Additional advice for pharmacists:
Non-prescription availability of Emidon-OM:
Pharmacists are asked to take the following steps when supplying Emidon-OM without prescription:
- Ask questions to exclude supply for people for whom Emidon-OM is contraindicated (see above)
- Advise people to take Emidon-OM only for nausea and vomiting–it should no longer be taken for bloating and heartburn
- Advise people to take the lowest dose for the shortest possible time up to a maximum daily dose of 3 tablets and for a maximum period of 48 hours
Post-publication note, December 2019
Following further European review, Emidon-OM is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg because of a lack of evidence for benefit. Findings from a placebo-controlled study in children with acute gastroenteritis that did not show Emidon-OM to be more effective than placebo at relieving nausea and vomiting. See Drug Safety Update, December 2019.
Article date: May 2014
Emidon-OM is a dopamine antagonist with antiemetic properties.
A European review assessed the benefits and risks of Emidon-OM following continued reports of cardiac side effects. The review confirmed a small increased risk of serious cardiac side effects. A higher risk was observed particularly in people older than 60 years, people taking daily oral Emidon-OM doses of more than 30 mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors at the same time as Emidon-OM. For indications other than nausea and vomiting, the benefits were not considered to outweigh the cardiac risk. Based on the results of this review, the treatment advice for Emidon-OM has been updated.
The overall safety profile of Emidon-OM, and in particular its cardiac risk and potential interactions with other medications, should be taken into account if there is a clinical need to use it at doses or durations greater than those authorised (eg, to control side effects of Parkinson’s disease treatment in some patients).
Emidon-OM use in children is under further investigation. Emidon-OM licence-holders are required to conduct studies to provide further data to support Emidon-OM efficacy in children.
Unwanted effects on the central nervous system (CNS) are produced by metoclopram >Emidon-OM as a result of its lower CNS penetration.
Acute and chronic extrapyramidal effects from dopamine receptor blockade in the basal ganglia can lead to acute dystonias (especially in girls, young women and the very elderly), akathisia and a parkinsonian-like syndrome. Tardive dyskinesias can develop with prolonged use (see also Chapter 24 ). Because of the risk of neurological adverse effects, metoclopramide should not be taken for more than 5 days.
Galactorrhoea, gynaecomastia and amenorrhoea caused by hyperprolactinaemia from pituitary dopamine receptor blockade.
Dry mouth (with Emidon-OM), diarrhoea.
Emidon-OM can cause serious ventricular arrhythmias due to QT prolongation on the electrocardiogram (ECG). Its use should be limited to no more than 7 days.
Uses for domper >
Emidon-OM is a medicine that increases the movements or contractions of the stomach and bowel. Emidon-OM is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease.
Emidon-OM is to be given only by or under the immediate supervision of your doctor.
Emidon-OM is a peripheral D2 receptor antagonist and is used as a prokinetic and antiemetic of low therapeutic efficacy.
Emidon-OM Drug Interactions Are Serious
It is extremely important that prescribers and patients using this drug are aware of the risk for drug interactions and pay particular attention to two types of drugs that may interact with Emidon-OM :
Those that inhibit cytochrome P450-3A4 (including some antiemetics and antidepressants frequently coadministered in patients with gastroparesis), thereby increasing serum levels of Emidon-OM (and subsequent risk for QTc prolongation).
Those that prolong the QT interval (including some antimicrobials, antifungal agents, and ondansetron), thus enhancing overall risk for QT prolongation and the overall increase of the QT interval.
There is limited prescribing information emphasizing the possible interaction between Emidon-OM and other QT-prolonging drugs.
More important, given that this is not an FDA-approved drug, it would not appear on the pharmacy listing nor on the electronic medical record (EMR) to enable a cross-check for potential drug-drug interactions. Accordingly, patients, prescribers, and pharmacists would probably not recognize the potential increased risk for cardiac arrhythmias and sudden death resulting from these interactions and inadequate cardiac monitoring.
Emidon-OM is an alternative to metoclopramide with a reduced incidence of extrapyramidal side-effects. It acts locally on gut and is dosed orally, 10–20 mg 3–4 times daily.
Levomepromazine is a class 1 antipsychotic and has useful activity in refractory nausea and vomiting at low doses. Doses range from 3.125 mg up to 25 mg daily and can be given orally or via the subcutaneous route.
Metoclopramide acts centrally and locally, and risk of extrapyramidal side-effects increases in the young and the elderly. Doses of up to 20 mg 6 hourly can be used for severe nausea.
- Emidon-OM is now restricted to use in the relief of nausea and vomiting
- It should be used at the lowest effective dose for the shortest possible time
Are there long-term concerns about the use of Emidon-OM?
The manufacturer states in its literature that chronic treatment with Emidon-OM in rodents has resulted in increased numbers of breast tumours in the rodents. The literature goes on to state that this has never been documented in humans. Note that toxicity studies of medication usually require treatment with huge doses over periods of time involving most or all of the animal’s lifetime. Note also that not breastfeeding increases the risk of breast cancer, and breast cancer risk decreases the longer you breastfeed.
Tell your doctor if you have ever had any unusual or allergic reaction to Emidon-OM or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Before using Emidon-OM
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Emidon-OM, the following should be considered:
Emidon-OM may interact with a number of important medications so check with your doctor or pharmacist before starting Emidon-OM or before starting any new medicines.
About domper >
Emidon-OM is used to relieve feelings of sickness (nausea) or being sick (vomiting). Feeling sick can be a common symptom, but it may be due to a number of different causes. You will only be recommended an anti-emetic like Emidon-OM if the cause of your sickness is known.