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Domperidone chemical structure
|ATC code |
|Molecular weight||425.911 g/mol|
|Metabolism||Hepatic and intestinal (first-pass)|
|Elimination half-life||7 hours|
|Excretion||Breast milk, renal|
|Pregnancy category||Not classified (US)|
|Legal status||Not approved for use or sale: US; prescription medicine: Australia, Canada; Over the Counter (OTC): UK, Belgium, Ireland, Italy, Japan, Netherlands, South Africa, Switzerland, China, Russia, Slovakia, Malta, South Korea, and Romania|
|Routes of administration||Oral, intravenous, rectal|
Domperidone (trade name Motilium or Motillium) is an antidopaminergic drug, developed by Janssen Pharmaceutica, and used orally, rectally or intravenously, generally to suppress nausea and vomiting. It has also been used to stimulate lactation.
Domperidone is used, together with metoclopramide, cyclizine, and 5HT3 receptor antagonists (such as granisetron) in the treatment of nausea and vomiting. It can be used in patients with Parkinson's disease because, unlike metoclopramide[How to reference and link to summary or text], domperidone does not cross the blood-brain barrier.
The hormone prolactin stimulates lactation in humans, and its release is inhibited by the dopamine secreted by the hypothalamus. Domperidone, by acting as an anti-dopaminergic, results in increased prolactin secretion, and thus promotes lactation.
Domperidone is a first choice anti-emetic in most countries, together with metoclopramide. It is however not approved for prescription in the US. Although it has never been officially approved for use in the United States, domperidone is sometimes purchased from pharmacies in other countries for this purpose. Since, according to the American FDA, domperidone is not approved for enhanced lactation in any country, it is sometimes self-prescribed from original research or prescribed "off-label" for this use in countries around the world.
Janssen Pharmaceutical has brought Domperidone before the FDA several times in the last two decades, with the most recent effort in the 1990s. Numerous U.S. clinical drug trials have demonstrated its safety and efficacy in dealing with gastroparesis symptoms, but the FDA turned down Janssen's application for Domperidone, even though the FDA's division of gastrointestinal drugs had approved Domperidone.
In June 2004, the United States' main regulation agency, the Food and Drug Administration (FDA), issued a letter warning women not to take domperidone, citing unknown risks to parents and infants, and warned pharmacies that domestic sale was illegal, and that import shipments from other countries would be searched and seized. Domperidone is excreted in breast milk, and no studies on its effects on breastfeeding infants have been reported in the literature. Individual incidents of problems with the drug include cardiac arrest and arrhythmia, complications with other medications, as well as complications with improper intravenous use
Some doctors and pharmacists do not fully accept the FDA's reasoning and still favor domperidone's use in increasing milk supply. Such doctors and pharmacists claim the drug is safe in the doses given for this purpose but have no evidential data or studies to base their claim. The American Academy of Pediatrics considers domperidone "usually compatible with breastfeeding".
There is a new controversy in Britain regarding lethal levels of sodium found in children who are administered this drug. It is now subject to a medical review following a number of criminal trials.
Domperidone blocks the action of dopamine. It has strong affinities for the D2 and D3 dopamine receptors , which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which - among others - regulates nausea and vomiting (area postrema on the floor of the fourth ventricle and rhomboid fossa).
Also conjunction with Pantoprazole as Dompan Tablets mktg by MEDLEY Pharma. Ltd.
- Domperidone MedSafe NZ Government
- Silvers D, Kipnes M, Broadstone V, et al (1998). Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial. DOM-USA-5 Study Group. Clinical therapeutics 20 (3): 438–53.
- Domperidone for lactating women, Canadian Medical Association Journal, Orlando P. da Silva and David C. Knoppert. 2004 Sep 28;171(7):725-6.
- FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production FDA
- Letter to Consumer Safety Office, FDA Gastroparesis and Dysmotilities Association
- Official Statements From Prominent Physicians breastfeedingonline.com
- Maternal Medication Usually Compatible With Breastfeeding American Academy of Pediatrics
- Current news coverage of latest trial The Scotsman
- PDSP Ki Database.
- GPDA letter to the FDA about Domperidone for gastroparesis
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