ADOPTIVE BREASTFEEDING
NEWMAN-GOLDFARB PROTOCOLS FOR INDUCED LACTATIONIntroduction to Induced Lactation
Medical Conditions and the Protocols
Medications and Herbs
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.
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.
Although domperidone is not readily available in the US, you may still obtain the medication.
Here is what Dr. Thomas Hale says about domperidone in his book "Medications and Mother's Milk, 2002", Pharmasoft Publishing, p. 230
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.
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
| T 1/2 | = | 7-14 hours (oral) | M/P | = | 0.25 | |
| PHL | = | PB | = | 93% | ||
| PK | = | 30 min. | Oral | = | 13-17% | |
| MW | = | 426 | pKa | = | ||
| Vd | = |
Author's Note: Please check with your doctor before beginning any
medication.
Newman-Goldfarb Protocols. © Lenore Goldfarb, B.Comm, B.Sc, IBCLC
and Jack Newman, MD FRCPC, November 2002
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