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Pronunciation:

(dom PE ri done)

Synonyms:

Domperidone Maleate

Generic Available:

Yes

Canadian Brand Names:

Alti-Domperidone; Apo-Domperidone®; Dom-Domperidone; FTP-Domperidone Maleate; Motilium®; Novo-Domperidone; Nu-Domperidone; ratio-Domperidone

Use:

Symptomatic management of upper GI motility disorders associated with chronic and subacute gastritis and diabetic gastroparesis; prevention of GI symptoms associated with use of dopamine-agonist anti-Parkinson agents

Restrictions:

Not available in U.S.

Pregnancy Risk Factor:

Pregnancy Implications:

Animal studies have not shown drug-related teratogenic or primary embryotoxic effects on animal fetuses, however, comparative studies have not been done in humans. Use only when benefit outweighs potential risk in a pregnant woman.

Lactation:

Enters breast milk/not recommended (AAP rates as "compatible")

Contraindications:

Hypersensitivity to domperidone or any component of the formulation; patients with GI hemorrhage, mechanical obstruction, or perforation; patients with prolactin-releasing pituitary tumor

Warnings/Precautions:

Domperidone may increase prolactin levels (dose-dependent response). Elevated prolactin may be asymptomatic (clinical consequence of chronically-elevated prolactin is unknown) or may present symptomatically as galactorrhea, gynecomastia, amenorrhea, or impotence (reversible upon decreasing dose or discontinuing drug).

QTc prolongation, life-threatening tachyarrhythmias, and cardiac arrest have been reported after domperidone use; these adverse effects may be precipitated in hypokalemic patients. Use with caution in patients with hepatic impairment. Use caution when administering domperidone to patients with a personal or family history of breast cancer. Use with caution in patients on MAO inhibitors. Safety and efficacy have not been established in pediatric patients.

Adverse Reactions:

1% to 10%:

Central nervous system: Headache/migraine (1%); does not cross blood-brain barrier; fewer CNS effects compared to metoclopramide

Gastrointestinal: Xerostomia (2%)

<1%: Abdominal cramps, constipation, diarrhea, dizziness, dysuria, edema, extrapyramidal symptoms (EPS) rarely, galactorrhea, gynecomastia, heartburn, hot flashes, increased prolactin, insomnia, irritability, nervousness, thirst, lethargy, leg cramps, mastalgia, menstrual irregularities, nausea, palpitation, pruritus, rash, regurgitation, stomatitis, urinary frequency, urticaria, weakness

Overdosage/Toxicology:

Symptoms of overdose include CNS effects (drowsiness, disorientation, and extrapyramidal reactions) and cardiovascular effects (arrhythmias and hypotension). Treatment is supportive.

Drug Interactions:

Substrate of CYP3A4 (minor)

Anticholinergics: May decrease effects of domperidone.

Domperidone may increase the rate of absorption of drugs from small bowel, while slowing absorption of drugs from the stomach. Absorption of sustained-release or enteric-coated tablets may be altered.

QTc-prolonging drugs: Use with caution in combination with domperidone; includes type Ia and type III antiarrhythmics, some fluoroquinolones, and selected antipsychotics (thioridazine, mesoridazine).

Stability:

Store at room temperature of 15°C to 30°C (59°F to 86°F); protect from light and moisture.

Mechanism of Action:

Domperidone has peripheral dopamine receptor blocking properties. It increases esophageal peristalsis and increases lower esophageal sphincter pressure, increases gastric motility and peristalsis, and enhances gastroduodenal coordination, therefore, facilitating gastric emptying and decreasing small bowel transit time.

Pharmacodynamics/Kinetics:

Protein binding: 93%

Metabolism: Hepatic via N-dealkylation (CYP3A4) and hydroxylation

Half-life elimination: 7 hours

Time to peak serum concentration: 30 minutes

Excretion: Feces (66%); urine (31%)

Dosage:

Oral: Adults:

GI motility disorders: 10 mg 3-4 times/day, 15-30 minutes before meals; severe/resistant cases: 20 mg 3-4 times/day, 15-30 minutes before meals

Nausea/vomiting associated with dopamine-agonist anti-Parkinson agents: 20 mg 3-4 times/day

Dosage adjustment in renal impairment: Decrease dose to 10-20 mg 1-2 times/day

Administration:

In GI motility disorders, administer 15-30 minutes prior to meals.

Monitoring Parameters:

Agitation, irritability, confusion, and rarely EPS

Dietary Considerations:

In GI motility disorders, should be taken 15-30 minutes prior to meals.

Patient Education:

Take as directed, 15-30 minutes prior to meals. Do not increase dosage without consulting prescriber (adverse effects may occur with overuse). May cause dizziness, headache, insomnia and irritability. Contact prescriber if experience abnormal, uncontrolled movements or confusion occur. Report breast pain or enlargement, milk production, menstrual irregularities, or impotence. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Additional Information:

Not available in U.S.

The Food and Drug Administration (FDA) has issued a warning concerning the off-label use of domperidone to increase milk production in breast-feeding women. Domperidone is not available for any use in the United States and does not have approval for this indication in other countries. However, the FDA is aware that women are obtaining domperidone from U.S. compounding pharmacies and foreign sources for this purpose. The FDA notes that there are health risks associated with the use of this product that is why it has been removed from marketing.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dosage Forms:

Tablet: 10 mg [domperidone maleate 12.72 mg]

International Brand Names:

Alti-Domperidone (CA); Apo-Domperidone® (CA); Cinet® (PT); Costi® (BG, CY, JO, SK); Costil® (ID); Dany® (TH); Digestadon® (ID); Digestivo Giuliani® (IT); Dolium® (TH); Dom-Domperidone (CA); Domedon® (ID); Domerdon® (TH); Dometa® (ID); Dometic® (ID); Domidon® (DE); Domidone® (TH); Dompel® (SG); Dompenyl® (SG); Domperdone® (TH); Domperide® (HK, JO, KW, LB, MT, MY, RO); Domperidon AbZ® (DE); Domperidona® (CL); Domperidona Gamir® (ES); Domperidona L.CH.® (CL); Domperidon AL® (DE); Domperidon beta® (DE); Domperidone® (GB); Domperidone Teva® (IT); Domperidon Hexal® (DE); Domperidon-ratiopharm® (DE); Domperidon Stada® (DE); Domperidon-TEVA® (DE); Domperidon von ct® (DE); Domper-M® (TH); Domper YSP® (SG); Domstal® (RO); Donum® (TH); Doridone® (SG); Ecuamon® (AR); Euciton® (AR); Fobidon® (IT); FTP-Domperidone Maleate (CA); Galflux® (ID); Gastrocure® (NL); Gastronorm® (IT); Gerdilium® (ID); Harmetone® (CO); Idon® (CL); Merck-Domperidon® (BE); Mirax-M® (TH); Mirax® (SG, TH); Mocydone® (TH); Modomed® (TH); Mogasinte® (PT); Molax-M® (TH); Molax® (TH); Moperidona® (AR); Moticon® (TH); Motidon® (TH); Motilium® (AR, AT, AU, BE, BG, BR, CA, CH, CR, CY, CZ, DE, DK, DO, EG, ES, FR, GB, GT, HK, HN, HU, ID, IE, IL, IT, JO, LB, LK, LU, MT, MX, NL, NZ, PA, PL, PT, RO, RU, SG, SV, TH, TR, ZA); Motilium Effervescent® (ZA); Motilium lingual® (PL); Motilium-M® (TH); Motilyo® (FR); Movelium-M® (TH); Movelium® (TH); Nautigo® (IN); Nauzelin® (ES, JP); Ninlium® (TH); Novo-Domperidone (CA); Nu-Domperidone (CA); Peptomet® (CY); Peridon® (IT); Péridys® (FR); Pondperdone® (TH); ratio-Domperidone (CA); Remotil® (PT); SCD Domeridone® (SG); Tametil® (SI); Tilidon® (ID); Vometa® (ID); Vomidone® (ID); Vomidon® (ZA); Zilium® (BE)

References

da Silva OP, Knoppert DC, Angelini MM, et al, "Effect of Domperidone on Milk Production in Mothers of Premature Newborns: A Randomized, Double-Blind, Placebo-Controlled Trial,"CMAJ, 2001, 164(1):17-21.

Drolet B, Rousseau G, Daleau P, et al, "Domperidone Should Not be Considered a No-Risk Alternative to Cisapride in the Treatment of Gastrointestinal Motility Disorders,"Circulation, 2000, 102(16):1883-5.

"FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production," FDA Talk Paper T04-17, June 7, 2004, available at http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html, last accessed February 8, 2005.

pms-Domperidone product monograph, Pharmascience Inc, Quebec, October 1997.

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