Adults

Relief of symptoms of type, nausea and vomiting, sensation of distension, epigastric, upper abdominal discomfort or gastric regurgitation

ANSM alert of 10/03/2014

The PRAC concludes that the balance of benefits and risks remains favorable in children and adults with the proviso of restricting indication to treatment and symptomatic of nausea and vomiting.

ANSM alert of 01/09/14

The benefit-risk ratio of domperidone for the relief of symptoms of nausea and vomiting remains positive in adults, adolescents and children

It is recommended to take this medication before meals If the medication is taken after meals its absorption is somewhat delayed
The initial duration of treatment is four weeks. Patients should be examined, again after four weeks and the need for further treatment will be assessed.


1 tablet at 20 mg, three or four times daily, the maximum daily dose being 80 mg.
The orodispersible tablet is a tablet that quickly disintegrates in the mouth through saliva and can be swallowed without water.
As a general rule, let the tablet melt in the mouth without chewing it, if necessary, drink a glass of water after taking the tablet.
The orodispersible tablet may also be dispersed in half a glass of water by stirring immediately prior to administration.
The compressed form is not suitable for children weighing less than 35 kg.

Children will be treated, preferably with a suspension form, drinkable.

ANSM alert of 20/02/2014

Pending the recommendations of the PRAC expected for March 2014, the ANSM recommends

- to reconsider the usefulness of any new prescription

- to strictly observe the indications and to take into account the cardiac risk (including QT prolongation) in particular in patients with risk factors, - to limit the prescription to the duration , The shortest (usually 7 days maximum), and the lowest dose possible, but not more than 30 mg / day in adults The risk may be higher in patients older than 60 Years or in those treated with higher daily doses 30 mg
Alert ANSM of 10/03/2014 Concerning the dosage, the PRAC recommends, For the oral forms, Children or adolescents of less than 35, kg: 0.25 mg / kg per catch up to 3 times per day.

ANSM alert of 01/09/14

Orodispersible tablet, white, to substantially white, round, biconvex.

Class: Pharmacotherapeutic: STIMULANTS OF MOTRICITY, INTESTINAL

ATC code: A03FA03

Domperidone is an antagonist of dopamine with anti-emetic properties that does not readily cross the blood-brain barrier.



This medicinal product does not alter (or neglect) the ability to drive or use machines.

This drug is contraindicated in the following cases

· Known hypersensitivity to domperidone or to any of the excipients

· Pituitary tumor with prolactinoma (prolactinoma).

This drug should not be used when the stimulation of gastric motricity may prove harmful: gastrointestinal haemorrhage, obstruction, mechanical or digestive perforation

ANSM alert of 01/09/14

Medicines that contain domperidone are now contraindicated in patients with hepatic impairment, moderate or severe in cases of conditions that may lengthen or may affect cardiac conduction in patients with heart disease. Underlying conditions such as congestive heart failure, concomitant use of drugs that prolong the QT interval, or potent inhibitors of cytochrome P450 3A4.
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This medicine contains "sulfite" and may cause severe allergic reactions and bronchospasm.


The total amount of domperidone excreted in human milk is estimated to be less than 7 μg per day at the maximum recommended dosage. Toxicity to newborns is unknown.

As a result, BIPERIDYSFLASH should not be used during breastfeeding.

Use in the case of liver problems

Because Domperidone is highly metabolized in the liver, BIPERIDYSFLASH should not be used in patients with liver problems.
Renal insufficiency

In patients with severe renal impairment (creatinine, serum> 6 mg / 100 ml, ie> 0.6 mmol / l), the elimination half-life of domperidone Was increased by 7.4 to 20.8 hours, but plasma concentrations of active product were lower than in healthy volunteers

Since the kidneys excrete a very small amount of undegraded active product, it is unlikely that, in a single administration, the dose should be adjusted in patients suffering from renal insufficiency, In the case of repeated administration, the frequency of doses should be reduced to one or two doses per day, depending on the degree of renal insufficiency, and the dose may have to be decreased. Br>

Patients with renal impairment under prolonged treatment should be monitored regularly.

Effects, cardiovascular

Epidemiological studies have shown that the use of domperidone may be associated with an increased risk of arrhythmias, severe ventricular arrhythmias, or sudden cardiac death (see Undesirable effects). The risk may be higher in patients aged over 60 years or in those treated with daily doses greater than 30 mg. Domperidone should be used at the lowest effective dose in adults and children

It is recommended to use with caution domperidone and other medicines prolonging the QTc interval in patients with longer cardiac conduction intervals, especially the QTc interval, and patients with electrolyte disorders Or underlying cardiac diseases such as congestive heart failure.


Concomitant use of oral ketoconazole, oral erythromycin or other potent CYP3A4 inhibitors that increase length and the QTc interval should be avoided (see section 4.3 Interaction with other medicinal products and other forms of anti- Interactions with other drugs and other forms of interactions)

The main metabolic pathway of domperidone involves CYP3A4. In vitro data suggest that concomitant administration of drugs that significantly inhibit CYP3A4 may result in increased plasma concentrations of domperidone.

Different studies of pharmacokinetic / pharmacodynamic in vivo interactions with oral ketoconazole or oral erythromycin in healthy subjects confirmed strong inhibition of domperidone-dependent first-pass metabolism CYP3A4; By these substances

Combining domperidone 10 mg orally four times daily with ketoconazole 200 mg twice a day, an average QTc prolongation of 9.8 ms was observed during the observation period, with ad hoc fluctuations From 1.2 to 17.5 ms. Combining domperidone 10 mg four times daily with erythromycin 500 mg three times daily, the mean QTc interval during the observation period was prolonged by 9.9 ms with spot changes ranging from 1.6 to 14.3 ms. In each of these interaction studies, C max and AUC of domperidone at steady state were approximately multiplied by three. In these studies, domperidone 10 mg administered orally as monotherapy four times a day resulted in an increase in mean QTc of 1.6 ms (ketoconazole study) and 2.5 ms (study erythromycin), while Ketoconazole monotherapy (200 mg twice daily) and erythromycin monotherapy (500 mg three times daily) resulted in an increase in QTc of 3.8 and 4.9 ms, respectively, Observation.
Without object.

Symptoms

Cases of overdosage have been reported mainly in infants and children. Symptoms of overdose may include: agitation, disturbances of consciousness, convulsions, disorientation, somnolence and effects, extrapyramidal.
Processing

There is no specific antidote to domperidone, but in case of overdosage, gastric lavage and administration of activated carbon may be helpful. Close medical surveillance and symptomatic treatment are recommended.



The drug is excreted in the breast milk of lactating rats (mostly in the form of metabolites: maximum concentrations of 40 or 800 ng / ml after oral or intravenous administration of 2.5 mg / Kg). The concentrations of domperidone in the breast milk of breastfeeding women represent 10-50% of the corresponding plasma concentrations and should not exceed 10 ng / ml. The total amount of domperidone excreted in human milk is estimated to be less than 7 μg per day at the maximum recommended dosage. Toxicity to newborns is unknown. It is therefore recommended to mothers taking this medication not to breastfeed their children.

The undesirable effects are classified according to their frequency according to the following convention: very common (> 1/10), frequent (> 1/100, 1/1000, 1 / 100,000