Motion - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 48.44 mg, cellulose microcrystalline - 10.0 mg, povidone (polyvinylpyrrolidone low molecular weight) - 10.0 mg, glycerol (glycerin) - 0.56 mg, magnesium stearate 1.0 mg, corn starch - up to the preparation of a tablet without a coat with a mass of 100, 0 mg

Auxiliary substances (shell): hypromellose - 1.74 mg, macrogol 6000 0.26 mg to obtain a film-coated tablet weighing 102.0 mg.

Description:

Round, biconvex tablets, covered with a film shell of white color, on the cross section the nucleus is white.

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, soothes hiccups and eliminates 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). Time to reach the maximum concentration (TC_max) - 1 hour.Bioavailability - 15% (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. Metabolized in the liver and in the intestinal wall (by hydroxylation and Ndealkylation). 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, eructation, heartburn with or without casting gastric contents into the oral cavity.

Contraindications:

- Hlactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- pronounced electrolyte disorders or heart diseases, such as chronic heart failure;

- hypersensitivity to domperidone or any other component of the drug;

- bleeding from the gastrointestinal tract, mechanical intestinal obstruction, perforation of the stomach or intestines;

- hepatic insufficiency of moderate and severe severity;

- prolactinoma;

- pregnancy, the period of breastfeeding;

- Children under 12 years old with a body weight of less than 35 kg;

- simultaneous use of oral forms of ketoconazole, erythromycin or other drugs that increase the interval QT, or isoenzyme inhibitors CYP34A, such as fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin, etc.

Carefully:Renal failure.

Pregnancy and lactation:

The use of Motionium® is contraindicated in pregnancy.

If you need to use Motionium®, breastfeeding should be discontinued.

Dosing and Administration:

Inside, for 15-30 mimes before meals, without chewing, squeezed enough water.

Adults and children over 12 years of age weighing more than 35 kg - 1 tablet (10 mg) 3 times a day.

It is recommended to take it regularly at a certain time. If you miss one dose, take the next tablet as soon as possible. If the time of taking the next dose of the drug is appropriate, an additional dose of the drug should not be taken to compensate for the missed dose.

Do not take two doses of the drug at the same time.

The drug is recommended to take in the minimum effective dose. The maximum daily dose is 30 mg.

In patients with hepatic insufficiency mild dose correction is not required. A drug contraindicated in patients with hepatic insufficiency of moderate and severe severity.

In patients with renal insufficiency correction of a single dose is not required. However, with repeated use, it is recommended to reduce the dose, as well as reduce the frequency of application up to 1-2 times a day, depending on the severity of renal failure.

Side effects:

The incidence of adverse reactions is classified according to WHO guidelines: very often> 1/10, often> 1/100 to <1/10, infrequently from> 1/1000 to <1/100, rarely> 1/10000 to <1 / 1000, very rarely from <1/10000, the frequency is unknown - according to the available data, it was not possible to establish the frequency of occurrence.

From the immune system: very rarely - allergic reactions, including anaphylaxis, anaphylactic shock, anaphylactic reactions, angioedema.

From the nervous system: very rarely, extrapyramidal disorders, convulsions, increased excitability and irritability, drowsiness, headache. Extrapyramidal disorders, as a rule, are reversible and disappear when discontinuing therapy with domperidone.

From the digestive system: rarely - gastrointestinal disorders, including transient intestinal spasms; very rarely diarrhea.

From the side of the cardiovascular system: frequency unknown - ventricular arrhythmia, prolongation of QT interval, ventricular tachycardia of the type "pirouette", sudden coronary death.

From the skin and subcutaneous tissues: very rarely - itching, rash, hives.Other: rarely - hyperprolactinaemia, galactorrhea, gynecomastia, amenorrhea; very rarely - a change in the indicators of functional liver tests.

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 drugs neutralize the action 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, levodopa).

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:

During the use of the drug, care should be taken when driving vehicles and engaging in potentially hazardous activities requiring increased concentration and speed of psychomotor reactions due to the risk of adverse reactions that may affect the above activities.

Form release / dosage:

Tablets, film-coated, 10 mg.

Packaging:

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

For 1, 2, 3, 4 or 5 contour squares, together with the instructions for use, are placed in a pack of cardboard.

Storage conditions:

In 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 the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N003437 / 01

Date of registration:16.06.2009 / 21.02.2017

Expiration Date:Unlimited

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Representation: & nbspAVVA ENG JSC AVVA ENG JSC Russia

Information update date: & nbsp31.05.2018

Illustrated instructions

Instructions

Motionium® (Motonium®)