Motillion Pharmland tablets 10 mg No. 10x3

Compound

Regardless of the form of release, the medicine contains domperidone as an active substance.
Motilium suspension contains the following additional components: sodium saccharinate, sodium carboxymethylcellulose, methyl parahydroxybenzoate, sodium hydroxide, water, MCC, sorbitol , propyl parahydroxybenzoate, polysorbate.

Excipients of lozenges: gelatin, aspartame, poloxamer 188, mannitol, mint essence.

Coated Motilium tablets contain lactose, microcrystalline cellulose, polyvidone, hydrogenated vegetable oil, hypromelose, corn starch, gelatinized potato starch, magnesium stearate, sodium lauryl sulfate.

Dosage forms and composition

Motilium contains the active dose of the substance domperidone. It is a strong dopamine receptor blocker. Several types of the drug are available for oral administration:

1. Regular film-coated tablets: white, convex, engraved “10M”. Each contains 10 mg of domperidone, lactose, MCC, hydrogenated vegetable fat, starch, polyvidone and other auxiliary components. The package contains 1–3 blisters.
2. Lingual lozenges with a similar dosage, slightly minty taste. The active substance in them is supplemented with gelatin, menthol, aspartame and mannitol. Packed in 10–30 pieces.
3. Suspension for children. White, syrupy, sweetish liquid containing 1 mg of domperidone per 100 ml. Packaged in dark glass bottles with a screw cap. The drug also contains sodium saccharinate, water, sorbitol, polysorbate and stabilizers. Each package of the product has a special syringe for precise dosing.

Pharmacodynamics and pharmacokinetics

The medicine inhibits dopamine receptors . This property, in combination with the gastrokinetic effect, determines the antiemetic effect of the drug.

When used internally, Motilium increases the pressure of the lower esophageal sphincter , accelerates gastric emptying and helps improve antroduodenal motility .

After taking on an empty stomach, the active substance of the drug is absorbed from the gastrointestinal tract in a short time. The degree of absorption of domperidone is reduced due to a decrease in the acidity of gastric juice. plasma concentration is observed after approximately 0.5-1 hour. In people with moderate liver dysfunction it can be 1.5 times higher than in healthy people.

Absolute bioavailability is about 15%. When using the medicine after meals, the maximum concentration is reached later. In healthy people, bioavailability increases when taken after meals. If you have problems with the gastrointestinal tract, you should use the drug 15-30 minutes before meals.

The degree of binding of the active substance to plasma proteins is 91-93%. Once in the body, it undergoes rapid and active biotransformation in the liver through hydroxylation and N-dealkylation.

The drug is excreted 31% in urine and 66% in feces. About 11% of the active substance is excreted unchanged.

The plasma half-life after a single dose is 7-9 hours. In people with severe renal impairment, the half-life increases to 20.8 hours and plasma concentrations decrease. Only about 1% is excreted unchanged through the kidneys. In people with impaired liver function, the half-life is 15-23 hours.

Therapeutic effect

Motilium has the ability to eliminate nausea, stop vomiting, and gently activate intestinal motility. The active component of the drug, domperidone, exhibits some properties of an antipsychotic, suppressing sensitivity to dopamine. Unlike other inhibitors, it is more neutral: it does not cause dystonia, tremor, or nervous tics.

The drug increases the tone of muscle fibers and enhances contractions of the esophageal sphincter in its lower part. Thanks to this, the evacuation function of the stomach is normalized, signs of dyspepsia, indigestion, and other motility disorders and diseases of the gastrointestinal tract are eliminated.

The drug is absorbed by the mucous membranes within a few minutes and actively binds to blood proteins. Transformed by liver cells. It is excreted from the body by the kidneys and with intestinal contents within 0.5–1 days after administration.

Domperidone stimulates the release of prolactin. The secretion of gastric juice and its acidity are not affected. When consumed during or immediately after a meal, the effect of Motilium may slow down somewhat.

Indications for use of Motilium

Indications for the use of Motilium: vomiting, hiccups, nausea, atony and hypotension , cholecystitis , reflux esophagitis , peptic ulcers , the need to accelerate peristalsis before X-ray studies of the gastrointestinal tract, biliary dyskinesia cholangitis , flatulence .

As a component of complex treatment, the drug is taken for exacerbation of gastric and duodenal ulcers .

Indications for the use of Motilium for children: gastroesophageal reflux , cyclic vomiting, regurgitation syndrome .

Contraindications

The medicine has the following contraindications:

• bleeding in the gastrointestinal tract, perforation , mechanical obstruction ;
• prolactinoma;
• negative reaction of the body to the components of the drug;
• severe or moderate liver dysfunction

The drug should be taken with caution in case of kidney dysfunction , as well as cardiac and disorders .

It is advisable to consult a specialist about possible contraindications to the use of the medicine.

Side effects

The following side effects are possible when taking this medicine:

• endocrine system: amenorrhea , hyperprolactinemia (in rare cases can cause galactorrhea ), gynecomastia ;
• Gastrointestinal tract: spasms in the intestines;
• allergies : urticaria , rash;
• nervous system: extrapyramidal disorders .

Negative effects are observed only in extremely rare cases.

Side effects and interactions

When treating with Motilium, caution should be exercised when using antacids and agents that reduce secretory activity. It is recommended to separate them by time.

The simultaneous use of antifungal drugs, some drugs against HIV infection and macrolides contributes to the prolonged presence of Motilium in the blood. This is important to consider for people with impaired liver and endocrine system functions.

Most patients tolerate therapy well. In rare cases, the drug may cause menstrual irregularities or gynemastia due to changes in prolactin levels in women.

In case of an overdose, spasms in the intestinal area, loss of appetite, drowsiness, and an unpleasant taste in the mouth are likely to occur.

Instructions for use of Motilium (Method and dosage)

The instructions for use of Motilium indicate that the dosage regimen may vary depending on whether the tablets or suspension are used in each specific case.

In case of chronic dyspepsia, adults need to take the medicine 10 mg (1 tablet) on an empty stomach 3 times a day. If necessary, you can use the drug before bedtime. For those who use Motilium suspension and tablets, the instructions for use do not recommend exceeding the daily dosage of 80 mg.

Children are given syrup in a dosage of 2.5 ml of medicine per 10 kg of weight. This should be done 3 times a day on an empty stomach. If necessary, take the medicine before bedtime.

Instructions for use of Motilium for children over 1 year of age also indicate that, if necessary, the dose can be increased by 2 times. The maximum dosage per day is 2.4 mg/kg, but not more than 80 mg.

In case of nausea and vomiting, take syrup in a dosage of 20 ml or 2 tablets. This should be done 3-4 times a day on an empty stomach and before bedtime. Daily dosage – no more than 80 mg.

Suspension for children is given at the rate of 5 ml of product per 10 kg of weight. The medicine is taken 3-4 times a day on an empty stomach and before bedtime. The maximum daily dosage is 2.4 mg/kg, but not more than 80 mg.

Tablets can only be given to adults and children weighing over 35 kg. If your body weight is less, you need to use the so-called children's Motilium in the form of syrup.

Before use, the bottle of suspension must be shaken well. To open it, you need to press on the plastic cover and turn it. Next, remove the cap containing the Motilium suspension; the instructions for use indicate that it should only be drawn up using a special pipette that comes with the drug.

Motillion Pharmland tablets 10 mg No. 10x3

Name

Motillion Pharmland 10mg No. 30

Description

The tablets are yellow, round, flat-cylindrical, chamfered, with a score on one side.

Main active ingredient

Domperidone

Release form

pills

Dosage

10 mg

Pharmacodynamics

Domperidone? dopamine antagonist with antiemetic properties. Domperidone does not penetrate the blood-brain barrier (BBB) ​​well. The use of domperidone is very rarely accompanied by extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin from the pituitary gland. The antiemetic effect is possibly due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone, located outside the BBB in the area postrema. Animal studies, as well as low concentrations of domperidone found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors. When taken orally in humans, domperidone increases lower esophageal sphincter pressure, improves antroduodenal motility, and accelerates gastric emptying. Domperidone has no effect on gastric secretion.

Pharmacokinetics

Domperidone is rapidly absorbed after oral administration on an empty stomach, with maximum plasma concentrations (Cmax) achieved within 30? 60 min. The low absolute bioavailability of domperidone when taken orally (approximately 15%) is associated with extensive first-pass metabolism in the intestinal wall and liver. Although the bioavailability of domperidone in healthy people increases when taken after meals, patients with gastrointestinal complaints should take domperidone 15 times a day. 30 minutes before meals. A decrease in gastric acidity leads to a decrease in the absorption of domperidone. Oral bioavailability is reduced by prior administration of cimetidine and sodium bicarbonate. When taking the drug after a meal, achieving maximum absorption requires more time and area under the curve “concentration of the active substance? time" (AUC) increases slightly. When taken orally, domperidone does not accumulate and does not induce its own metabolism; the maximum plasma concentration of 21 ng/ml 90 minutes after oral administration of the drug at a dose of 30 mg per day was almost the same as the maximum plasma concentration of 18 ng/ml after taking the first dose. Domperidone binds to plasma proteins by 91? 93%. Animal distribution studies using radiolabeled drug showed significant tissue distribution but low concentrations in the brain. Small amounts of the drug crossed the placenta in rats. Domperidone undergoes rapid and extensive metabolism in the liver by hydroxylation and N-dealkylation. In vitro metabolism studies using diagnostic inhibitors have shown that CYP3A4 is the main 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% of the amount excreted in the feces and approximately 1% of the amount excreted in the urine). The half-life from blood plasma after a single oral dose is 7? 9 hours in healthy people, but increases in patients with severe renal failure. In patients with moderate hepatic impairment (Pugh score 7 × 9, Child-Pugh class B), the AUC and Cmax of domperidone are 2.9 and 1.5 times higher than in healthy subjects, respectively. The unbound fraction increases by 25% and the terminal half-life increases from 15 to 23 hours. In patients with mild hepatic impairment, systemic exposure is slightly reduced compared with that in healthy subjects based on AUC and Cmax values, without changes in protein binding or terminal half-life. No studies have been conducted in patients with severe hepatic impairment (see Contraindications section). In patients with severe renal impairment (serum creatinine level > 6 mg/100 ml, i.e. > 0.6 mmol/l) half-life Domperidone increases from 7.4 to 20.8 hours, but plasma drug concentrations are lower than in people with normal renal function. A small amount of unchanged drug (about 1%) is excreted by the kidneys (see section “Dosage and Administration”). Data on pharmacokinetics in children are not available.

Indications for use

Adults and children over 12 years of age: Relief of symptoms of nausea and vomiting.

Directions for use and doses

Motillion Pharmland should be used at the minimum effective dose for the shortest period of time necessary to control nausea and vomiting. It is recommended to take orally before meals. When taken after meals, the absorption of domperidone slows down. It is recommended to take the drug at the time prescribed by the doctor. If a dose is missed, the next dose of the drug must be taken at the usual time. Do not double the dose to make up for a missed dose. The medicine should not be used for more than one week. Adults and children (12 years and older and/or weighing 35 kg or more). One 10 mg tablet 3 times a day. The maximum daily dose is 30 mg. Children (under 12 years of age and/or weighing less than 35 kg). Due to the need for precise dosing, tablets are not suitable for use in children and adolescents weighing less than 35 kg. Impaired liver function Motillion Pharmland is contraindicated in case of moderate and severe impairment of liver function (see section "Contraindications"). Dose adjustment is not required for mild impairment of liver function. Impaired renal function Since the half-life of domperidone increases in severe renal impairment, when repeated use, the frequency of taking Motillion Pharmland should be reduced to 1-2 times a day depending on the severity of the impairment, and a dose reduction may also be required.

Use during pregnancy and lactation

Pregnancy Data on the use of domperidone in pregnant women are limited. Animal studies have shown reproductive toxicity at maternally toxic doses. Motillion Pharmland should be used during pregnancy only in cases where the expected therapeutic benefit to the mother outweighs the risk to the fetus. Breastfeeding period Domperidone is excreted in breast milk. The child receives in breast milk less than 0.1% of the dosage taken by the mother, adjusted for body weight. The possibility of developing side effects, in particular from the heart, cannot be excluded. If it is unavoidable to prescribe domperidone, a decision should be made to stop breastfeeding. Given the benefits of breastfeeding, domperidone therapy should be discontinued. If it is necessary to prescribe domperidone, it is necessary to evaluate the likely benefits of therapy for the woman and the negative consequences of stopping breastfeeding for the child. Caution should be exercised if there are risk factors for QTc prolongation in breastfed infants.

Precautionary measures

Impaired renal function In severe renal impairment, the half-life of domperidone increases. The frequency of taking the drug Motillion Pharmland in case of severe renal failure should be reduced to 1? 2 times a day, depending on the severity of the disorders, a dose reduction may also be required. Cardiovascular Effects Domperidone has been associated with prolongation of the QT interval on the ECG. During post-marketing surveillance, rare cases of QT prolongation and torsades de pointes have been reported in patients taking domperidone. These cases included information on patients with various risk factors, electrolyte abnormalities, and concomitant medications that increase risk factors. Epidemiological studies have shown an increased risk of serious ventricular arrhythmias or sudden cardiac death with domperidone use. Risk factors were: age over 60 years, use of a daily dose of more than 30 mg, simultaneous use of drugs that cause prolongation of the QT interval or are CYP3A4 inhibitors. Domperidone should be used in adults and children at the minimum effective dose. Domperidone is contraindicated in patients with a history of cardiac conduction slowing, especially QTc prolongation; in patients with significant electrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesemia), bradycardia; in patients with heart disease (for example, chronic heart failure) due to an increased risk of ventricular arrhythmia. Electrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia are risk factors for arrhythmia. If symptoms of arrhythmia occur, you should immediately stop taking domperidone and consult a doctor. Concomitant use with strong CYP3A4 inhibitors: Concomitant use with ketoconazole (orally), erythromycin, or other strong CYP3A4 inhibitors known to prolong the QTc interval is contraindicated. Excipients Motillion Pharmland tablets contain lactose. It is not recommended to take this drug in patients with rare hereditary diseases: lactose intolerance, lactase deficiency or glucose/galactose malabsorption.

Interaction with other drugs

Increased risk of QT interval prolongation due to pharmacodynamic and/or pharmacokinetic interactions. The simultaneous use of the following drugs is contraindicated due to prolongation of the QT interval: Class IA antiarrhythmic drugs (for example, disopyramide, hydroquinidine, quinidine); Class IIIA antiarrhythmic drugs (eg, amiodarone, dofetilide, dronedarone, ibutilide, sotalol); Some antipsychotic drugs (eg, haloperidol, pimozide, sertindole); Some antidepressants (eg, citalopram, escitalopram); Certain antibiotics (eg, erythromycin, levofloxacin, moxifloxacin, spiramycin); Some antifungals (eg, pentamidine); Some antimalarials (in particular, halofantrine, lumefantrine); Certain gastrointestinal medications (eg, cisapride, dolasetron, prucalopride); Some antihistamines (eg, mequitazine, mizolastine); Certain drugs used for cancer (eg, toremifene, vandetanib, vincamine); Certain other medications (eg, bepridil, difemanil, methadone) (see Contraindications section). Potent CYP3A4 inhibitors (regardless of their effect on the QT interval), for example: protease inhibitors; systemic antifungal drugs from the azole group; some macrolides (erythromycin, clarithromycin, telithromycin) (see section “Contraindications”). Concomitant use of the following drugs is not recommended: moderate CYP3A4 inhibitors, such as diltiazem, verapamil and some macrolides (see section "Contraindications"). The simultaneous use of the following drugs requires caution: drugs that cause bradycardia and/or hypokalemia; some macrolides that can provoke a prolongation of the QT interval: azithromycin and roxithromycin (clarithromycin is contraindicated because it is a strong CYP3A4 inhibitor). The above list of substances is not exhaustive.

Contraindications

hypersensitivity to domperidone or any of the components of the drug; prolactin-secreting tumor of the pituitary gland (prolactinoma); gastrointestinal bleeding, mechanical obstruction or perforation, in which stimulation of gastric motility may be dangerous; simultaneous use with drugs that cause prolongation of the QT interval; simultaneous use with strong CYP3A4 inhibitors (regardless of their effect on the QT interval); patients with moderate to severe liver dysfunction; cardiac conduction disturbances, especially prolongation of the QT interval, as well as significant electrolyte imbalances or the presence of heart disease, such as chronic heart failure.

Compound

Each tablet contains: Active substance: domperidone 10 mg. Excipients: lactose monohydrate, corn starch, povidone, tartrazine Supra (E 102), talc, magnesium stearate, colloidal anhydrous silicon dioxide.

Overdose

Symptoms Overdose has been reported primarily in infants and children. Symptoms of overdose may include agitation, altered consciousness, convulsions, disorientation, drowsiness and extrapyramidal disturbances. Treatment: There is no specific antidote for domperidone. In case of overdose, immediate standard symptomatic therapy is necessary. Due to the possible prolongation of the QT interval, ECG monitoring is necessary. To eliminate extrapyramidal disorders, it is possible to use anticholinergics and/or antiparkinsonian drugs.

Side effect

The following side effects were distributed according to frequency of occurrence as follows: very often (>1/10), often (>1/100, 1/1000, 1/10000,

Storage conditions

Store in a place protected from light at a temperature not exceeding 25°C.

Overdose

Overdose symptoms: drowsiness , extrapyramidal reactions , disorientation .

special antidote . In case of overdose, it is advisable to rinse the patient’s stomach and give activated carbon . It is necessary to monitor the patient's condition and carry out supportive measures.

In case of extrapyramidal reactions, anticholinergic and antihistamine drugs may be effective

Interaction

Anticholinergics may block the action of Motilium. Antifungal drugs of the azole group, HIV protease inhibitors and antibiotics belonging to the macrolide group can inhibit the biotransformation of domperidone and increase its content in the blood plasma , so this combination should be prescribed with caution.

The simultaneous use of Motilium and Ketoconazole in oral form, as well as Erythromycin and strong inhibitors of the CYP3A4 isoenzyme , which cause prolongation of the QT interval .

Special instructions for the use of the drug Motilium

When taken in combination with antacids or antisecretory drugs, it should be taken after meals and not at the same time. Motilium should not be prescribed to patients with lactose intolerance, galactosemia and glucose malabsorption. In case of liver diseases , prescribe with caution due to the high level of metabolism of the drug in the liver. For kidney diseases in patients with severe renal failure, when Motilium is re-administered, the frequency of administration is reduced to 1-2 times a day, depending on the severity of the condition. During long-term therapy, the patient must remain under constant supervision. During pregnancy and breastfeeding. Motilium should be prescribed only when the expectation of a therapeutic effect is justified and the risk is eliminated. During breastfeeding, the use of Motilium is not recommended. In therapeutic doses, Motilium does not affect the ability to drive vehicles or operate machinery.

Analogues of Motilium

Level 4 ATX code matches:
Passazhix

Motinorm

Domrid

Itomed

Metoclopramide

Domperidone

Motilak

Ganaton

Cerucal

The following analogues of Motilium are known:

• Domrid;
• Brulium Lingvatabs;
• Motinol;
• Gastropom-Apo;
• Motinorm;
• Domidon;
• Domperidone Hexal;
• Domperidone Sandoz;
• Domperidone-Credopharm;
• Domperidone-Ostoma;
• Domrid Sr;
• Motilak;
• Motoricum;
• Peridonium;
• Nausilium;
• Motorix;
• Peridon;
• Perilium.

Some analogues are cheaper than Motilium. These include, for example, Nausilium , Motorix , Motinorm , Domrid , Domidon .

Before taking Motilium analogues, you need to carefully study the instructions. Some of them are not suitable for children.

What is better - Motilium or Motilak?

find out which is better Motilium or Motilak only by experience. The active ingredient of both drugs is domperidone . Motilium is available in tablets and suspension form, while Motilak is available only in tablet form. The composition of the auxiliary components of the drugs is different, so if you have an individual intolerance to any of them, only one drug will do.

Both drugs normalize and prolong gastrointestinal motility , relieve vomiting and nausea. In addition, they help eliminate heartburn , flatulence and belching .

The difference between them is also the cost. Motilium costs 2-3 times more than Motilak . People who have taken both drugs claim that there is no qualitative difference between them.

During pregnancy (and lactation)

data on the effect of the drug during pregnancy . There is no information about the risk to the fetus. However, it is advisable to allow the drug during pregnancy only if the benefit of treatment is greater than the potential threat to the fetus.

When breastfeeding, the concentration of the active substance of the drug is 10-50% of its level in the blood . It is not known whether the drug has negative effects on newborns. Taking the drug is also possible only if the benefit to the mother is greater than the possible risk to the baby.

Interactions of the drug Motilium

Anticholinergic drugs may counteract the effects of Motilium. Antacid and antisecretory drugs, when taken simultaneously with Motilium, reduce its bioavailability. When used simultaneously with ketoconazole (a cytochrome P450 inhibitor), which inhibits the primary metabolism of domperidone, there is a 3-fold increase in the maximum concentration of domperidone and an increase in AUC in the plateau phase. As a result, it is not recommended to prescribe azole drugs, macrolides, HIV protease inhibitors, and nefazodone simultaneously with domperidone. Also, when used with ketoconazole, an increase in the QT by 10-20 ms may be observed. Digoxin and paracetamol, when used simultaneously with domperidone, do not affect the level of these drugs. Motilium mezhet combines with: • neuroleptics, enhances their effect. • dopamine agonists (levodopa, bromocriptine).

Reviews about Motilium

Reviews of Motilium characterize the drug as a highly effective, fast-acting remedy. It is very popular among consumers. Reviews of Motilium for children are also mostly positive. This remedy is often recommended by pediatricians, but not for infants. In the latter case, the effect of the drug has not been studied. In addition, the medicine is rarely used by nursing mothers, since its harm to lactation has not been studied.

Among the negative aspects, those who took Motilium note only a slightly inflated cost.

Motilium price, where to buy

The price of Motilium suspension is on average 540 rubles. This form of release is mainly used for children. The average price of Motilium in lozenges is 530 rubles. You can buy the product in this form of release in many pharmacies; as a rule, it is purchased for adults. In addition, coated tablets are popular. The price of Motilium in this form of release is 620 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

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