PERIDON ® Domperidone

PERIDON ® 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 PERIDON ® Domperidone

PERIDON ® is used to relieve the patient of symptoms such as nausea, vomiting, epigastric swelling, abdominal pain and gastro-intestinal regurgitation.

In pediatric age PERIDON ® can be used successfully in the treatment of nausea and vomiting.

Mechanism of action PERIDON ® Domperidone

PERIDON ® is one of the most widely used drugs in the treatment of nausea and vomiting, thanks to its marked anti-emetic properties. Its therapeutic action is to be found both in the antagonistic action against dopamine receptors expressed at the gastro-intestinal level, and in a central action in the post-recreate area of the blood-brain barrier.

Pharmacodynamic studies, however, have shown, as the main effect of domperidone is the peripheral one, useful for guaranteeing inter alia an improvement in intestinal tonicity as well as an effective progression in the near-distal sense of the intestinal content, reducing also the episodes of gastric reflux.

The formulation in coated or effervescent tablets, makes it particularly easy to take this medicine, which quickly absorbed at the level of the gastro-intestinal tract, reaches the maximum plasma concentration in 30/60 minutes, while those in suppositories allow a more rapid effect and better absorption.

Following an extensive hepatic metabolism and a half-life around 8 hours, the active principle is eliminated mainly through the faeces.

Studies carried out and clinical efficacy

1. DOMPERIDONE AND DISPEPSIA

Treatment with domperidone has been shown to be particularly useful in reducing epigastric pain, abdominal distension and the feeling of nausea in patients with functional dyspepsia, without the appearance of clinically relevant side effects.

2. DOMPERIDONE IN CLINICAL PRACTICE

The excellent therapeutic efficacy of domperidone, as a dopamine receptor antagonist, has guaranteed the possibility of using this active ingredient in the treatment of various symptoms such as nausea, vomiting, abdominal pain, abdominal distension and diabetic gastropathy, being able to be used effectively also in place of metoclopramide.

3. THE INFFICACY OF THE DOMPERIDONE IN THE TREATMENT OF NEONATAL REFLUX

Gastroesophageal reflux is a particularly noticeable condition in newborns, probably associated with an esophageal sphincter hypotonia. Contrary to what was expected, the use of pro-kinetics was not useful in reducing these episodes, indeed it led to a paradoxical increase in reflux episodes probably related to an increase in peristaltic incoordination.

Method of use and dosage

PERIDON ® 10mg domperidone-coated tablets, or effervescent granules for domperidone 1mg / ml oral suspension, domperidone suppositories for adults, domperidone suppositories for children, 30 mg domperidone:

the therapeutic treatment should start under strict medical supervision, with the dosage of one or two tablets or sachets 3 or 4 times a day or a suppository once or twice a day, and continue for 4 weeks, at the end of which, it would be appropriate consult your doctor.

For pediatric patients, strict medical supervision is recommended, with significantly lower doses than the adult.

It would be preferable to take the drug before meals in order to optimize the absorption of the active ingredient.

Always consult your doctor before taking PERIDON ®

Warnings PERIDON ® Domperidone

Known for the impressive hepatic metabolism that domperidone faces, it would be advisable to avoid or pay particular attention to the administration of PERIDON ® in patients with reduced liver function.

The same care should be maintained even in patients with reduced kidney function.

The correct formulation of the dosage, a medical task, is particularly important in order to avoid overdose reactions, responsible for neurological symptoms and extrapyramidal manifestations, which are particularly frequent in children.

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

During pregnancy and lactation it is important to ask your doctor or pharmacist for advice before taking any medicine.

Peridon should be used during pregnancy only if this is justified by the expected therapeutic benefits.

Breastfeeding

Domperidone is excreted in human milk and breast-fed children receive less than 0.1% of the adjusted dose based on maternal weight. The occurrence of adverse effects, in particular of cardiac effects, cannot be excluded after exposure through breast milk. In this case, it is necessary to decide whether to stop breastfeeding or to stop / suspend domperidone therapy by evaluating the benefits of breastfeeding for the baby and the benefits of therapy for the mother. Caution should be exercised with risk factors that prolong the QTc interval in breast-fed infants.

Interactions

Given the widespread hepatic metabolism of domperidone, supported by the CYP3A4 cytochromial enzymes, the concomitant intake of inhibitors of this enzyme such as ketoconazole and erythromycin, could alter the pharmacokinetic and pharmacodynamic properties of the active ingredient, making both the therapeutic effect and the potential effects unpredictable side.

Contraindications PERIDON ® Domperidone

PERIDON ® 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.

This medicine is also contraindicated in case of known hypersensitivity to domperidone or one of its excipients.

Undesirable effects - Side effects

Clinical studies and post-marketing monitoring have shown a good tolerability of the drug. Gastro-intestinal, immunological or neurological disorders were rare, while more frequent, especially in predisposed patients, was the appearance of hyperprolactinemia, which in any case tends to resolve spontaneously and completely once therapy is suspended.