Active substanceDomperidoneDomperidone
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    For one tablet:

    active substance: domperidone 10 mg;

    Excipients: starch potato 16.8 mg, lactose monohydrate (sugar milk) 78.9 mg / cellulose microcrystalline 5 mg, silicon dioxide colloid (aerosil) 1.2 mg, polyvinylpyrrolidone medium molecular weight (povidone) 1.4 mg, magnesium stearate 1.2 mg , sodium lauryl sulfate 1.5 mg;

    shell auxiliary substances: opadrai II [hydroxypropylmethylcellulose (hypromellose) 1.2 mg, lactose monohydrate 1.6 mg, macrogol-4000 0.4 mg, titanium dioxide 0.8 mg] 4 mg.
    Description:

    The tablets covered with a film cover, white or almost white color, round, biconcave form. On the cross-section, two layers are visible: the shell is white or almost white, the core is white or white with a yellowish tinge.

    Pharmacotherapeutic group:antiemetics - dopamine receptor blocker central
    ATX: & nbsp

    A.03.F.A.03   Domperidone

    Pharmacodynamics:

    It blocks peripheral and central (in the trigger zone of the brain) dopamine receptors, eliminates the inhibitory effect of dopamine on the motor function of the gastrointestinal tract and increases the evacuation and motor activity of the stomach. Has antiemetic effect, eliminates hiccups and nausea.Increases the concentration of prolactin in the blood serum.

    Pharmacokinetics:

    Absorption after ingestion, fasting - fast (intake after meals, decreased acidity of gastric juice slow down and reduce absorption). The maximum concentration is 1 hour. Bioavailability is 15% (the effect of "first passage" through the liver). The connection with plasma proteins is 90%. Penetrates into various tissues, it does not pass well through the blood-brain barrier. Metabolised in the liver and in the intestinal wall (by hydroxylation and N-dealkylation). Output through the intestine 66%, kidneys - 33%, incl. in unchanged form - 10% and 1%, respectively. The half-life is 7-9 hours, with pronounced chronic renal failure - lengthening.

    Indications:

    Vomiting and nausea of ​​various genesis (including against the background of functional and organic diseases, infections, toxemia, radiation therapy, diet disorders, drug genesis - the intake of morphine, apomorphine, levodopa and bromocriptine, while carrying out endoscopic and radiocontrast studies of the gastrointestinal tract), hiccough, atony of the gastrointestinal tract (including postoperative); the need to accelerate peristalsis in radiocontrast studies of the gastrointestinal tract.

    Dyspeptic disorders on the background of delayed emptying of the stomach, gastroesophageal reflux and esophagitis: a feeling of overfilling in the epigastrium, a sensation of bloating, flatulence, gastralgia, heartburn, belching with or without casting gastric contents into the oral cavity.

    Contraindications:

    Hypersensitivity, lactose intolerance, glucose-galactose malabsorption, bleeding from the gastrointestinal tract, mechanical intestinal obstruction, perforation of the stomach or intestine, prolactinoma, children's age (up to 5 years and children weighing up to 20 kg).

    Carefully:

    Renal / hepatic failure, lactation, pregnancy.

    Pregnancy and lactation:Use in pregnancy and lactation is possible if the benefit to the mother exceeds the risk of side effects in the fetus and the baby.
    Dosing and Administration:

    Inside, 15-20 minutes before meals. Adults and children over 5 years with chronic dyspeptic phenomena - 10 mg 3-4 times a day and, if necessary, additionally before bedtime. At the expressed nausea and vomiting - on 20 mg 3-4 times a day and before a dream.

    For patients with renal insufficiency, dose adjustment is necessary,the frequency of reception should not exceed 1-2 times during the day.

    Side effects:

    From the digestive system: transient intestinal spasms.

    From the nervous system: extrapyramidal disorders (in children and in persons with increased permeability of the blood-brain barrier).

    Allergic reactions: skin rash; hives.

    Other: hyperprolactinemia (galactorrhea, gynecomastia).

    Overdose:

    Symptoms: drowsiness, disorientation, extrapyramidal disorders (especially in children).

    Treatment: reception of activated carbon, with extrapyramidal disorders - anticholinergic drugs, anti-Parkinsonian or antihistamine drugs with anticholinergic properties.

    Interaction:

    Cimetidine, sodium hydrogen carbonate reduce the bioavailability of domperidone.

    Anticholinergic and antacid drugs neutralize the action of domperidone.

    Increase the concentration of domperidone in plasma: antifungal azole agents, antibiotics from the macrolide group, HIV protease inhibitors, nefazodone (antidepressant).

    Compatible with the use of antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, L-dopa).

    Simultaneous administration with paracetamol and digoxin had no effect on the concentration of these drugs in the blood.

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

    There is no data on the impact on the ability to drive vehicles and work with machinery.

    Form release / dosage:Tablets, film-coated, 10 mg.
    Packaging:

    For 10 or 15 tablets in a contour mesh package.

    3 contour packs of 10 tablets or 2 contour packs of 15 tablets together with instructions for use are placed in a pack of cardboard.

    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:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001281
    Date of registration:25.11.2011 / 30.11.2012
    Date of cancellation:2016-11-25
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspTATHIMFARM PREPARATIONS OJSC TATHIMFARM PREPARATIONS OJSC Russia
    Information update date: & nbsp18.01.2016
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