Pharmacodynamics. Domperidone is a dopamine antagonist with antiemetic properties. However, domperidone does not penetrate the blood-brain barrier well. The use of domperidone is rarely accompanied by extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin from the pituitary gland. Its antiemetic effect may be due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone. Animal studies and the low concentrations of the drug found in the brain indicate a central effect of domperidone on dopamine receptors. When administered orally, domperidone increases the duration of antral and duodenal contractions, accelerates gastric emptying, and increases lower esophageal sphincter pressure in healthy individuals. Domperidone has no effect on gastric secretion. Pharmacokinetics. Domperidone is rapidly absorbed after oral administration on an empty stomach, peak plasma concentrations are reached within 30-60 minutes. The low absolute oral bioavailability of domperidone (approximately 15%) is associated with extensive first-pass metabolism in the intestinal wall and liver. Domperidone should be taken 15-30 minutes before meals. Decreased acidity in the stomach leads to impaired absorption of domperidone. Oral bioavailability is reduced by prior administration of cimetidine and sodium bicarbonate. When taking the drug after a meal, it takes longer to achieve maximum absorption, and the area under the pharmacokinetic curve (AUC) slightly increases. When taken orally, domperidone does not accumulate and does not induce its own metabolism; the peak plasma concentration of 21 ng/ml 90 minutes after 2 weeks of oral administration at a dose of 30 mg per day was almost the same as the peak plasma concentration of 18 ng/ml after the first dose. Domperidone binds to plasma proteins by 91-93%. Distribution studies with the radiolabeled drug in animals have shown significant tissue distribution of the drug, but low concentrations in the brain. Small amounts of the drug cross the placenta in rats. Domperidone undergoes rapid and extensive metabolism by hydroxylation and N-dealkylation. In vitro metabolism studies with diagnostic inhibitors have shown that CYP3A4 is the major form of cytochrome P450 involved in the N-dealkylation of domperidone, while CYP3A4, CYP1A2, and CYP2E1 are involved in the aromatic hydroxylation of domperidone. Excretion in urine and feces is 31% and 66% of the oral dose, respectively. The proportion of the drug excreted unchanged is small (10% in feces and approximately 1% in urine). The plasma half-life after a single oral dose is 7-9 hours in healthy volunteers, but is increased in patients with severe renal insufficiency. In such patients (serum creatinine > 6 mg / 100 ml, i.e. > 0.6 mmol / l), the half-life of domperidone increases from 7.4 to 20.8 hours, but plasma concentrations of the drug are lower than in healthy volunteers . A small amount of unchanged drug (about 1%) is excreted by the kidneys. In patients with moderate hepatic impairment (Pugh score 7-9, Child-Pugh score B), domperidone AUC and maximum plasma concentration were 2.9 and 1.5 times higher than in healthy volunteers, respectively. The unbound fraction increased by 25% and the half-life increased from 15 to 23 hours. Patients with mild hepatic impairment had slightly reduced systemic drug levels compared to healthy volunteers based on peak concentration and AUC with no change in protein binding or half-life. Patients with severe hepatic impairment have not been studied.

Antiemetic drug Motilium stimulates intestinal motility and has the effects of some antipsychotics and metoclopramide, domperidone is a dopamine antagonist. Compared to metoclopramide and neuroleptics, the drug does not cross the blood-brain barrier well, so its administration is not accompanied by extrapyramidal side effects (in adult patients). However, domperidone enhances the secretion of prolactin from the pituitary cells.

Perhaps the antiemetic effect is a consequence of a combination of antagonism to dopamine receptors located in the trigger region of chemoreceptors and gastrokinetic (peripheral) action. Increases the duration of duodenal and antral contractions when taken orally, improves gastric emptying. In healthy people, there is a relief in the evacuation of their stomach of semi-solid and liquid fractions, in sick people - mostly solid ones with a slowdown in the evacuation processes. In healthy people, it also increases the tone and pressure of the sphincter in the lower part of the esophagus. Does not affect the secretion of gastric juice.

Indications for use

Dyspeptic phenomena that are associated with gastroesophageal reflux, delayed gastric emptying, esophagitis (feeling of bloating, feeling of fullness in the epigastrium, vomiting, epigastric pain, flatulence, belching, nausea, regurgitation and heartburn);
nausea and vomiting associated with dopamine agonists in Parkinson's disease (such as bromocriptine and L-dopa);
nausea and vomiting of an infectious, organic or functional nature, as well as nausea and vomiting associated with a violation of the diet, radiotherapy or drug treatment;
cyclic vomiting, regurgitation syndrome, gastroesophageal reflux and other changes in gastric motility in children.

Mode of application

For children weighing 35 kg or more, it is recommended to prescribe Motilium tablets, coated. Motilium lingual tablets are intended for children over 5 years of age and adults. A lingual tablet is placed on the tongue, after which it instantly dissolves and is swallowed without drinking water. In pediatric practice, for children under 5 years of age, it is recommended to prescribe Motilium suspension.

Motilium in chronic dyspeptic conditions
Children and adults take 10 mg 15-30 minutes before meals 3 times a day. If necessary, you can take the drug before bedtime. The maximum dose is 80 mg / day. For children over 12 years of age and adults, the dosage can be doubled as needed.
Motilium suspension is used at the rate of 2.5 ml / 10 kg of the child's body weight (which is a dose of 250 μg per 1 kg of body weight). The dosage can be doubled if necessary only for children older than 1 year. The maximum dose is 2.4 mg per 1 kg of body weight per day, but not more than 80 mg per day.

Motilium for nausea and vomiting
Children over 12 years old and adults use 20 mg Motilium 3-4 times a day before meals and at bedtime. The maximum dose is 80 mg / day. Children 5-12 years old - 10 mg 3-4 times a day before meals and at bedtime. In the form of a suspension, it is recommended to prescribe at the rate of 5 ml per 10 kilograms of body weight (500 mcg per 1 kg of body weight of a child) before meals, as well as at bedtime (3-4 times a day). The maximum dose is 2.4 mg / kg of the child's body weight per day, but not more than 80 mg.

Motilium in renal failure
In case of renal insufficiency, it is necessary to lengthen the intervals between taking the drug. Correction of a single dose is not required, since only a small part of the drug is eliminated unchanged by the kidneys. When re-appointment, the number of doses of the drug should be reduced to 1-2 times a day, it may also be necessary to reduce the dosage (depending on the degree of renal insufficiency).

Suspension application rules

Suspension Motilium is in a package that is protected from accidental opening by children. Before using the vial Motilium suspension need to shake. The bottle opens like this:
1. Press on the plastic bottle cap from above and at the same time turn it counterclockwise.
2. Remove the unscrewed cover.
3. Remove the pipette from the case (only in the package with 100 ml bottles).
4. Raise the top ring to the mark that corresponds to the child's body weight while holding the bottom ring in place.
5. Pull out the filled pipette by holding the bottom ring.
6. Rinse the pipette with purified water after use, put the empty pipette in a case.
7. Close the bottle.

Rules for the use of lingual tablets
are available in blister packs. Quick-dissolving lingual tablets are very brittle, therefore, to maintain their integrity, it is necessary to carefully squeeze the foil and remove them from the package:
1. Take the blister foil by the edge and remove it from the cell.
2. Gently press down on the cell and remove the tablet.

Side effects

From the endocrine system: amenorrhea, gynecomastia, hyperprolactinemia is possible, which occasionally leads to galactorrhea.
From the side of the central nervous system: extrapyramidal disorders in children are very rarely possible. They are reversible and stop after discontinuation of the drug. In adults, extrapyramidal disorders are extremely rare. In children under 1 year old, due to the insufficiency of the blood-brain barrier or in case of violation of its functions, side effects of a neurological nature are possible.

On the part of the digestive system: gastrointestinal disorders (rare), in isolated cases, transient spastic contractions of the intestine are possible.
Allergic reactions: urticaria and rash (rare).

Contraindications

Perforation of the gastrointestinal tract or obstruction of a mechanical etiology (in these cases, stimulation of the activity of the gastrointestinal tract can be dangerous);
prolactinoma (a pituitary tumor that secretes prolactin);
gastrointestinal bleeding;
hypersensitivity to domperidone or other components of Motilium;
reception against the background of ketoconazole in oral forms of release.

Pregnancy

There is not enough information about prescribing the drug to pregnant women. There are no data on provoking developmental anomalies in children whose mothers used Motilium. However, the appointment of Motilium is recommended only if the therapeutic benefit for the mother predominates over the potential risks for the child (fetus). It is especially not recommended to prescribe the drug before 12 weeks of pregnancy.

Active ingredient concentration Motilium in breast milk women is 10-50% of the plasma concentration, but not more than 10 ng / ml. When taking the maximum allowable dosages, the total amount of domperidone that passes into breast milk is not less than 7 mcg per day. At the moment, there is no information whether this concentration of domperidone negatively affects breastfed children. It is recommended, if Motilium is necessary during lactation, to refrain from breastfeeding (with the exception of the predominance of the expected benefits over the possible risks).

Interaction with other drugs

Antisecretory and antacid agents should not be used concomitantly with the drug, since they reduce the absorption of domperidone.
With internal use, the bioavailability of domperidone is reduced if sodium bicarbonate or cimetidine has been taken before.

The antidyspeptic effect of Motilium can be neutralized by anticholinergics. Basically, the metabolic reactions of domperidone occur with the participation of the cytochrome P450 system (isoenzyme 3A4). Since domperidone has a gastrokinetic effect, it is theoretically possible for Motilium to influence the absorption of other drugs used simultaneously (especially enteric-coated tablets or drugs with a slow release of the active substance). In practice, taking Motilium in patients taking digoxin or paracetamol did not change the plasma concentrations of the active ingredients of these drugs.

According to in vitro experiments, it can be assumed that when domperidone is used in combination with drugs that inhibit this enzyme to a significant extent, an increase in the content of domperidone in blood plasma is likely. Strong inhibitors of the CYP3A4 isoenzyme: azole antimycotics, macrolide antibacterials, nefazodone and HIV protease inhibitors. Ketoconazole inhibits the primary metabolism of domperidone associated with CYP3A4 in experiments on healthy volunteers, therefore, in the plateau phase, an increase in AUC and Cmax of domperidone by about 3 times is achieved.

It was found that the combination of ketoconazole (200 mg 2 times a day) and domperidone (10 mg 4 times a day) prolongs the duration of the QT interval by approximately 10-20 msec. Clinically significant changes in the duration of the QT interval were not detected with monotherapy with Motilium, both in medium therapeutic dosages and when administered at a dose exceeding 2 times the maximum daily dosage (160 mg). Domperidone does not potentiate the effects of neuroleptics, so these combinations are allowed. Motilium inhibits the side effects of levodopa and bromocriptine (dopaminergic receptor agonists) without affecting their therapeutic effects.

Overdose

There may be disorientation, drowsiness and extrapyramidal reactions (mainly in pediatric patients). In the treatment of extrapyramidal disorders, agents for the treatment of Parkinson's disease and anticholinergics may be necessary. Treatment of an overdose of Motilium begins with gastric lavage. The rest is symptomatic therapy.

Release form

Tablets Motilium
Tablets are biconvex, round, with a shell of light cream or white color. Engraved "Janssen" on one side and "M/10" on the other. Fracture white. In blister 10; 30 pieces.

Suspension Motilium
White, homogeneous suspension in vials of 100; 200 ml. Supplied with a 10 ml graduated cap and a 5 ml measuring pipette.

Lingual tablets Motilium
Fast-dissolving tablets of a round form of white color. There are 10 pieces in a blister. In a cardboard box 1 or 3 blisters.

Storage conditions

Under temperature conditions of 15-30°C, out of the reach of children. The shelf life of lingual tablets is 3 years; suspensions or tablets - 5 years. Lingual and film-coated tablets are approved for over-the-counter dispensing. The suspension is dispensed by prescription only.

Synonyms

Motilium, Cilroton, Nauzelin, Euciton, Nauseline, Peridal, Peridon.

Compound

Motilium film-coated tablets

Inactive substances: corn starch, lactose, pregelatinized potato starch, microcrystalline cellulose, magnesium stearate, polyvidone, hydrogenated vegetable oil, sodium lauryl sulfate, hypromellose.

Suspension Motilium
Active ingredient (in 5 ml): domperidone 5 mg.
Inactive ingredients: propyl parahydroxybenzoate, microcrystalline cellulose, sodium carboxymethylcellulose, sorbitol, sodium saccharinate, methyl parahydroxybenzoate, polysorbate, sodium hydroxide, purified water.

Lingual tablets Motilium
Active ingredient (in 1 tablet): domperidone 10 mg.
Inactive ingredients: aspartame, gelatin, mannitol, mint flavor.

Additionally

If the drug is prescribed in conjunction with antisecretory or antacid agents, the latter should be taken after meals. Patients with hepatic insufficiency Motilium should be administered with caution, since domperidone is mostly metabolized in the liver. Those patients who take the drug for a long time should be under medical supervision.

For children of the first year of life, all drugs, including Motilium, are used with caution due to the possible development of neurological symptoms due to increased penetration through the blood-brain barrier (in adults, the drug does not penetrate the blood-brain barrier). When the dose of domperidol is exceeded in children, the drug provokes various neurological phenomena. Domperidone does not have a negative impact when working with mechanisms and driving a car.

Main settings

Name:	MOTILIUM
ATX code:	A03FA03 -

Thank you

Motilium represents antiemetic, which also has the ability to reduce the severity of dyspeptic symptoms (heartburn, flatulence, belching, nausea, vomiting, feeling of fullness and pain in the stomach after eating, etc.) due to impaired evacuation of the food bolus from the stomach to the intestines. Therefore, Motilium is used to stop vomiting, as well as alleviate dyspeptic symptoms in reflux esophagitis, gastroesophageal reflux, GERD, esophagitis, gastric hypotension, as well as against the background of cytostatic therapy or radiotherapy of tumors.

Release forms, names and composition of Motilium

Motilium is currently available in the following three dosage forms:
1. Tablets for resorption in the oral cavity;
2. Coated tablets for oral administration;
3. Suspension for oral administration.

Coated and oral lozenges are usually referred to simply as "Motilium tablets" without specifying which variety is being referred to. And the suspension is often called Motilium syrup in everyday speech. However, since Motilium does not exist in the form of a syrup, people use this term to refer to the liquid form of the drug, without going into the subtleties of the differences between suspension, solution, syrup, emulsion, etc. In addition, the suspension is often called children's Motilium, since it is this dosage form that is used in pediatric practice.

The composition of all dosage forms of Motilium as an active substance includes domperidone in the following different dosages:

• Tablets for resorption in the oral cavity - 10 mg;
• Tablets for oral administration in the shell - 10 mg;
• Suspension - 1 mg per 1 ml.

Auxiliary components of all three dosage forms of Motilium are shown in the table.

Lozenges	Coated tablets	Suspension
Gelatin	Lactose	Saccharin sodium
Mannitol	Corn starch	Sorbitol
aspartame	Potato starch	Sodium hydroxide
mint essence	Polividon	Polysorbate
Poloxamer 188		Microcrystalline cellulose
	magnesium stearate	Purified water
	Hydrogenated vegetable oil	Sodium carboxymethylcellulose
	Lauryl sulfate	Methyl parahydroxybenzoate
	Hypromellose	Propyl parahydroxybenzoate

The lozenges are round in shape and white or almost white in color. Coated tablets are round, white or off-white in color and marked "Janssen" and "M/10" on the flat surfaces. If the tablet in the shell is broken, then at the break it will be uniformly white, without inclusions. Both types of tablets are available in packs of 10 or 30 pieces.

The suspension is a white opaque liquid of a homogeneous structure and jelly-like consistency. Produced in dark glass bottles of 100 ml.

What helps Motilium (therapeutic effects)

Motilium has the following pharmacological effects:

• Suppression of the activity of the vomiting center in the brain;
• Increase in the intensity and duration of contractions of the stomach and duodenum;
• Increased pressure in the esophagus;
• Acceleration of the evacuation of the food bolus from the stomach into the duodenum.

These pharmacological effects provide a therapeutic effect of Motilium, which consists in stopping the symptoms of indigestion (flatulence, belching, feeling of heaviness and pain in the stomach after eating, nausea, vomiting, heartburn, etc.) caused by diseases of the stomach, in which the evacuation process is disturbed its contents (gastritis, peptic ulcer, reflux esophagitis, GERD, hypotension of the stomach), as a result of which food stagnates and does not pass into the duodenum in time.

Motilium improves the contractile activity of the stomach muscles, which leads to a faster evacuation of the food bolus into the duodenum. And due to the fact that food does not stagnate and does not irritate the stomach, a person experiences painful symptoms of dyspepsia (belching, heartburn, flatulence, etc.). That is, Motilium helps to get rid of the symptoms of stomach diseases, in which food stagnates in it. And since these symptoms can also occur in a healthy person, for example, when overeating, eating fatty or unusual foods, or with other violations of a normal balanced diet, Motilium will also help in this case to get rid of the discomfort associated with stomach overcrowding.

Due to the increase in pressure in the esophagus, Motilium prevents gastroesophageal reflux, reducing heartburn and other symptoms (sour belching, etc.), as well as helping to cure GERD (gastroesophageal reflux disease). That is, Motilium helps to stop the symptoms of gastroesophageal reflux and GERD.

And due to the suppression of the activity of the vomiting center, Motilium is able to eliminate vomiting provoked by an infectious disease, taking medications, various chronic pathologies of any organs and systems, as well as functional digestive disorders caused by the use of unknown or unusual food and other similar factors.

Motilium - indications for use

Suspension and both types of Motilium tablets are indicated for use in the following identical cases:
1. Relief of the following symptoms of hypotension of the stomach, gastritis, GERD, reflux esophagitis, gastroesophageal reflux arising from food retention in the stomach and its slow evacuation into the intestines:

• Feeling of heaviness, pressure or fullness in the stomach after eating;
• Pain in the stomach after eating;
• Bloating
• Belching, including sour contents;
• Vomit;
• Heartburn;
• Regurgitation (throwing a fairly large amount of stomach contents into the oral cavity).

2. Nausea or vomiting caused by infectious diseases, pathologies of any internal organs, or functional disorders (for example, errors in diet, motion sickness, eating too much food at a time, etc.).
3. Nausea and vomiting provoked by medication, as well as radiotherapy and chemotherapy for tumors.

4. Nausea and vomiting provoked by taking Levodopa, Bromocriptine or other drugs of the dopamine agonist group in parkinsonism.
5. Relief of nausea and gag reflex during medical procedures, for example, the introduction of a gastric tube, the production of EFGDS, etc.
6. regurgitation syndrome in children.
7. Cyclic vomiting in children.
8. Gastroesophageal reflux in children.
9. Disorders of gastric motility in children.

Instructions for use

Consider the rules for using both types of Motilium tablets in one section, since they differ slightly. And we will consider the rules for using Motilium suspension in a separate section.

Motilium tablets - instructions for use

The absorbable and coated tablets should be taken 15 to 30 minutes before a meal. Also, if necessary, Motilium can be taken at bedtime.

The coated tablet is simply swallowed without biting or chewing with half a glass of water. A lozenge is placed on the tongue and wait a few seconds until it breaks up into small particles. After that, the formed particles are swallowed and, if necessary, washed down with a few sips of water. However, if for some reason there is no water, then absorbable tablets can not be washed down after they have disintegrated into small particles on the tongue and have been swallowed.

The coated tablets can be removed from the blister without any special precautions. And with absorbable tablets, care must be taken, as they are quite fragile. In order to avoid breaking and spilling the tablets, it is recommended not to squeeze them out of the blister through the foil, but to carefully cut the edge of the cell with scissors. You can also carefully remove the foil from one cell and remove the tablet from it.

To stop the manifestations of dyspepsia (belching, heartburn, flatulence, feeling of fullness in the stomach, etc.) in chronic diseases of the stomach and esophagus, adults and children over 5 years old should take 1 tablet 3 times a day before meals, and, if necessary, before sleep. If there is no effect, children over 12 years of age and adults can double the dosage, that is, take 2 tablets 3 times a day before meals.

With nausea and vomiting for their relief, children over 12 years of age and adults should take 2 tablets 3 to 4 times a day before meals and at bedtime. And for children 5-12 years old, for the relief of nausea and vomiting, 1 tablet 3-4 times a day before meals and at bedtime should be given.

For children 5-12 years old, the maximum allowable daily dosage of Motilium is 2.4 mg (1/4 tablet) per 1 kg of body weight, but not more than 80 mg (8 tablets). For adults and adolescents over 12 years of age, the maximum allowable daily dosage of Motilium is 80 mg.

For children under 5 years of age, the drug is given in the form of a suspension and the dosage is calculated individually according to body weight, based on the ratio of 2.5 ml per 10 kg of weight. Motilium tablets are not used in children under 5 years of age and weighing less than 35 kg.

Motilium suspension (Motilium for children) - instructions for use

The suspension is intended for use in children under 5 years of age and weighing less than 35 kg. In children of the first year of life, the drug should be used only as directed by a doctor and under constant supervision.

Suspension, as well as tablets, should be given to the child 15 to 30 minutes before meals and, if necessary, at bedtime. The amount of the drug, measured with a special syringe, must be poured into a spoon or into a small container (glass, glass, etc.) and given to the child to drink. You can drink the suspension as you wish.

The dosage of the suspension for use for various conditions in children is the same and depends only on body weight. The dosage each time is calculated individually according to the ratio of 0.25 - 0.5 ml of suspension for every 1 kg of the child's body weight. The calculated amount of suspension is given to the child 3-4 times a day before meals and, if necessary, at bedtime.

However, since a convenient measuring syringe is supplied with the bottle, which simultaneously indicates the child's weight in increments of 1 kg and the corresponding amount of suspension in ml, you can not calculate the dosage for the baby. Simply use the included measuring syringe.

The maximum allowable daily dosage of Motilium suspension for children under 5 years of age is 2.4 ml per 1 kg of body weight, but not more than 80 mg (80 ml of suspension).

If necessary, the suspension can be taken by both adults and adolescents over 12 years of age at a dosage of 10-20 ml 3-4 times a day. The maximum allowable daily dose of the suspension for adults and adolescents over 12 years of age is 80 ml.

Each time before use, shake the vial with the suspension, and then open it according to the following algorithm:
1. Press on the cover from above while turning it counterclockwise;
2. Remove cover;
3. Remove the measuring syringe from the package and lower it into the vial so that its tip goes into the suspension by 1-3 cm;
4. Holding the lower ring of the syringe with your fingers, raise the piston to a mark that corresponds to the weight of the child;
5. Holding the syringe by the lower ring, remove it from the vial;
6. Squeeze the suspension into a spoon or other container;
7. Rinse the syringe well with warm water after use;
8. Close the vial.

special instructions

Do not use Motilium for the relief and prevention of postoperative vomiting.

In renal insufficiency, it is recommended to maximize the intervals between two subsequent doses of the drug, but the dosage is not required to be reduced. However, if a person suffering from renal insufficiency must take Motilium for a long time, then the entire daily dosage should be divided into 1-2 doses, and not 3-4. If the kidney function worsens during the use of the drug, then it is necessary to reduce the dosage of the drug.

In case of liver failure, the drug in any form should be used with caution, constantly monitoring the functions and condition of the liver.

When using Motilium simultaneously with antacids (Renny, Phosphalugel, Almagel, Maalox, etc.) and H2-histamine blockers (Ranitidine, Famotidine, etc.), their intake should be spaced in time. It is optimal to take Motilium before meals, and antacids and H2-histamine blockers - after meals.

The coated tablets contain lactose, so they should not be taken by people suffering from milk sugar intolerance, as well as malabsorption of glucose and galactose. Also, lozenges should not be taken by people who have an increased risk of developing hyperphenylalaninemia due to their aspartame content.

In children under 1 year of age, Motilium in rare cases can provoke neurological side effects, therefore, when using the drug, one should strictly adhere to the recommended dosages, without increasing them on their own.

Use during pregnancy and breastfeeding

During pregnancy, Motilium can be taken only if the intended benefit to the mother outweighs the possible risks to the fetus. When breastfeeding, Motilium should not be taken, since the drug is in milk at a concentration of 50% of that in the blood.

Influence on the ability to control mechanisms

Motilium does not affect a person's ability to control mechanisms, therefore, against the background of the use of the drug, you can engage in any type of activity that requires a high concentration of attention and speed of reactions.

Overdose

An overdose of Motilium is possible and is manifested by the following symptoms:

• Disorientation;
• Agitation (excitement);
• Altered consciousness;
• Extrapyramidal reactions (tremor, speech disorder, tics, myoclonus, etc.).

For the treatment of overdose, a single gastric lavage is performed, followed by the intake of a sorbent (activated carbon, Polysorb, Polyphepan, etc.). In the future, if necessary, antihistamine and cholinergic drugs, drugs for the treatment of parkinsonism are used to stop extrapyramidal reactions.

Interaction with other drugs

Reduce the severity of the therapeutic effect of Motilium anticholinergics (Aprofen, Atropine, Scopolamine, Dicyclomine, Cyclizine, Benaktizin, etc.), Cimetidine and sodium bicarbonate. Enhance the action of Motilium Fluconazole, Itraconazole, Ketoconazole, Coriconazole, Clarithromycin, Erythromycin, Amprenavir, Atazanavir, Fosamprenavir, Indinavir, Nelfinavir, Ritonavir, Saquinavir, Diltiazem, Verapamil, Amiodarone, Aprepitant, Nefazodone and Telithromycin.

Ketoconazole and Erythromycin, when used simultaneously with Motilium, cause ECG changes that normalize after discontinuation of the drugs.

Side effects of Motilium

Suspension and both varieties of Motilium tablets can cause the same following side effects from various organs and systems:
1. Gastrointestinal tract:

• Spasms of the intestines;
• Changes in the activity of AsAT, AlAT and alkaline phosphatase;
• Thirst;
• Appetite disturbance.

2. Nervous system:

• Extrapyramidal syndrome (tics, tremor, speech disorder, parkinson-like movements, muscle tone disorders, etc.);
• convulsions;
• Drowsiness;

3. Mental disorders:

• Agitation (excitement);

4. The immune system:

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

5. Endocrine system:

• An increase in the level of prolactin in the blood;
• Galactorrhea (leakage of milk from the breast);

6. Skin covers:

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

Contraindications for use

Suspension and both varieties of Motilium tablets are contraindicated for use if a person has the following diseases or conditions:

• Prolactinoma (a tumor of the pituitary gland of the brain that produces prolactin);
• Hyperprolactinemia (increased levels of prolactin in the blood);
• Simultaneous administration of drugs containing ketoconazole, erythromycin, fluconazole, voriconazole, clarithromycin, amiodarone or telithromycin as active substances;
• Gastrointestinal bleeding;
• Mechanical obstruction of the intestine;
• Perforation of any organ of the digestive tract;
• Body weight less than 35 kg (for tablets);
• Individual sensitivity or intolerance to the components of the drug;
• Pregnancy and lactation.

In children under 1 year of age, Motilium should only be used in the form of a suspension and with caution.

Motilium - analogues

On the pharmaceutical market, Motilium has analogues and synonyms. Synonyms are products containing, like Motilium, domperidone as an active substance. Analogues are medicines containing other active substances, but having the most similar spectrum of therapeutic action.

Synonyms of Motilium are the following drugs:

• Damelium tablets;
• Domet tablets;
• Domperidone, Domperidone Geksal and Domperidone-Teva tablets;
• Domstal tablets;
• Motiject tablets;
• Motilac lozenges and film-coated tablets;
• Motinorm syrup and tablets;
• Motonium tablets;
• Passagex tablets are chewable and coated.

Analogues of Motilium are the following drugs:

• Aceclidine solution for subcutaneous injection;
• Ganaton tablets;
• Dimetpramide tablets and solution for intramuscular injections;
• Itomed tablets;
• Itopra tablets;
• Melomide hydrochloride tablets and solution for intravenous and intramuscular injections;
• Metoclopramide tablets and solution for intravenous and intramuscular injections;
• metoclopramide-acry tablets;
• Metoclopramide-Vial, Metoclopramide-Promed, Metoclopramide-ESCOM solution for intravenous and intramuscular injections;
• Perinorm tablets, oral solution and solution for intravenous and intramuscular injections;
• Ceruglan tablets and solution for intravenous and intramuscular injections;
• Cerucal tablets and solution for intravenous and intramuscular injections.

Cheap analogues

Among the synonyms of Motilium, the cheapest drugs are the following:

• Domet - 76 - 108 rubles;
• Domperidone - 99 - 113 rubles;
• Passazhiks - 84 - 107 rubles;
• Motilak - 126 - 232 rubles;
• Motonium - 94 - 100 rubles.

Among the analogues of Motilium, the cheapest drugs are the following:

• Dimetpramide - 89 - 168 rubles;
• Metoclopramide 35 - 135 rubles;
• Perinorm 99 - 183 rubles;
• Tseruglan 19 - 42 rubles;
• Cerucal 125 - 142 rubles.

Russian analogues of Motilium

Synonyms and analogues of Motilium produced by Russian pharmaceutical plants are shown in the table.

Reviews

Reviews on the use of Motilium in adults in most cases are positive, due to the high effectiveness of the drug when taken according to indications. However, in the reviews, not everything is unambiguous and there are a large number of nuances, since the range of conditions under which people took Motilium is quite wide and varied.

So, adults took Motilium in two main cases. First, the drug was taken episodically to relieve nausea and vomiting that arose due to existing diseases of the digestive tract, dietary disorders, or an infectious disease. Secondly, adults took Motilium as part of the complex therapy of stomach diseases (gastritis, peptic ulcer, pyloric stenosis, etc.), reflux and GERD in order to relieve flatulence, a feeling of fullness in the epigastrium, belching, early satiety, vomiting and other symptoms of the disorder. digestion of food, characteristic of these diseases.

With occasional use of Motilium to stop vomiting and nausea, the drug eliminates these symptoms in about 2/3 cases after the first pill. Stopping vomiting and nausea significantly improves a person’s general well-being, allowing him to calmly drink various solutions to replenish fluid loss, as well as take other medications, the action of which is aimed at eliminating the cause of symptoms and treating the disease. In such situations, reviews of Motilium were positive.

In the remaining 1/3 of cases, people had to take Motilium to stop vomiting for several days in a row before each meal or liquid. This mode of using the drug, of course, does not please people, therefore, in such situations, as a rule, they leave a neutral or negative review.

And when taking Motilium to relieve dyspeptic symptoms (belching, nausea, vomiting, flatulence, feeling of stomach fullness, epigastric pain, etc.), characteristic of chronic stomach diseases, GERD and reflux, the drug was effective in almost 100% of cases, Therefore, this category of reviews about him is almost all positive.

Motilium for children - reviews

Currently, there is a very interesting situation when, in practice, Motilium is used in children for a wide range of different conditions, and very often not according to indications, but according to their own ideas about the physiological functions of the child's body. Naturally, in such a situation, reviews of Motilium are very diverse. To navigate them, consider the reviews of people who gave the drug to a child for various reasons.

Reviews on the use of Motilium for the relief of vomiting in children with rotavirus infections, any other acute infectious diseases, as well as in response to medication in about 2/3 of cases, are positive. This is due to the fact that the drug stopped vomiting and improved the general condition of the child, who began to actively play, ask for drink, eat, etc. Moreover, in some cases, a single dose of the drug was enough to stop vomiting, and in others, it was necessary to give the child syrup several times a day for 2 to 3 days. When vomiting did not stop after a single dose of the drug, then the parents gave Motilium to the child before each meal, drink or other medication.

Approximately 1/3 - 1/4 reviews of Motilium for the relief of vomiting in acute conditions in children are negative, which, as a rule, is due not so much to the properties of the drug as to a subjective attitude towards it, high expectations, and also use not according to indications. Very often, parents try to give their child Motilium with vomiting provoked by poisoning, and when the drug does not have the expected effect, they are disappointed and leave negative feedback. In fact, Motilium will not stop vomiting in case of poisoning, since it is due to the entry of toxic substances into the blood from the intestine, and not a disorder of the stomach. In such cases, you need to take sorbents that bind toxic substances. And Motilium can be drunk only before taking the sorbent, so that the child does not vomit within the next 10-15 minutes and the main therapeutic drug is not brought out.

The second part of the reviews about Motilium concerns its use in infants and young children in order to reduce gas formation, bloating and regurgitation. In this case, almost all reviews of the drug are positive, since the syrup effectively stopped these symptoms.

The third part of the reviews about the drug concerns its use in diseases of the digestive tract in children (GERD, gastritis, gastroduodenitis, esophagitis, reflux) in order to relieve the unpleasant symptoms of slow gastric emptying (feelings of heaviness in the stomach, abdominal pain, belching, flatulence, nausea, vomiting and etc.). This category of reviews is in most cases positive, since parents achieve a good therapeutic effect with regular use of Motilium syrup according to the instructions.

The fourth part of the reviews about Motilium concerns its use not according to indications. So, many parents give syrup to children so that the food from the stomach is evacuated faster, and they can eat more at a time. This use of syrup is based on the fact that Motilium stops the feeling of fullness in the stomach. Usually, the drug is used in this way when trying to make the child "eat well" and gain weight, which, according to parents and doctors, is insufficient. Naturally, such a method of improving the child's appetite and increasing the amount of food he eats does not work for a number of reasons, and parents leave a negative review about the drug.

Firstly, Motilium reduces the feeling of fullness in the stomach and accelerates the passage of the food bolus into the intestines only in diseases such as peptic ulcer, gastritis, GERD, esophagitis and reflux! And if the child does not suffer from such diseases, then his food is evacuated from the stomach to the intestines at a normal rate, and attempts to reduce this period of time only lead to the fact that the food bolus is poorly processed and digested by gastric juice. This will cause the baby colic, flatulence, bloating and other discomfort. In other words, by trying to speed up the evacuation of the food bolus from the stomach to the intestines in order to “make room” for another large portion of food, parents only disrupt the normal process of digestion in a child, which can ultimately cause the development of severe chronic diseases of the gastrointestinal tract.

Secondly, while taking Motilium, the child will not be able to eat more, but, on the contrary, will be saturated with a smaller amount of food. This is due to the fact that the food bolus will quickly enter the intestines, from where the nutrients will begin to be absorbed into the blood and give a signal to the brain about the onset of satiety. As a result, the child will be satisfied with much less food than before.

That is, the use of Motilium in order to "improve" the child's nutrition is not only irrational, inappropriate, ineffective and not according to indications, but also dangerous. In order for the child to gain weight, you need to feed him small portions of high-calorie and tasty food 4 to 6 times a day. And trying to feed him a large portion of low-calorie food only stretches the stomach, disrupts the normal process of digestion and creates the basis for the development of gastrointestinal diseases.

Ganaton or Motilium?

Ganaton is a prokinetic drug, that is, it improves the motor function of the stomach, accelerating the evacuation of its contents and, thereby, stopping the painful symptoms associated with food retention in it (heartburn, belching, flatulence, feeling of fullness and pain in the stomach, etc. .). And Motilium can be used for the same conditions as Ganaton, but also for stopping vomiting. That is, the spectrum of indications of Motilium overlaps that of Ganaton. However, the effectiveness of Ganaton is 10% higher compared to Motilium.

This means that for the relief of painful symptoms (nausea, vomiting, heartburn, belching, feeling of fullness and pain in the epigastrium, etc.) of diseases of the stomach and esophagus (gastritis, esophagitis, GERD, peptic ulcer, etc.), both Ganaton and and Motilium. However, Ganaton is preferable in such situations, since this drug is intended specifically for use in the complex therapy of these conditions.

Ganaton is also preferable in cases where it is necessary to take drugs for a long period of time or in conjunction with other drugs. This is usually necessary in the treatment of chronic diseases of the stomach and esophagus.

For episodic relief of symptoms of dyspepsia (heartburn, belching, vomiting, nausea, a feeling of fullness in the stomach, epigastric pain after eating, etc.) arising from a violation of the diet or for other reasons, you can use any drug that, for any reasons people like it more.

To stop vomiting and nausea caused by taking any medications, infections, gastrointestinal diseases and functional digestive disorders, Motilium should be chosen, since Ganaton is ineffective in such situations.

Motilium should also be chosen if it is necessary to use drugs with similar properties in children, since Ganaton cannot be used to treat babies.

Motilium or Motilac?

Motilium and Motilac are synonyms, that is, they contain exactly the same active ingredient domperidone. In terms of therapeutic effects, Motilac and Motilium do not differ from each other, however, the first drug causes side effects more often.

Thus, in the absence of any special requirements for the drug, as well as with overall good drug tolerance, when side effects are rare, you can choose any remedy - Motilak or Motilium, based only on subjective preferences (for example, for some reason like one drug more than another, relatives or friends respond positively). If a person is prone to developing side effects or does not tolerate any medications well, then Motilium should be preferred.

However, Motilium is available in tablets and suspensions, while Motilac is available only in tablets. Therefore, Motilac cannot be used for children, but Motilium can. That is, if it is necessary to use the remedy in children or in people who for some reason find it difficult to swallow tablets, Motilium should be preferred. If a person can take pills, then you can choose any remedy based on your own subjective preferences.

Motilium (tablets and suspension) - price

The cost of various dosage forms of Motilium varies in pharmacies of Russian cities within the following limits:

• Suspension 1 mg / ml, bottle 100 ml - 485 - 672 rubles;
• Lozenges 10 mg, 10 pieces - 345 - 458 rubles;
• Lozenges 10 mg, 30 pieces - 550 - 701 rubles;
• Coated tablets 10 mg, 30 pieces - 452 - 589 rubles.

Before use, you should consult with a specialist.

In Latin, the name of the drug is reproduced as Motilium. Antiemetic stimulates digestion. The drug eliminates unpleasant symptoms that appear against the background of overeating, poisoning or diseases of the digestive tract, helps with delayed defecation.

Compound

Domperidone is the active ingredient in this drug. Motilium lingual contains aspartame, gelatin, mint flavor, manitol and poloxamer 88 as additional components. Other components are present: talc, macrogol, starch, aerosil, titanium dioxide, polyvinyl alcohol, cellulose.

Release form

The drug is available in the form of lozenges, tablets for oral administration and suspension.

Tablets

Tablets are packaged in 10, 30 pieces in a carton.

Suspension

Liquid for oral administration is sold in bottles of 100, 200 ml.

pharmachologic effect

Food moves faster due to improved peristalsis of the digestive tract. The tone of the cardiac sphincter is increased. The drug blocks peripheral dopamine receptors and eliminates vomiting.

Pharmacokinetics

Domperidone is rapidly absorbed if taken before meals. After 30-60 minutes, the maximum concentration of the drug is detected in the blood. The low absolute bioavailability of the active substance is associated with an extensive metabolic process in the intestinal wall and liver. There is a uniform distribution of domperidone in the tissues, but in the brain tissues the concentration is low. The active ingredient binds to plasma proteins by 91-93%. It is excreted unchanged in feces and urine.

What helps

Drops and tablets regulate the digestive system and eliminate unpleasant phenomena:

• vomiting after drug therapy;
• a feeling of fullness in the abdomen and pain;
• the presence of regurgitation syndrome in babies with possible vomiting;
• heaviness in the abdomen;
• esophagitis;
• stagnant processes in the digestive organs;
• gastroesophageal reflux;
• premature feeling of fullness after eating a small amount of food.

It is used to eliminate frequent vomiting and nausea as a result of poisoning, infection or indigestion.

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Application for hemorrhoids

Domperidone helps to normalize stool with hemorrhoids. The active ingredient improves intestinal motility and normalizes the act of defecation.

Side effect

Side effects may occur:

• no menstruation;
• increases the level of prolactin;
• mammary glands increase;
• there are intestinal cramps and stool disorder;
• motor disorders appear in children;
• excitability increases.

In rare cases, allergic reactions to components occur.

Contraindications for use

It is forbidden to use this remedy for patients who have some disorders in the body:

• the hormone prolactin is elevated in the blood plasma;
• perforation of the digestive tract;
• intestinal obstruction;
• pituitary tumors;
• heart failure;
• gastrointestinal bleeding.

Patients who are prone to allergies to the components of drops or tablets do not take an antiemetic.

How to take Motilium

Oral tablets are prescribed for adult patients and children who weigh more than 35 kg. Sublingual tablets are prescribed for children over 5 years of age. Film-coated tablets are washed down with a small amount of liquid. Sublingual tablets are placed under the tongue and wait for complete dissolution. It is not necessary to drink the tablet with water after dissolution. It is advisable to carry out the procedure 15 minutes before meals.

According to the instructions for use, for the treatment of signs of chronic dyspepsia, take 1 tablet (10 mg) 3 times a day. The dosage is increased to 2 tablets when nausea and vomiting occur, while leaving the dose three times a day. It is allowed to take the tablets before bedtime. Double the dose can be in case of ineffectiveness. No more than 80 mg (8 tablets) are allowed per day.

During pregnancy and lactation

During pregnancy and lactation, the reception is carried out after consultation with an experienced specialist.

For kids

Children weighing less than 35 kg are prescribed the drug in the form of a suspension. The drug is prescribed before meals and shortly before bedtime at the rate of 2.5 ml per 10 kg of weight. The maximum amount of suspension for a child per day is 2.4 mg / kg. Children under one year do not need to double the dosage on their own. Before use in infants, you should consult a doctor.

For elderly patients

How much can you take

You can take without a doctor's prescription for 48 hours.

How much is valid

The drug works for 3-4 hours.

Special instructions for the use of Motilium

For impaired liver function

Patients with impaired liver function are prescribed with caution.

For impaired renal function

With repeated use, reduce the intake to 1-2 times a day. If necessary, reduce the dose of the drug.

Overdose

In case of an overdose, disorientation, drowsiness occurs. Children may have movement disorders. At the first symptoms of an overdose, gastric lavage is performed.

Drug interactions of Motilium with other drugs

Together with antisecretory and antacid drugs do not use this drug for vomiting. The bioavailability of the antiemetic is reduced when combined with sodium bicarbonate and cimetidine. The concentration of domperidone in the blood increases while taking drugs that inhibit the activity of this component. The antiemetic suppresses the side effects of drugs such as Bromocriptine and Levodopa.

Terms of dispensing from pharmacies

You can buy this remedy at a pharmacy after presenting a prescription from your doctor.

Terms and conditions of storage

Price

The cost of tablets in Russia is from 370 to 620 rubles. The price of a suspension is from 600 to 640 rubles.

Analogues of the drug Motilium

If this drug is not available, there are similar means:

1. Motilak. The Russian analogue contains domperidone. Use the remedy for various dyspeptic disorders. The tool accelerates bowel movements, eliminates nausea and vomiting. It is contraindicated for children under 5 years of age. The cost of Motilac in a pharmacy is 270 rubles
2. Cerucal. Presented in the form of a solution and tablets. The antiemetic contains metoclopramide hydrochloride. Assign to reduce vomiting, incl. before conducting diagnostic tests. Pregnant women and children under 3 years of age are not prescribed. The cost is from 130 to 250 rubles.
3. Trimedat. The antispasmodic drug contains trimebutine maleate as an active ingredient. Trimedat eliminates digestive disorders, relieves pain. Available in the form of syrup and tablets. Suspension is allowed to be given to newborns. The price of the drug is from 320 to 540 rubles.
4. Ganaton. The active ingredient is itopride. Ganaton enhances gastrointestinal motility. Indicated in chronic gastritis. Contraindicated in children under 16 years of age. Produced in the form of tablets. The cost of this tool is from 370 to 990 rubles.

These drugs are available by prescription. Safe reception is possible after a comprehensive examination and consultation with a doctor.

Quickly about medicines. Domperidone

Motilium during early pregnancy: contraindications, side effects

Trimedat | analogues

Active substance

Domperidone (domperidone)

Release form, composition and packaging

Suspension for oral administration uniform, white.

Excipients: microcrystalline cellulose and sodium carmellose - 12 mg, non-crystallized liquid sorbitol 70% - 455.4 mg, methyl parahydroxybenzoate - 1.8 mg, propyl parahydroxybenzoate - 0.2 mg, sodium saccharinate - 0.2 mg, polysorbate 20 - 0.1 mg, sodium hydroxide - about 10 mcg ( from 0 to 30 mcg), water - up to 1 ml.

100 ml - dark glass bottles with a screw cap, protected from accidental opening by children (1) complete with dosing syringe - packs of cardboard.

Lozenges white or almost white, round.

	1 tab.
domperidone	10 mg

Excipients: gelatin - 5.513 mg, - 4.136 mg, aspartame - 0.75 mg, mint essence - 0.3 mg, poloxamer 188 - 1.125 mg.

10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.

pharmachologic effect

When taking the drug after a meal, it takes longer to reach C max, and the AUC increases slightly.

Distribution

When taken orally, domperidone does not accumulate and does not induce its own metabolism. After taking domperidone orally for 2 weeks at a dose of 30 mg/day, Cmax in blood plasma after 90 minutes was 21 ng/ml and was almost the same as after taking the first dose (18 ng/ml).

Plasma protein binding - 91-93%.

Distribution studies of the radioactively labeled drug in animals have shown broad tissue distribution but low concentrations in the brain. Small amounts of the drug cross the placental barrier in rats.

Metabolism

Domperidone undergoes rapid and extensive metabolism by hydroxylation and N-dealkylation. In vitro metabolism studies with diagnostic inhibitors have shown that CYP3A4 is the major form of cytochrome P450 involved in the N-dealkylation of domperidone, while CYP3A4, CYP1A2, and CYP2E1 are involved in the aromatic hydroxylation of domperidone.

breeding

Excretion by the kidneys and intestines is 31% and 66% of the oral dose, respectively. The proportion of the drug excreted unchanged is small (10% in feces and approximately 1% in urine). Plasma T 1/2 after a single oral dose is 7-9 hours in healthy volunteers, but increases in patients with severe renal insufficiency.

Pharmacokinetics in special clinical situations

In patients with severe renal insufficiency (serum creatinine > 6 mg / 100 ml, i.e. > 0.6 mmol / l), T 1/2 domperidone increases from 7.4 to 20.8 hours, but plasma concentrations of the drug are lower than in patients with normal kidney function. A small amount of unchanged drug (about 1%) is excreted by the kidneys.

In patients with moderate hepatic impairment (Child-Pugh score 7-9), AUC and Cmax of domperidone were 2.9 and 1.5 times higher than in healthy volunteers, respectively. The proportion of unbound fraction increased by 25%, and T 1/2 increased from 15 to 23 hours. In patients with mild hepatic impairment, there were slightly reduced systemic levels of the drug compared to those in healthy volunteers based on C max and AUC without changes in binding to proteins or T 1/2. Patients with severe hepatic impairment have not been studied.

Indications

- a complex of dyspeptic symptoms, often associated with delayed gastric emptying, gastroesophageal reflux, esophagitis (a feeling of fullness in the epigastrium, a feeling of bloating, pain in the upper abdomen, belching with or without gastric contents, flatulence, nausea, vomiting, heartburn);

- nausea and vomiting of functional, organic, infectious origin, as well as those caused by radiotherapy, drug therapy or dietary disorders;

- Nausea and vomiting caused by dopamine agonists when used in Parkinson's disease (such as levodopa and bromocriptine).

Contraindications

- hypersensitivity to domperidone or any of the components of the drug;

- prolactinoma;

- simultaneous use of oral forms of ketoconazole, erythromycin or other potent inhibitors of the CYP3A4 isoenzyme, causing lengthening of the QTc interval, such as clarithromycin, itraconazole, fluconazole, posaconazole, ritonavir, saquinavir, amiodarone, telithromycin, telaprevir and voriconazole;

- gastrointestinal bleeding, mechanical obstruction or perforation (i.e., when stimulation of the motor function of the stomach can be dangerous);

- liver failure of moderate and severe severity;

- body weight less than 35 kg (for lozenges);

- children's age up to 12 years with a body weight of less than 35 kg (for lozenges);

- phenylketonuria (for lozenges);

- pregnancy;

- period of breastfeeding.

Carefully: impaired renal function; violation of the rhythm and conduction of the heart (including prolongation of the QT interval), electrolyte imbalance, congestive heart failure.

Dosage

In patients of all age categories, usually for the treatment of acute nausea and vomiting, the maximum duration of continuous administration of the drug should not exceed 1 week. If nausea and vomiting persist for more than 1 week, the patient should re-consult their physician. For other indications, the duration of therapy is 4 weeks. If the symptoms do not disappear within 4 weeks, it is necessary to re-examine the patient and evaluate the need for continued therapy.

Suspension

Adults and adolescents over 12 years of age and children weighing ≥35 kg- 10 ml 3 times / day. The maximum daily dose is 30 ml (30 mg).

Infants and children under 12 years of age who weigh<35 кг - 0.25 mg per 1 kg of body weight 3-4 times / day. The maximum daily dose is 30 ml (30 mg).

Motilium suspension should be used at the lowest effective dose.

To determine the dose, use the child's body weight scale "0-20 kg" on the syringe.

The dose should be determined very carefully, taking into account body weight, not exceeding the recommended maximum daily dosage. In children, an overdose can cause disorders of the nervous system.

Suspension instructions

Before use, mix the contents of the vial by gently shaking it to avoid foaming.

The 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 cap of the vial while turning it counterclockwise;

Remove screwed cover.

Place the syringe into the vial. While holding the bottom ring in place, raise the top ring to the mark corresponding to the child's weight in kg.

Holding the lower ring, remove the filled syringe from the vial.

Empty the syringe. Close the vial. Rinse the syringe with water.

Lozenges

Adults and children over 12 years of age and weighing ≥35 kg- 10 mg (1 tab.) 3 times / day. The maximum daily dose is 30 mg (3 tablets).

Children under 12 years of age and weighing ≥35 kg- 10 mg (1 tab.) 3 times / day. The maximum daily dose is not more than 30 mg (3 tablets).

V children's practice in general, Motilium suspension should be used.

Directions for use

Since the lozenges are rather fragile, they should not be forced through the foil to avoid damage.

In order to get a tablet from a blister, you need the following:

Take the foil by the edge and completely remove it from the cell in which the tablet is located;

Press gently from below;

Take the tablet out of the package.

Put the tablet on the tongue. Within a few seconds, it will disintegrate on the surface of the tongue, it can be swallowed with saliva without drinking water.

Special patient groups

Since T 1/2 domperidone at severe renal failure(with serum creatinine > 6 mg / 100 ml, i.e. > 0.6 mmol / l) increases, the frequency of taking the drug Motilium should be reduced to 1 or 2 times / day, depending on the severity of the insufficiency. Patients with severe renal insufficiency should be monitored regularly.

The use of the drug is contraindicated in patients with moderate (7–9 points according to the Child-Pugh classification) or severe (Child-Pugh score >9) liver failure. At patients with mild (Child-Pugh score 5-6) liver failure dose adjustment of the drug is not required.

Side effects

According to clinical studies

Adverse reactions observed in ≥1% of patients treated with Motilium: depression, anxiety, decreased or absent libido, headache, drowsiness, akathisia, dry mouth, diarrhea, rash, itching, galactorrhea, gynecomastia, pain and tenderness in the mammary glands, menstrual irregularities and amenorrhea, lactation disorders, asthenia.

Adverse reactions observed in<1% пациентов, принимавших Мотилиум: hypersensitivity, urticaria, swelling and discharge from the mammary glands.

The following undesirable effects were classified as follows: very often (≥10%), often (≥1%, but<10%), нечасто (≥0.1%, но <1%), peдко (≥0.01%, но <0.1%) и очень редко (<0.01%, включая отдельные случаи).

According to spontaneous reports of adverse events identified in the post-registration period

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

Mental disorders: very rarely - irritability, nervousness (mainly in newborns and children).

From the nervous system: very rarely - dizziness, extrapyramidal disorders, convulsions (mainly in newborns and children).

very rarely - prolongation of the QT interval, ventricular arrhythmia *, sudden coronary death *.

very rarely - urinary retention.

very rarely - angioedema, urticaria.

From the side of laboratory indicators: very rarely - deviations in laboratory parameters of liver function, increased levels of prolactin in the blood.

Adverse reactions identified during post-registration clinical studies

From the side of the immune system: frequency unknown - anaphylactic reactions, including anaphylactic shock.

Mental disorders: infrequently - increased excitability (mainly in newborns and children), nervousness.

From the nervous system: often - dizziness; rarely - convulsions (mainly in newborns and children); the frequency is unknown - extrapyramidal disorders (mainly in newborns and children).

From the side of the cardiovascular system: frequency unknown - prolongation of the QT interval, serious ventricular arrhythmias *, sudden coronary death *.

From the side of the kidneys and urinary tract: infrequently - urinary retention.

From the skin and subcutaneous tissues: frequency unknown - angioedema.

From the side of laboratory data: infrequently - deviations of laboratory indicators of liver function; rarely - an increase in the level of prolactin in the blood.

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

Overdose

Symptoms overdoses occur most commonly in infants and older children and may include irritability, altered consciousness, convulsions, confusion, drowsiness, and extrapyramidal reactions.

Treatment: There is no specific antidote for domperidone. In case of an overdose, gastric lavage is recommended within one hour from the moment of taking the drug and the use of activated charcoal. It is recommended to closely monitor the patient's condition and conduct maintenance therapy. Anticholinergics and drugs used to treat parkinsonism may be effective in relieving extrapyramidal disorders that have arisen.

drug interaction

Anticholinergic drugs can neutralize the effect of the drug Motilium.

The oral bioavailability of the drug Motilium decreases after a previous intake of cimetidine or. You should not take antacids and antisecretory drugs at the same time as domperidone, because. they reduce its bioavailability after oral administration.

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 plasma concentrations of domperidone. Strong CYP3A4 inhibitors include azole antifungals (such as fluconazole*, itraconazole, ketoconazole*, and voriconazole*), macrolide antibiotics (such as clarithromycin* and erythromycin*), HIV protease inhibitors (such as amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir), calcium antagonists (such as diltiazem and verapamil), amiodarone*, aprepitant, nefazodone, telithromycin*. Drugs marked with an asterisk also prolong the QTc interval.

In a number of pharmacokinetic and pharmacodynamic interaction studies of domperidone with oral ketoconazole and oral erythromycin in healthy volunteers, these drugs have been shown to significantly inhibit the primary metabolism carried out by the CYP3A4 isoenzyme. With the simultaneous administration of 10 mg of domperidone 4 times / day and 200 mg of ketoconazole 2 times / day, there was an increase in the QT interval with an average of 9.8 ms during the entire observation period, at some points the changes varied from 1.2 to 17.5 ms. With the simultaneous administration of 10 mg of domperidone 4 times / day and 500 mg of erythromycin 3 times / day, there was an increase in the QT interval with an average of 9.9 ms during the entire observation period, at some points the changes varied from 1.6 to 14.3 ms. In each of these studies, C max and AUC of domperidone were approximately 3-fold increased.

It is currently unknown what contribution to the change in the QTc interval is made by elevated plasma concentrations of domperidone.

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

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

The combined use of anticholinergic drugs (eg, dextromethorphan, diphenhydramine) may interfere with the development of the antidyspeptic effects of the drug Motilium in the form of a suspension.

Theoretically, since Motilium has a gastrokinetic effect, it could influence the absorption of concomitantly administered oral preparations, in particular extended-release preparations or enteric-coated preparations. However, the use of domperidone in patients receiving paracetamol or digoxin did not affect the level of these drugs in the blood.

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

special instructions

When Motilium is used together with antacids or antisecretory drugs, the latter should be taken after meals, and not before meals, i.e. they should not be taken concomitantly with Motilium.

Application in diseases of 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. The risk may be more likely in patients over 60 years of age and in patients taking the drug in daily doses of more than 30 mg. Patients over 60 years of age should use the drug with caution and consult a doctor before taking it.

The use of domperidone and other drugs that lead to prolongation of the QTc interval is not recommended in patients with existing conduction disorders, in particular prolongation of the QTc interval, and in patients with severe electrolyte imbalance (hypokalemia, hyperkalemia, hypomagnesemia) or with bradycardia, or in patients with concomitant heart disease such as congestive heart failure. As you know, against the background of electrolyte imbalance and bradycardia, the risk of arrhythmias increases.

If signs or symptoms appear that may be associated with cardiac arrhythmia, therapy with Motilium should be discontinued and a doctor should be consulted.

Use in kidney disease

Because a very small percentage of the drug is excreted by the kidneys unchanged, then adjustment of a single dose in patients with renal insufficiency is not required. However, with the re-appointment of the drug Motilium, the frequency of use should be reduced to 1-2 times / day, depending on the severity of impaired renal function, and it may also be necessary to reduce the dose. With long-term therapy, patients should be monitored regularly.

Potential for drug interactions

The main route of metabolism of domperidone is via CYP3A4. In vitro data and human studies indicate that concomitant use of medicinal products that significantly inhibit this enzyme may be associated with an increase in plasma domperidone concentrations. The combined use of domperidone with potent inhibitors of CYP3A4, which, according to the data obtained, cause a prolongation of the QT interval is contraindicated.

Caution must be exercised when co-administering domperidone with potent CYP3A4 inhibitors that do not prolong the QT interval, such as indinavir; Patients should be carefully monitored for signs or symptoms of adverse reactions.

Care must be taken when co-administering domperidone with medicinal products known to prolong the QT interval; Patients should be carefully monitored for signs or symptoms of cardiovascular adverse reactions.

Examples of such medicines:

Class IA antiarrhythmics (eg, disopyramide, quinidine);

Class III antiarrhythmics (eg, amiodarone, dofetilide, dronedarone, ibutilide, sotalol);

Certain antipsychotics (eg, haloperidol, pimozide, sertindole);

certain antidepressants (eg citalopram, escitalopram);

certain antibiotics (eg, levofloxacin, moxifloxacin);

Certain antifungals (eg pentamidine);

Certain antimalarials (eg halofantrine);

Certain gastrointestinal drugs (eg, dolasetron);

Certain anticancer drugs (eg, toremifene, vandetanib);

Certain other medicines (eg bepridil, methadone).

Excipients

Motilium Oral Suspension contains sorbitol and is not recommended for use in patients with sorbitol intolerance.

Motilium Express lozenges contain aspartame and should therefore not be used in patients with hyperphenylalaninemia.

Disposal of the drug

If the medicinal product has become unusable or the expiration date has expired, it should not be thrown into wastewater or into the street. It is necessary to place the drug in a bag and put it in a trash container. These measures will help protect the environment.

Pediatric use

Motilium in rare cases can cause neurological 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, you should strictly adhere to the recommended dose. Neurological side effects can be caused in children by an overdose of the drug, but other possible causes of such effects must be taken into account.

Influence on the ability to drive vehicles and control mechanisms

Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions due to the risk of adverse reactions that may affect these abilities.

Pregnancy and lactation

Pregnancy

There are insufficient data on the use of domperidone during pregnancy.

To date, there is no evidence of an increased risk of malformations in humans. However, the drug should be prescribed during pregnancy only in cases where its use is justified by the expected therapeutic benefit.

lactation period

The amount of domperidone that can enter the baby's body with breast milk is small.

The maximum relative dose for infants (%) is estimated at about 0.1% of the dose taken by the mother, based on body weight. It is not known whether this level has a negative effect on newborns. In this regard, when using the drug during lactation, it is recommended to stop breastfeeding.

Application in childhood

Motilium Express is contraindicated in children under 12 years of age with a body weight of less than 35 kg.

In pediatric practice, Motilium suspension should mainly be used.

For impaired renal function

WITH caution

Terms and conditions of storage

Motilium suspension should be stored out of the reach of children at a temperature of 15° to 30°C. Shelf life - 3 years.

Motilium EXPRESS should be stored in its original packaging out of the reach of children, in a dry place at a temperature not exceeding 25°C. Shelf life - 2 years.

Do not use after the expiration date.