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Domperidone is to be given only by or under the immediate supervision of your doctor. This product is available in the following dosage forms: Tablet Suspension. Before Using.(7) For this reason, it is considered the drug of choice for increasing milk production when it is.
In 2011, the PhVWP recommended that the product information for domperidone-containing medicines be updated to reflect the risk of these adverse effects and to warn that domperidone should be used with caution in patients with certain heart conditions. View domperidone drug records Follow MIMS on Twitter Sign up for MIMS bulletins.
Domperidone is a dopamine antagonist with anti-emetic properties SCIENCE PHOTO LIBRARY. The advice was issued after a European Medicines Agency (EMA) review of the safety and efficacy of domperidone concluded that there is a small increased risk of serious cardiac adverse drug reactions related to.
Should the CMDh position be adopted by majority vote, the CMDh position will be sent to the European Commission, for the adoption of an EU-wide legally binding decision. Name Language First published Last updated.
In addition, it must not be used with other medicines that have similar effects on the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side effects).
The review of domperidone was carried out at the request of the Belgian medicines authority over concerns about the medicines effects on the heart. The injectable form of domperidone was withdrawn in 1985 because of such side effects.
The EMA review concluded that when used to relieve nausea and vomiting the benefits of domperidone outweigh the risks. The drug should be used at the lowest effective dose for the shortest possible duration (not usually exceeding one week) with a recommended dose in adults.
The review has been carried out by the PRAC, the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations. As domperidone-containing medicines are all authorised nationally, the PRAC recommendation will be forwarded to the Co-ordination Group.
The CMDh is a regulatory body representing EU Member States, and is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU. If the CMDh position is agreed by consensus, the agreement will be directly implemented by the Member States.
These patients may also be given the medicine as suppositories of 30 mg twice daily. Where the medicine is licensed in children and adolescents weighing less than 35 kg, it should be given by mouth at a dose of 0.25 mg per kg bodyweight up to three.
PRAC considered that reducing the recommended dose and duration of treatment was a particular key to minimising the risks with domperidone. The Committee noted that although use was long-established, data supporting the effectiveness of domperidone in children and data supporting the effectiveness of the suppositories.
Measuring devices should be included with liquid formulations to allow accurate dosing by bodyweight. The medicine should not normally be used for longer than one week. Domperidone should no longer be authorised to treat other conditions such as bloating or heartburn.
However, cases of heart problems in patients using the medicine continued to be reported, and the PRAC was therefore asked to examine whether the benefits still outweighed the risks for these medicines in their approved uses, and whether their marketing authorisations should be maintained or.
The MHRA has issued new advice for domperidone which states that it should no longer be used to relieve symptoms of heartburn, bloating or stomach discomfort and should be avoided in people with serious underlying heart conditions.