Motilium suspension

Motilium - antiemetic drug, which is able to stimulate the motility of the gastrointestinal tract.

The drug for children and adults alleviates the condition with nausea, heartburn, vomiting, belching, bloating, heaviness in the stomach and excessive gas generation. When poisoning and the above conditions, Motilium restores disturbed processes and accelerates recovery.

Produced in the form of tablets, coated with a shell and suspension for oral administration. Before using the drug to treat children should consult a pediatrician, there are contraindications.

Clinical and pharmacological group

Antiemetic drug of central action, blocking dopamine receptors.

Conditions of leave from pharmacies

It is released on prescription.

Price list

How much does Motilium cost? The average price in pharmacies is at the level of650 rubles.

Form of issue and composition

Suspension for oral administration. White color. Consistency is homogeneous. The active component is domperidone.

Auxiliary components:

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sodium carmellose;
propyl parahydroxybenzoate;
sodium hydroxide;
sorbitol, liquid, non-crystalline;
methylparahydroxybenzoate;
sodium saccharinate;
microcrystalline cellulose;
polysorbate;
purified water.

Packing: bottle of dark glass, 100 ml.

Pharmacological effect

Motilium aims to stimulate intestinal peristalsis and provide antiemetic action. The main constituent of the drug is domperidone, acting as a dopamine antagonist, which explains the antiemetic effect of the drug.

Domperidone is characterized by an inability to overcome the barrier between the circulatory system and the central nervous system (GEB). As a result, extrapyramidal side effects are rarely observed. Due to the active component of Montilium, the production of prolactin by pituitary cells increases.

Among other properties, when administered orally, it is worth noting:

Increased sphincter tone and pressure;
No effect on the secretion of gastric juice;
Elimination of difficulties with defecations of semi-solid and liquid feces in people who do not have health problems, and hard - in sick patients while slowing their evacuation.

Pharmacokinetics

The active substance Motilium quickly absorbed and reaches the maximum presence in the blood plasma within an hour after taking the medication. Reduced acidity of the stomach worsens the absorption of the drug.

Domperidone does not accumulate in the body, is completely metabolized in the digestive tract and liver and is excreted with waste of vital activity. At oral intake with urine, up to 31% of domperidone is excreted, with feces - up to 66%. A small fraction of the substance is excreted from the body in its original form. Half-life in a healthy person is about 8 hours.

The study of distribution of the drug on experimental animals indicates a low penetration of domperidone into the brain. Data on the pharmacokinetics of the drug were obtained in the study of adult volunteers.

Indications for use

What helps? Motilium is used in diseases of the upper parts of the digestive tract, which reduce motor-evacuation functions. Indications for use:

abdominal pain;
bloating;
feeling of overfilling in epigastrium;
heartburn, flatulence;
frequent regurgitation, cyclic vomiting;
nausea and vomiting caused by a violation of diet or drug therapy;
disruption of the stomach in children;
a complex of dyspeptic symptoms that are associated with a slowdown in gastric emptying.

Suspension is used for gastrointestinal reflux and regurgitation in newborns.

Contraindications

Absolute:

Prolactinoma (prolactin-secreting pituitary tumor);
Dysfunction of the liver of moderate and severe degree;
Body weight in children less than 35 kg - for tablets;
Hypersensitivity to Motilium components;
Lactose intolerance, galactosemia, impaired absorption of glucose / galactose - for tablets;
Conditions in which the stimulation of gastric motility is counter-indicative, for example, mechanical obstruction, perforation, gastrointestinal bleeding;
Simultaneous use of oral forms of erythromycin, ketoconazole and other strong inhibitors of the isoenzyme CYP3A4, causing prolongation of the QT interval, such as clarithromycin, voriconazole, amiodarone fluconazole, and telithromycin.

Relative (caution due to risk of complications):

Congestive heart failure;
Violation of conduction and heart rhythm, including prolongation of the QT interval;
Impaired renal function;
Violations of the electrolyte balance.

Use in pregnancy and lactation

Data on the use of Motilium during pregnancy is not enough.

To date, there is no evidence of an increased risk of human developmental malformations. Nevertheless, Motilium® should be prescribed during pregnancy only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.

In women, the concentration of domperidone in breast milk is 10-50% of the corresponding plasma concentration and does not exceed 10 ng / ml. The total amount of domperidone excreted into breast milk is less than 7 μg / day when the maximum permissible doses are applied. It is not known whether this level has a negative effect on newborns. Therefore, if you need the use of the drug Motilium® during lactation, breastfeeding should be discontinued.

Dosage and route of administration

In the instructions for use it is indicated that it is recommended to take the drug Motilium before meals, in case of reception after eating, the absorption of domperidone slightly slows down. The duration of continuous use of the drug without a doctor's recommendation should not exceed 28 days.

Infants and children under 12 years: 0.25-0.5 mg domperidone (0.25-0.5 ml suspension) per 1 kg body weight 3-4 times / day. The maximum daily dose is 2.4 mg / kg, but not more than 80 ml (80 mg). To determine the dose, the child's body mass scale "0-20 kg" on the syringe should be used.
Adults and adolescents over 12 years of age and weighing 35 kg or more: 10-20 ml 3-4 times / day. The maximum daily dose is 80 ml (80 mg).

Patients with impaired renal function:since T1 / 2 domperidone increases with severe violations of kidney function, with repeated use of the frequency of drug intake Motilium should be reduced to 1-2 times / day depending on the severity of the disorders, a dose reduction may also be required. With prolonged therapy, a regular examination of such patients should be carried out.

Patients with hepatic impairment:Motilium is contraindicated in violations of the liver function of medium and severe degree. With light violations of liver function, dose adjustment is not required.

Rules for the application of suspension

Before use, mix the contents of the vial, shaking it gently to prevent the formation of foam.

Suspension is supplied in a package protected from accidental opening by children. The bottle should be opened as follows: press on top of the plastic bottle cap, while turning it counter-clockwise; remove the unscrewed cover.

Place the syringe in the vial. While holding the lower ring in place, raise the upper ring to the mark corresponding to the weight of the child's body (kg). Hold the bottom ring, pull the filled syringe from the vial. Empty the syringe. Close the vial. Rinse the syringe with water.

Side effects

Suspension and both types of Motilium tablets can cause the following side effects from different organs and systems:

Nervous system:

Extrapyramidal syndrome (tics, tremors, speech disorders, parkinson-like movements, muscle tone disorders, etc.);
Convulsions;
Drowsiness;
Headache.

Gastrointestinal tract:

Spasms of the intestine;
Change in activity of ASAT, ALAT and APF;
Diarrhea;
Constipation;
Dry mouth;
Thirst;
Impairment of appetite.

The immune system:

Anaphylactic reactions (Quincke's edema, anaphylactic shock, urticaria);
Allergic reactions.

Endocrine system:

Increased prolactin levels in the blood;
Galactorrhea (flow of milk from the chest);
Amenorrhea (absence of menstruation);
Gynecomastia.

Mental disorders:

Agitation (excitement);
Nervousness.

6. Skin:

Itching;
Rashes.

Extrapyramidal disorders, as a rule, occur in children, but are transient, that is, they disappear on their own after the termination of Motilium administration and do not require special treatment.

Overdose

An overdose of the drug leads to the manifestation of the symptoms described in the side effect section. Neurological complications can be manifested with greater intensity.

In case of accidental administration of large doses, you should take the sorbent and contact the hospital. When receiving significant doses, gastric lavage is indicated. In some cases, antihistamines are used to eliminate allergy manifestations.

special instructions

When combined with Motilium with antacid or antisecretory drugs, the latter take after eating, not before eating, i.e. they should not be taken concomitantly with Motilium.

Suspension Motilium contains sorbitol, so it should not be taken to patients with sorbitol intolerance.

Use in Pediatrics:

Motilium in rare cases can cause neurologic side effects. The risk of neurological side effects in young children is higher, because metabolic functions and BBB in the first months of life are not fully developed. In this regard, it is very accurate to calculate the dose of Motilium for newborns, children of the first year of life and children of early preschool age and strictly adhere to this dose. Neurological adverse effects may be caused in children by an overdose of the drug, but other possible causes of such effects should be taken into account.

Effects on the cardiovascular system:

Some epidemiological studies have shown that the use of domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden coronary death. Risk may be more likely in patients over 60 years of age and in patients taking the drug at daily doses of more than 30 mg. It is recommended to use domperidone in the lowest effective dose in adults and children.

Application in diseases of the kidney:

Since T1 / 2 domperidone increases with severe violations of kidney function, with the repeated use of Motilium, the frequency of use should be reduced to 1-2 times / day, depending on the severity of renal dysfunction, and it may also be necessary to reduce the dose. With prolonged therapy, a regular examination of such patients should be carried out.

Impact on the ability to drive vehicles and manage mechanisms

Motilium does not have or has a negligible impact on the ability to drive and work with machinery.

Rules for the disposal of the drug:

The patient should be informed that if the drug has become unusable or the expiration date has expired, do not dispose of it in sewage or on the street. It is necessary to place the drug in a bag and put it in a garbage container. These measures will help protect the environment.

Drug Interactions

Anticholinergic drugs can neutralize the effect of Motilium.

Bioavailability of Motilium when ingested decreases after previous administration of cimetidine or sodium bicarbonate. Do not take antacid and antisecretory drugs at the same time as Motilium. they reduce its bioavailability.

In a number of studies of pharmacokinetic and pharmacodynamic interactions of domperidone with oral ketoconazole and oral erythromycin in healthy volunteers have been shown that these drugs significantly inhibit the primary metabolism of domperidone, carried out by the isoenzyme CYP3A4.

The main role in the metabolism of domperidone is played by the CYP3A4 isoenzyme. The results of in vitro studies and clinical experience show that the simultaneous use of drugs that significantly inhibit this isoenzyme, can cause an increase in domperidone concentrations in plasma. Among the strong inhibitors of CYP3A4 are: azole antifungal drugs such as fluconazole *, itraconazole, ketoconazole * and voriconazole *; antibiotics-macrolides, for example clarithromycin * and erythromycin *; HIV protease inhibitors, for example amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir; calcium antagonists, such as diltiazem and verapamil; amiodarone *; aprepitant; nefazodone. (Drugs marked with an asterisk, in addition, extend the interval of QTc).

At present, it is not known what contribution to the change in the QTc interval is made by increased concentrations of domperidone in plasma.

With concurrent administration of 10 mg of domperidone 4 times / day and 200 mg of ketoconazole 2 times / day, the QTc interval was prolonged on average by 9.8 ms during the whole period of observation, at certain moments the changes varied from 1.2 to 17.5 ms. With simultaneous administration of 10 mg of domperidone 4 times / day and 500 mg of erythromycin 3 times / day, the QTc interval was prolonged on average by 9.9 ms during the whole period of observation, at some moments the changes varied from 1.6 to 14.3 ms. In each of these studies, Cmax and AUC domperidone were increased approximately 3-fold.

In these studies, monotherapy with domperidone (10 mg 4 times / day) resulted in an extension of the QTc interval by 1.6 ms (ketoconazole study) and 2.5 ms (erythromycin study), whereas monotherapy ketoconazole (200 mg 2 times / day) and monotherapy with erythromycin (500 mg 3 times / day) resulted in prolongation of the QTc interval by 3.8 and 4.9 ms, respectively, during the entire observation period.

In another study using multiple doses in healthy volunteers, no significant prolongation of the QTc interval was observed during the stationary monotherapy with domperidone (40 mg 4 times / day, total daily dose of 160 mg, which is 2 times the recommended maximum daily dose). At the same time, the concentrations of domperidone in plasma were similar to those in studies of the interaction of domperidone with other drugs.

Theoretically (because the drug has a gastrokinetic effect), Motilium could affect the absorption of concomitantly used oral preparations, in particular, sustained-release preparations of the active substance or preparations coated with an enteric coating. However, the use of domperidone in patients with paracetamol or digoxin did not affect the concentration of these drugs in the blood.

Motilium can be taken concomitantly with neuroleptics, the effect of which it does not enhance; dopamine receptor agonists (bromocriptine, levodopa), undesirable whose peripheral effects, such as digestive disorders, nausea, vomiting, it suppresses, without affecting their central effects.

Reviews

We picked up some responses from people who took the drug Motilium:

Ksenia. She gave the child 1.5 years for 2 weeks, was prescribed in combination with an enzyme and lactobacilli for the treatment of ultra-long flatulence, possibly against the background of the bend of the gallbladder. There was a temporary improvement, than the specifically caused truth is not known until the next teeth came up. But the drug in general, no reaction was not, no rash, no changes in the stool.
Denis. I will not say about the suspension, but the tablets are very even. Lying in the desk in the office, because I often suffer from the severity in the stomach after eating.. After the army's habit of quickly and tightly filling the stomach makes itself felt. And Motilium helps the stomach to run, if I do not, crawl then like a sleepy boa, the work is worthwhile, in general, though go home and sleep.
Vera. I have a terrible toxicosis, I already tortured it simply. The doctor has appointed to take motilium three times a day, so that nausea and vomiting have passed. I started taking it and for now I see only positive results. Earlier in the morning, I was always, as if on a schedule, nauseous, but now it's less and less often. I must go to the doctor and specify how much time he needs to drink, he helped me a lot.

Analogues

Structural analogues of Motilium are:

Domet;
Motigect;
Domperidone;
Passenger .;
Domperidon-Teva;
Domperidone HEXAL;
Domstal;
Motilac;
Damelyum; The monotonous;
Motion.

Before using analogues, consult your doctor.

Storage conditions and shelf life

Keep the drug Motilium needed at a temperature of 15-30 ° C in the place, guda will not reach the children. Soluble tablets are stored for 3 years; suspension or tablet for 5 years.