Domperidone general information

The Protocols for Induced Lactation — A Guide for Maximising Breastmilk Production 
By Jack Newman, MD, FRCPC and Lenore Goldfarb, Ph.D., CCC, IBCLC

Based on the original Induced Lactation Protocol conceived and published by Jack Newman MD

The Newman-Goldfarb protocols were developed from information published in Dr. Newman’s book “Dr. Jack Newman’s Guide to Breastfeeding” (Harper-Collins, 2000). In the US the title is “The Ultimate Breastfeeding Book of Answers” by Dr. Jack Newman (Prima Publishing, 2000).

Domperidone – Information for Breastfeeding Parents

Domperidone (Motilium) is a drug that, as a side effect, increases breastmilk production by increasing prolactin (a hormone involved in making milk) secretion from the pituitary gland. Domperidone is generally used for problems with the gastrointestinal (GI) tract, or gut. It has not been released in Canada for increasing milk supply, but this does not mean it cannot be prescribed for this reason, just that the manufacturer does not support this use. There are many studies that show that domperidone works to increase milk supply and is relatively safe to use.

Metoclopramine (Maxeran, Reglan) is also known to increase milk supply, but it has frequent and unpleasant side effects (like fatigue, irritability, and depression). Domperidone has fewer side effects and is better tolerated by most people – this is because it does not enter the brain in significant amounts. Note, even if you have “enough milk”, increasing the milk supply also increases the flow of milk. This is helpful for many situations, including sore nipples, fussiness at the breast, and refusing to latch.

Domperidone should not be the only approach to address breastfeeding challenges. It should be used along with other strategies to increase milk supply and improve the breastfeeding situation. See the other information sheets at www.ibconline.ca, including “Protocol to Increase Breastmilk Intake” and “Late Onset Decreased Milk Supply or Flow”.

Using Domperidone

Generally, we start with 30 mg (three 10 mg tablets) three times per day – a total of 9 tablets per day. In some situations we will go as high as 40 mg four times per day (or, for convenience, 60 mg once per day and 50 mg twice per day). The pharmacist may instruct you to take each does 30 minutes before eating, but that is because of its usual use for digestive problems. Taking domperidone on an empty stomach does allow it to be better absorbed, but it is not necessary to do this for it to work to increase breastmilk production. Spread the doses out throughout the day and take it when it is most convenient for you.

After starting domperidone, it often takes three or four days before you notice any effect. It usually takes about two weeks to get a maximum effect, but some find it takes even longer. It may also be important to remember that domperidone usually only begins to work three or four weeks after birth, but sometimes earlier. Sometimes the herbal remedies work best early on (see the information sheet, “Herbal Remedies for Milk Supply” at www.ibconline.ca).

Side Effects

As with all medications, side effects are possible. There is no such thing as a 100% safe drug. However, in our clinical experience, side effects in the breastfeeding parent are very uncommon. Some people may experience headache, dry mouth, abdominal cramps, weight gain/increased appetite, and alteration of menstrual periods (usually stopping them, if they have resumed; breakthrough bleeding is also possible). Most of those who experience side effects find they disappear after a few days.

The amount of domperidone that gets into the breastmilk is very small and side effects in the baby should not be expected. Domperidone is sometimes given to babies with reflux and the amount they get through the milk is a very small percentage of what they would get if they were treated with domperidone directly.

How Long to Take Domperidone

As a general recommendation, continue taking domperidone until your baby is well established on solid foods. Some people are able to stop domperidone sooner than this, if the breastfeeding challenges have resolved and things have been going very well for a least a few weeks. Some people continue domperidone for many months and some beyond a year. Worldwide experience with domperidone over at least 20 years suggests that long-term side effects are uncommon.

Stopping Domperidone

When you are ready to stop taking domperidone, you should gradually wean off it. This is to prevent a possibly significant drop in your milk supply and side-effects (like anxiety and loss of appetite) that may occur if domperidone is stopped suddenly.

To wean from domperidone, decrease your daily dose by one tablet per day per week (so, for example, if you are taking 30 mg three times per day, or nine tablets per day, you would first decrease to eight tablets per day). After seven days, if you see no decrease in your milk supply, decrease the daily dose by one tablet again. Continue in this way until you have completely stopped the medication. If, at any point during the weaning process, you notice your milk supply decreasing significantly or your previous breastfeeding challenges (or new ones) arise, return to the previous effective dose. Try resuming the weaning process again after a couple of weeks.

You may hear about domperidone:

In 2004, the Federal Drug Administration (FDA) in the United States put out a warning against using domperidone because of possible heart-related side effects. However, these side effects occurred only when the drug was given intravenously to otherwise very sick patients, taking many other drugs.

In 2012, Health Canada endorsed a warning put forth by the company who manufacturers domperidone. This warning was about oral doses higher than 30 mg per day and the risk of heart-related side effects. However, the research cited to support this warning involved patients with an average age of over 70 years old, many of whom had pre-existing health conditions. These warnings do not apply to the population to whom we prescribe domperidone (typically younger, healthy women) and we have continued to prescribe it to breastfeeding parents as we have for more than 30 years. We have treated thousands of people with domperidone and we are not aware of any one of them experiencing heart-related side effects due to domperidone. Also, as of 2015, Health Canada had never received any reports of serious heart-related adverse effects in anyone of childbearing age taking domperidone.

Questions or concerns?

Email Dr. Jack Newman (read the page carefully, and answer the listed questions).

Make an appointment at the Newman Breastfeeding Clinic.


The information presented here is general and not a substitute for personalized treatment from an International Board Certified Lactation Consultant (IBCLC) or other qualified medical professionals. This information sheet may be copied and distributed without further permission on the condition that it is not used in any context that violates the WHO International Code on the Marketing of Breastmilk Substitutes (1981) and subsequent World Health Assembly resolutions. If you don’t know what this means, please This email address is being protected from spambots. You need JavaScript enabled to view it. to ask!


©IBC, November 2016

Domperidone: How it works and how it compares to Reglan

Several medications have, as a side effect, the production of breastmilk. Digitalis, cholopramzine and other major tranquilizers are just a few of them. With medical management, it is not necessary to have been pregnant in order to produce breastmilk.

Domperidone is an anti-emetic or anti-nausea drug that was initially prescribed for people with upper gastrointestinal problems. Domperidone is not a hormone but it has a side effect that results in an increase in prolactin levels. It was discovered that, when some women would take the drug, this increase in prolactin levels could in turn cause lactation.

As with most drugs, very little of the domperidone ends up in the breastmilk. The baby gets only minute amounts. There is another similar drug that is found in the US called Reglan (Metoclopramide). However, it is not recommended for long-term use in lactating women. It crosses the blood-brain barrier and can cause neurological problems and depression.Note that, according to the the American Academy of Pediatrics classification, Reglan (metoclopramide) is a drug “whose effect on nursing infants is unknown or may be of concern.”

Domperidone is not known to cross the blood-brain barrier in significant amounts and is used to treat chronic conditions that require its long-term use. It is not known to cause depression. Since domperidone does not cross the blood-brain barrier it is much safer for mother and baby. They even give domperidone to babies in Canada suffering from from severe regurgitation. Right now domperidone is not widely available in the US except at a few compounding pharmacies, but domperidone has been approved for use in breastfeeding mothers by the American Academy of Pediatrics.

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.


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.


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.


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


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

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

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

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