Metoclopramide
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Metoclopramide is a medication used to treat nausea, vomiting, gastroparesis, and gastroesophageal reflux disease.<ref name=AHFS>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> It is also used to treat migraine headaches.<ref>Template:Cite journal</ref>
Common side effects include feeling tired, diarrhea, akathisia, and tardive dyskinesia. More serious side effects include neuroleptic malignant syndrome and depression.<ref name=AHFS/> It is thus rarely recommended that people take the medication for longer than twelve weeks.<ref name=AHFS/> No evidence of harm has been found after being taken by many pregnant women.<ref name=AHFS/><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> It belongs to the group of medications known as dopamine-receptor antagonists and works as a prokinetic.<ref name=AHFS/>
In 2012, metoclopramide was one of the top 100 most prescribed medications in the United States.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> It is available as a generic medication.<ref name=AHFS/> It is on the World Health Organization's List of Essential Medicines.<ref name="WHO22nd">Template:Cite book</ref> In 2022, it was the 245th most commonly prescribed medication in the United States, with more than 1Template:Nbspmillion prescriptions.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> Template:TOC limit
Medical usesEdit
NauseaEdit
Metoclopramide is commonly used to treat nausea and vomiting associated with conditions such as uremia, radiation sickness, cancer and the effects of chemotherapy, labor, infection, and emetogenic drugs.<ref name=AHFS/><ref name=Maxolon>{{#invoke:citation/CS1|citation |CitationClass=web }} </ref><ref name=AMH2006>Template:Cite book</ref><ref name="xpil.medicines.org.uk">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> As a perioperative anti-emetic, the effective dose is usually 25 to 50 mg (compared to the usual 10 mg dose).
It is also used in pregnancy as a second choice for treatment of hyperemesis gravidarum (severe nausea and vomiting of pregnancy).<ref name=AHFS/>
It is also used preventatively by some EMS providers when transporting people who are conscious and spinally immobilized.<ref>"Ambulance Victoria Clinical Guideline A0701"{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
MigraineEdit
In migraine headaches, metoclopramide may be used in combination with paracetamol (acetaminophen) or in combination with aspirin.<ref name="Derry2013">Template:Cite journal</ref>
GastroparesisEdit
Evidence also supports its use for gastroparesis, a condition that causes the stomach to empty poorly, and as of 2010 it was the only drug approved by the FDA for that condition.<ref name=AHFS/><ref name=Rao2010rev/>
It is also used in gastroesophageal reflux disease.<ref name="AHFS" /><ref name="Reglan FDA label">{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
LactationEdit
While metoclopramide is used to increase breast milk production, evidence for its effectiveness for this indication is poor.<ref>Template:Cite journal</ref> Its safety for this use is also unclear.<ref>Template:Cite journal</ref>
ProceduresEdit
Intravenous metoclopramide is used in small-bowel follow-through, small-bowel enema, and radionuclide gastric-emptying studies to reduce the time taken for the barium to go through the intestines, thus reducing the total time needed for the procedures. Metoclopramide also prevents vomiting after oral ingestion of barium.<ref>Template:Cite book</ref>
ContraindicationsEdit
Metoclopramide is contraindicated in pheochromocytoma. It should be used with caution in Parkinson's disease since, as a dopamine antagonist, it may worsen symptoms. Long-term use should be avoided in people with clinical depression, as it may worsen one's mental state.<ref name=AMH2006/> It is contraindicated for people with a suspected bowel obstruction,<ref name=AHFS/> in epilepsy, if a stomach operation has been performed in the previous three or four days, perforation or blockage of the stomach, and in newborn babies.<ref name="xpil.medicines.org.uk"/>
The European Medicines Agency reviewed the drug's safety in 2011, which determined that it should not be prescribed in high doses, for periods of more than five days, or given to children below 1 year of age. They suggested its use in older children should be restricted to treating post-chemotherapy or post-surgery nausea and vomiting, and even then only for patients where other treatments have failed. For adults, they recommended its use be restricted to treating migraines and post-chemotherapy or post-surgery patients.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
PregnancyEdit
Metoclopramide has long been used in all stages of pregnancy with no evidence of harm to the mother or foetus.<ref name=Briggs2008>Template:Cite book</ref> A large cohort study of babies born to Israeli women exposed to metoclopramide during pregnancy found no evidence that the drug increases the risk of congenital malformations, low birth weight, preterm birth, or perinatal mortality.<ref name=Matok2009>Template:Cite journal</ref> A large cohort study in Denmark found, in addition, no association between metoclopramide exposure and miscarriage.<ref>Template:Cite journal</ref> Metoclopramide is excreted into milk.<ref name=Briggs2008/>
InfantsEdit
A systematic review found a wide range of reported outcomes for the treatment of gastroesophageal reflux disease (GERD) in infants rating the evidence as "poor" and "inconclusive" for safety and efficacy for the treatment of GERD in infants.<ref name=Hibbs2006>Template:Cite journal</ref>
Side effectsEdit
Common adverse drug reactions (ADRs) associated with metoclopramide therapy include restlessness (akathisia), and focal dystonia. Infrequent ADRs include hypertension, hypotension, hyperprolactinaemia leading to galactorrhea, headache, and extrapyramidal effects such as oculogyric crisis.<ref name=AMH2006/><ref name="Reglan FDA label"/>
Metoclopramide may be the most common cause of drug-induced movement disorders.<ref name=FDA2009/> The risk of extrapyramidal effects is increased in people under 20 years of age, and with high-dose or prolonged therapy.<ref name=Maxolon/><ref name=AMH2006/> Tardive dyskinesia may be persistent and irreversible in some people. The majority of reports of tardive dyskinesia occur in people who have used metoclopramide for more than three months.<ref name=FDA2009/> Consequently, the US Food and Drug Administration (FDA) recommends that metoclopramide be used for short-term treatment, preferably less than 12 weeks. In 2009, the FDA required all manufacturers of metoclopramide to issue a black box warning regarding the risk of tardive dyskinesia with chronic or high-dose use of the drug.<ref name=FDA2009>Template:Cite press release {{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
Dystonic reactions may be treated with benzatropine, diphenhydramine, trihexyphenidyl, or procyclidine. Symptoms usually subside with intramuscularly injected diphenhydramine.<ref name="Reglan FDA label"/> Agents in the benzodiazepine class of drugs may be helpful, but benefits are usually modest, and the side effects of sedation and weakness can be problematic.<ref>Template:Cite book</ref>
In some cases, the akathisia effects of metoclopramide are directly related to the infusion rate when the drug is administered intravenously. Side effects were usually seen in the first 15 minutes after administering the dose of metoclopramide.<ref>Template:Cite book</ref>
Withdrawal effects were reported for a female taking metoclopramide for about six months. The adverse symptoms oscillated between akinesian and akathisian, including amenorrhea, and appeared like secondary parkinsonism. Adverse effects remained a year after the metoclopramide had been gradually withdrawn.<ref>Noll AM, Pinsky D (June 1991). “Withdrawal Effects of Metoclopramide". The Western Journal of Medicine. 154 (6): 726-728. PMC1002885</ref>
Rare side effectsEdit
Diabetes, age, and female gender are risk factors that increase the likelihood of experiencing a neuropsychiatric side effect of metoclopramide.<ref name=reviewpsy/>
- Panic disorder<ref name=review>Template:Cite journal</ref>
- Major depressive disorder<ref name=review/>
- Agoraphobia<ref name=review/>
- Agranulocytosis, supraventricular tachycardia, hyperaldosteronism, neuroleptic malignant syndrome, akathisia and tardive dyskinesia.
- Methaemoglobinaemia*<ref name=AMH2006/><ref name="Reglan FDA label" />
PharmacologyEdit
Metoclopramide appears to bind to dopamine D2 receptors with nanomolar affinity (Ki = 28.8 nM),<ref>Template:Cite journal</ref> where it is a receptor antagonist, and is also a mixed 5-HT3 receptor antagonist/5-HT4 receptor agonist.<ref name=reviewpsy>Template:Cite journal</ref>
Mechanism of actionEdit
The antiemetic action of metoclopramide is due to its antagonist activity at D2 receptors in the chemoreceptor trigger zone in the brain — this action prevents nausea and vomiting triggered by most stimuli.<ref name=Rang2003>Template:Cite book</ref> At higher doses, 5-HT3 antagonist activity may also contribute to the antiemetic effect.<ref name=Fischer/>Template:Failed verification
The gastroprokinetic activity of metoclopramide is mediated by muscarinic activity, D2 receptor antagonist activity, and 5-HT4 receptor agonist activity.<ref name=Sweetman2004>Template:Cite book</ref><ref name=Tonini1995>Template:Cite journal</ref> The gastroprokinetic effect itself may also contribute to the antiemetic effect.Template:Citation needed Metoclopramide also increases the tone of the lower esophageal sphincter.<ref name=Feldman2010>Template:Cite book</ref>
Metoclopramide might influence mood because of its antagonistic blockade on 5-HT3 and agonistic (activating) action on 5-HT4.<ref name=reviewpsy/>
While muscarinic receptors affect gastrointestinal motility, metoclopramide’s prokinetic effects are not primarily due to direct muscarinic receptor activity. Instead, they result from its actions on 5-HT4 and D2 receptors.
PharmacokineticsEdit
CYP2D6 metabolizes metoclopramide, a reversible inhibitor, but not inactivator, of CYP2D6. The major metabolites of metoclopramide are N-hydroxylation and N-deethylation by all common CYP enzymes.<ref>Template:Cite journal</ref>
ChemistryEdit
Metoclopramide is a substituted benzamide; cisapride and mosapride are structurally related.<ref name=Fischer>Template:Cite book</ref>
HistoryEdit
Metoclopramide was first described by Louis Justin-Besançon and Charles Laville in 1964, while working to improve the anti-dysrhythmic properties of procainamide.<ref name=Sneader2005>Template:Cite book</ref><ref>Template:Cite journal</ref><ref name=Justin1964>Template:Cite journal</ref><ref name=Henzi>Template:Cite book</ref> That research project also produced the product sulpiride.<ref name=Sneader2005/> The first clinical trials were published by Tourneu et al. in 1964 and by Boisson and Albot in 1966.<ref name=Henzi/> Justin-Besançon and Laville worked for Laboratoires Delagrange<ref name=Sneader2005/> and that company introduced the drug Primperan in 1964.<ref>Template:Cite book</ref><ref>Template:Cite journal</ref> Laboratoires Delagrange was acquired by Synthelabo in 1991<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> which eventually became part of Sanofi.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
A.H. Robins introduced the drug in the US under the brand name Reglan in 1979<ref>Template:Cite book</ref> as an injectable<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> and an oral form was approved in 1980.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> in 1989 A.H. Robins was acquired by American Home Products,<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> which changed its name to Wyeth in 2002.<ref name=NYT2002>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
The drugs were initially used to control nausea for people with severe headaches or migraines, and later used for nausea caused by radiation therapy and chemotherapy, and later yet for treating nausea caused by anesthesia.<ref name=Henzi/> In the US the injectable form was labelled for chemotherapy-induced nausea and the oral form was eventually labelled for gastroesophageal reflux disease.<ref name=Pink1986/>
It became widely used in the 1980s, becoming the most commonly used drug to treat anesthesia-induced nausea<ref name=Henzi/> and for treating gastritis in emergency rooms.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
The first generics were introduced in 1985.<ref name=Pink1986>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
In the early 1980s signs began to emerge in pharmacovigilance studies from Sweden that the drug was causing tardive dyskinesia in some patients.<ref>Template:Cite journal</ref> The FDA required a warning about tardive dyskinesia to be added to the drug label in 1985 stating that: "tardive dyskinesia . . . may develop in patients treated with metoclopramide,” and warned against use longer than 12 weeks, as that was how long the drug has been tested.<ref>Template:Cite journal</ref><ref name=Law3602012>{{#invoke:citation/CS1|citation |CitationClass=web }}com</ref> In 2009 the FDA required that a black box warning be added to the label.<ref name=Rao2010rev>Template:Cite journal</ref><ref name=FDA2009/>
The emergence of this severe side effect led to a wave of product liability litigation against generic manufacturers as well as Wyeth.<ref name=Noah>Template:Cite journal</ref> The litigation was complicated since there was a lack of clarity in jurisdiction between state laws, where product liability is determined, and federal law, which determines how drugs are labelled, as well as between generics companies, which had no control over labelling, and the originator company, which did.<ref name=Noah/><ref name=Pepper>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> The litigation yielded at least two important cases. In Conte v. Wyeth in the California state courts, the claims of the plaintiff against the generic companies Pliva, Teva, and Purepac that had sold the drugs that the plaintiff actually took, and the claims against Wyeth, whose product the plaintiff never took, were all dismissed by the trial court, but the case was appealed, and in 2008 the appellate court upheld the dismissal of the cases against the generic companies, but reversed on Wyeth, allowing the case against Wyeth to proceed.<ref name=Noah/><ref name=Pepper/><ref>Template:Cite court</ref> This established an "innovator liability" or "pioneer liability" for pharmaceutical companies.<ref name=Noah/> The precedent was not widely followed in California nor in other states.<ref name=Pepper/> Litigation over the same issues related to metoclopramide also reached the US Supreme Court in Pliva, Inc. v. Mensing,<ref>Template:Cite court</ref> in which the court held in 2011 that generic companies cannot be held liable for information, or the lack of information, on the originator's label.<ref name=Law3602012/><ref name=Pepper/><ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> As of August 2015 there were about 5000 suits pending across the US and efforts to consolidate them into a class action had failed.Template:Citation needed
Shortly following the Pliva decision, the FDA proposed a rule change that would allow generics manufacturers to update the label if the originating drug had been withdrawn from the market for reasons other than safety.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> As of May 2016 the rule, which turned out to be controversial since it would open generic companies to product liability suits, was still not finalized, and the FDA had stated the final rule would be issued in April 2017.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref> The FDA issued a draft guidance for generic companies to update labels in July 2016.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
Society and cultureEdit
Brand namesEdit
| CitationClass=web
}}</ref><ref>Template:Cite book</ref> | ||
| A | citation | CitationClass=web
}}</ref> Anausin Métoclopramide, Anolexinon, Antiementin, Antigram (Metoclopramide and Acetylsalicylic Acid), Aswell |
| B | Balon, Betaclopramide, Bio-Metaclopramide, Bitecain AA | |
| C | Carnotprim, Carnotprim, Cephalgan (metoclopramide and carbasalate calcium), Cerucal, Chiaowelgen, Chitou, Clifar (Metoclopramide and Simeticone), Clodaset (metoclopramide and ondansetron), Clodoxin (metoclopramide and pyridoxine), Clomitene, Clopamon, Clopan, Cloperan, Cloprame, Clopramel, Clozil | |
| D | Damaben, Degan, Delipramil, Di-Aero OM (metoclopramide and simeticone), Dibertil, Digenor (Metoclopramide and Dimeticone), Digespar (Metoclopramide and Simeticone), Digestivo S. Pellegrino, Dikinex Repe (Metoclopramide and Pancreatin), Dirpasid, Doperan, Dringen | |
| E | Egityl (metoclopramide and acetylsalicylic Acid), Elieten, Eline, Elitan, Emenil, Emeprid (veterinary use), Emeran, Emetal, Emoject, Emperal, Enakur, Enteran, Enzimar, Espaven M.D. (Metoclopramide and Dimethicone), Ethiferan, Eucil | |
| F | Factorine (Metoclopramide and Simeticone) | |
| G | Gastro-Timelets, Gastrocalm, Gastronerton, Gastrosil, Geneprami | |
| H | H-Peran, Hawkperan, Hemibe, Horompelin | |
| I | Imperan, Isaprandil, Itan | |
| J | ||
| K | K.B. Meta, Klometol, Klopra | |
| L | Lexapram, Linperan, Linwels | |
| M | Malon, Manosil, Maril, Matolon, Maxeran, Maxolon, Maxolone, Meclam, Meclid, Meclizine, Meclomid, Meclopstad, Meniperan, Mepram, Met-Sil, Metajex, Metalon, Metamide, Metilprednisolona Richet, Metoceolat, Metoclor, Metoco, Metocol, Metocontin, Metomide (veterinary use), Metonia, Metopar (Metoclopramide and Paracetamol), Metopar (Metoclopramide and Paracetamol), Metopelan, Metoperan, Metoperon, Metopran, Metotag, Metozolv, Metpamid, Metsil, Mevaperan, Midatenk, Migaura (Metoclopramide and Paracetamol), Migpriv (Metoclopramide and Acetylsalicylic Acid), Migracid (Metoclopramide and Paracetamol), Migraeflux MCP (Metoclopramide and Paracetamol), Migrafin (Metoclopramide and Aspirin), Migralave + MCP (Metoclopramide and Paracetamol), MigraMax (Metoclopramide and Acetylsalicylic Acid), Migräne-Neuridal (Metoclopramide and Paracetamol), Migränerton (Metoclopramide and Paracetamol), Motilon | |
| N | N-Metoclopramid, Nastifran, Nausil, Nevomitan, Nilatika, Novomit | |
| O | Opram | |
| P | Pacimol-M (Metoclopramide and Paracetamol), Pangastren (Metoclopramide and Simeticone), Paramax (Metoclopramide and Paracetamol), Paspertin, Peraprin, Perinorm, Perinorm-MPS (Metoclopramide and Dimeticone), Perone, Piralen, Plamide, Plamine, Plasil, PMS-Metoclopramide, Podokedon, Polun, Poriran, Pradis, Pramidin, Pramidyl, Pramin, Praux, Premig (Metoclopramide and Acetylsalicylic Acid), Premosan, Prenderon, Prevomic, Primadol (Metoclopramide and Paracetamol), Primavera-N, Premier, Primlan, Primperan, Primperil, Primperoxane (Metoclopramide and Dimeticone), Primram, Primran, Primsel, Pripram, Prokinyl, Promeran, Prometin, Prowel, Pulin, Pulinpelin, Pulperan, Pusuan, Putelome, Pylomid | |
| Q | ||
| R | R-J, Raclonid, Randum, Reglan, Reglomar, Reliveran, Remetin, Riamide, Rilaquin, Rowelcon | |
| S | Sabax Metoclopramide, Sinprim, Sinthato, Soho, Indonesia, Sotatic, Stomallin, Suweilan | |
| T | Talex (Metoclopramide and Pancreatin), Tivomit, Tomit, Torowilon | |
| U | ||
| V | Vertivom, Vilapon, Vitamet, Vomend (veterinary use), Vomesea, Vomiles, Vomipram, Vomitrol, Vosea | |
| W | Wei Lian, Winperan | |
| X | ||
| Y | ||
| Z | Zudaw |
Veterinary useEdit
Metoclopramide is commonly used to prevent vomiting in cats and dogs. It is also used as a gut stimulant in rabbits.<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>
ReferencesEdit
External linksEdit
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