Is pantoprazole (proton pump inhibitor) 40mg plus domperidone (antiemetic and prokinetic agent) 30mg safe during breastfeeding?

Safety of Pantoprazole 40mg Plus Domperidone 30mg During Breastfeeding

Both pantoprazole 40mg and domperidone 30mg are compatible with breastfeeding, with minimal drug transfer to breast milk and no expected adverse effects in the infant.

Pantoprazole Safety Profile

Pantoprazole is minimally excreted into breast milk and is safe during breastfeeding. 1

• The milk/plasma ratio is only 0.022, measured at peak concentration 2 hours after a 40mg dose 1
• The relative infant dose is extremely low at 0.14% of the weight-normalized maternal dose 1
• The actual infant exposure is estimated at only 7.3 micrograms when consuming 200 mL of milk at peak concentration 1
• The systemic absorption in the infant is expected to be even lower because pantoprazole is unstable in acidic pH and will be degraded in the infant's stomach 1
• No adverse events were detected in the breastfed infant in the published study 1

Domperidone Safety and Efficacy Profile

Domperidone is compatible with breastfeeding and is actually used therapeutically to increase milk production in lactating women. 2, 3

Transfer to Breast Milk

• Domperidone levels in breast milk are low due to extensive first-pass hepatic and intestinal metabolism when taken orally 3
• The Association of Anaesthetists explicitly lists domperidone among anti-emetics compatible with breastfeeding 2
• In studies exposing 113 infants to domperidone through breastfeeding, no adverse effects were observed in 85 infants 4

Clinical Use as Galactagogue

• The American College of Obstetricians and Gynecologists identifies domperidone as a primary galactagogue medication for increasing breast milk supply 3
• The standard dose is 10 mg orally three times daily (30mg total daily) for 14-28 days 3
• Domperidone significantly increases daily milk volume by 90.53 mL/day in mothers of preterm infants with low milk supply, without significant maternal side effects 5
• A recent randomized controlled trial showed breast milk production increased from 156 mL to 400.9 mL after 14 days of domperidone treatment, with 95% of babies exclusively breastfeeding at discharge 6

Important Caveats

While domperidone is compatible with breastfeeding, be aware of regulatory and cardiac considerations:

• Domperidone is not FDA-approved in the United States for any indication, though it is approved in other countries for gastrointestinal disorders 3, 7
• The FDA issued warnings regarding cardiac risks including QT prolongation, torsades de pointes, and sudden cardiac death, particularly in women 4, 7
• Screen for cardiac risk factors before prescribing, including personal or family history of arrhythmias, electrolyte abnormalities, and concomitant QT-prolonging medications 4, 7
• Despite FDA warnings, domperidone can be used with appropriate caution and monitoring 2, 3

Clinical Algorithm for Combined Use

You can safely prescribe this combination for a breastfeeding woman using the following approach:

1. Confirm the indication: Pantoprazole for gastroesophageal reflux/peptic disease and domperidone for gastroparesis, nausea, or lactation enhancement 2, 3

2. Screen for cardiac contraindications: Check for history of arrhythmias, prolonged QT interval, significant cardiac disease, electrolyte abnormalities, and review all medications for QT-prolonging drugs 4, 7

3. Counsel the mother: Explain that both medications transfer minimally to breast milk and no adverse effects are expected in the infant 2, 3, 1

4. Monitor the infant: Advise the mother to observe for any unusual drowsiness, feeding difficulties, or other concerning symptoms, though these are not expected 3

5. No interruption of breastfeeding is required with either medication at these doses 2, 1