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Lipika Samal M.D. and Paul A. Pham, Pharm.D.
04-14-2010
- Not FDA approved
- FDA encourages physicians who would like to prescribe domperidone for their patients with severe gastrointestinal disorders that are refractory to standard therapy to open an Investigational New Drug Application (IND).
- Domperidone is a dopamine antagonist (blocking both D1 & D2 receptors).
- Domperidone facilitates gastrointestinal smooth muscle activity by inhibiting dopamine at the D1 receptors and inhibiting neuronal release of acetylcholine by blocking D2 receptors.
Treatment of gastric hypomotility: 10 to 20 milligrams up to three times daily, before meals and at night.
brand
name
| generic
| Mfg
| brand
forms
| cost*
|
| Domperidone maleate | domperidone | Available under a treatment IND. Call the FDA (301) 796-3400 | oral
tablet
10mg | n/a |
*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP).
AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's
information, and the McKesson database.
^Dosage is indicated in mg unless otherwise noted.
- Renal excretion is low so dosage adjustment may not be necessary.
- Extensive liver metabolism. Avoid or use with caution in severe liver disease.
- Excreted in breast milk; the FDA advises against use in breastfeeding women.
- Most studies have reported minimal side effects with repeated doses of domperidone, usually between 30 and 60 mg daily, for several weeks.
- Occasional reported side effects include dry mouth, transient skin rash or itching, headache, thirst, abdominal cramps, diarrhea, drowsiness and nervousness.
- CNS: somnolence, akathisia, asthenia, anxiety, depression, and reduced mental acuity
- Endocrine: hyperprolactinemia, gynecomastia, mastalgia, menstrual disturbances, galactorrhea
- Cardiac: ventricular fibrillation (reported with high dose IV administration), prolonged QT interval
- CNS: extrapyramidal symptoms (EPS), neuroleptic Malignant Syndrome (NMS), seizures are rare since domperidone has low CNS penetration.
- Torsades de Pointes
- Lithium may interact with dopamine antagonists, particularly haldol, and may also interact with domperidone. Weakness, dyskinesias, increased extrapyramidal symptoms, and encephalopathy may occur with coadministration and should be avoided. Lithium levels should be monitored and titrated to the low therapeutic range.
- Not currently FDA approved for treatment of diabetic gastroparesis but often used off-label for this indication
- For the management of diabetic gastroparesis, domperidone can be considered in cases unresponsive to metoclopramide or low dose erythromycin.
- Domperidone and metoclopramide likely have similar effects in alleviating symptoms of diabetic gastroparesis, but domperidone results in less CNS side effects (Patterson).
- Potentially serious side effects include cardiac arrest and arrhythmias.
- The FDA does not recommend the use of domperidone to stimulate lactation.
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