or kidney, debilitated patients, and before the upcoming extensive surgical intervention.
Symptoms: hypoglycemia (feeling of hunger, feeling tired and weak, headache, irritability, anxiety, drowsiness, restless sleep, nightmares, behavioral changes like those observed during alcohol intoxication, impaired concentration, impaired speech and vision, confusion, paleness, nausea , heart palpitations, convulsions, cold sweat, coma, etc.).
Treatment: with moderate hypoglycemia, without neurological symptoms and loss of consciousness - taking carbohydrates (sugar or glucose solution) inside and adjusting the dose or diet. In severe form (convulsions, loss of consciousness, coma) - IV the introduction of 50% glucose solution followed by infusion of a 10% solution to maintain blood glucose levels of at least 5.5 mmol / l.
- Brand name: NovoNorm
- Active ingredient: Repaglinide
Studies and clinical trials of Repaglinide (Click to expand)
- Repaglinide – prandial glucose regulator: a new class of oral antidiabetic drugs
- Synthesis, characterization and evaluation of novel methoxypolyethyleneglycol- grafted- poly(ester-urethane)s for controlled release of repaglinide
- Preparation and evaluation of novel blend microspheres of poly(lactic-co-glycolic)acid and pluronic F68/127 for controlled release of repaglinide
- Simultaneous estimation of six anti-diabetic drugs—glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human plasma assay
- An Efficient and Cost-Effective Synthesis of 3-Ethoxy-4-ethoxycarbonyl-phenylacetic Acid: A Key Acid Synthon of Repaglinide (VI).
- Synthesis and in vitro Evaluation of (S)-2-([11C]Methoxy)-4- [3-methyl-1-(2-piperidine-1-yl-phenyl)-butyl-carbamoyl]-benzoic Acid ([11C]Methoxy-repaglinide): A Potential β-Cell Imaging Agent.
- Compared to glibenclamide, repaglinide treatment results in a more rapid fall in glucose level and beta-cell secretion after glucose stimulation
- Studies on binary lipid matrix based solid lipid nanoparticles of repaglinide: in vitro and in vivo evaluation
- In vitro characterization and in vivo toxicity study of repaglinide loaded poly (methyl methacrylate) nanoparticles
- Synthesis and in vitro evaluation of (S)-2-([11C]methoxy)-4-[3-methyl-1-(2-piperidine-1-yl-phenyl)-butyl-carbamoyl]-benzoic acid ([11C]methoxy-repaglinide): a potential β-cell imaging agent
- Polymorphic organic anion transporting polypeptide 1B1 is a major determinant of repaglinide pharmacokinetics
- Cyclosporine markedly raises the plasma concentrations of repaglinide
- Telithromycin, but not montelukast, increases the plasma concentrations and effects of the cytochrome P450 3A4 and 2C8 substrate repaglinide
- Electrochemical characterization of repaglinide and its determination in human plasma using liquid chromatography with dual-channel coulometric detection
- Ionization, lipophilicity and solubility properties of repaglinide
- Method development and validation of repaglinide in human plasma by HPLC and its application in pharmacokinetic studies
- Polymorphism in CYP2C8 is associated with reduced plasma concentrations of repaglinide
- The pharmacokinetic profile of theophylline is not significantly altered by repaglinide co-administration
- Disposition of one dose of 14C-repaglinide during non-labeled repaglinide multiple dosing
- Repaglinide pharmacokinetics in healthy & chronic liver disease subjects
- Impurity profile study of repaglinide
- CYP2C8 and CYP3A4 are the principal enzymes involved in the human in vitro biotransformation of the insulin secretagogue repaglinide
- The CYP2C8 inhibitor trimethoprim increases the plasma concentrations of repaglinide in healthy subjects