Low Levels of Amlodipine in Breast Milk and Plasma

Breastfeed Med. 2018 Nov;13(9):622-626. doi: 10.1089/bfm.2018.0158. Epub 2018 Sep 28.


Objective: Few clinical reports have addressed the use of the antihypertensive drug amlodipine during breastfeeding. The objective of this study is to characterize concentration-time profiles of amlodipine in maternal and infant plasma, and milk.

Materials and methods: Plasma and breast milk samples were obtained from eight nursing mothers and their nine newborn nursing infants (median postnatal age: 6.5 days, range 5-7 days). Participants were recruited from February 2009 to June 2009. Multiple blood and milk samples were obtained from the mothers over a 24 hours dosing interval. The blood of infants was also obtained at before and 8 hours after nursing. Amlodipine concentrations were determined by high-performance liquid chromatography. Relative infant dose (RID) was calculated by dividing the infant's dose via milk in mg/kg/day by the maternal dose in mg/kg/day, assuming that a daily intake of milk is 150 mL/kg/day in the infants.

Results: Maximal amlodipine concentrations in mothers ranged from 4.4 to 14.7 ng/mL in plasma, and 6.5 to 19.7 ng/mL in milk (Average milk/plasma ratio: 1.4). RID was 3.4% of the maternal weight-adjusted dose. All plasma concentrations in infants were under the quantitation limit (0.4 ng/mL).

Conclusion: Infant exposure to amlodipine in breast milk appears very small, suggesting that amlodipine can be used with little influence on infants during breastfeeding.

Keywords: amlodipine; antihypertensive agents; breastfeeding; chromatography; human milk; infant.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amlodipine / blood*
  • Amlodipine / therapeutic use
  • Antihypertensive Agents / blood*
  • Antihypertensive Agents / therapeutic use
  • Breast Feeding*
  • Chromatography
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Infant, Newborn
  • Milk, Human / chemistry*
  • Young Adult


  • Antihypertensive Agents
  • Amlodipine