Itomed® (Itomed®)

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

    For 1 tablet:

    active substance: titopride hydrochloride 50.00 mg.

    Excipients: core: lactose monohydrate 74.68 mg, corn pregelatinized corn starch 5.00 mg, croscarmellose sodium 1.80 mg, silicon dioxide colloid 1.00 mg, magnesium stearate 2.52 mg; core mass 135.00 mg;

    shell: opadray 85F18422 white 3.00 mg (polyvinyl alcohol partially hydrolyzed 1,200 mg, titanium dioxide 0.750 mg, macrogol 4000 0.606 mg, talc 0.444 mg).

    Weight of the tablet is 138.00 mg.
    Description:

    Round, biconvex tablets covered with a film coat, white or almost white, with a notch on one side. On the fracture - white or almost white.

    Pharmacotherapeutic group:Gastrointestinal motility - acetylcholine ejection stimulant
    ATX: & nbsp

    A.03.F.A.07   Itopride

    Pharmacodynamics:

    Strengthens the motility of the gastrointestinal tract due to antagonism with D2dopamine receptors and inhibition of acetylcholinesterase. Activates the release of acetylcholine, inhibits its destruction.

    Has antiemetic effect due to interaction with D2receptors located in the trigger zone.Causes a dose-dependent suppression of emesis caused by apomorphine. Activates propulsive motility of the stomach due to antagonism with D2receptors and dose-dependent inhibition of acetylcholinesterase activity.

    Has a specific effect on the upper gastrointestinal tract, accelerates transit through the stomach, improves its emptying. Has no effect on serum concentrations of gastrin.

    Pharmacokinetics:

    Quickly and well absorbed in the digestive tract. The relative bioavailability of the drug is 60%. The maximum concentration in plasma (CmOh) - 0,28 mkg / ml, after taking 50 mg of the drug the time to reach the maximum concentration in the plasma (TCmOh) about 0.5-0.75 hours. With repeated admission of 50-200 mg 3 times a day for 7 days, pharmacokinetics is linear in nature, cumulation is minimal.

    It binds to plasma proteins (mainly with albumin) by 96%, with α1glycoprotein by less than 15%. It is actively distributed in tissues and is found in high concentrations in the kidneys, the small intestine, the liver, the adrenal glands, and the stomach. The volume of distribution is 6.1 l / kg. In therapeutic doses, it penetrates insignificantly into the brain and spinal cord, into breast milk.

    Metabolised in the liver under the action of flavin-dependent monooxygenase. Three metabolites have been identified, one of which exhibits little activity: 2-3% of the activity of itopride.

    It is excreted by the kidneys. The half-life of the drug (T1/2) is 6 h, in patients with trimethylaminuria T1/2 increases.

    Indications:Symptomatic treatment of functional non-ulcer dyspepsia (chronic gastritis): flatulence, gastralgia, a feeling of discomfort in the epigastric region, anorexia, heartburn, nausea, vomiting.
    Contraindications:Hypersensitivity to itopride or any auxiliary component of the drug, gastrointestinal bleeding, mechanical obstruction and perforation of the gastrointestinal tract, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, children's age (under 16), pregnancy, lactation.
    Carefully:

    Patients taking cholinesterase and M-cholinomimetic inhibitors, as well as elderly patients with reduced liver and kidney function.

    Pregnancy and lactation:

    Itopride is contraindicated in pregnancy.

    When taking the drug in therapeutic doses itopride slightly penetrates into breast milk, so you should stop taking the drug during breastfeeding (see the section "Contraindications").

    Dosing and Administration:

    Inside, before meals, 1 tablet 3 times a day. The daily dose of the drug is 3 tablets (150 mg). In elderly patients, the dose is reduced.

    If the drug was not taken on time, then in the future it should be taken at regular intervals. It is not recommended to take the drug in a double dose to compensate for missed.

    Side effects:

    From the hematopoiesis: leukopenia, thrombocytopenia.

    From the endocrine system: gynecomastia, hyperprolactinemia.

    From the digestive system: increased salivation, nausea, diarrhea, constipation, jaundice, pain in the epigastric region.

    From the nervous system: headache, sleep disturbance, irritability, dizziness, tremor.

    Allergic reactions: hives; anaphylactic shock.

    Laboratory indicators: increased activity of aspartic aminotransferase (ACT), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), alkaline phosphatase (AF), hyperbilirubinemia.

    Overdose:

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

    Interaction:

    Accelerates the absorption of other drugs.

    Prokinetic effect of the drug does not change under the influence of drugs that reduce the acidity of gastric juice (cimetidine, ranitidine, tetrenone, cetraxate).

    M-cholinoblockers decrease the effectiveness of aspenpride.

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

    Special instructions:

    When symptoms of galactorrhea and gynecomastia manifest, interrupt or stop treatment altogether.

    In the treatment of primary biliary cirrhosis, transient decompensation of liver cirrhosis can occur, which disappears after drug withdrawal.

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

    During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Tablets, film-coated, 50 mg.
    Packaging:

    For 20 tablets in a blister of PVC / aluminum foil.

    For 2 or 5 blisters together with instructions for medical use in a cardboard box.

    Storage conditions:

    In a dry, dark place at a temperature of 15-25 ° C.

    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001128
    Date of registration:03.11.2011
    Date of cancellation:2016-11-03
    The owner of the registration certificate:PRO.MED.CS Prague as.PRO.MED.CS Prague as. Czech Republic
    Manufacturer: & nbsp
    Representation: & nbspPRO.MED.CS Prague as. PRO.MED.CS Prague as. Czech Republic
    Information update date: & nbsp04.11.2015
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