Motilium is a centrally acting antiemetic that blocks dopamine receptors.
Release form and composition
- Film-coated tablets: round, biconvex, from pure white to pale cream color, on one side is “JANSSEN”, on the other is “M / 10” (10 or 30 pieces in a blister, in a cardboard box 1 blister );
- Suspension for oral administration: a uniform consistency, white (100 ml in dark glass bottles, in a cardboard bundle one bottle complete with a dosing syringe).
Active ingredient - dromperidone: in 1 tablet - 10 mg, in 1 ml of suspension - 1 mg.
Additional components of tablets:
- Excipients: hydrogenated cottonseed oil, pregelatinized starch, microcrystalline cellulose, polyvidone (K-90), corn starch, sodium lauryl sulfate, lactose monohydrate, magnesium stearate;
- The composition of the film shell: sodium lauryl sulfate, hypromellose 2910 5 MPa × s, purified water.
Additional components of the suspension: sorbitol liquid noncrystallized 70%, propyl parahydroxybenzoate, polysorbate 20, sodium saccharinate, sodium hydroxide, methyl parahydroxybenzoate, microcrystalline cellulose and carmellose sodium, water.
Indications for use
Motilium is used for a complex of dyspeptic symptoms, often associated with gastroesophageal reflux, esophagitis, and delayed gastric emptying:
- Early satiety, pain in the upper abdomen, feeling of fullness in the epigastrium, feeling of bloating;
- Nausea, vomiting;
- Flatulence, belching;
- Heartburn and belching, including with gastric contents.
In addition, Motilium is used for nausea and vomiting caused by a violation of the diet or drug therapy, as well as infectious, organic or functional origin.
The specific indication for use of Motilium is nausea and vomiting caused by taking dopamine agonists (such as bromocriptine and levodopa) in Parkinson's disease.
- Prolactinoma (prolactin-secreting pituitary tumor);
- Liver dysfunction of moderate and severe;
- Conditions in which the stimulation of the motor function of the stomach is contraindicated, for example, mechanical obstruction, perforation, gastrointestinal bleeding;
- The simultaneous use of oral forms of erythromycin, ketoconazole and other strong inhibitors of the isoenzyme CYP3A4, causing a prolongation of the QT interval, such as clarithromycin, voriconazole, amiodarone fluconazole, and telithromycin;
- Lactose intolerance, galactosemia, impaired glucose / galactose absorption for tablets;
- Body weight in children less than 35 kg - for tablets;
- Hypersensitivity to the components of Motilium.
Relative (care should be taken because of the risk of complications):
- Violation of conductivity and heart rate, including prolongation of the QT interval;
- Impaired renal function;
- Congestive heart failure;
- Electrolyte imbalance.
Dosing and Administration
Motilium should be taken orally, preferably before meals, because food slows down the absorption of domperidone.
- Adults and teenagers over 12 years old: 1-2 tablets 3-4 times a day (no more than 8 tablets / day);
- Children weighing more than 35 kg: 1 tablet 3-4 times a day. If the desired effect is absent, the dose is increased, but not more than 80 mg of domperidone per day.
- Adults, adolescents over 12 years old and children weighing more than 35 kg: 10-20 ml 3-4 times a day, but not more than 80 ml;
- Infants and children up to 12 years: 0.25-0.5 ml per kilogram of body weight 3-4 times a day. The maximum permissible daily dose of 2.4 ml / kg, but not more than 80 mg. For convenience of dosing, a scale with marks of the child’s mass is applied from 0 to 20 kg.
Without the recommendation of a doctor to continuously take the drug can be no more than 28 days.
Immediately before taking the bottle should be gently shaken, well mixing its contents.
Rules for the use of suspensions:
- Pressing on top of the plastic cover, turn it counterclockwise and remove;
- Place the syringe in the vial;
- Holding the lower ring in place, lift the upper ring to the mark corresponding to the child's weight (in kilograms);
- Holding the bottom ring, remove the filled syringe from the vial;
- Close the vial;
- After taking the drug, flush the syringe with water.
Basically Motilium well tolerated. In rare cases, the following side effects occur:
- Digestive system: gastrointestinal disorders, impaired liver function tests, transient intestinal spasms;
- Nervous system: convulsions, headache, drowsiness, extrapyramidal effects (in children - rarely, in adults - in isolated cases; completely reversible, disappear independently after discontinuation of the drug);
- Mind: nervousness, agitation;
- Immune system: allergic and anaphylactic reactions;
- Endocrine system: an increase in the level of prolactin in the blood plasma, in some cases contributing to the appearance of neuro-endocrine phenomena (amenorrhea, gynecomastia, galactorrhea);
- Skin: itching, rash.
Patients with renal insufficiency do not need a dose adjustment, however, with repeated use of Motilium, the frequency of administration should be reduced to 1-2 times a day. In some cases, a decrease in a single / daily dose is also indicated. If you need long-term treatment, you need to constantly monitor the condition of the patient.
In rare cases, the drug can cause neurological side effects in children. For this reason, it is important to adhere to the recommended dose.
In the case of simultaneous administration of antisecretory or antacid agents, they should be taken after meals.
Motilium does not adversely affect the attention and speed of reactions.
The bioavailability of Motilium, taken internally, is reduced in the case of previous intake of sodium bicarbonate or cimetidine.
At the same time do not take antisecretory and antacid drugs, because they reduce the bioavailability of domperidone.
Anticholinergic drugs can level the effect of Motilium.
Drugs that significantly inhibit the CYP3A4 isoenzyme, can increase the concentration of domperidone in the blood plasma. These include azole antifungal drugs (ketoconazole *, itraconazole, voriconazole *, fluconazole *), macrolide antibiotics (for example, erythromycin *, clarithromycin *), HIV protease inhibitors (for example, indinavir, fosamprenavir, nolphinavir, and aphrophyxinavir, nalvavir, acupunavir, nalvavir, nyvavir, nirvirvol, fluconazole *); ), calcium antagonists (verapamil, diltiazem), amiodarone *, nefazodone, aprepitant, telithromycin. Marked with an asterisk (*) drugs, in addition, lengthen the interval QTc.
Motilium has a gastrokinetic property; therefore, it is assumed that it can affect the absorption of simultaneously used oral preparations, in particular, coated with an enteric coating, and agents with a slow release of the active substance. However, domperidone use by patients during the period of use of digoxin or paracetamol did not affect the level of these drugs in the blood.
If necessary, Motilium can be used simultaneously with antipsychotic drugs (their effect does not increase), as well as with dopamine receptor agonists (levodopa or bromocriptine) - domperidone suppresses their peripheral effects (nausea, vomiting, digestive disorders), but does not affect the central action.
Terms and conditions of storage
Store at a temperature of 15-30 ° C out of the reach of children.
Shelf life - 5 years.