MOTILIUM ® Domperidone

MOTILIUM ® is a domperidone drug

THERAPEUTIC GROUP: Drugs for functional gastrointestinal disorders - prokinetics

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications MOTILIUM ® Domperidone

MOTILIUM ® is useful in reducing the feeling of nausea, epigastric filling and discomfort in the upper abdominal tract.

This medicine is also used successfully in the treatment of vomiting and regurgitation of gastric contents.

Mechanism of action MOTILIUM ® Domperidone

Domperidone, contained in MOTILIUM ® and taken orally, is rapidly absorbed from the gastro-intestinal tract, reaching the maximum plasma concentration between 30 and 60 minutes.

The high first-pass metabolism to which this active ingredient meets, leads to a significant reduction in plasma concentrations, which are around 15%. After its action, the metabolite is eliminated for 2/3 through the faeces and for the remainder through the urine.

Its marked anti-emetic action seems to be due both to a central action, guaranteed by the regulating effect on the kinetics of the gastro-intestinal apparatus, and by a central action, modulating the activation of receptors present on the post-extreme area of the blood-brain barrier, probably involved in the genesis of the emetic stimulus.

In humans, however, the antidopaminergic effect seems to prevail over the local district, rather than the central one, guaranteeing an improvement in intestinal tonicity and peristalsis, accelerating gastric emptying, and favoring the progression of the intestinal content in the near-distal sense.

Studies carried out and clinical efficacy

1. DOMPERIDONE IN CONVALESCENCE

Domperidone has been shown to be particularly effective in restoring the correct functionality of the gastro-intestinal tract, following surgery. More precisely, this active ingredient was more effective and decidedly faster than the metaclopramide, usually used in these situations, to support the functionality of the gastro-intestinal muscles.

2. DOMPERIDONE AND GASTROESOFAGEO REFLUX

Among the various symptoms present in asthmatic patients, it is also possible to include gastro-esophageal reflux, which occurs mainly during the night. The concomitant administration of domperidone and omeprazole has proved particularly effective in treating this problem, achieving greater success than monotherapy.

3.DOMPERIDONE AND SECRETION OF MATERNO MILK

It is known that domperidone can act on the pituitary gland increasing the production and relative secretion of prolactin. This secretion was so important that it significantly increased the secretion of milk in women during the lactation phase. However, the nutritional composition of milk has remained almost unchanged.

Method of use and dosage

MOTILIUM ® Domperidone 10mg coated tablets, or effervescent granules for domperidone 1mg / ml oral suspension: the recommended dose is 10 mg (equivalent to one tablet or 1 sachet) to be taken 3 or 4 times a day.

The intake should take place before meals, as the absorption of the active ingredients is strongly inhibited by the presence of food, and does not exceed 4 weeks.

If no positive effects have been recorded during this time, your doctor may decide to prolong the use of this medicine, depending on the patient's clinical condition.

IN ANY CASE, BEFORE TAKING MOTILIUM ® Domperidone - THE REQUIREMENT AND CHECK OF YOUR DOCTOR IS NECESSARY.

Warnings MOTILIUM ® Domperidone

The intake of MOTILIUM ® in patients with reduced liver and kidney function should be carried out with particular care, and under strict medical supervision, given the important hepatic metabolism and renal secretion that domperidone encounters.

The same care should also be reserved for pediatric patients, for whom the incidence of neurological problems is evidently increased.

Effervescent capsules and granulate contain respectively lactose and aspartame, therefore its intake could be associated with serious side effects in patients suffering from lactose intolerance, galactose / glucose malabsorption, lactase enzyme deficiency or in case of increased exposure to hyperphenylalaninemia.

PREGNANCY AND BREASTFEEDING

At the moment there are no particularly significant trials that clarify the safety profile of domperidone when taken during pregnancy, while most of the data relating to experimentation on animal models have shown a potential teratogenic effect on the fetus when taken at high doses. In light of these data, and given the secretion of the active ingredient in breast milk, the use of MOTILIUM ® is not recommended during pregnancy and breastfeeding.

Interactions

It is known that domperidone undergoes an imposing metabolism of first passage at the hepatic level by the cytochromial enzymes CYP3A4, easily modulated by different active principles.

The concomitant intake of inhibitors of this enzyme such as ketoconazole and erythromycin, has been shown to alter the pharmacokinetic and pharmacodynamic properties of domperidone increasing the possible incidence of side effects, especially in the cardiovascular system.

Contraindications MOTILIUM ® Domperidone

MOTILIUM ® is contraindicated in patients in whom the increased motility of the gastro-intestinal tract may be associated with the worsening of their health or in patients with increased prolactin production.

Naturally in case of hypersensitivity to one of its components, the administration of MOTILIUM ® should be avoided.

Undesirable effects - Side effects

Cases of hyperprolactinemia have been observed following the use of MOTILIUM ® often associated with neuro-endocrine disorders such as galactorrhea, gynecomastia and amenorrhea.

More rarely gastro-intestinal disorders, extrapyramidal syndromes, alterations of the cardiovascular system and allergic reactions have been observed.