Active substanceTrimebutinTrimebutin
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  • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    active substance: trimebutinand maleate 100 mg, 200 mg;

    Excipients: lactose, silicon dioxide colloid, talc, corn starch, magnesium stearate.

    Description:White tablets are flat-cylindrical with a squeezed out symbol on one side, representing two letters TM, on top and bottom of which are arranged in a line of three triangles and two cross-cutting risks on the other side of the tablet (for a dosage of 100 mg). Tablets of white color round biconcave with a squeezed out symbol on one side in the form of two drop-shaped elements and a risk on the other side (for a dosage of 200 mg).
    Pharmacotherapeutic group:Spasmolytic agent.
    ATX: & nbsp

    A.03.A.A.05   Trimebutin

    Pharmacodynamics:

    Trimebutin, acting on the enkephalinergic system of the intestine, is the regulator of its peristalsis.Possessing affinity for the receptors of excitation and suppression, it has a stimulating effect in hypokinetic states of smooth muscles of the intestine and spasmolytic - in hyperkinetic. The drug acts throughout the gastrointestinal tract, reduces the pressure of the esophageal sphincter, promotes gastric emptying and enhances intestinal peristalsis, and also facilitates the response of the smooth muscles of the colon to food stimuli. Trimebutin restores the normal physiological activity of the musculature of the intestine for various diseases of the gastrointestinal tract associated with motor disorders.

    Pharmacokinetics:

    After oral administration trimebutin quickly absorbed from the gastrointestinal tract, the maximum concentration in the blood plasma (Cmax) is achieved after 1-2 hours. Bioavailability is 4-6%. Volume of distribution (Vd) - 88 liters. The degree of binding to plasma proteins is low - about 5%. Trimebutin to a small extent penetrates through the placental barrier.

    Metabolism and excretion:

    Trimebutin is biotransformed in the liver and excreted in the urine mainly in the form of metabolites (approximately 70% within the first 24 hours).

    The half-life (T1 / 2) is about 12 hours.

    Indications:

    - Motor disorders in functional diseases of the gastrointestinal tract, gastroesophageal reflux disease, dyspeptic disorders in gastroduodenal diseases (abdominal pain, digestive disorders, nausea, vomiting), irritable bowel syndrome (functional disease of the gastrointestinal tract, manifested, in particular, by pain and colic in the abdominal cavity, intestinal spasms, flatulence, diarrhea and / or constipation).

    - Postoperative paralytic intestinal obstruction, preparation for X-ray and endoscopic examination of the gastrointestinal tract.

    Use in children: dyspeptic disorders associated with impaired motility of the gastrointestinal tract.

    Contraindications:Hypersensitivity to the components that make up the drug. Children under 3 years old - for this dosage form.
    Pregnancy and lactation:

    It is not recommended to use the drug in the first trimester of pregnancy.

    It is not recommended to prescribe Trimedate during lactation, due to the lack of reliable clinical data confirming the safety of the drug during this period.

    AT experimental research there was no evidence of teratogenicity and embryotoxicity of the drug.

    Dosing and Administration:Adults and children from 12 years: 100-200 mg 3 times a day. Children 3-5 years: 25 mg 3 times a day. Children 5-12 years: 50 mg 3 times a day.
    Side effects:

    Rarely: skin reactions

    Overdose:

    Until now, no cases of an overdose of Trimedate have been reported.

    Interaction:

    Drug interaction of the drug Trimedate is not described.

    Form release / dosage:Tablets 100 mg, 200 mg.
    Packaging:For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
    For 1, 2 or 3 contour mesh packaging along with the instruction for use is placed in a pack of cardboard box.
    Storage conditions:

    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 expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-005534/07
    Date of registration:28.12.2007
    The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.10.2015
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