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Domperidone (United States: Available via FDA investigational drug [IND] protocol only): Drug information

Domperidone (United States: Available via FDA investigational drug [IND] protocol only): Drug information
(For additional information see "Domperidone (United States: Available via FDA investigational drug [IND] protocol only): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • APO-Domperidone;
  • BIO-Domperidone;
  • DOM-Domperidone;
  • Domperidone-10;
  • GMD-Domperidone;
  • JAMP-Domperidone;
  • Mar-Domperidone;
  • PMS-Domperidone;
  • Priva-Domperidone;
  • PRZ-Domperidone;
  • TARO-Domperidone;
  • TEVA-Domperidone
Pharmacologic Category
  • Dopamine Antagonist;
  • Gastrointestinal Agent, Prokinetic
Dosing: Adult

Note: Use the lowest effective dose for the shortest duration necessary.

GI motility disorders (diabetic gastroparesis, gastritis): Oral: 10 mg 3 times daily (maximum: 30 mg/day). The American College of Gastroenterology recommends initiating at 10 mg 3 times daily (Camilleri 2013).

Nausea/vomiting associated with dopamine-agonist anti-Parkinson agents: Oral: 10 mg 3 times daily (maximum: 30 mg/day).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer’s labeling; however, depending on severity of impairment, frequency should be reduced to 1 to 2 times daily and dosage reduction considered with repeated administration.

Dosing: Hepatic Impairment: Adult

Mild impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution (undergoes hepatic metabolism).

Moderate or severe impairment: Use is contraindicated.

Dosing: Older Adult

Refer to adult dosing.

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 10 mg

Product Availability

Not available in the US

Prescribing and Access Restrictions

Domperidone is available via an Investigational New Drug Application (IND) in the United States for severe GI disorders refractory to standard therapy. For more information on the requirements for the IND, contact the Food and Drug Administration (FDA) at 301-796-3400.

Administration: Adult

Oral: In GI motility disorders, administer 15 to 30 minutes prior to meals and at bedtime if needed.

Use: Labeled Indications

Note: Not approved in the United States.

GI motility disorders: Symptomatic management of upper GI motility disorders associated with chronic and subacute gastritis and diabetic gastroparesis

Nausea/vomiting associated with dopamine-agonist anti-Parkinson agents: Prevention of GI symptoms (eg, nausea, vomiting) associated with use of dopamine-agonist anti-Parkinson agents

Medication Safety Issues
Sound-alike/look-alike issues:

Domperidone may be confused with iloperidone, paliperidone

Other safety concerns:

ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Headache (≤1%), migraine (≤1%)

Gastrointestinal: Xerostomia (2%)

<1%, postmarketing, and/or case reports: Abdominal cramps, acid regurgitation, change in appetite, conjunctivitis, constipation, diarrhea, dizziness, dysuria, edema, extrapyramidal reaction (rare), galactorrhea, gynecomastia, heartburn, hot flash, increased serum ALT, increased serum AST, increased serum cholesterol, increased serum prolactin, increased thirst, insomnia, irritability, leg cramps, lethargy, mastalgia, menstrual disease, nausea, nervousness, palpitations, pruritus, skin rash, stomatitis, torsades de pointes, urinary frequency, urticaria, weakness

Contraindications

Hypersensitivity to domperidone or any component of the formulation; prolactin-releasing pituitary tumor (prolactinoma); known existing prolongation of cardiac conduction intervals, particularly QT; significant electrolyte disturbances; underlying cardiac disease (eg, heart failure); moderate or severe hepatic impairment; patients with GI hemorrhage, mechanical obstruction, or perforation; concomitant use with potent CYP3A4 inhibitors such as azole antifungals (eg, ketoconazole), macrolides (eg, erythromycin), protease inhibitors, or nefazodone; concomitant use with QT-prolonging drugs

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: [Canadian Boxed Warning]: Domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death, particularly with doses >30 mg or when used in patients >60 years of age. Use the lowest possible dose for the shortest duration necessary. Do not exceed 30 mg/day. Avoid use of domperidone for the following: concomitant use of drugs which prolong the QTc interval and with potent CYP3A4 inhibitors which may increase domperidone exposure, existing prolongation of cardiac conduction intervals (particularly QT), significant electrolyte disturbances or underlying cardiac diseases (eg, heart failure). QTc prolongation, life-threatening tachyarrhythmias (eg, torsade de pointes), and cardiac arrest have been reported after use; these adverse effects may be precipitated in patients with preexisting prolonged cardiac conduction or other underlying cardiac disease, hypokalemia, or receiving other QTc-prolonging agents. The American College of Gastroenterology guidelines recommend baseline and follow-up ECGs and avoiding use if corrected QT is >450 msec in male patients or >470 msec in female patients (Arnold 2013; Camilleri 2013).

• Elevated prolactin levels: May increase prolactin levels (dose-dependent response); 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). Use is contraindicated in patients with prolactinomas.

Disease-related concerns:

• Breast cancer: Use caution when administering to patients with a personal or family history of breast cancer; evidence regarding an association between chronic use of dopamine-receptor antagonists and breast cancer is limited and nonconclusive.

• Hepatic impairment: Undergoes extensive hepatic metabolism; use is contraindicated in patients with moderate to severe hepatic impairment; use with caution in mild impairment.

• Renal impairment: Use with caution in patients with severe renal impairment; dosage and/or frequency of administration may need adjusted with repeated use and/or long-term therapy. Monitor renal function regularly, particularly with long-term therapy.

Other warnings/precautions:

• Breast milk production stimulant: In 2004, the Food and Drug Administration (FDA) issued a warning recommending that domperidone not be used off-label to increase milk production in breast-feeding women due to safety concerns. Several cases of cardiac arrhythmia, cardiac arrest, and sudden death have been reported in patients receiving intravenous domperidone. The risk of similar adverse events in breast-feeding women is unknown. Domperidone is not available for any use in the United States (except via severe GI disorder IND) and does not have approval for this indication in other countries.

Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2B6 (minor), CYP2C8 (minor), CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Anticholinergic Agents: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Domperidone. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Domperidone. Risk X: Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Domperidone. Risk X: Avoid combination

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fosfomycin: Gastrointestinal Agents (Prokinetic) may decrease the serum concentration of Fosfomycin. Risk C: Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Haloperidol: May enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Lefamulin: May enhance the QTc-prolonging effect of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Risk X: Avoid combination

Levoketoconazole: QT-prolonging CYP3A4 Substrates may enhance the QTc-prolonging effect of Levoketoconazole. Levoketoconazole may increase the serum concentration of QT-prolonging CYP3A4 Substrates. Risk X: Avoid combination

Levosulpiride: Benzamide Derivatives may enhance the adverse/toxic effect of Levosulpiride. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Domperidone. Monoamine Oxidase Inhibitors may diminish the therapeutic effect of Domperidone. Domperidone may diminish the therapeutic effect of Monoamine Oxidase Inhibitors. Risk C: Monitor therapy

Ondansetron: Domperidone may enhance the QTc-prolonging effect of Ondansetron. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Opioid Agonists: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Pentamidine (Systemic): Domperidone may enhance the QTc-prolonging effect of Pentamidine (Systemic). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Posaconazole: May increase the serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Risk X: Avoid combination

QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of Domperidone. Risk X: Avoid combination

QT-prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): Domperidone may enhance the QTc-prolonging effect of QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk). QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Domperidone. Risk X: Avoid combination

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of Domperidone. QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Domperidone. Risk X: Avoid combination

Sirolimus (Conventional): Gastrointestinal Agents (Prokinetic) may increase the serum concentration of Sirolimus (Conventional). Risk C: Monitor therapy

Food Interactions

Domperidone serum concentrations may be increased when taken with grapefruit juice. Management: Avoid concurrent use.

Pregnancy Considerations

Outcome information following maternal use of domperidone during pregnancy is limited. Based on available information from observational studies and health care database studies, an increased risk of adverse fetal events has not been observed following maternal use of domperidone in the first trimester (Araujo 2021; Choi 2013; Cottin 2015; Hishinuma 2021; Ishikawa 2022).

Breastfeeding Considerations

Domperidone is present in breast milk.

Information related to the presence of domperidone in breast milk is available from multiple studies (da Silva 2001; Hofmeyr 1983; Knoppert 2013; Wan 2008).

• One study included 6 mothers of preterm infants with a postpartum milk production of <300 mL/day following 2 to 3 weeks of usual interventions to increase milk production. Domperidone was administered in doses of 30 or 60 mg/day in evenly divided doses every 8 hours and breast milk was sampled at intervals over 8 hours following 1 week of therapy. Median concentrations of domperidone in breast milk were 0.28 ng/mL following a 30 mg/day dose and 0.49 ng/mL with the 60 mg/day dose. Using the median milk concentrations, authors of the study calculated the estimated exposure to the breastfeeding infant to be 0.04 mcg/kg/day (relative infant dose 0.012% compared to a weight-adjusted maternal dose of 30 mg/day) or 0.07 mcg/kg/day (relative infant dose 0.009% compared to a weight-adjusted maternal dose of 60 mg/day) (Wan 2008).

• Domperidone was used in a study of women 14 to 21 days postpartum with a daily milk volume of <500 mL following delivery at <33 weeks' gestation. Patients in this study received oral domperidone 10 mg 3 times a day (n = 8) or 20 mg 3 times a day (n = 7) for 4 weeks. Breast milk was sampled 3, 6, and 8 hours after the maternal dose, between days 10 and 15 of therapy. The highest median milk concentration of domperidone was 6.9 ng/mL, which occurred 3 hours after the 20 mg dose. Adverse events were not observed in the breastfed infants (Knoppert 2013). Using a milk concentration of 6.9 ng/mL, the relative infant dose of domperidone is 0.12% compared to a weight-adjusted maternal dose of 20 mg, providing an estimated daily infant dose via breast milk of 0.001 mg/kg/day.

• Most available studies did not evaluate adverse events in breastfed infants following maternal use of domperidone (Shen 2021). One study reported events following maternal use of domperidone 10 mg 3 times daily (n = 45 mothers, 52 infants) or placebo (n = 45 mothers, 51 infants). Two cases of QTc interval change (442 to >500 msec) were noted in newborns in the domperidone group and 1 case in the placebo group after 14 days. There were no symptoms noted in the infants and no treatment was required (Asztalos 2017).

• Breastfeeding is not recommended by the manufacturer. However, breastfeeding is generally considered acceptable when the relative infant dose of a medication is <10% (Anderson 2016; Ito 2000).

Domperidone may increase prolactin concentrations and cause galactorrhea and gynecomastia. As such, it has been used off label as a galactagogue in patients with insufficient milk production. Pooled data from available studies note milk production may be increased over placebo (Foong 2020; Grzeskowiak 2018; Osadchy 2012; Paul 2015; Shen 2021; Taylor 2019).

Case reports describe the use of domperidone (in combination with other therapies) to induce lactation in transgender patients undergoing feminizing hormone therapy, or adoptive patients who wish to breastfeed (Al-Mohsen 2021; Reisman 2018; Wamboldt 2021).

Canadian product labeling notes domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death, particularly with doses >30 mg or use in older patients. A retrospective study conducted by linking administrative health databases in Canada found the incidence of ventricular tachycardia or sudden cardiac death in postpartum patients between 15 and 55 years of age taking domperidone to be rare. Postpartum use of domperidone decreased over the study period (2004 to 2017) and any potential increased risk associated with these adverse events was not able to be confirmed. The data collected were not able to limit to only patients using domperidone for lactation but did exclude patients using domperidone prior to pregnancy (Moriello 2021). The risk of adverse cardiac events may be increased in patients with a history of arrythmias or those using concomitant medications that may inhibit the metabolism of domperidone (ABM [Brodribb 2018]). Psychiatric symptoms, including insomnia and anxiety/panic attacks, were reported in 2 women 1 to 2 weeks after discontinuing domperidone (Doyle 2018; Papastergiou 2013). Other adverse events reported in the mother are similar to those reported following domperidone use for labeled indications (Shen 2021).

Domperidone is not currently approved in any country as a galactagogue (Sewell 2017). The US Food and Drug Administration (FDA) has issued a warning recommending that domperidone not be used off label to increase milk production in breastfeeding patients due to safety concerns related to cardiac arrhythmias, cardiac arrest, and sudden death (FDA 2004). In Canada where domperidone is approved for other indications, a maximum daily dose has been recommended to decrease the incidence of abnormal heart rhythms and cardiac arrest (Health Canada 2015); some studies evaluating domperidone off label as a galactagogue have used doses higher than the maximum recommended labeled indication (Jantarasaengaram 2012; Knoppert 2013).

Due to the potential for adverse maternal events, a full evaluation for medical causes of low milk supply and nonpharmacologic measures should be considered prior to the use of medications as galactagogues. The Academy of Breastfeeding Medicine does not recommend use of any specific galactagogue due to inconclusive data and potential adverse effects. If use of domperidone is being considered, patients should be screened for a history of cardiac arrhythmias and concurrent use of medications that may increase the risk of arrhythmias. An ECG prior to use and 48 hours after domperidone is initiated may be considered for some patients. Various doses and durations of therapy have been suggested; generally, the maximum effect is observed by 7 to 14 days. The lowest possible dose for the shortest duration of time is recommended. In addition, consider a gradual discontinuation of domperidone (ABM [Brodribb 2018]).

Monitoring Parameters

Renal function; ECG (baseline and then periodically during therapy)

Mechanism of Action

Domperidone has peripheral dopamine receptor blocking properties and does not readily cross the blood-brain barrier. 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.

Pharmacokinetics

Protein binding: 93%

Metabolism: Hepatic via CYP3A4, N-dealkylation and hydroxylation

Half-life elimination: 7 hours (increases to ~21 hours in severe renal impairment)

Time to peak serum concentration: 30 minutes

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

Brand Names: International
  • Agilam (VE);
  • Almedon (PK);
  • Amistop (BH);
  • Apildon (HK);
  • Bropasmo (PY);
  • Brulium (UA);
  • Cilroton (GR);
  • Costi (TW);
  • Costil (ID);
  • Dany (TH);
  • Dispel (PH);
  • Domerdon (TH);
  • Domerid (IE, MT);
  • Dometa (ID);
  • Domidon (UA);
  • Domigest (EG);
  • Domne (MY);
  • Domp (BD);
  • Domp-M (TH);
  • Dompe (TW);
  • Domper (MY, PH, TW);
  • Domperid (CN);
  • Domperine (KR);
  • Dompidone (EG);
  • Dompil (VN);
  • Dompy (AE, BH, QA);
  • Domrid (UA);
  • Domstal (IN, ZW);
  • Don-A (PH);
  • Dosin (CL);
  • Emelium (LK);
  • Gasdol (CL);
  • Gasidone (PH);
  • Gastroflux (GT);
  • Gastromotil (EG);
  • Gerdilium (ID);
  • GI Norm (PH);
  • Hamidon (KR);
  • Harmetone (CO);
  • Idon (PE, PY);
  • Mocydone M (TH);
  • Mododom (AE, LB, QA);
  • Modomed (TH);
  • Mogasinte (PT);
  • Motidone (MY);
  • Motigut (MY);
  • Motilat (JO, LB);
  • Motilia (PH);
  • Motilium (AE, AR, AT, AU, BB, BE, BG, BH, BM, BR, BS, BZ, CH, CN, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FR, GB, GT, GY, HK, HN, HU, ID, IE, IL, IT, JM, JO, KR, KW, LB, LK, LT, LU, LV, MT, MX, MY, NI, NL, NZ, PA, PE, PH, PK, PR, PT, PY, QA, RO, RU, SG, SR, SV, TR, TT, TW, UA, UY, VN, ZA, ZW);
  • Motilium [tabs.] (PL);
  • Motinorm (IN, PH);
  • Mutilium (SA);
  • Nauzelin (ES, JP);
  • Netaf (PE);
  • Nidolium (TW);
  • Ninlium (TH);
  • Nordonil (PT);
  • Oroperidys (FR);
  • Pepridon (PH);
  • Peptomet (BH, CY);
  • Peridon (IT, JO);
  • Peridone (LK);
  • Peridys (FR);
  • Prevomit FT (VN);
  • Prokinin (QA);
  • Rabugen (MY);
  • Rabugen-M (HK, MY);
  • Remotil (PT);
  • Seronex (CR, DO, GT, HN, MX, NI, PA, SV);
  • Siligaz (CL);
  • Smood (MY);
  • Stopvom (IN);
  • Tametil (HR);
  • Tilidon (ID);
  • Vave (BD);
  • Vemetis-10 (HK);
  • Vometa (ID, PH);
  • Vometa FT (LK, MY);
  • Vomitil (PK);
  • Vomitil-M (TH);
  • Weitul (TW);
  • Xepadon (BD);
  • Yaridon (ID);
  • Zidon-DT (IN);
  • Zilium (BE);
  • Zydom (PH)


For country abbreviations used in Lexicomp (show table)

REFERENCES

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  32. Taylor A, Logan G, Twells L, Newhook LA. Human milk expression after domperidone treatment in postpartum women: a systematic review and meta-analysis of randomized controlled trials. J Hum Lact. 2019;35(3):501-509. doi:10.1177/0890334418812069 [PubMed 30481478]
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