Motilium is a medicine that increases the movements or contractions of the stomach and bowel. Motilium is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson’s Disease.
30 tablets 10 mg
Mode of action:
Motilium - intestinal motility stimulant, has the same anti-emetic effect. Active ingredient - domperidone. Boasting some of the effects of neuroleptics and metoclopramide, domperidone is a dopamine antagonist. As compared to metoclopramide, and neuroleptic drug is poorly passes through the blood-brain barrier, so it is not accompanied by reception extrapyramidal side effects ( in adults ). However, domperidone increased allocation of pituitary prolactin cells.
Did antiemetic effect is due to a combination of antagonism of dopamine receptors located in the chemoreceptor trigger field and gastrokinetic ( peripheral ) effect. Increases the duration of antral and duodenal contractions when administered, improves gastric emptying. In healthy observed facilitation of escape their stomach solid and liquid fractions in patients persons - mostly solid at slowing the processes of evacuation. In healthy tone increases as the pressure in the lower sphincter of the esophagus. No effect on secretion of gastric juice.
Indications for use:
• dyspeptic phenomena that are associated with gastro- oesophageal reflux, delayed gastric emptying, reflux esophagitis ( bloated feeling, a feeling of fullness in the epigastrium, vomiting, epigastric pain, bloating, belching, nausea, regurgitation and heartburn);
• nausea and vomiting associated with the reception of dopamine agonists in Parkinson's disease (such as bromocriptine and L- dopa );
• nausea and vomiting, infection, organic or functional nature, as well as nausea and vomiting associated with the violation of the diet, radiotherapy or drug treatment;
• Cyclic vomiting syndrome, vomiting, gastro -esophageal reflux and other changes in gastric motility in children.
How to use:
For children weighing 35 kg or more is recommended to prescribe Motilium tablets, coated tablets. Motilium lingual tablets are designed for children over 5 years old and adults. Lingual tablet placed on the tongue, after which it dissolves instantly and swallow it, do not wash it down with water. In pediatric practice for children younger than 5 years old are encouraged to nominate a suspension of Motilium.
Chronic diarrhea state
Children and adults with 10 mg applied for 15-30 minutes before mealtime three times a day. If necessary, you can take the drug at bedtime. Maximum dose - 80 mg / day. For children over 12 years of age and adults can double the dose if needed.
Motilium slurry - applied at the rate of 2.5 ml/10 kg body weight of the child ( that is the dose 250 mg per 1 kg body weight). The dosage can be doubled if necessary only for children older than 1 year. The maximum dose - 2.4 mg per 1 kg of body weight per day, but not higher than 80 mg / day.
For nausea and vomiting
Children over 12 and adults use Motilium 20 mg 3-4 times a day before meals and at bedtime. Maximum dose - 80 mg / day. Children 5-12 years - 10 mg 3-4 times a day before meals and at bedtime. In a slurry recommended to assign a rate of 5 ml per 10 kg of body weight (500 g per 1 kg of weight of the child ) before meals and at bedtime as (3-4 times daily). The maximum dose - 2.4 mg / kg body weight per day child but not more than 80 mg.
In renal insufficiency
In renal insufficiency is necessary to lengthen the intervals between doses of the drug. Correction of a single dose is not required, since only a small portion of the drug is eliminated unchanged by the kidneys. With repeated administration of the drug should be reduced to 1-2 times daily, may also require reduced dosages ( according to the degree of renal function failure ).
Rules for applying slurry:
The suspension is in the package, which is protected against accidental opening of the children. Before using the bottle should be shaken suspension of Motilium. The bottle is opened as follows:
1. A plastic bottle cap to put pressure on the top and at the same time to turn it counter -clockwise.
2. Unscrewed the cap off.
3.Dostat pipette out of the case (located in the box with only 100 ml bottles ).
4. Raise the top ring to the mark, which corresponds to the weight of the child, holding the bottom ring in place.
5. Pull -filled pipette by holding the bottom ring.
6. Rinse the pipette with purified water after use, the empty pipette to put into the case.
7. Bottle close.
Terms of use lingual tablets:
Motilium lingual tablets are available in blister packs. Instant lingual tablets are very fragile, so to maintain their integrity must be careful to push the foil and take them out of the box :
1. Take the edge of the blister foil and remove it from the cell.
2. Gently push on the bottom of the cell and get a pill.
Side effects:
On the part of the endocrine system: amenorrhea, gynecomastia, can hyperprolactinemia, which occasionally leads to galactorrhea.
CNS: rarely possible extrapyramidal disorders in children. They are reversible and are stopped after discontinuation of the drug. In adults, extrapyramidal disorders are extremely rare. In children under 1 year due to lack of blood-brain barrier, or in violation of its functions are possible side effects of neurological.
From the digestive system : disorders of the gastrointestinal tract ( rare), in rare cases, can reduce the transient spastic bowel.
Allergic reactions: urticaria, rash (rare).
Contraindications:
• gastrointestinal perforation or obstruction of mechanical etiology (in these cases, stimulation of the activity of the gastrointestinal tract can be dangerous );
• prolactinoma ( pituitary tumor secreting prolactin );
• gastrointestinal bleeding;
• hypersensitivity to domperidone or other components of Motilium;
• taking on the background of oral ketoconazole in the forms of production.
Pregnancy:
Not enough information about the appointment of the drug for pregnant women. No evidence of provoking malformations in children whose mothers used Motilium. However, the appointment Motilium is recommended only if the prevalence of therapeutic benefit to the mother's exposure to potential risks to the baby ( fetus). Especially not recommended to prescribe a drug to 12 weeks of pregnancy.
Motilium active substance concentration in breast milk of women of 10-50 % of plasma concentration, but not more than 10 ng / ml. When receiving a maximum allowable total dosage amount of domperidone which misses the breastmilk least 7 mg per day. At the moment there is no information whether negatively affect the concentration of domperidone on breast-fed infants. Recommended if needed during lactation reception Motilium, abstain from breast -feeding ( with the exception of the predominance of the expected benefits of the potential risks ).
Interactions with other drugs:
Simultaneously with the drug should not be used antisecretory and antacid sredstvaa because they reduce the absorption of domperidone.
When the domestic use of domperidone bioavailability is reduced if taken before sodium bicarbonate or cimetidine. Protivodispeptichesky Motilium can neutralize the effect of anticholinergics. Most metabolic reactions take place with the participation of domperidone cytochrome P450 ( isoenzyme 3A4). Since domperidone have gastrokinetic action Motilium theoretically possible influence on the absorption of other drugs used simultaneously ( especially tablets, which are coated with enteric-coated or sustained drug release formulations ). In practice, the reception Motilium in patients taking digoxin or paracetamol, did not change the concentration of the active ingredients of these drugs in the blood plasma.
According to in vitro experiments, it can be assumed that the application of domperidone in combination with drugs that inhibit the enzyme largely probably increase of domperidone in the blood plasma. Strong inhibitors isoenzyme CYP3A4: azole antifungals, macrolide antibacterial agents, nefazodone and HIV protease inhibitors. Ketoconazole inhibits the metabolism of primary domperidone associated with CYP3A4 in experiments on healthy volunteers, so the plateau phase is achieved by an increase in Cmax and AUC of domperidone is about 3 times.
It was revealed that the combination of ketoconazole (200 mg 2 times a day) and domperidone (10 mg 4 times daily ) was observed lengthening of the QT interval of about 10-20 ms. Clinically significant changes in the QT interval length detected monotherapy Motilium sredneterapevticheskih in dosages and at all doses greater than 2 times the maximum daily dose (160 mg). Domperidone did not potentiate the effects of neuroleptics, so these combinations are allowed. Motilium suppress side effects of levodopa and bromocriptine ( agonists of dopaminergic receptors) without affecting their therapeutic effects.
Overdose:
There may be disorientation, drowsiness, and extrapyramidal reactions (mainly in pediatric patients ). In the treatment of extrapyramidal disorders may be needed for the treatment of Parkinson's disease and anticholinergics. Treatment of overdose Motilium begin with gastric lavage. The rest - symptomatic therapy.
Product:
Motilium tablets
Tablets biconvex, round with a cover of light cream or white. On one side engraving «Janssen», on the other - «M/10». The break in white. In the blister 10, 30 pieces.
Motilium suspension
White, homogenous suspension in bottles 100, 200 ml. The set comes graded cap a 10-ml measuring pipette 5 ml.
Motilium lingual tablets
Fast dissolving tablets White round. In the blister 10 pieces. In a cardboard box 1 or 3 blisters.
Storage:
When temperature conditions 15-30 ° C of the reach of children. Shelf life lingual tablets - 3 years suspension or tablets - 5 years. Lingual tablets and coated tablets, approved for prescription medicines. The suspension is released only by prescription.
Synonyms:
Motilium, Cilroton, Nauzelin, Euciton, Nauseline, Peridal, risperidone.
Ingredients:
Motilium tablets, coated tablets
Active substance ( 1 tablet ) 10 mg domperidone.
Inactive ingredients: corn starch, lactose, pre- gelatinized potato starch, microcrystalline cellulose, magnesium stearate, Valium, hydrogenated vegetable oil, sodium lauryl sulfate, Valium.
Motilium suspension
Active substance ( 5 ml): 5 mg domperidone.
Inactive ingredients: Propyl, microcrystalline cellulose, sodium carboxymethyl cellulose, sorbitol, sodium saccharin, methyl parahydroxybenzoate, polysorbate, sodium hydroxide, purified water.
Motilium lingual tablets
Active substance ( 1 tablet ) 10 mg domperidone.
Inactive ingredients: aspartame, gelatin, mannitol, mint flavoring.
In addition:
If the drug is being administered with antisecretory or antacid, the last to be taken after meals. Patients with hepatic insufficiency Motilium should be used with caution, as domperidone mostly metabolized in the liver. Those patients who take the drug for a long time, should be under medical supervision.
The children of the first year of life, all medicines, including Motilium, used with caution because of the possible development of neurologic symptoms due to increased penetration of the blood-brain barrier ( adult drug does not cross the blood-brain barrier). If you exceed the dose of the drug in children domperidola provokes a variety of neurological conditions. Domperidone does not have a negative impact when working with machinery and driving a car.
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