Motilium - instructions for use, reviews, analogs and formulations (10 mg tablets and 10 mg resorption, suspension or syrup) for the treatment of nausea and vomiting in adults, children and pregnancy
In this article, you can read the instructions for using the drug Motilium. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Motilium in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Motilium in the presence of existing structural analogues. Use to treat nausea and vomiting in adults, children, as well as during pregnancy and lactation.
Motilium - antiemetic, central blocker of dopamine receptors. Domperidone (the active ingredient of Motilium) is a dopamine antagonist with antiemetic properties. Domperidone poorly penetrates the blood-brain barrier. 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. The 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 low drug concentrations found in the brain indicate a central effect of domperidone on dopamine receptors.
When applied inside, Motilium prolongs the duration of antrum and duodenal contractions, increases the pressure in the esophagus and accelerates the emptying of the stomach in healthy people.
Domperidone has no effect on gastric secretion.
Pharmacokinetics
After ingestion on an empty stomach, Motilium is rapidly absorbed from the digestive tract. Although in healthy people the bioavailability of domperidone increases with admission after meals,patients with gastrointestinal complaints should take domperidone 15-30 minutes before meals. Hypoacidity of gastric juice reduces the absorption of domperidone. When ingesting domperidone does not cumulate and does not induce its own metabolism. Excretion in urine and feces is 31% and 66% of the oral dose, respectively. Output unchanged with faeces (10%) and urine (approximately 1%).
Indications
A complex of dyspeptic symptoms, often associated with
delayed emptying of the stomach, gastroesophageal reflux, esophagitis:
- a feeling of overfilling in the epigastrium, early satiety, a sensation of bloating, pain in the upper abdomen;
- eructation, flatulence;
- nausea, vomiting;
- heartburn, belching with or without gastric contents;
- nausea and vomiting of a functional, organic, infectious origin, caused by radiotherapy, drug therapy or a violation of diet. A specific indication is nausea and vomiting caused by dopamine agonists when used in Parkinson's disease (such as levodopa and bromocriptine).
Forms of release
Tablets, film-coated 10 mg.
Tablets for resorption of 10 mg.
Suspension or syrup for oral administration.
Instructions for use and dosing regimen
Pills
It is recommended to take Motilium tablets before meals, in case of reception after eating, absorption of domperidone may slow down.
Adults and adolescents over 12 years of age are prescribed 1-2 tablets 3 or 4 times a day, the maximum daily dose is 80 mg.
Children are prescribed 1 tablet 3-4 times a day. In the absence of the desired effect, this dose can be doubled. The maximum daily dose is 80 mg.
Tablets Motilium are shown only for adults and children with a body weight of over 35 kg, in pediatric practice a suspension of Motilium should be used.
Lozenges
For chronic dyspepsia, adults and children over 5 years of age are prescribed 10 mg (1 tablet) 3 times a day for 15-30 minutes before meals and, if necessary, before bedtime.
The maximum daily dose for children aged 5 to 12 years is 2.4 mg / kg body weight, but not more than 80 mg.
If necessary, in the absence of effect, a single dose can be doubled for adults and children over the age of 12 years. The maximum daily dose is 80 mg.
For nausea and vomiting, adults and children over 12 years of age are prescribed 20 mg (2 tablets) 3-4 times daily before meals and at bedtime.The maximum daily dose is 80 mg.
Children aged 5 to 12 years are prescribed 10 mg (1 tablet) 3-4 times a day before meals and at bedtime. The maximum daily dose is 2.4 mg / kg of body weight, but not more than 80 mg.
Motilium in the form of tablets for resorption is shown only for adults and children with a body weight of more than 35 kg.
Rules for the use of tablets for resorption
Tablets for resorption are available in blister packs. Because the tablets are rather fragile, they should not be pushed through the foil to avoid damage.
In order to get 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 push down and remove the tablet from the package. The tablet should be put on the tongue. Within a few seconds it will break up on the surface of the tongue and it can be swallowed with saliva, without washing down with water.
Suspension or syrup
It is recommended to take the preparation Motilium before meals, in case of reception after eating, absorption of domperidone may slow down.
Adults and adolescents over 12 years of age and weighing more than 35 kg are given 10-20 ml of suspension 3 or 4 times a day, the maximum daily dose is 80 ml.
For children, incl.infants, appoint 0.25-0.5 mg domperidone (0.25-0.5 ml suspension) per 1 kg of body weight 3 or 4 times a day. The maximum daily dose is 2.4 mg per 1 kg of body weight, but not more than 80 mg per day. To determine the dose, use the "0-20 kg" scale of the child's body on the syringe.
Rules for the application of suspension
Before use, the vial with suspension should be shaken. Suspension is supplied in a package protected from accidental opening by children. The bottle should be opened as follows: press on top of the plastic bottle cap, while turning it counter-clockwise; remove the unscrewed cover.
Then put the syringe in the vial. While holding the lower ring in place, raise the upper ring to the mark corresponding to the weight of the child's body (kg). Hold the bottom ring, pull the filled syringe from the vial. Empty the syringe. Close the vial. Rinse the syringe with water.
Side effect
- gastrointestinal disorders;
- transient intestinal spasms;
- convulsions;
- drowsiness;
- headache;
- nervousness;
- anaphylactic reactions, including anaphylactic shock;
- angioedema;
- allergic reactions;
- hives;
- galactorrhea;
- gynecomastia;
- amenorrhea;
- itching;
- rash.
Contraindications
- prolactin-secreting pituitary tumor (prolactinoma);
- simultaneous administration of oral forms of ketoconazole, erythromycin, or other strong inhibitors of the CYP3A4 isoenzyme, elongating the QTc interval, such as fluconazole, voriconazole, clarithromycin, amiodarone and telithromycin;
- gastrointestinal bleeding, mechanical obstruction or perforation of the digestive tract, in which stimulation of gastric motility may be dangerous;
- body weight less than 35 kg;
- established intolerance of the drug and its components.
Application in pregnancy and lactation
Data on the use of Motilium during pregnancy is not enough.
To date, there is no evidence of an increased risk of human developmental malformations. Nevertheless, Motilium should be prescribed during pregnancy only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.
In women, the concentration of domperidone in breast milk is 10 to 50% of the corresponding plasma concentration and does not exceed 10 ng / ml. The total amount of domperidone excreted into breast milk is less than 7 μg per day, with the maximum permissible doses applied.It is not known whether this level has a negative effect on infants. Therefore, when using the drug Motilium during lactation, breastfeeding should be discontinued.
special instructions
When combined with Motilium antatsidnymi or antisecretory drugs, the latter should be taken after meals, and not before meals, i.e. they should not be taken concomitantly with Motilium.
The film-coated tablets contain lactose, so they should not be used in patients with lactose intolerance, galactosemia, and impaired absorption of glucose and galactose.
Given the high degree of metabolism of domperidone in the liver, caution should be given to Motilium in patients with hepatic impairment.
Since a very small percentage of the drug is excreted by the kidneys unchanged, the correction of a single dose in patients with renal insufficiency is not required. However, with a repeated appointment, the frequency of administration should be reduced to 1 or 2 times a day, depending on the severity of the insufficiency, and it may also be necessary to reduce the dose.
With prolonged therapy, patients should be under regular supervision.
Use in Pediatrics
Motilium in rare cases can cause neurologic side effects. Therefore, the recommended dose should be strictly adhered to. Neurological adverse effects may be caused in children by an overdose of the drug, but other possible causes of such effects should be taken into account.
Impact on the ability to drive vehicles and manage mechanisms
Motilium does not have or has a negligible impact on the ability to drive and work with machinery.
Drug Interactions
Anticholinergic drugs can neutralize the effect of Motilium.
Bioavailability of the drug Motilium at ingestion decreases after the previous intake of cimetidine or sodium bicarbonate. Do not take antacid and antisecretory drugs at the same time as domperidone. they reduce its bioavailability after ingestion.
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 simultaneous use of drugs that significantly inhibit this isoenzyme may cause an increase in domperidone concentrations in plasma. Among the strong inhibitors of CYP3A4 are: azole antifungal drugs such as fluconazole, itraconazole, Ketoconazole and voriconazole; antibiotics-macrolides, for example Clarithromycin and erythromycin; HIV protease inhibitors, for example amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir; calcium antagonists, such as diltiazem and verapamil; amiodarone; aprepitant; nefazodone; telithromycin. (Drugs marked with an asterisk, in addition, extend the interval of QTc).
A number of studies of pharmacokinetic and pharmacodynamic interactions of domperidone with oral ketoconazole and oral Erythromycin in healthy volunteers have shown that these drugs significantly inhibit the primary metabolism of domperidone, carried out by the CYP3A4 isoenzyme.
At present, it is not known what contribution to the change in the QTc interval is made by increased concentrations of domperidone in plasma.
Theoretically (t.the drug has a gastrokinetic effect). Motilium could influence the absorption of concomitantly administered drugs, in particular, sustained-release preparations or enteric-coated preparations. However, the use of domperidone in patients with Paracetamol or Digoxin did not affect the level of these drugs in the blood.
Motilium can be taken concomitantly with neuroleptics, the effect of which it does not enhance; dopamine receptor agonists (bromocriptine, levodopa), whose undesirable peripheral effects, such as digestive disorders, nausea, vomiting, suppress, without affecting their central effects.
Analogues of the drug Motilium
Structural analogs for the active substance:
- Damelyum;
- Domet;
- Domperidone;
- Domperidone HEXAL;
- Domperidon-Teva;
- Domstal;
- Motigect;
- Motilac;
- The monotonous;
- Motion;
- The passenger.
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