Domperidone

Domperidone

Clinical data
Pregnancy category	Not classified (US)
Routes of administration	Oral, intravenous, rectal
ATC code	A03FA03 (WHO)
Legal status
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
Pharmacokinetic data
Bioavailability	High
Protein binding	91–93%
Metabolism	Hepatic and intestinal (first-pass)
Elimination half-life	7 hours
Excretion	Breast milk, renal
Identifiers
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
CAS Number	57808-66-9
PubChem CID	3151
DrugBank	APRD00418
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C22H24ClN5O2
Molar mass	425.911 g/mol

WikiDoc Resources for Domperidone
Articles
Most recent articles on Domperidone Most cited articles on Domperidone Review articles on Domperidone Articles on Domperidone in N Eng J Med, Lancet, BMJ
Media
Powerpoint slides on Domperidone Images of Domperidone Photos of Domperidone Podcasts & MP3s on Domperidone Videos on Domperidone
Evidence Based Medicine
Cochrane Collaboration on Domperidone Bandolier on Domperidone TRIP on Domperidone
Clinical Trials
Ongoing Trials on Domperidone at Clinical Trials.gov Trial results on Domperidone Clinical Trials on Domperidone at Google
Guidelines / Policies / Govt
US National Guidelines Clearinghouse on Domperidone NICE Guidance on Domperidone NHS PRODIGY Guidance FDA on Domperidone CDC on Domperidone
Books
Books on Domperidone
News
Domperidone in the news Be alerted to news on Domperidone News trends on Domperidone
Commentary
Blogs on Domperidone
Definitions
Definitions of Domperidone
Patient Resources / Community
Patient resources on Domperidone Discussion groups on Domperidone Patient Handouts on Domperidone Directions to Hospitals Treating Domperidone Risk calculators and risk factors for Domperidone
Healthcare Provider Resources
Symptoms of Domperidone Causes & Risk Factors for Domperidone Diagnostic studies for Domperidone Treatment of Domperidone
Continuing Medical Education (CME)
CME Programs on Domperidone
International
Domperidone en Espanol Domperidone en Francais
Business
Domperidone in the Marketplace Patents on Domperidone
Experimental / Informatics
List of terms related to Domperidone

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

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.

Uses

Gastrointestinal problems

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 has also been found effective in the treatment of gastroparesis, a stomach motility condition, and for paediatric Gastroesophageal reflux (infant vomiting).

Lactation

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. Since, according to the FDA, domperidone is not approved for enhanced lactation in any country, it is still prescribed "off-label" for this use in countries besides the United States.

Controversy

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

It has been widely speculated that this action by the FDA is related to increasing drug importation from countries such as Canada.

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. 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.

Brand

Domperidone is marketed in India by Ion healthcare under the brand name MELDOM-DT.

Also conjuction with Pantoprazole as Dompan Tablets mktg by MEDLEY Pharma. Ltd.

External links

• Domperidone Issue Brief International Academy of Compounding Pharmacists.
• GPDA letter to the FDA about Domperidone for gastroparesis