Sources
Help build the largest human-edited directory on the web.
Submit a site - Become an editor
Wikipedia. Licensed under the GNU Free Documentation License.
Are you an expert in this subject? Join the discussion and share your knowledge at Wikipedia.org.
Domperidone
From Wikipedia, the free encyclopedia
 |
|
|
Domperidone
|
|
| Systematic (IUPAC) name | |
| 1,3-dihydro-5-chloro-1-(1-(3-(2,3-dihydro- 2-oxo-1H-benzimidazol-1-yl)propyl)- 4-piperidinyl)-2H-benzimidazol-2-one |
|
| Identifiers | |
| CAS number | |
| ATC code | A03 |
| PubChem | |
| DrugBank | |
| Chemical data | |
| Formula | C22H24ClN5O2 |
| Mol. mass | 425.911 g/mol |
| Pharmacokinetic data | |
| Bioavailability | High |
| Protein binding | 91%-93% |
| Metabolism | ? |
| Half life | 7 hours |
| Excretion | Breast milk, renal |
| Therapeutic considerations | |
| Pregnancy cat. |
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[1] |
| Routes | Oral, intravenous, rectal |
Domperidone (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.
Contents |
Domperidone is used, together with metoclopramide, cyclizine, and 5HT3 receptor antagonists (such as granisetron) in the treatment of nausea and vomiting. It is useful in patients with Parkinson's disease because, unlike metoclopramide, domperidone does not cross the blood-brain barrier. Domperidone is also prescribed for the treatment of gastroparesis, a stomach motility condition.
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.
Although it has never been officially approved for use in the United States, domperidone is widely purchased from pharmacies in other countries for this purpose. However, according to the FDA, domperidone is not approved for this use in any country, although it is often prescribed "off-label".[2]
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.[3]
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[2]
It has been widely speculated that this action by the FDA is related to increasing drug importation from countries such as Canada.[citation needed] However, organisations such as the American Association of Pediatrics have endorsed the FDA action.
Yet prominent doctors and pharmacists have rejected the FDA's reasoning and still promote domperidone's use in increasing milk supply. Such doctors and pharmacists are confident the drug is safe in the doses given for this purpose.[4] The American Academy of Pediatrics considers domperidone "usually compatible with breastfeeding".[5]
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.[6]
- ^ Domperidone MedSafe NZ Government
- ^ a b 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
- Domperidone for lactating women, Canadian Medical Association Journal, Orlando P. da Silva and David C. Knoppert. 2004 Sep 28;171(7):725-6.
- Domperidone Issue Brief International Academy of Compounding Pharmacists.
- Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial.
- GPDA letter to the FDA about Domperidone for gastroparesis
- Links to external chemical sources