Motilium for children instructions for use of the drug

January 22, 2021 | No comments | Consultations

Very often, children of different ages, starting from the newborn period, experience problems associated with impaired motility of the stomach and intestinal tract. While there are a large number of medications offered by pharmacists, not many of them are approved for use by tiny children in infancy and early childhood. The drug Motilium is presented in three dosage forms, taking into account the age of the patients. In addition to eliminating dyspeptic symptoms, it has the ability to relieve nausea and vomiting, which can bother children with drug and food poisoning, motion sickness, viral intoxication during acute respiratory diseases and rotavirus infections.

• 2 Indications for use in children of different ages

  2.1 Babies

• 2.2 Children over one year old

Composition and packaging

The suspension is white, homogeneous, in 100 ml bottles, packed in a cardboard box. The tablets are white, round in shape. Available in blisters of 10 pieces. There are 1 or 3 blisters per cardboard package.

Suspension

• Active ingredients: domperidone (0.001 mg).
• Additional components : microcrystalline cellulose, sodium carmellose, non-crystallized liquid sorbitol, methyl parahydroxybenzoate and propyl parahydroxybenzoate, sodium saccharinate, polysorbate, sodium hydroxide, water.

Pills

• Active ingredients: domperidone (0.01 mg).
• Additional components: gelatin, mannitol, aspartame, mint essence, poloxamer.

How the drug is sold and stored

The medicine can be bought at a pharmacy. If you need the drug in tablets, pharmacists will sell them without a prescription. If you purchase a medicine in liquid form, you may need a prescription from a doctor.

The drug is stored at home. Choose a dry and dark place. The optimal storage temperature varies from 15 to 30 degrees. The advantage is that after printing the bottle does not need to be put in the refrigerator. The suspension is stored for three years, lozenges for two years. Tablets for oral use have the longest shelf life. They are good for five years.

The average price of 100 ml syrup depends on the pricing policy of the pharmacy and the city of sale. It varies between 750 – 800 rubles, a package of 10 tablets costs 500 – 550 rubles.

Operating principle

The active substance domperidone affects the muscles of the duodenum and antrum of the stomach, ensures their longer contraction and, as a result, the rapid removal of food from the gastric cavity into the intestine. It also increases the compression of the sphincter of the lower esophagus, which makes it impossible for food to pass through the esophagus. It has no effect on the production of gastric juice.

Effect of the drug and release form

The drug Motilium with the active ingredient domperidone is classified as a centrally acting antiemetic intended for oral administration. The medicine is designed to relieve symptoms of disorders of the upper intestines and stomach. After the patient swallows the required dose, domperidone raises pressure in the lower part of the esophagus, activates the motility of the duodenum and small intestine and stimulates the emptying of the stomach from digested food. The substance does not affect the degree of gastric juice secretion and its acidity.

Three forms of release of the drug Motilium are used in children of different ages

In pediatrics, different forms of Motilium are used.

1. Motilium in coated tablets. Prescribed to adolescents over 12 years of age with a body weight of at least 35 kg. One film-coated tablet contains 10 mg of domperidone. There are 10 or 30 tablets in a package.
2. Instant tablets with mint flavor. Suitable for children 5–7 years old. Prescribed for children over 5 years old and weighing at least 35 kg. There are 10 or 30 tablets in a package.
3. The suspension is a sweet white liquid in a 100 ml bottle. A special dispenser syringe is attached to it. Allowed for use in healthy full-term infants from 1 month of age. The dosage is calculated in mg of domperidone per kilogram of the baby’s weight.

Motilium preparations are allowed to be prescribed to children only taking into account age and weight in each specific case.

Side effect

According to scientific studies (very rare): dry mouth, anxiety, drowsiness, headache, diarrhea, rashes, itching, galactorrhea, pain in the mammary glands, increased sensitivity of the mammary glands, asthenia.

According to reports from those taking the drug:

• The immune system. Anaphylactic reactions are very rare.
• Mental disorders. Agitation and nervousness are very rare.
• Nervous system. Extrapyramidal disorders, seizures - very rare.
• Skin covering. Angioedema, urticaria.

• Kidneys and urinary tract. Urinary retention is very rare.
• Reproductive system and mammary glands. Gynecomastia, amenorrhea – rare.
• Organs of vision. Oculogyric crisis is very rare.
• Laboratory and instrumental data. Changes in laboratory parameters of liver function, an increase in blood prolactin are very rare.

There are known cases of extrapyramidal phenomena, mainly in newborns and babies of the first year of life, as well as convulsions and agitation.

If any of the above reactions occur, you should consult a doctor.

Indications for use in children of different ages

It is prohibited to use Motilium on your own without consulting a specialist, because parents cannot fully assess the seriousness of the child’s condition..

Babies

For the youngest patients (newborns, infants), the pediatrician can prescribe this medicine in a number of situations:

• regurgitation of milk or belching of air;
• infant colic;
• vomiting during motion sickness in transport (followed by a visit to a pediatrician and neurologist to determine the exact cause);
• diarrhea or constipation.

With persistent vomiting or diarrhea, there is a high risk of dehydration, which is extremely dangerous for the baby. Call a doctor immediately!

When treating colic, Motilium is started as an auxiliary symptomatic remedy.

Children over one year old

Motilium is indicated for the following symptoms:

• bloating;
• feeling of fullness in the stomach;
• rapid satiety when eating followed by heaviness;
• pain, cramps in the upper abdomen;
• slow emptying of the stomach, sluggish bowel movements;
• belching food or air;
• flatulence;
• reflux of semi-digested food or hydrochloric acid from the stomach into the esophagus or into the oral cavity;
• inflammatory processes of the mucous membrane of the esophageal tube;
• heartburn in the epigastric region, burning behind the sternum in the lower esophagus;
• nausea, vomiting after large amounts of food eaten, in case of diet violations;
• nausea, vomiting as a result of poisoning with low-quality products;
• problems in the biliary tract,
• motion sickness in transport;
• vomiting during rotavirus infections;
• vomiting caused by taking medications.

Instructions for use of Motilium suspension for children and adults

• Adults and adolescents over 12 years of age (weighing over 35 kg) – 10 ml three times a day. The maximum dose per day is 30 ml (0.03 g).
• Infants and children under 12 years of age (up to 35 kg) – 0.25 mg per 1 kg of weight 3-4 times a day. The maximum daily dose is 30 ml (0.03 g).

The suspension is used in the lowest effective dose. The “0–20 kg” body weight scale on the syringe that comes with the syrup bottle will help you determine the required dose.

Before use, shake the syrup slightly in the bottle, avoiding foaming. You can open the bottle by pressing the cap and then turning it counterclockwise.

Motilium for kids

Release form, composition and packaging

The suspension for oral administration is homogeneous, white. 5 ml domperidone 5 mg. Excipients: sodium saccharin, microcrystalline cellulose, sodium carboxymethylcellulose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, polysorbate, purified water.

Clinical and pharmacological group: Centrally acting antiemetic drug that blocks dopamine receptors.

pharmachologic effect

Antiemetic drug, stimulant of gastrointestinal motility. Domperidone is a dopamine antagonist that, similar to metoclopramide and some antipsychotics, has antiemetic properties. However, unlike these drugs, domperidone penetrates the BBB poorly. Domperidone is rarely associated with extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin from the pituitary gland.

The antiemetic effect may be due to a combination of peripheral (gastrokinetic) action and antagonism of dopamine receptors in the chemoreceptor trigger zone. When taken orally, domperidone increases the duration of antral and duodenal contractions, accelerates gastric emptying - the release of liquid and semi-solid fractions in healthy people and solid fractions in patients when this process has been slowed down, and increases the pressure of the sphincter of the lower esophagus in healthy people. Domperidone has no effect on gastric secretion.

Pharmacokinetics

Suction

After oral administration on an empty stomach, domperidone is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved within approximately 1 hour. The low absolute bioavailability of domperidone when taken orally (approximately 15%) is due to extensive primary metabolism in the intestinal wall and liver. Although in healthy people the bioavailability of domperidone increases when taken after a meal, patients with gastrointestinal complaints should take domperidone 15-30 minutes before meals. Hypoacidity of gastric juice reduces the absorption of domperidone. When taking the drug after a meal, it takes longer to reach Cmax and the AUC increases slightly.

Distribution

When taken orally, domperidone does not accumulate or induce its own metabolism. After taking domperidone for 2 weeks at a dose of 30 mg/day, Cmax in blood plasma 90 minutes after the last dose was 21 ng/ml and was almost the same as after taking the first dose (18 ng/ml). Plasma protein binding - 91-93%. Concentrations of domperidone in breast milk of lactating women are 4 times lower than the corresponding concentrations in blood plasma.

Metabolism

Domperidone is metabolized in the liver by hydroxylation and N-dealkylation. In in vitro drug metabolism studies using diagnostic inhibitors, it was found that isoenzyme 3A4 is the main isoenzyme of the cytochrome P450 system involved in the process of N-dealkylation of domperidone, while isoenzymes CYP3A4, CYP1A2 and CYP2E1 are involved in the aromatic hydroxylation of domperidone.

Removal

Excretion in urine and feces is 31% and 66% of the dose taken, respectively. It is excreted unchanged in feces (10%) and urine (approximately 1%). T1/2 from blood plasma after taking a single dose in healthy volunteers is 7-9 hours.

Pharmacokinetics in special clinical situations

In patients with severe renal failure (serum creatinine level more than 6 mg/dL), T1/2 of domperidone increases from 7.4 hours to 20.8 hours, but plasma concentrations of the drug are lower than in healthy volunteers.

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, flatulence, nausea, vomiting, heartburn and regurgitation);
• nausea and vomiting of functional, organic, infectious origin caused by radiotherapy, drug therapy or diet disorders;
• nausea and vomiting caused by dopamine agonists when used in Parkinson's disease (such as L-dopa and bromocriptine);
• regurgitation syndrome, cyclic vomiting, gastroesophageal reflux and other gastric motility disorders in children.

Dosage regimen

Film-coated tablets are indicated for adults and children weighing more than 35 kg. Lozenges are indicated for adults and children over 5 years of age. In pediatric practice (especially children under 5 years of age), it is recommended to use Motilium in the form of a suspension.

For chronic dyspepsia, adults and children are prescribed 10 mg 3 times a day 15-30 minutes before meals and, if necessary, before bedtime. The maximum daily dose is 80 mg.

If necessary, for adults and children over 12 years of age, the dose can be doubled.

For children , the drug in the form of a suspension is prescribed at the rate of 2.5 ml/10 kg of body weight (which corresponds to 250 mcg/kg of body weight) 3 times a day before meals and, if necessary, before bedtime. If necessary, the indicated dose can be doubled (except for children under 1 year of age). The maximum daily dose is 2.4 mg/kg body weight, but not more than 80 mg. For nausea and vomiting, adults and children over 12 years of age are prescribed 20 mg 3-4 times a day before meals and at bedtime. The maximum daily dose is 80 mg.

Children aged 5 to 12 years are prescribed 10 mg 3-4 times a day before meals and at bedtime. The drug in the form of a suspension is prescribed at the rate of 5 ml/10 kg of body weight (which corresponds to 500 mcg/kg of body weight) 3-4 times a day before meals and before bedtime. This dose is achieved by filling the pipette twice. The maximum daily dose is 2.4 mg/kg body weight, but not more than 80 mg.

In case of renal failure, it is recommended to increase the interval between taking the drug. Because Since a very small percentage of the drug is excreted unchanged by the kidneys, there is hardly any need to adjust a single dose in patients with renal failure. However, when re-prescribed, the frequency of administration should be reduced to 1-2 times a day, depending on the severity of renal failure, and a dose reduction may also be required.

Rules for using the suspension

The bottle of suspension should be shaken before use. The suspension is supplied in child-resistant packaging, so the bottle should be opened as follows:

1. Press down on the plastic cap of the bottle while turning it counterclockwise.
2. Remove the unscrewed cap.
3. Remove the pipette from the case (supplied only with the 100 ml bottle).
4. Holding the lower ring in place, raise the upper one to the mark corresponding to the child’s weight (in kg).
5. Holding the lower ring, remove the filled pipette from the bottle.
6. After use, rinse the pipette with water, place the empty pipette back in the case and close the bottle.

Rules for the use of lozenges

Lozenges are available in blister packs. Since the tablets are quite fragile, they should not be pressed through the foil to avoid damage. In order to remove a tablet from the blister, take the foil by the edge and completely remove it from the cell in which the tablet is located. Then gently press down from below and remove the tablet from the package. The tablet should be placed on the tongue. Within a few seconds it will disintegrate on the surface of the tongue and can be swallowed with saliva without washing it down with water.

Side effect

• From the digestive system: rarely – gastrointestinal disorders; in isolated cases - transient intestinal spasms.
• From the central nervous system: extrapyramidal symptoms (very rarely - in children; in isolated cases - in adults); completely reversible and disappear after cessation of treatment. If the BBB is insufficiently developed (for example, in children under 1 year of age) or its functions are impaired, the possibility of neurological side effects cannot be completely excluded.
• From the endocrine system: hyperprolactinemia is possible, rarely leading to galactorrhea, gynecomastia, amenorrhea. Allergic reactions: rarely - rash, urticaria.

Contraindications

• gastrointestinal bleeding;
• mechanical obstruction or perforation, in which stimulation of the motor function of the stomach can be dangerous;
• prolactin-secreting tumor of the pituitary gland (prolactinoma);
• simultaneous use of oral forms of ketoconazole;
• hypersensitivity to the components of the drug.

Pregnancy and lactation

There is insufficient data on the use of Motilium during pregnancy. To date, there is no evidence of an increased risk of developmental defects in humans. However, the use of Motilium during pregnancy (especially in the first trimester) is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk for the fetus.

In women, the concentration of domperidone in breast milk is 10-50% of the corresponding concentration in plasma and does not exceed 10 ng/ml. The total amount of domperidone excreted into breast milk is less than 7 mcg/day when using the maximum permissible doses. It is unknown whether this level has a negative effect on newborns. Therefore, if it is necessary to use Motilium during lactation, breastfeeding should be stopped.

Use for liver dysfunction

Motilium should be prescribed with caution to patients with liver failure, given the high degree of metabolism of domperidone in the liver.

Use for renal impairment

Overdose

Infants and older children are more likely to experience overdose, which is characterized by agitation, altered consciousness, seizures, confusion, somnolence, and extrapyramidal disturbances. In such cases , it is recommended to rinse the stomach , then take activated charcoal and monitor further reactions. As for the last phenomenon of overdose, in this case the doctor may prescribe antihistamines.

Interaction with other drugs

Some antitussives may significantly reduce the effectiveness of Motilium. Azole antifungals (fluconazole, ketoconazole, etc.), macrolide antibiotics (erythromycin, etc.), HIV protease inhibitors, calcium antagonists, as well as amiodarone, aprepitant, nefazodone, telithromycin can excessively increase the amount of domperidone in the plasma. In addition, some of the medications listed can disrupt the heart rhythm.

Motilium can be combined without fear with antipsychotics, bromocriptine and levodopa.

Analogs

In Ukraine, there are several medicines similar to the action of Motilium, including drugs for children: Gastropom, Domrid, Cerucal, Itomed, Domperidon-stomy, Peridon, Peridonium, Mosid, Primer, Metoclopramide, Metukal, Motinol, Perilium, Motinorm, Motorix , Motoricum.

The above analogues are mostly intended for adults, as well as adolescents over 16 years of age, but the last four names are prescribed to children 12 years of age and younger, and moreover, they are cheaper than Motilium.

Reviews

Lada: “I would like to leave a review about Motilium, since I took it myself and was satisfied with the effect. But I didn’t know that there was a suspension for children - now I’ll take this into account for the future!”

Olga : “My daughter is 14 years old, the poor thing constantly gets sick in transport, especially if she eats before the trip - she can’t even make it through a stop. Therefore, taking the drug on the eve of the trip is the only way out of the situation.”

Lera: “My son has been suffering from vomiting since birth, the surgeon prescribed Motilium for us. Since then we have been drinking it every day, for two years now, in order to somehow escape from this trouble.”

Svetlana: “My son reacted negatively to this medication - immediately after taking it he was covered in itchy hives. I had to use Suprastin tablets, in the instructions for use you can find out how to give them to children - you never know!”

Lida: “A wonderful drug, and most importantly, it works quickly! There was no need for analogues; this medicine is available in any pharmacy.”

special instructions

When using the drug Motilium in combination with antacid or antisecretory drugs, the latter should be taken after meals and not before meals, i.e. they should not be taken simultaneously with Motilium.

Motilium suspension contains sorbitol and should not be taken by patients intolerant to sorbitol.

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

Video

Abdominal diseases are probably the most common bodily disorders of children. They have many reasons, including problems that you can cope with on your own, and there are certain signs that you should pay attention to in order to promptly consult a doctor for help. I suggest you find out about all this by watching the episode of the program, which is hosted by a children’s doctor known throughout the country:

Did this article help you understand the use of Motilium for children? Be sure to leave your review in the comments below and tell us how effective the product is. If your child is worried about nausea on public transport, study the list of motion sickness tablets for children and familiarize yourself with the features of their use. Read in what cases activated charcoal is given to children. Also, I think you will be interested in learning more about the popular drug for regulating the gastrointestinal microflora in newborns and older children - Linex. Let your little ones be healthy!

Does Motilium help cope with regurgitation in infants?

The first year of any child’s life is very important in terms of future health.
At this time, there is a gradual development of the functioning of all its organs, including the digestive organs. Colic, frequent regurgitation, changes in stool character, problems with bowel movements - all this worries every baby to one degree or another.

And if these phenomena greatly disturb the baby’s well-being, negatively affect his sleep, behavior, and reduce appetite, then the help of medications cannot be avoided.

Motilium is a group of frequently prescribed drugs for tummy problems in newborns and children up to one year old. The pediatrician must describe how to properly administer this medicine. The instructions for use will help you understand the nuances of using Motilium.

Pharmacological properties of the drug Motilium

The instructions for use indicate that Motilium is an anti-vomiting medicine containing domperidone as the main active ingredient. Due to the fact that the medicine blocks dopamine receptors upon receipt, inhibition of the increased activity of the digestive system organs is observed.

Motilium accelerates the emptying of a full stomach, enhances motility, and eliminates reflux. Due to a similar mechanism of action, the drug is used in the treatment of newborns and children of the first year of life to eliminate:

• Frequent regurgitation
• Excessive gas formation
• Bowel movement disorders

The drug can be used after dyspeptic symptoms have appeared while taking certain medications, after poisoning.

Motilium is also effective in cases of persistent constipation in young children - the drug normalizes peristalsis and promotes the movement of the bolus of food through the intestines without difficulty.

The instructions for use explain that Motilium penetrates the blood-brain barrier only in the very minimum dosage, so the medicine practically does not cause increased drowsiness, anxiety, weakness, or headaches in children. The drug is well tolerated and has positive reviews of its use from children’s parents.

Release form

The drug Motilium is available in three dosage forms - these are regular tablets, instant dissolving tablets, and suspension. In addition to the main active ingredient domperidone, the medication also contains a number of additional components that improve the absorption of the drug. For young children, a suspension is recommended for use.

Features of using Motilium for children

The medicine Motilium, both for the smallest newborns and for children under one year of age and older, must be prescribed by a doctor. There are certain indications and contraindications for the use of this drug, which should always be taken into account when prescribing medications and when choosing their dosage.

An antiemetic helps relieve the symptoms of a digestive tract disorder, but the drug does not address the cause of the disease. Therefore, this medicine can be used for children if there is confidence that regurgitation, colic in the tummy, problems with bowel movements are caused only by the development of organ function.

If an additional cause of a pathological disorder in digestion is identified, then a number of other medications are additionally used. It is possible to accurately determine the cause of problems with the baby’s digestive system only after additional diagnostic methods.

Motilium is also recommended to be given when poisoning with poor-quality food has occurred. The drug copes well with vomiting and eliminates dyspeptic disorders. But in addition to such treatment, it is imperative to use means to remove toxins from the body and drugs to restore the functioning of internal organs.

Dosage

Drug therapy for children in the first year of life is the responsibility of the doctor, so parents should always contact their pediatrician for advice.

You need to know that Motilium is not always prescribed. If a baby experiences only flatulence in the first months of life, treatment is also possible with drugs with a different mechanism of action.

The drug is effective when frequent and heavy regurgitation is accompanied by colic, poor appetite, low weight gain, and constipation. Positive reviews confirm that children’s well-being improves after just a few days of using Motilium.

For all indications, the dosage for children is selected depending on their weight. For babies up to one year and the first five years of life, only a suspension is recommended for use, since it is easier and much faster to digest and, of course, it is much easier to give the liquid form to the baby.

To make it easier to understand the dosage of the medicine, you must first read the instructions for its use. Features of the dosage of the drug and the conditions for its administration include:

A single dosage for children under one year of age should not exceed 2.5 milligrams for every 10 kg of weight; the medicine is given three times a day. In case of severe dyspeptic symptoms, the dosage can be increased no more than twice, but the total volume of the suspension drunk per day should not exceed 80 mg.

The first positive changes are noted on the second or third day of treatment. The baby spits up less, and decreased colic also leads to improved sleep. If your baby’s tummy bothers you in the evening hours, then before bedtime you can give another dose of Motilium. According to reviews, this technique helps the child sleep peacefully without experiencing discomfort from bloating.

The suspension is taken approximately 15 minutes before feeding the baby; it must first be shaken well. During this time, the components of the medicine are absorbed by the gastric mucosa, and regurgitation and nausea do not occur in the future.

The instructions for use warn that Motilium should not be given simultaneously with antacids or sorbents, since the therapeutic effectiveness of all drugs is reduced. If necessary, prescribed sorbents can be given to the baby 15-20 minutes after feeding.

Contraindications and side effects of Motilium

The drug Motilium should be used to eliminate any dyspeptic changes in a child only as prescribed by the attending physician, since it is necessary to find out whether there are any contraindications to the use of this medication.

Motilium is not prescribed if there are signs of intestinal obstruction, gastric or intestinal bleeding. The medicine is discontinued and if the baby shows signs of hypersensitivity to Motilium, they can be expressed by allergic rashes on the body, the development of edema.

Some reviews warn that this remedy can cause twitching of the child's limbs, a decrease in motor activity, and changes in muscle tone. After discontinuation of the drug, all these adverse reactions disappear without consequences.

Motilium today is considered practically the only drug approved for the elimination of nausea, severe vomiting and frequent regurgitation in children in the first months of life, including newborns.

The medicine affects the central nervous system in a minimal amount and is therefore free from a number of side effects.

But the child’s parents should always remember that Motilium is a remedy for eliminating symptoms; it cannot eliminate the cause of gastrointestinal diseases.

It is not reviews on the Internet that will help you accurately decide on the choice of drug for each child, but a consultation with a pediatrician. Competently prescribing a treatment regimen helps to quickly relieve all the child’s discomfort.

The price of the drug Motilium depends on the form of its release. Suspension in 100 ml bottles costs from 400 rubles or more. Some parents are deterred from purchasing the drug by its high cost, so you can ask your pediatrician to prescribe a cheaper analogue.

Source: https://ogrudnichke.ru/lechenie/motilium-grudnichku.html