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Proprietary medicinal products based on metoclopramide, intestinal motility stimulant: PROKINYL

Opinions on drugs - Posted on Feb 01 2016

Reason for request

Renewal of inclusion

Use in adults and children to be restricted to situations where prescription of an antiemetic appears indispensable

  • Metoclopramide, a neuroleptic dopamine antagonist, is indicated in adults for the prevention and/or treatment of nausea and vomiting, including that associated with chemotherapy, radiation therapy, surgery and migraine, depending on the proprietary medicinal product concerned.
  • In children above 1 year old, it is restricted to the second-line treatment of post-operative nausea and vomiting (IV administration only) and the prevention of delayed chemotherapy-induced nausea and vomiting (oral and IV administration only).
  • PRIMPERAN may be prescribed to adults and/or children, depending on the proprietary medicinal product concerned. ANAUSIN METOCLOPRAMIDE and PROKINYL are restricted to adults.
  • In adults, as in children, its efficacy is poorly established in the indications and at the dosage in the current Marketing Authorisation. Its use must not be considered unless the prescription of an antiemetic appears indispensable and it is in strict accordance with its Marketing Authorisation.
  • Metoclopramide can trigger serious adverse effects, mainly of a neurological nature: sometimes irreversible peripheral extrapyramidal symptoms and tardive dyskinesia, particularly in elderly individuals. Serious cardiac adverse effects (ventricular arrhythmia, sudden cardiac death) have also been observed, but the excess risk attributable to metoclopramide cannot be quantified. The probable risk factors that have been identified are the concomitant use of other medicines that also prolong the QTc interval, advanced age and hypokalemia.



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