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Additional information about the drug Domperidone


Domperidone, sold under the brand name Motilium among others, is a peripherally selective dopamine D 2 receptor antagonist that was developed by Janssen Pharmaceutica and is used as an antiemetic, gastroprokinetic agent, and galactagogue.
Contents
1 Medical uses
1.1 Nausea and vomiting
1.2 Gastroparesis
1.3 Parkinson’s disease
1.4 Functional dyspepsia
1.5 Lactation
1.6 Pediatric reflux
2 Contraindications
3 Side effects
3.1 Excess prolactin levels
3.2 Rare reactions
3.2.1 Cardiac reactions
3.2.2 Possible central toxicity in infants
4 Interactions
5 Pharmacology
5.1 Pharmacodynamics
5.1.1 Effects on prolactin levels
5.1.2 Effects on TSH levels
5.2 Pharmacokinetics
6 Chemistry
7 History
8 Society and culture
8.1 Generic names
8.2 Availability
8.3 Formulations
9 Research
10 References
11 External links
Medical uses
It was reported in 2007 that domperidone is available in 58 countries, including Canada, 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 a legally marketed human drug and it is not approved for sale in the U.S. On 7 June 2004, FDA issued a public warning that distributing any domperidone-containing products is illegal.
Nausea and vomiting
There is some evidence that domperidone has antiemetic activity.
Gastroparesis
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.
Domperidone may be useful in diabetic and idiopathic gastroparesis.
However, increased rate of gastric emptying induced by drugs like domperidone does not always correlate (equate) well with relief of symptoms.
Parkinson’s disease
Parkinson’s disease is a chronic neurological condition where a decrease in dopamine in the brain leads to rigidity (stiffness of movement), tremor and other symptoms and signs. Poor gastrointestinal function, nausea and vomiting is a major problem for people with Parkinson’s disease because most medications used to treat Parkinson’s disease are given by mouth. These medications, such as levodopa, can cause nausea as a side effect. Furthermore, anti-nausea drugs, such as metoclopramide, which do cross the blood–brain barrier may worsen the extra-pyramidal symptoms of Parkinson’s disease.
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.
Although these features make domperidone a useful drug in Parkinson’s disease, caution is needed due to the cardiotoxic side effects of domperidone especially when given intravenously, in elderly people and in high doses (> 30 mg per day).
Functional dyspepsia
Domperidone may be used in functional dyspepsia in both adults and children.
Lactation
The hormone prolactin stimulates lactation (production of breast milk). Dopamine, released by the hypothalamus stops the release of prolactin from the pituitary gland. Domperidone, by acting as an anti-dopaminergic agent, results in increased prolactin secretion, and thus promotes lactation (that is, it is a galactogogue ). In some nations, including Australia, domperidone is used off-label, based on uncertain and anecdotal evidence of its usefulness, as a therapy for mothers who are having difficulty breastfeeding.
A study called the EMPOWER trial was designed to assess the effectiveness and safety of domperidone in assisting mothers of preterm babies to supply breast milk for their infants.
To induce lactation, domperidone is used at a dosage of 10 to 20 mg 3 or 4 times per day by mouth.
Pediatric reflux
Domperidone has been found effective in the treatment of pediatric reflux.
Contraindications
CYP3A4 inhibitors (e.g., triazole antifungal medications such as ketoconazole, itraconazole, fluconazole ; macrolide antibiotics such as erythromycin and clarithromycin ; grapefruit juice ; other potent CYP3A4 inhibitors)
QT-prolonging drugs like amiodarone
Prolactin secreting pituitary tumor ( prolactinoma ) or hyperprolactinemia
Mechanical bowel disorders such as bowel obstruction, gastrointestinal haemorrhage or bowel perforation
Moderate hepatic impairment (liver disease)
Severe renal impairment (kidney disease)
Cardiac disease
Side effects
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 ).
Excess prolactin levels
Due to D 2 receptor blockade, domperidone causes hyperprolactinemia.
Rare reactions
Cardiac reactions
Domperidone use is associated with an increased risk of sudden cardiac death (by 70%)
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.
Possible central toxicity in infants
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.
Interactions
Domperidone is almost exclusively metabolized by CYP3A4, and for this reason, inhibitors and inducers of this enzyme may alter the metabolism and concentrations of domperidone. Moreover, domperidone has been identified as a modest mechanism-based (irreversible) inhibitor of CYP3A4 (K i = 12 μM), and it has been estimated that it may increase the serum concentrations of CYP3A4 substrates by approximately 50%.
Itraconazole and ketoconazole, both used to treat fungal infections, are potent CYP3A4 inhibitors and increase the plasma concentration of domperidone.
Erythromycin and certain other macrolide antibiotics are CYP3A4 inhibitors and inhibit the metabolism of domperidone ( in vitro ), thus increasing the concentration of domperidone and potential side effects of the drug. This is of concern as both drugs may be used to treat gastroparesis.
There is evidence that domperidone should not be taken with grapefruit juice, which is a known CYP3A4 inhibitor.
Pharmacology
Pharmacodynamics
Domperidone is a peripherally selective dopamine D 2 and D 3 receptor antagonist.
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).
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.
Effects on TSH levels
Along with prolactin, domperidone has, to a lesser extent, been found to increase the secretion of thyroid-stimulating hormone (TSH), even in patients with hypothyroidism.
Pharmacokinetics
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)
Chemistry
Domperidone is a benzimidazole derivative and is structurally related to butyrophenone neuroleptics like haloperidol.
History
1974 – Domperidone synthesized at Janssen Pharmaceutica
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
Generic names
Domperidone is the generic name of the drug and its INN, USAN, BAN, and JAN.
Availability
In 2007, it was reported that domperidone was available in 58 countries.
Domperidone is not generally approved for use in the United States. There is an exception for use in people with treatment-refractory gastrointestinal symptoms under an FDA Investigational New Drug application.
Formulations
Formulations
Nation
Manufacturer
Brand
Formulations
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
Bangladesh

Ridon

Canada

Motilium (1985–2002)
Generic brands available
France
Janssen
Motilium
10 mg tablets only with prescription generic domperidone available
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
Torrent pharmaceuticals
Domstal

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
Taiwan

Dotitone

Thailand

Motilium M

Turkey
Saba
Motinorm


GlaxoSmithKline
Motinorm

Research
Domperidone has been studied as a potential hormonal contraceptive to prevent pregnancy in women.

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