Domperidone General Information

Domperidone is widely available in every country in the world. In the United States domperidone is not yet FDA approved but it is currently available at select compounding pharmacies with a doctor’s prescription. In Canada, domperidone was approved more than 20 years ago by Health Canada. This made it possible for a generic version to come onto the market enabling Canadians to obtain this medication economically.

Note that: It is perfectly legal for a US doctor to prescribe domperidone even though it isn’t available in the US. Any Canadian pharmacy can send you domperidone if you get a prescription from your doctor. And it is legal for a US citizen to bring domperidone into the US for personal use provided it is accompanied by a doctor’s prescription, a letter stating that the medication is for the patient’s personal use, and the shipment does not exceed a 3 month supply.

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FDA regulations

Note: for best results it’s a good idea to take domperidone 1/2 hour before meals and at least 1 hour before pumping or breastfeeding.

FDA regulations state that the following criteria must be met to import medications into the US. It is legal for US residents to import medications from outside the US provided the following conditions are met.

1. The product was purchased for personal use and does not exceed a 3 month supply.
2. The product is not for resale.
3. The intended use of the product is appropriately identified.
4. The patient seeking to import the product affirms in writing that it’s for the patient’s own use.
5. The patient provides the name and address of the doctor licensed in the US responsible for his or her treatment with the product.
6. The medication is not a controlled substance, e.g. sleeping pills, Valium, narcotics.

   Although domperidone is not readily available in the US, you may still obtain the medication.

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Here is what Dr. Thomas Hale says about domperidone in his book “Medications and Mother’s Milk, 2002”, Pharmasoft Publishing, p. 230

Domperidone

Trade name: Motilium
Can/Aus/ UK: Motilium
Uses: Nausea and vomiting, stimulates lactation
AAP: Approved by the American Academy of Pediatrics for use in breastfeeding mothers

Domperidone (Motilium) is a peripheral dopamine antagonist (similar to Reglan) generally used for controlling nausea and vomiting, dyspepsia, and gastric reflux. It is an investigational drug in the USA, and available only for compassionate use. It blocks peripheral dopamine receptors in the GI wall and in the CTZ (nausea center) in the brain stem and is currently used in Canada as an antiemetic. ¹ Unlike Reglan, it does not enter the brain compartment and it has few CNS effects such as depression.

It is also known to produce significant increases in prolactin levels and has proven useful as a galactagogue ¹ Serum prolactin levels have been found to increase from 8.1 ng/mL to 124.1 ng/mLin non-lactating women after one 20 mg dose ². Concentrations of domperidone reported in milk vary according to dose but following a dose of 10 mg three times daily; the average concentration in milk was 2.6 ug/L ³ . In a study by da Silva, 16 mothers with premature infants and low milk production (mean=112.8 mL/d in domperidone group; 48.2 mL/d in placebo group) were randomly chosen to receive placebo (n=9) or domperidone (10 mg TID) (n=7) for 7 days ⁴. Milk volume increased from 112.8 to 162.2 mL/d in the domperidone group sand 48.2 to 56.1 mL/d in the placebo group. Prolactin levels increased from 12.9 to 119.3 ug/L in the domperidone group, and 15.6 to 18.1 ug/L in the placebo group. On day 5, the mean domperidone concentration was 6.6 ng/mL in plasma and 1.2 ng/mL in breastmilk of the treated group (n=6). No adverse effects were reported in infants or mothers.

The usual oral dose for controlling GI distress is 10-20 mg three to four times daily although for nausea and vomiting the dose can be higher (up to 40 mg). The galactagogue [milk making] dose is suggested to be 10-20 mg orally 3-4 times daily. At present, this product is unavailable in the USA.

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Pregnancy Risk Category:

Lactation Risk Category: L2 "Drug, which has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant. And/or, the evidence of a demonstrated risk, which is likely to follow use of this medication in a breastfeeding woman, is remote."

Theoretic Infant Dose: 0.4 ug/kg/day

Adult Concerns: Dry mouth, skin rash, itching, headache, thirst, abdominal cramps, diarrhea, drowsiness. Seizures have occurred rarely.

Pediatric Concerns: None reported.

Drug Interactions: Cimetidine, famotidine, nizatidine, ranitidine (H-2 blockers) reduce absorption of domperidone. Prior use of bicarbonate reduces absorption of domperidone.

Alternatives: Metoclopramide, Cisapride

Adult dosage: 20-40 mg 3-4 times daily

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T 1/2	=	7-14 hours (oral)		M/P	=	0.25
PHL	=			PB	=	93%
PK	=	30 min.		Oral	=	13-17%
MW	=	426		pKa	=
Vd	=

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References

1. Hofmeyr GJ and van Iddekinge B. Domperidone and lactation. Lanet i, 647,1983
2. Brouwers JR, Assies J, Wiersinga WM, Huizing G, Tytgat GN, Plasma prolactin levels after acute and subchronic oral administration of domperidone and of metoclopramide: a cross-over study in healthy volunteers. Clin Endocrinol (Oxf) 12(5): 435-40, 1980.
3. Hofmeyr GJ, et. Al. Domperidone: secretion in breast milk and effect on perperal prolactin levels. Brit. J. Obs. and Gyn. 92:141-144,1985.
4. da Silva OP, Knoppert DC, Angelini MM, Forret PA. Effect of randomized, double-blind, placebo-controlled trial. CMAJ. 164(1):17-21,2001

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Author’s Note: Please check with your doctor before beginning any medication.