What is the recommended duration and dosage of domperidone (10mg TID) for a breastfeeding woman with poor milk supply who has responded well to treatment?

Domperidone Duration and Dosing for Lactation Enhancement

Continue domperidone 10mg TID for 6-16 weeks total duration, with most women using it for approximately 6 weeks (median duration), though some may require longer treatment up to 16 weeks depending on response. 1

Current Dose Assessment

Your patient is already on an appropriate and safe dose:

• 10mg three times daily (30mg/day total) is the standard evidence-based dose for lactation enhancement 2, 3
• This dose falls within the lower half of the dosing spectrum used in clinical practice, where 50% of women use ≤30mg/day 1
• No dose escalation is needed if she is experiencing "excellent success" at this current dose 1

Duration of Treatment

Typical treatment duration ranges from 3-16 weeks, with a median of 6 weeks: 1

• Most women discontinue domperidone once adequate milk supply is established and maintained
• Some women require longer courses (up to 16 weeks) if supply remains dependent on the medication 1
• There is no absolute maximum duration specified in the literature, but treatment should be reassessed regularly

Safety Considerations at This Dose

At 30mg/day, the side effect profile is favorable:

• Only 38% of women experience side effects at doses ≤30mg/day, compared to 48% at 31-60mg/day and 73% at >61mg/day 1
• Common side effects include weight gain (25%), headaches (17%), and dry mouth (13%) 1
• Only 9% of women discontinue domperidone due to side effects 1

Domperidone demonstrates no significant increase in maternal side effects compared to placebo in mothers of preterm infants (RR = 1.20,95% CI [0.74 to 1.97]) 4

Monitoring and Reassessment

Monitor for:

• Continued effectiveness of milk supply enhancement
• Any maternal side effects (particularly headaches, weight gain, dry mouth) 1
• Infant well-being and adequate weight gain 2

Plan for discontinuation:

• Once milk supply is stable and adequate for 2-4 weeks, consider gradual weaning of domperidone
• Some women may experience supply decrease upon discontinuation and require reinitiation 1

Important Regulatory Context

Critical caveat: Domperidone is not FDA-approved in the United States for any indication, including lactation enhancement 5. The FDA issued warnings regarding cardiac risks including QT prolongation and arrhythmias 5. However, domperidone is approved and commonly used in other countries (including Canada, Australia, and many European nations) for lactation enhancement 1, 2.

Alternative consideration: If domperidone becomes unavailable or contraindicated, metoclopramide is FDA-approved and recommended by the American College of Obstetricians and Gynecologists as an alternative galactagogue, though it may be less effective 6, 4.

Clinical Algorithm for Continuation

1. Continue current dose of 10mg TID (no increase needed with excellent response) 2
2. Plan for 6-week course initially, with option to extend to 16 weeks if needed 1
3. Reassess at 6 weeks: If supply is stable, attempt gradual taper
4. If supply decreases with taper: Resume full dose and continue for additional 4-10 weeks 1
5. Monitor for side effects at each visit, particularly cardiac symptoms (palpitations, dizziness) 5