It is not licensed for any indication in the USA because of concerns about arrhythmia.

… The manufacturer of Arcoxia received a non-approvalable letter from the FDA in April of 2007.

20 women in a double-blind, placebo-controlled protocol. All medicines can have adverse effects. The prescription of domperidone should be avoided in the following situations (1-3); where either mother or baby has any evidence of cardiac abnormalities and specifically arrhythmia is receiving other medications known to prolong QT interval or potent CYP3A4 inhibitors e.g. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.Depending on your condition, you may need to take Arcoxia for a few days or for a longer period.For osteoarthritis and rheumatoid arthritis Arcoxia helps relieve your symptoms but it does not cure it.

Renal and mild hepatic impairment. The mean relative infant dose was 0.01% after a 30 mg daily dose and 0.009% at 60 mg quotes a relative infant dose range of 0.01% – 0.04%, well below the 10% regarded There are no studies that provide an evidence base on how long to continue domperidone in the case of inadequate lactation .

The safety of domperidone in pregnancy remains unknown. You may need medical treatment if you get some of the adverse effects.Ask your doctor or pharmacist to answer any questions you may have.Tell your doctor if you notice or have any of the following and they worry you:These are usually the mild adverse effects of Arcoxia.If any of the following happen, stop taking Arcoxia and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:Other adverse effects not listed above may also occur in some patients.

Only one study looked at mothers who had not delivered prematurely . It is also useful for women with identified hormonal difficulties that could affect milk supply, e.g. By continuing to browse the site you are agreeing to our policy on the use of cookies. † The frequency category of “Rare” was defined per the Summary of Product Characteristics (SmPC) guidance (rev. Domperidone is a medicine available in a number of countries worldwide.

It allows continued monitoring of the benefit/risk balance of the medicinal product.

{01} Animal studies have not shown that domperidone has any teratogenic or primary embryotoxic effects on the fetus. However, our findings require further confirmation in larger studies. Dose modification in mild hepatic impairment is however not needed (see section 5.2).Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.

Such patients on prolonged therapy should be reviewed regularly (see sections 4.4 and 5.2)Domperidone is contraindicated in the following situations: • when stimulation of the gastric motility could be harmful, e.g .,in patients with gastro-intestinal haemorrhage, mechanical obstruction or perforation. It is important that you use the lowest dose that controls your pain and you should not take Arcoxia for longer than necessary. These include:These medicines may be affected by Arcoxia or may affect how well it works.
• Known hypersensitivity to domperidone or any of the excipients After a slow withdrawal from domperidone, one study found no significant increase in formula supplementation suggesting that once sufficient milk production is established, it is maintained even without the use of domperidone showed that in 3 out of 4 women who had taken domperidone for 4 weeks at full dose, 2 weeks at reducing dose, milk supply was maintained.

• certain anti-depressants (e.g., citalopram, escitalopram) Name must be less than 100 characters



We also use third-party cookies that help us analyze and understand how you use this website. The plasma half-life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency.In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and CIn subjects with severe renal insufficiency (creatinine clearance <30ml/min/1.73mHowever, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.
Domperidone has been prescribed off label for babies with reflux.So individual prescribing decisions should be made bearing in mind the recommendations of MHRA and the risk to mother and baby of not establishing full lactation  Other than those identified by MHRA, side effects are rare – they include stomach cramps, dry mouth, headache and occasionally domperidone is associated with depressed mood (although less than metoclopramide).Domperidone has been used as a galactagogue (to increase milk supply), use for which is off-label, utilising its effect of increasing prolactin. Following the study period the dose was tapered to a twice daily then daily regime before stopping.

2018 Dec;11(4):154-159. doi: 10.1177/1753495X18769170. Please enable it to take advantage of the complete set of features! In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. , erythromycin, levofloxacin, moxifloxacin, spiramycin) A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. It may be a valuable tool to support mothers who have delivered pre-term and who maintain their lactation over a prolonged period by expression, or mothers who have had a poor start to breastfeeding who need to relactate to some extent.



The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GORD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies. The Cmax and AUC values of domperidone increased proportionally with dose in the 10 mg to 20 mg dose range.

Breast-feeding