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 BIPERIDYS before meals. If medication is taken after meals, absorption is somewhat delayed The initial duration of treatment is four weeks. Adults and adolescents (over 12 years and over 35 kg) ½ to 1 tablet of 20 mg, Three or four times daily maximum daily dose 80 mg The tablet form is not suitable for children weighing less than 35 kg Children will be treated preferentially with a form of oral suspension

ANSM alert of 20/02/2014

Pending the recommendations of the PRAC expected for March 2014, 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) especially in patients with risk factors, - to limit the prescription to the duration (Usually not more than 7 days) and at the lowest dose possible, but not more than 30 mg / day in adults The risk may be higher in patients 60 years or in those treated with; daily doses above 30 mg.

Alert ANSM of 10/03/2014 Concerning dosage, PRAC recommends For oral forms Children or adolescents less than 35 kg: 0.25 mg / kg per dose up to 3 times per day

ANSM alert of 01/09/14

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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The film-coated tablets contain lactose and may be unsuitable in patients suffering from lactose intolerance, galactosemia or malabsorption of glucose or galactose.
This medicinal product contains castor oil and may cause gastrointestinal disturbances (mild laxative effect, diarrhea).

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. Therefore, BIPERIDYS should not be used during breastfeeding

Use in the case of liver problems

Because Domperidone is highly metabolised in the liver, BIPERIDYS should not be used in patients with hepatic impairment

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 has been lengthened From 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 non-degraded 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. Patients with renal failure on 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.

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.

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.

1/10), frequent (> 1/100, 1/1000, 1 / 100,000