Itopra (Itopra)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceItoprideItopride
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    • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet contains:

    active substance: titopride hydrochloride 50.0 mg;

    Excipients: lactose monohydrate 40.0 mg, corn starch 10.0 mg, giprolose 4.0 mg, carmellose sodium 15.0 mg, magnesium stearate 3.0 mg;

    sheath: fall off OY-S-7223 4.8 mg: giprolose 1.51 mg, hypromellose 1.51 mg, titanium dioxide 1.51 mg, macrogol-400 0.27 mg.

    Description:

    Round, biconvex tablets, covered with a film shell of white or almost white color. On one side of the tablet, the embossing method is marked with "ID 50 ".The cross section of the nucleus is white or almost white.

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

    A.03.F.A.07   Itopride

    Pharmacodynamics:

    Itopride hydrochloride enhances the motility of the gastrointestinal tract due to antagonism with D2dopamine receptors and inhibition of acetylcholinesterase. Itopride hydrochloride activates the release of acetylcholine, inhibits its destruction. Itopride hydrochloride has an antiemetic effect due to interaction with D2receptors located in the trigger zone.Causes a dose-dependent suppression of emesis caused by apomorphine.

    Itopride hydrochloride activates propulsive motility of the stomach due to antagonism with D2receptors and dose-dependent inhibition of acetylcholinesterase activity. Itopride hydrochloride has a specific effect on the upper sections of the gastrointestinal tract, accelerates transit through the stomach, improves its emptying.

    Has no effect on serum concentrations of gastrin.

    Pharmacokinetics:

    Suction

    Ittopride hydrochloride is rapidly and well absorbed in the gastrointestinal tract. Relative bioavailability is 60%. The maximum concentration in the blood plasma (CmOh) - 0.28 μg / ml. The period of reaching the maximum concentration in the blood plasma (TSmOh) - 0.5-0.75 hours after taking 50 mg of the drug. At repeated admission to 50-200 mg 3 times a day for 7 days pharmacokinetics is linear, cumulation of the drug is minimal.

    The connection with proteins is 96% (mainly with albumin); with alpha-1-acid glycoprotein - less than 15%.

    Distribution

    Ittopride hydrochloride is distributed in the kidneys, small intestine, liver, adrenal gland, stomach. Volume of distribution (Vd) - 6.1 l / kg.

    In therapeutic doses of tenthpride hydrochloride slightly penetrates into the brain and spinal cord, as well as into breast milk.

    Metabolism and excretion

    The drug is metabolized in the liver by the action of flavin-dependent monooxygenase. Three metabolites have been identified, only one of them exhibits little activity (2-3% of the activity of ticopride hydrochloride), which has no pharmacological significance.

    Itopride hydrochloride and its metabolites are excreted mainly by the kidneys. The half-life (T1/2) - is 6 hours, in patients with trimethylaminuria T1/2 increases.

    Indications:Symptomatic treatment of functional non-ulcer dyspepsia (chronic gastritis), in particular - relief of bloating (flatulence), pain or discomfort in the epigastric region (anastasia), anorexia, heartburn, nausea, vomiting, feelings of rapid satiety.
    Contraindications:

    Hypersensitivity to tesentropium or any auxiliary component of the drug, gastrointestinal bleeding, mechanical obstruction and perforation of the gastrointestinal tract, children under 16 years of age, pregnancy and lactation (breastfeeding),deficiency of lactase, lactose intolerance, glucose-galactose malabsorption, since the dosage form contains lactose.

    Carefully:

    Caution should be used in the preparation of Itopra in patients for whom the appearance of cholinergic adverse reactions (associated with increased action of acetylcholine under the influence of the drug) may aggravate the course of the underlying disease.

    Pregnancy and lactation:

    Itopra is contraindicated in pregnancy and lactation (breastfeeding).

    Dosing and Administration:

    Inside, before meals, 50 mg 3 times a day.

    The recommended daily dose is 150 mg.

    This dose can be reduced taking into account the age of the patient.

    Side effects:

    From the hematopoiesis: leukopenia, thrombocytopenia.

    Allergic reactions: skin hyperemia, itching, rash, anaphylactic shock.

    From the endocrine system: gynecomastia, increased prolactin levels.

    From the digestive system: increased salivation, nausea, diarrhea, constipation, abdominal pain, jaundice.

    From the nervous system: headache, dizziness, tremor.

    Laboratory indicators: increased activity of aspartate aminotransferase (ACT), alanine aminotransferase (ALT), gamma glutamyltranspeptidase, alkaline phosphatase, bilirubin level.

    Overdose:

    Cases of overdose in humans are not described.

    Treatment: when a possible overdose shows gastric lavage and symptomatic therapy.

    Interaction:

    Accelerates the absorption of other drugs (cimetidine, ranitidine, tetrenone, cetraxate).

    Prokinetic effect of the drug does not change under the influence of drugs that reduce the acidity of gastric juice.

    M-cholinoblockers decrease the effectiveness of aspenpride.

    The cholinergic effect of tytopride may increase with the simultaneous administration of M-holinoblokatorov, as well as inhibitors of cholinesterase.

    Special instructions:The indication, if necessary, of the characteristics of the action of the drug at the first admission or when it is abolished

    With the withdrawal of the drug Itopra, the symptoms of the withdrawal syndrome are not described.

    Special precautions for the destruction of unused medications not required.

    Effect on the ability to drive transp. cf. and fur:

    Care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration and speed of psychomotor reactions, since the drug may cause dizziness and other side effects that may affect these abilities.

    Form release / dosage:

    Tablets, film-coated, 50 mg.

    Packaging:

    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    According to 1, 2, 3, 4, 5, 10 contour cell packs of 10 tablets together with instructions for use in a cardboard box.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002272
    Date of registration:11.10.2013 / 18.01.2017
    Expiration Date:11.10.2018
    Date of cancellation:2018-10-11
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.08.2017
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