Glyurenorm® (Glurenorm®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceGlikvidonGlikvidon
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  • Glyurenorm®
    pills inwards 
    Boehringer Ingelheim International GmbH     Germany
  • Yuglin
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    Pharmasintez-Tyumen, Open Company     Russia
    • Dosage form: & nbsppills
    Composition:
    1 tablet contains:
    Active substance: glikvidon - 30 mg;
    Excipients: lactose monohydrate - 134.6 mg, corn starch dried - 70 mg, corn starch soluble - 5 mg, magnesium stearate - 0.4 mg.
    Description:

    Smooth, round, white with beveled edges of the tablet; with risk on one side and engraving "57C" on both sides of the risks; on the other side the company logo is engraved.

    Pharmacotherapeutic group:Hypoglycemic agent for oral use of the second-generation sulfonylurea group.
    ATX: & nbsp

    A.10.B.B.08   Glikvidon

    Pharmacodynamics:
    GLUENORORM - a hypoglycemic agent for oral use refers to the derivatives of sulfonylureas of the second generation, has pancreatic and extra-pancreatic effects. Stimulates the secretion of insulin, potentiating the glucose-mediated way of insulin formation. In animal experiments, it has been shown that GLUNRENORM reduces insulin resistance in the liver and adipose tissue by increasing receptors for insulin, as well as stimulation of post-receptor. mechanism, mediated by insulin.The hypoglycemic effect develops 60 to 90 minutes after ingestion, the maximum of action occurs in 2-3 hours and lasts about 8-10 hours. Glikvidon refers to short-acting sulfonylureas and is therefore used in patients with type 2 diabetes with an increased risk of hypoglycemia, for example in elderly patients and patients with renal impairment.
    Since the excretion of glycidone by the kidneys is negligible, GLUNRENORM can be used in patients with renal impairment and diabetic nephropathy. There is evidence that the use of glycidone in patients with type 2 diabetes mellitus having concomitant liver disease is effective and safe. Only the excretion of inactive metabolites in these patients is somewhat delayed. However, patients with diabetes mellitus and concomitant severe liver disorders are not recommended.
    During clinical trials, it was found that the use of GLURORORM for 18 and 30 months did not lead to an increase in body weight, even cases of weight loss of 1 to 2 kg were noted. In comparative studies with other derivatives of sulfonylureas,that in patients taking GYLRENORM for more than a year there are no significant changes in body weight.
    Pharmacokinetics:
    Suction:
    After ingestion of a single dose of glycidone (15 mg or 30 mg), the drug is absorbed rapidly and almost completely (80 to 95%) from the gastrointestinal tract, reaching a plasma concentration of 0.65 μg / ml (range 0.12 to 2.14 μg / ml). The average time to reach the maximum plasma concentration in the plasma is 2 hours 15 minutes (range: 1.25 - 4.75 hours). The area under the concentration-time curve (AUC o-) is 5.1 μg h / ml (range: 1.5-10.1 μg h / ml).
    There are no differences in pharmacokinetic parameters in patients with diabetes mellitus and in healthy individuals.
    Distribution:
    Glikvidon has a high affinity for plasma proteins (> 99%). There is no data on the possible passage of glycidone or its metabolites
    through the blood-brain barrier or placenta. There is no data on the possibility of glycidone penetrating into breast milk.
    Metabolism:
    Glikvidon is completely metabolized in the liver, mainly by hydroxylation and demethylation. Metabolites of glycidone do not have or have poorly expressed pharmacological activity in comparison with the initial substance.
    Excretion:
    The major part of metabolites is excreted through intestines.The kidneys are only a small part of metabolites. AT studies showed that after taking Inside about 86% of the isotope labeled preparation (14FROM) is excreted through the intestine. Regardless of the dose and mode of administration, the kidneys are about 5% (in the form of metabolites) from the administered amount preparation. BREAKING THE GLUTENER kidneys remains minimal even with regular appointment.
    Half-life is 1.2 hours (in range - 0,4 - 3,0 hours), the final period half-life is approximately 8 hoursAsas (in the range of 5.7 - 9.4 hours).
    Elderly patients:
    In elderly patients and patients in the middleozrasta pharmacokinetic parameters are similar.
    Patients with impaired renal function and liver:
    The bulk of the drug is taken out through intestines. There is evidence that the metabolism drug does not change in patients with hepatic insufficiency. Excretion glycidone by the kidneys slightly, patients with impaired renal function the drug does not accumulate.
    Indications:

    Diabetes mellitus type 2 in patients of middle and advanced age (with ineffectiveness of diet therapy).

    Contraindications:

    -increased sensitivity to sulfonamides;

    Type 1 diabetes mellitus;

    -diabetic acidosis and ketoacidosis, precoma, coma;

    -State after resection of the pancreas glands;

    - acute intermittent porphyria;

    severe liver failure;

    -Some acute conditions (for example, infectious diseases or large surgical operations);

    -Birth, the period of the breast feeding;

    -red hereditary diseases, such as galactosemia, deficiency of lactase, glucose-galactose malabsorption, intolerance lactose;

    -About 18 years of age (due to insufficiency data on efficiency and safety drug in this age group).

    Carefully:

    febrile syndrome;

    Thyroid gland diseases (with violation of the function);

    deficiency of glucose-6-phosphate-dehydrogenase;

    alcoholism.

    Pregnancy and lactation:
    There is no data on the use of glycidone in women during pregnancy and breastfeeding. When pregnancy with concomitant diabetes requires a careful monitoring of the concentration of glucose in the plasma. The intake of oral hypoglycemic drugs in women during pregnancy is notprovides proper glycemic control. Therefore, the use of gljulnorma during pregnancy is contraindicated.
    In case of pregnancy or during pregnancy planning during the period of application of GYLENORMA, the drug should be canceled and switched to insulin.
    Dosing and Administration:
    The drug is used inside. It is necessary to follow the doctor's recommendations regarding the dose of the drug and compliance with the diet. Do not stop taking the medication without consulting your doctor.
    The initial dose of GLUTENROM is usually 1/2 tablet (15 mg) at breakfast time. The drug must be taken at the beginning of the meal. After taking Gluten-free, food should not be taken miss.

    If taking 1/2 tablet (15 mg) does not result in improvement, after consulting a doctor The dose should be gradually increased. If daily dose of gluten-free does not exceed 2 tablets (60 mg), it can be prescribed in one session, during breakfast.

    When appointing a higher dose, the best effect can be achieved upon admission daily dose divided into 2-3 doses. AT In this case, the highest dose should be taken at breakfast. Increase dose more 4 tablets (120 mg) per day are usually notleads to a further increase effectiveness.

    The maximum daily dose is 4 tablets (120 mg).

    Admission of the drug in patients with impaired kidney function.

    About 5% of the metabolites of the drug is excreted kidneys. In patients with impaired function no kidney correction is required.

    Admission of the drug in patients with impaired function of the liver.

    Taking a dose exceeding 75 mg patients with impaired liver function requires careful monitoring of the condition patient. The drug should not be administered patients with severe impairment of function liver, as 95% of the dose is metabolized in liver and is excreted through the intestine.

    Combination Therapy

    With insufficient clinical effect ionotherapy with GLURORORM can be recommended only additional appointment of metformin.

    Side effects:

    From the side of the blood and lymphatic system: thrombocytopenia, leukopenia, agranulocytosis.

    From the side of metabolism: hypoglycemia.

    From the nervous system: headache, dizziness, drowsiness, paresthesia, a sense of fatigue.

    From the side of the organ of vision: naccommodation cracks.

    From the cardiovascular system: angina, extrasystole, cardiovascular system,arterial insufficiency hypotension.

    From the gastrointestinal tract: nausea, vomiting, constipation, diarrhea, feeling discomfort in the abdomen, dryness in the oral cavity, decreased appetite.

    From the liver and biliary tract: xosteasis.

    From the skin and subcutaneous tissue: rash, itching, hives, Stevens-Johnson, the reaction of photosensitization.

    Other: pain in the chest.

    Overdose:

    Overdose of sulfonylurea derivatives can lead to hypoglycemia.

    Symptoms: tachycardia, increased sweating, hunger, palpitation, tremor, headache, insomnia, irritability, speech and vision impairment, motor anxiety and loss of consciousness. Treatment: in case of symptoms of hypoglycemia, glucose (dextrose) or foods rich in carbohydrates should be ingested. In severe hypoglycemia (loss of consciousness, coma) intravenously injected with dextrose. After the restoration of consciousness - the reception of digestible carbohydrates (to avoid the re-development of hypoglycemia).

    Interaction:

    It is possible to intensify hypoglycemic action with simultaneous administration of glycidone and angiotensin-converting enzyme inhibitors, allopurinol, analgesics and nonsteroidal anti-inflammatory drugs, antifungals, chloramphenicol, clarithromycin, clofibrate, coumarin derivatives, fluoroquinolones, heparin, monoamine oxidase inhibitors, sulfinpyrazone, sulfonyl amides, tetracyclines and tricyclic antidepressants, cyclophosphamide and its derivatives, insulin and oral hypoglycemic means.

    Beta-blockers, sympatholytic drugs (including clonidine), reserpine and guanethidine may increase the hypoglycemic effect and simultaneously mask symptoms hypoglycemia.

    Possible reduction of hypoglycemic actions with simultaneous appointment glycidone and aminoglutethimide, sympathomimetics, glucocorticosteroids, thyroid hormones, glucagon, thiazide and "loop" diuretics, oral contraceptives, diazoxide, phenothiazine and drugs containing nicotine acid.

    Barbiturates, rifampicin and phenytoin also can reduce the hypoglycemic effect glycidone.

    Strengthen or weaken hypoglycemic effect of glycidone was described with the use of H2-histamine receptors (cimetidine, ranitidine) and alcohol.

    Special instructions:
    Patients with diabetes should strictly follow the doctor's recommendations.
    Especially careful control is needed when choosing a dose or when switching from another hypoglycemic drug. Oral hypoglycemic agents should not replace a therapeutic diet, which allows you to control the body weight of the patient. Skipping meals or not following a doctor's recommendation can significantly reduce the concentration of glucose in the blood and lead to unconsciousness. When taking a pill before meals, and not as recommended, at the beginning of food intake, the effect of the drug on the concentration of glucose in the blood is more pronounced, which increases the risk of developing hypoglycemia.
    When symptoms of hypoglycemia appear, you must immediately take food containing sugar. In the case of persisting hypoglycemia, you should immediately consult a doctor.
    Physical activity can exacerbate hypoglycemic effects.
    Alcohol or stress may increase or decrease the hypoglycemic effect of sulfonylurea derivatives. The use of sulfonylurea derivatives in patients with insufficiency of glucose-6-phosphate dehydrogenase can lead to the development of hemolytic anemia. Since GLUNRENORM refers to sulfonylurea derivatives, care must be taken when using the drug in patients with glucose-b-phosphate dehydrogenase deficiency and, if possible, it is necessary to decide on the drug change.
    One Glutenorm tablet contains 134.6 mg of lactose (538.4 mg of lactose in the maximum daily dose). Patients with rare hereditary diseases: galactosemia, lactase deficiency, glucose-galactose malabsorption and intolerance to lactose, should not take Gluten.
    Glikvidon refers to short-acting sulfonylureas and is therefore used in patients with type 2 diabetes with an increased risk of hypoglycemia, for example in elderly patients and patients with impaired renal function.
    Since the excretion of glycidone by the kidneys is insignificant, GLUNORROM can be used in patients with renal impairment and diabetic nephropathy. However, treatment of patients with severe renal failure should be carried out under close medical supervision.
    There is evidence that the use of glycidone in patients with type 2 diabetes mellitus having concomitant liver disease is effective and safe. Only the excretion of inactive metabolites in these patients is somewhat delayed. However, patients with diabetes mellitus and concomitant severe impairment of liver function is not recommended.
    During clinical trials, it was found that the use of GLURORORM for 18 and 30 months did not lead to an increase in body weight, even cases of weight loss of 1 to 2 kg were noted. In comparative studies with other sulfonylureas, it has been shown that patients taking GYLRENORM for more than a year do not have significant changes in body weight.

    Effect on the ability to drive transp. cf. and fur:
    There is no evidence of the effect of the drug on the ability to drive vehicles and mechanisms. However, patients should be warned about such manifestations of hypoglycemia as drowsiness, dizziness,violation of accommodation, which can occur against the background of taking the drug. Required take care when driving vehicles and mechanisms.
    When hypoglycemic conditions should be avoided the management of vehicles and mechanisms.


    Form release / dosage:Tablets 30 mg.
    Packaging:For 10 tablets in a contour squamous packaging (blister) of PVC / AI. By 3, 6 or 12 blisters with instructions for use in a cardboard box.
    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:
    5 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014529 / 01
    Date of registration:29.10.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Boehringer Ingelheim International GmbHBoehringer Ingelheim International GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspBehringer Ingelheim, LLCBehringer Ingelheim, LLC
    Information update date: & nbsp23.12.2015
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