Active substanceMetoclopramideMetoclopramide
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  • Dosage form: & nbsppills
    Composition:

    For one tablet:

    Metoclopramide hydrochloride monohydrate -0.0105 g

    (in terms of anhydrous) -0.0100 g

    Excipients:

    lactose monohydrate (sugar milk) - 0.0660 g

    potato starch - 0.0200 g

    calcium stearate - 0.0010 g

    Povidone-K30 0.0020 g

    silicon dioxide colloid (aerosil) - 0.0005 g

    Description:Tablets from white to white with a yellowish or kremovatym color shade, flat-cylindrical. with a bevel, marked "R" on one side or without it.
    Pharmacotherapeutic group:Antiemetics - dopamine receptor blocker central
    ATX: & nbsp

    A.03.F.A   Motility stimulators GIT

    A.03.F.A.01   Metoclopramide

    Pharmacodynamics:

    Antiemetic, is a specific blocker of dopamine (D2) and serotonin receptors. Has antiemetic effect, eliminates nausea and hiccups. Reduces the motor activity of the esophagus, increases the tone of the lower sphincter of the esophagus, accelerates the emptying of the stomach, and accelerates the movement of food through the small intestine, without causing diarrhea.

    Normalizes the secretion of bile, reduces spasm of the sphincter of Oddi, eliminates dyskinesia of the gallbladder. Stimulates the secretion of prolactin.

    Pharmacokinetics:

    Quickly absorbed from the gastrointestinal tract. Bioavailability is 60-80%. The time to reach the maximum concentration in the blood plasma is 1-2 hours. The half-life is 3 to 5 hours, if the kidney function is up to 14 hours.

    Removal of the drug occurs mainly kidneys for 24 hours in an unchanged form and in the form of conjugates.

    Passes through the placental and blood-brain barrier, penetrates into the mother's milk.

    Indications:

    - Vomiting, nausea, hiccough of different genesis (in some cases it can be effective in vomiting caused by radiation therapy or cytotoxic therapy);

    - atony and hypotension of the stomach and intestines (in particular, postoperative);

    - biliary dyskinesia;

    - reflux-esophagitis, flatulence, exacerbation of gastric ulcer and duodenal ulcer (as part of complex therapy);

    - when carrying out radiopaque studies of the gastrointestinal tract (to enhance peristalsis).

    Contraindications:Hypersensitivity, bleeding from the gastrointestinal tract, stenosis of the pylorus of the stomach, mechanical intestinal obstruction, perforation of the wall of the stomach or intestine, pheochromocytoma, extrapyramidal disorders, epilepsy, prolactin-dependent tumors, pregnancy, lactation, children under 18 years.
    Carefully:Bronchial asthma, arterial hypertension, Parkinson's disease, renal and / or hepatic insufficiency, advanced age.
    Pregnancy and lactation:

    Contraindicated use of the drug in the I trimester of pregnancy. In the II and III trimesters, the drug is used only in cases of extreme necessity, if the potential benefit to the mother exceeds the possible risk to the fetus.

    If it is necessary to use the drug during lactation, breastfeeding should be stopped for the entire treatment period.

    Dosing and Administration:Inside.Adults - 10 mg 3-4 times a day for 30 minutes before meals, the tablet is swallowed whole and washed down with a small amount of water. The maximum single dose is 20 mg, the daily dose is 60 mg.
    Side effects:

    From the nervous system: sometimes there may be a feeling of fatigue, headache, dizziness, a sense of fear, anxiety, depression, drowsiness, tinnitus; in some cases, a dyskinetic syndrome may develop (involuntary tick-like twitching of the muscles of the face, neck or shoulders). Perhaps the appearance of extrapyramidal disorders: spasm of facial muscles, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including oculogic crisis), spastic torticollis, opisthotonus, muscle hypertonia. With long-term treatment in some elderly patients, development of parkinsonism (tremor, twitching of muscles, limited mobility) is possible. In elderly patients with chronic renal failure, the development of tardive dyskinesia is also possible. In isolated cases, the development of malignant neuroleptic syndrome (characteristic signs: fever, muscle contracture, altered consciousness and increased blood pressure) is possible.

    On the part of the hematopoiesis system: agranulocytosis.

    From the cardiovascular system: supraventricular tachycardia, decreased or increased blood pressure.

    From the gastrointestinal tract: constipation, diarrhea, dry mouth.

    From the endocrine system: with long-term use of the drug in rare cases can occur gynecomastia (enlargement of the mammary glands in men), galactorrhea (spontaneous discharge of milk from the mammary glands), menstrual irregularities; in the development of these phenomena metoclopramide cancel.

    Overdose:

    Symptoms: drowsiness, confusion, irritability, anxiety, seizures, extrapyramidal movement disorders, cardiovascular system dysfunction with bradycardia, and a decrease or increase in blood pressure. When mild forms of poisoning symptoms disappear after 24 hours after drug withdrawal. Depending on the severity of the symptoms, it is recommended that monitoring of the patient's vital functions is recommended. Deaths of poisoning in case of an overdose have not been identified.

    Treatment: symptomatic. Extrapyramidal disorders are eliminated by the slow administration of biperidene in a dose for adults 2.5-5 mg (biperidene administered only in a hospital. under the supervision of doctors). To calm the patient, you can apply diazepam. When large amounts of metoclopramide enter the body, rinsing of the stomach is made, using Activated carbon and sodium sulfate.

    Interaction:The action of metoclopramide may weaken the anticholinesterase drugs. Metoclopramide enhances the absorption of antibiotics (tetracycline, ampicillin), paracetamol, acetylsalicylic acid, levodopa, lithium preparations, ethanol; reduces absorption of digoxin and cimetidine; increases the concentration of bromocriptine in plasma. Strengthens the effect of alcohol and drugs, depressing the central nervous system. Increases the bioavailability of cyclosporine, which may require monitoring of its concentration. It is not recommended to appoint simultaneously with antipsychotic and medicinal products and drugs (neuroleptics), as the risk of extrapyramidal reactions increases. The use of metoclopramide in combination with serotonin reuptake inhibitors can lead to increased development of extrapyramidal symptoms, including serotonin syndrome.
    Special instructions:

    During the period of treatment is not recommended to use ethanol.

    If necessary, central anticholinergic drugs and other antiparkinsonian drugs are treated.

    Older patients taking the drug may develop tardive dyskinesia. The risk of developing tardive dyskinesia depends on the duration of the course of pharmacotherapy and the total dose of the drug. Irreversible changes develop, as a rule, when the drug is prescribed for more than 12 weeks. It is not recommended to prescribe the drug for more than 12 weeks, except for cases when the benefit of prolonged use of the drug exceeds the potential risks of the development of an adverse reaction. When prescribing the drug with a short course and at low doses, it is also possible to develop tardive dyskinesia, but these changes usually disappear after a short time after the drug has been discontinued.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other activities that require a high concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Tablets 10 mg.
    Packaging:

    For 10, 14 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil or paper packaging.

    5, 10 contour cell packs of 10 tablets or 4 contour packs of 14 tablets with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light 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 the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001643
    Date of registration:29.07.2011 / 07.08.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.05.2018
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