|Trade names||Motilium, others|
|Drug class||D2 receptor antagonist; Prolactin releaser|
|Main uses||Nausea, gastroparesis|
|By mouth, intramuscular, rectal|
|AHFS/Drugs.com||Micromedex Detailed Consumer Information|
|Bioavailability||By mouth: 13–17%|
|Metabolism||Liver (CYP3A4/5) and intestinal (first-pass)|
|Elimination half-life||7.5 hours|
Breast milk: small quantities
|Chemical and physical data|
|Molar mass||425.92 g·mol−1|
|3D model (JSmol)|
|Melting point||242.5 °C (468.5 °F)|
Domperidone, sold under the brand name Motilium among others, is a medication used to relieve nausea, increase the transit of food through the stomach, treat migraines, and to promote breast milk production. It is taken by mouth. Due to the risk of side effects, use is recommended for less than a week and it is not recommended to increase breast milk.
Common side effects include a dry mouth. Other side effects include anxiety, diarrhea, and sexual dysfunction. Its use is not recommended in those with heart disease due to the risk of arrhythmias and sudden cardiac arrest. Use during breastfeeding is believed safe for the baby. Domperidone is a peripherally selective dopamine D2 receptor antagonist.
Domperidone was developed in 1974 by Janssen Pharmaceutica. It is available as a generic medication. In the United Kingdom a months supply costs the NHS about 3 pounds. While available in many countries, it is only available in the United States under compassionate use for severe gastrointestinal motility disorders not manageable by other treatments.
Nausea and vomiting
Gastroparesis is a medical condition characterised by delayed emptying of the stomach when there is no mechanical gastric outlet obstruction. Its cause is most commonly idiopathic, a diabetic complication or a result of abdominal surgery. The condition causes nausea, vomiting, fullness after eating, early satiety (feeling full before the meal is finished), abdominal pain and bloating.
However, increased rate of gastric emptying induced by drugs like domperidone does not always correlate (equate) well with relief of symptoms.
Domperidone can be used to relieve gastrointestinal symptoms in Parkinson's disease; it blocks peripheral D2 receptors but does not cross the blood–brain barrier in normal doses (the barrier between the blood circulation of the brain and the rest of the body) so has no effect on the extrapyramidal symptoms of the disease.
There is tentative evidence that domperidone moderately increases the volume of expressed breast milk in mothers of preterm babies where breast milk expression was inadequate. Domperidone; however, is not approved for this use and such use is not recommended due to the risk of side effects. A 2012 review found no studies support preventative use of a galactagogue medication at any gestation including domperidone.
Side effects associated with domperidone include dry mouth, abdominal cramps, diarrhea, nausea, rash, itching, hives, and hyperprolactinemia (the symptoms of which may include breast enlargement, galactorrhea, breast pain/tenderness, gynecomastia, hypogonadism, and menstrual irregularities). Due to blockade of D2 receptors in the central nervous system, D2 receptor antagonists like metoclopramide can also produce a variety of additional side effects including drowsiness, akathisia, restlessness, insomnia, lassitude, fatigue, extrapyramidal symptoms, dystonia, Parkinsonian symptoms, tardive dyskinesia, and depression. However, this is not the case with domperidone, because, unlike other D2 receptor antagonists, it minimally crosses the blood-brain-barrier, and for this reason, is rarely associated with such side effects.
Excess prolactin levels
Due to D2 receptor blockade, domperidone causes hyperprolactinemia. Hyperprolactinemia can suppress the secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus, in turn suppressing the secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) and resulting in hypogonadism (low sex hormone (e.g., testosterone, estradiol) levels). As such, male patients may experience low libido, erectile dysfunction, and impaired spermatogenesis. Also in accordance with hyperprolactinemia, 10–15% of female patients have been reported to experience mammoplasia (breast enlargement), mastodynia (breast pain/tenderness), galactorrhea (inappropriate or excessive milk production/secretion), and amenorrhea (cessation of menstrual cycles) with domperidone treatment. Gynecomastia has been reported in males treated with domperidone, and galactorrhea could occur in males as well.
Domperidone use is associated with an increased risk of sudden cardiac death (by 70%) most likely through its prolonging effect of the cardiac QT interval and ventricular arrhythmias. The cause is thought to be blockade of hERG voltage-gated potassium channels. The risks are dose-dependent, and appear to be greatest with high/very high doses via intravenous administration and in the elderly, as well as with drugs that interact with domperidone and increase its circulating concentrations (namely CYP3A4 inhibitors). Conflicting reports exist, however. In neonates and infants, QT prolongation is controversial and uncertain.
UK drug regulatory authorities (MHRA) have issued the following restriction on domperidone in 2014 due to increased risk of adverse cardiac effects:
Domperidone (Motilium) is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced. It should no longer be used for the treatment of bloating and heartburn. Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors. Patients with these conditions and patients receiving long-term treatment with domperidone should be reassessed at a routine appointment, in light of the new advice.
However, a 2015 Australian review concluded the following:
Based on the results of the two TQT (the regulatory agency gold standard for assessment of QT prolongation) domperidone does not appear to be strongly associated with QT prolongation at oral doses of 20 mg QID in healthy volunteers. Further, there are limited case reports supporting an association with cardiac dysfunction, and the frequently cited case-control studies have significant flaws. While there remains an ill-defined risk at higher systemic concentrations, especially in patients with a higher baseline risk of QT prolongation, our review does not support the view that domperidone presents intolerable risk.
In Britain a legal case involved the death of two children of a mother whose three children had all had hypernatraemia. She was charged with poisoning the children with salt. One of the children, who was born at 28 weeks gestation with respiratory complications and had a fundoplication for gastroesophageal reflux and failure to thrive was prescribed domperidone. An advocate for the mother suggested the child may have suffered neuroleptic malignant syndrome as a side effect of domperidone due to the drug crossing the child's immature blood-brain-barrier.
In healthy volunteers, ketoconazole increased the Cmax and AUC concentrations of domperidone by 3- to 10-fold. This was accompanied by a QT interval prolongation of about 10–20 milliseconds when domperidone 10 mg four times daily and ketoconazole 200 mg twice daily were administered, whereas domperidone by itself at the dosage assessed produced no such effect. As such, domperidone with ketoconazole or other CYP3A4 inhibitors is a potentially dangerous combination.
Domperidone is a peripherally selective dopamine D2 and D3 receptor antagonist. It has no clinically significant interaction with the D1 receptor, unlike metoclopramide. The medication provides relief from nausea by blocking D receptors. It blocks dopamine receptors in the anterior pituitary gland increasing release of prolactin which in turn increases lactation. Domperidone may be more useful in some patients and cause harm in others by way of the genetics of the person, such as polymorphisms in the drug transporter gene ABCB1 (which encodes P-glycoprotein), the voltage-gated potassium channel KCNH2 gene (hERG/Kv11.1), and the α1D—adrenoceptor ADRA1D gene.
Effects on prolactin levels
A single 20 mg oral dose of domperidone has been found to increase mean serum prolactin levels (measured 90 minutes post-administration) in non-lactating women from 8.1 ng/mL to 110.9 ng/mL (a 13.7-fold increase). This was similar to the increase in prolactin levels produced by a single 20 mg oral dose of metoclopramide (7.4 ng/mL to 124.1 ng/mL; 16.7-fold increase). After two weeks of chronic administration (30 mg/day in both cases), the increase in prolactin levels produced by domperidone was reduced (53.2 ng/mL; 6.6-fold above baseline), but the increase in prolactin levels produced by metoclopramide, conversely, was heightened (179.6 ng/mL; 24.3-fold above baseline). This indicates that acute and chronic administration of both domperidone and metoclopramide is effective in increasing prolactin levels, but that there are differential effects on the secretion of prolactin with chronic treatment. The mechanism of the difference is unknown. The increase in prolactin levels observed with the two drugs was, as expected, much greater in women than in men. This appears to be due to the higher estrogen levels in women, as estrogen stimulates prolactin secretion.
For comparison, normal prolactin levels in women are less than 20 ng/mL, prolactin levels peak at 100 to 300 ng/mL at parturition in pregnant women, and in lactating women, prolactin levels have been found to be 90 ng/mL at 10 days postpartum and 44 ng/mL at 180 days postpartum.
With oral administration, domperidone is extensively metabolized in the liver (almost exclusively by CYP3A4/5, though minor contributions by CYP1A2, CYP2D6, and CYP2C8 have also been reported) and in the intestines. Due to the marked first-pass effect via this route, the oral bioavailability of domperidone is low (13–17%); conversely, its bioavailability is high via intramuscular injection (90%). The terminal half-life of domperidone is 7.5 hours in healthy individuals, but can be prolonged to 20 hours in people with severe kidney dysfunction. All of the metabolites of domperidone are inactive as D2 receptor ligands. The drug is a substrate for the P-glycoprotein (ABCB1) transporter, and animal studies suggest that this is the reason for the low central nervous system penetration of domperidone.
- 1974 – Domperidone synthesized at Janssen Pharmaceutica following the research on antipsychotic drugs. Janssen pharmacologists discovered that some of antipsychotic drugs had a significant effect on dopamine receptors in the central chemoreceptor trigger zone that regulated vomiting and started searching for a dopamine antagonist that would not pass the blood–brain barrier, thereby being free of the extrapyramidal side effects that were associated with drugs of this type. This led to the discovery of domperidone as a strong anti-emetic with minimal central effects.
- 1978 – On 3 January 1978 Domperidone was patented in the United States under patent US4066772 A. The application has been filed on 17 May 1976. Jan Vandenberk, Ludo E. J. Kennis, Marcel J. M. C. Van der Aa and others has been cited as the inventors.
- 1979 – Domperidone marketed under trade name "Motilium" in Switzerland and (Western) Germany.
- 1999 – Domperidone was introduced in the forms of orally disintegrating tablets (based on Zydis technology).
- Janssen Pharmaceutical has brought domperidone before the United States Federal Drug Administration (FDA) several times, including in the 1990s.
- 2014 – In April 2014 Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) published official press-release suggesting to restrict the use of domperidone-containing medicines. It also approved earlier published suggestions by Pharmacovigilance Risk Assessment Committee (PRAC) to use domperidone only for curing nausea and vomiting and reduce maximum daily dosage to 10 mg.
Society and culture
In 2007 domperidone was available in 58 countries, including Canada. The approved indications of domperidone vary between nations. In Italy it is used in the treatment of gastroesophageal reflux disease and in Canada, the drug is indicated in upper gastrointestinal motility disorders and to prevent gastrointestinal symptoms associated with the use of dopamine agonist antiparkinsonian agents. In the United Kingdom, domperidone is only indicated for the treatment of nausea and vomiting and the treatment duration is usually limited to 1 week.
In the United States, domperidone is not currently generally approved for medical use. On 7 June 2004, FDA issued a public warning that distributing any domperidone-containing products is illegal. There is an exception for use in people with treatment-refractory gastrointestinal symptoms under an FDA Investigational New Drug application.
|Australia||Janssen–Cilag||Motilium||10 mg scored tablets|
|Belgium and the Netherlands||-||Motilium||From 2013 only by prescription in Belgium.|
|Bangladesh||Square||Motigut||10 mg scored tablets|
|Bangladesh||Orion Pharma||Cosy||10 mg scored tablets|
|Bangladesh||Astra Pharma||Domperon||10 mg scored tablets|
|Canada||-||Motilium (1985–2002)||Generic brands available|
|France||Janssen||Motilium||10 mg tablets only with prescription generic domperidone available|
|Greece||Johnson & Johnson Hellas||Cilroton||10 mg scored tablets|
|India||Salius Pharma||Escacid DXR||pantoprazole 40 mg and domperidone SR 30 mg|
|India||FDC Pharmaceuticals||Pepcia-D||Rabeprazole 20 mg and Domperidone SR 30 mg|
|India||Rhubarb pharmaceuticals||-||domperidone 5, 10 and 20 mg tablets.|
|India||Ipca Laboratories, Mumbai||Domperi suspension||domperidone 1 mg/ml, 30 ml suspension.|
|India||Ozone pharmaceuticals and chemicals||Pantazone-D||10 mg domperidone and 40 mg pantoprazole|
|India||Chimak Health Care||Pancert D||10 mg Domperidone and 40 mg pantoprazole|
|India||Draavin Pharma||Draaci-XD||Pantaprazole 40 mg and Domperione 30 mg|
|Iran||Abidi Pharmaceutical Co.||MOTiDON||10 mg tablet|
|Ireland||McNeil Healthcare||Motilium||10 mg orally disintegrating tablet (ODT)|
|Italy||-||Peridon||domperidone 10 mg tablets; 30 ml suspension|
|Lithuania||Johnson & Johnson||Motilium||-|
|Pakistan||Barrett Hodgson Pakistan||Domel|
|Pakistan||Johnson & Johnson Pakistan||Motilium-v||domperidone 10 mg tablets; 30 ml suspension|
|Pakistan||ATCO Laboratories Limited||Vomilux||domperidone 10 mg tablets|
|Pakistan||Aspin Pharma (Pvt) Limited||Motilium||domperidone 10 mg tablets|
|Philippines||Health Saver Pharma||Abdopen||-|
|Philippines||United Laboratories, Inc.||GI Norm||-|
|Portugal||Medinfar||Cinet||domperidone 1 mg/ml oral suspension (200 ml)|
|Russia||Janssen Pharmaceutica||Motilium||domperidone 10 mg film-coated tablets & ODT; 1 mg/ml suspension (100 ml)|
|-||OBL Pharm||Passagix||domperidone 10 mg film-coated tablets & chewable tablets|
|-||Dr. Reddy's Laboratories||Omez D||domperidone/omeprazole (10 mg/10 mg)|
|Saudi Arabia||JamJoom Pharmaceuticals||Dompy||Domperidone 10 mg tablets|
|Spain||Laboratorios Dr. Esteve, SA||Motilium||domperidone 1 mg/ml oral suspension (200 ml)|
|Sweden||Ebb medical||Domperidon Ebb (2013)||domperidone 10 mg ODT and peppermint|
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