MOTILIUM PILLS 10MG

Active ingredient and dosage form

Motilium coated tablets from white to pale cream color, round, biconvex, with the words "Janssen" on one side and "M / 10" on the other; on a break - white.
1 pill contains Domperidone 10 mg;
Excipients: lactose, corn starch, microcrystalline cellulose, pregelatinized potato starch, polyvidone, Magnesium stearate, vegetable oil, hydrogenated, sodium lauryl sulfate, hypromellose;
10 or 30 pieces in blister, 1 blister in a carton box.

Motilium lingual tablets white or almost white, round, instant.
1 pill contains domperidone 10 mg;
Excipients: gelatin, mannitol, aspartame, mint flavor.
10 pieces. in blisters, 1 or 3 blisters in a carton box.

Motilium oral suspension uniform, white color.
5 ml of the suspension contain domperidone 5 mg;
Excipients: sodium saccharinate, microcrystalline cellulose, sodium carboxymethylcellulose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, polysorbate, purified water.
100 or 200 ml in bottles, 1 bottle complete with a graduated pipette for 5 ml or a measuring cap for 10 ml in a carton box.

Mechanism of action

Motilium - an antiemetic drug, a motility stimulator of the gastrointestinal tract. Domperidone is a dopamine antagonist that, like Metoclopramide and some antipsychotics, has antiemetic properties. However, unlike these drugs domperidone poorly penetrates through the BBB. Domperidone use is rarely accompanied by extrapyramidal side effects, especially in adults, but domperidone stimulates the secretion of prolactin from the pituitary gland. The antiemetic effect is probably due to a combination of peripheral (gastrokinetic) action and antagonism of dopamine receptors in the trigger zone of chemoreceptors.
When administered 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 was slowed down, and increases the pressure of the sphincter of the lower esophagus in healthy people.
Domperidone has no effect on gastric secretion.

Indications and usage

- complex dyspeptic symptoms, often associated with delayed gastric emptying, gastroesophageal reflux, esophagitis (feeling of fullness in the epigastrium, 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 disorder;
- 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 disorders of gastric motility in children.

Contraindications

- Gastrointestinal bleeding;
- mechanical obstruction or perforation, in which the stimulation of the motor function of the stomach can be dangerous;
- prolactin-secreting pituitary tumor (prolactinoma).
- simultaneous administration of oral forms of Ketoconazole;
- hypersensitivity to the drug.

Adverse reactions

Gastrointestinal: rarely - gastrointestinal disorders; in isolated cases - transient spasms of the intestine.
From the side of the central nervous system: extrapyramidal symptoms (very rarely - in children; in isolated cases - in adults); completely reversible and disappear after cessation of treatment. With insufficient development of the BBB (for example, in children under 1 year of age) or the violation of its functions, the possibility of neurological side effects cannot be completely ruled out.
On the part of the endocrine system: possible hyperprolactinemia, rarely leading to galactorrhea, gynecomastia, amenorrhea.
Allergic reactions: rarely rash, urticaria.

Pregnancy and breastfeeding

Data on the use of Motilium in pregnancy is not enough.
To date, there is no evidence of increased risk of malformations in humans.However, the use of Motilium in pregnancy (especially in the first trimester) is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
In women, the concentration of domperidone in breast milk is 10-50% of the corresponding plasma concentration and does not exceed 10 ng / ml. The total amount of domperidone excreted into breast milk is less than 7 mcg / day when the maximum permissible dose is applied. It is not known whether this level has a negative effect on newborns. Therefore, if it is necessary to use Motilium in the period of lactation, breastfeeding is recommended to be discontinued unless the expected benefit outweighs the potential risk.

Special notes

In the combined use of Motilium with antacid or antisecretory drugs, the latter should be taken after a meal, i.e. they should not be taken at the same time as Motilium.
With caution should appoint Motilium patients with liver failure, given the high degree of metabolism of domperidone in the liver.
With prolonged therapy, patients should be under regular observation.
Use in pediatrics
Due to the fact that the metabolic processes and function of the BBB in the first months of life are not fully developed, infants should be prescribed any drug very carefully and under careful medical supervision. Sincetypical for Motilium lack of influence on the CNS is mainly the result of poorly pronounced penetration through the BBB, the occurrence of neurological symptoms cannot be completely excluded children under 1 year. Overdose can cause neurological side effects in children.
Influence on ability to drive motor transport and control mechanisms
Motilium does not affect the ability to drive and work with mechanisms.

Drug Interactions

Anticholinergic drugs can neutralize Motilium's anti-dyspeptic effect.
The bioavailability of Motilium when administered orally is reduced after previous administration of cimetidine or sodium bicarbonate. Do not take antacid and antisecretory drugs simultaneously with Motilium, because they reduce its bioavailability.
The main pathway of metabolic transformations of domperidone occurs with the participation of the isoenzyme 3A4 of the cytochrome P system450. On the basis of in vitro studies, it can be assumed that with simultaneous use of domperidone and drugs that significantly inhibit this isoenzyme, plasma domperidone levels may increase. Examples of inhibitors of CYP3A4 isoenzyme are the following drugs: antifungal drugs of the azole series, macrolide antibiotics, HIV protease inhibitors, nefazodone.
When conducting a study on healthy volunteers, the interaction of domperidone with ketoconazole revealed that ketoconazole inhibits CYP3A4-dependent primary metabolism of domperidone,resulting in an approximately threefold increase in Cmax and AUC of domperidone in the plateau phase. In the study of the interaction of domperidone and ketoconazole, it was shown that when domperidone is used together at a dose of 10 mg 4 times / day and ketoconazole at a dose of 200 mg 2 times / day, the QT interval is extended by 10–20 ms. When monotherapy with domperidone in similar doses, and when taking a daily dose of 160 mg (which is 2 times the maximum permissible daily dose), no clinically significant changes in the QT interval were noted.
Theoretically (since the drug has a gastrokinetic effect) Motilium could affect the absorption of concurrently used drugs, in particular, drugs with a slow release of the active substance, or enteric-coated preparations. However, the use of domperidone in patients with Paracetamol or selected therapy with Digoxin did not affect the level of these drugs in the blood.
Motilium can also be combined with neuroleptics, the effect of which it does not enhance; dopaminergic receptor agonists (bromocriptine, levodopa), the undesirable peripheral effects of which, such as digestive disorders, nausea, vomiting, it suppresses without neutralizing their main properties.

The drug should be stored out of reach of children at a temperature of 15 ° to 30 ° C.