Ganaton (Ganaton)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceItoprideItopride
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  • Ganaton
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    ABBOTT LABORATORIES, LTD.     Russia
  • Itomed®
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    PRO.MED.CS Prague as.     Czech Republic
  • Itopra
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    OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC     Russia
    • Dosage form: & nbspcoated tablets
    Composition:Active substance: tytopride hydrochloride 50 mg;

    auxiliary components (mg in 1 tablet): lactose 34,975 (including excess due to loss in mass during production of 2.93%), corn starch 15.0, carmellose 20.0, silica anhydrous 4.0, magnesium stearate 1.0, hypromellose 4.4, macrogol-6000 0.4, titanium dioxide 0.2, carnauba wax 0.025.

    Description:

    White round tablets covered with a film sheath, with a risk of one side and engraving "NS 803" on the other.

    Pharmacotherapeutic group:Motility Gastrointestinal - Acetylcholine Ejection Stimulator
    ATX: & nbsp

    A.03.F.A.07   Itopride

    Pharmacodynamics:

    Itopride hydrochloride increases motility of the gastrointestinal tract due to antagonism D2dopamine receptors and inhibition of acetylcholinesterase. Itopride activates the release of acetylcholine and inhibits its destruction.

    Itopride hydrochloride also produces an antiemetic effect through interaction with D2receptors located in the trigger zone. Itopride caused a dose-dependent suppression of emesis caused by apomorphine.

    Itopride hydrochloride activates propulsive motility of the stomach due to antagonism D2receptors and dose-dependent inhibition of acetylcholinesterase activity.

    Itopride hydrochloride has a specific effect on the upper gastrointestinal tract, accelerates transit through the stomach and improves its emptying.

    Itopride hydrochloride does not affect serum levels of gastrin.

    Pharmacokinetics:

    Suction

    Ittopride hydrochloride is rapidly and almost completely absorbed into the digestive tract. Its relative bioavailability is 60%, which is associated with metabolism during the first passage through the liver. Food does not affect bioavailability.

    The maximum concentration in plasma (CmOh) 0.28 μg / ml is achieved after 0.5-0.75 hours after administration of 50 mg of tautoprid hydrochloride.

    With the repeated administration of tenthpride hydrochloride inside at a dose of 50-200 mg three times a day for 7 days, the pharmacokinetics of the drug and its metabolites was linear, and the cumulation was minimal.

    Distribution

    Itopride hydrochloride 96% binds to plasma proteins, mainly with albumin. The binding to the alpha1-acid glycoprotein is less than 15% of the total binding.

    Ittopride is actively distributed into tissues (volume distribution 6.1 l / kg) and is found in high concentrations in the kidneys, small intestine, liver, adrenal and stomach. Penetration into the brain and spinal cord is minimal. Itopride penetrates into breast milk.

    Metabolism

    Itopride is subject to active biotransformation in the liver in humans. Three metabolites have been identified, only one of which exhibits little activity, which has no pharmacological significance (approximately 2-3% of that of the taredrop). The primary metabolite in humans is Noxide, which is formed as a result of oxidation of the quaternary amino-Ndimethyl group. Itopride metabolized by flavine-dependent monooxygenase (FMO3). Number and effectiveness of isoenzymes FMO in humans can differ depending on genetic polymorphism, which in rare cases leads to the development of an autosomal recessive state known as trimethylaminuria (the "fish smell" syndrome). In patients with trimethylaminuria, the half-elimination period of tytopride is increased.

    According to pharmacokinetic studies in vivo, itopride has no inhibitory or inducing action on CYP2C19 and CYP2E1. The therapy with asperipedum does not affect CYP or the activity of uridine diphosphate glucuronisyl transferase.

    Excretion

    Itopride hydrochloride and its metabolites are excreted mainly with urine.Renal excretion of tesentropium and its Noxide after a single dose of the drug inside at therapeutic doses in healthy people was 3.7 and 75.4%, respectively. The terminal half-elimination period of tytopride hydrochloride is about 6 hours.

    Indications:

    Applied for the treatment of gastrointestinal symptoms associated with delayed gastric motility and functional non-ulcer dyspepsia (chronic gastritis), such as bloating, early satiety, a feeling of fullness in the stomach after eating, pain or discomfort in the epigastric region, anorexia, heartburn, nausea and vomiting.

    Contraindications:

    - Hypersensitivity to tesentropium or any auxiliary component of the drug;

    - patients with gastrointestinal bleeding, mechanical obstruction or perforation;

    - children's age (up to 16 years);

    - pregnancy and lactation.

    Carefully:

    Due to increased Itopride action of acetylcholine, should be used with caution because of the possible development of cholinergic adverse reactions in the category of patients for whom they the appearance may aggravate the course of the underlying disease.

    Itopride should be administered with caution to elderly patients due to the frequent decrease in liver and kidney function, the presence of concomitant diseases or other treatment.

    Pregnancy and lactation:

    Pregnancy

    There is insufficient data on the use of ticopride hydrochloride by pregnant women. Use during pregnancy is possible only if there is no alternative therapy, and the potential benefit to the mother exceeds the potential risk to the fetus.

    Breastfeeding period

    There is a potential risk of developing adverse reactions in the infant, and there are also data on the isolation of tautopride with milk in rats. If you need to take during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Usually, adults are prescribed 1 tablet of Ganaton 50 mg 3 times daily before meals.

    The recommended daily dose is 150 mg.

    The specified dose can be reduced taking into account the age and symptoms of the patient.

    In clinical studies, the duration of treatment with the drug Ganaton was up to 8 weeks.

    Side effects:

    Co the sides of the blood and lymphatic system: leukopenia, thrombocytopenia.

    Allergic reactions: skin hyperemia, skin itching, rash, anaphylaxis.

    Endocrine disorders: increasing the level of prolactin, gynecomastia.

    Co the sides of the nervous system: dizziness, headache, tremor.

    Co side gastrointestinal: diarrhea, constipation, abdominal pain, increased salivation, nausea, jaundice.

    Changes in laboratory indicators: increased activity of aspartate aminotransferase (ACT), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, alkaline phosphatase and bilirubin level.

    Overdose:

    Cases of overdose in humans are not described.

    In case of an overdose, gastric lavage and symptomatic therapy are indicated.

    Interaction:

    Metabolic interaction is hardly possible, since itopride metabolized by the action of flavin monooxygenase, and not CYP450.

    With the simultaneous use of warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine and nicardipine hydrochloride, no binding changes were observed with the proteins.

    Itoprids strengthens the motility of the stomach, so it can affect the absorption of other drugs that are prescribed internally. Particular care should be taken when using drugs with a low therapeutic index,as well as forms with delayed release of the active substance or preparations with enteric-soluble coating.

    Anti-ulcer agents, such as cimetidine, ranitidine, tetrenone and cetraxate, do not affect the prokinetic effect of taredropoda.

    Anticholinergic drugs can weaken the effect of ittopride.

    Special instructions:

    Itopride enhances the action of acetylcholine and can cause cholinergic side reactions.

    Form release / dosage:

    Tablets, coated with a coating, 50 mg.

    Packaging:

    For 7, 10 or 14 tablets in a blister of PVC / AL-Folga.

    1, 2, 3, 4 or 5 blisters with instructions for use in a cardboard bundle.

    Storage conditions:

    At a temperature below 25 ° C, in a dry, dark place.

    The drug should be stored in places inaccessible to children.

    Shelf life:

    5 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002513
    Date of registration:09.09.2011 / 18.08.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:ABBOTT LABORATORIES, LTD. ABBOTT LABORATORIES, LTD. Russia
    Manufacturer: & nbsp
    Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia
    Information update date: & nbsp15.03.2017
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