Amlodipine use while Breastfeeding
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Amlodipine Levels and Effects while Breastfeeding
Summary of Use during Lactation
Limited information indicates that maternal use of amlodipine during breastfeeding has not caused any adverse effects in breastfed infants. However, some mothers appear to excrete rather amounts of amlodipine in milk that might affect some breastfed infants. Breastfed infants of mothers taking amlodipine should be observed carefully for adverse effects. Until more safety data become available, an alternate drug may be preferred.
Maternal Levels. Thirty-one postpartum women with pregnancy-induced hypertension received amlodipine 5 mg daily by mouth, with the dosage increased as needed to maintain blood pressure of 140/90 mm Hg or less. The final mean dosage for the group was 6 mg (0.01 mg/kg) daily. Simultaneous predose maternal blood and breastmilk samples were obtained within 3 weeks postpartum, after at least 6 days of therapy. The median milk concentration was 11.5 mcg/L (intraquartile range 9.8 to 18 mcg/L). The calculated median infant dosage was 4.2 mcg/kg (intraquartile range 3.1 to 6.3 mcg/kg), which corresponds to a weight-adjusted maternal dosage of 4.2% (intraquartile range 3.1 to 7.3%). In 5 mothers, the weight-adjusted maternal dosage was above 10%, with a maximum value of 15.2% in one mother. The actual infant exposure might be higher than reported in this study because only trough milk values were measured.
Infant Levels. A preterm infant of 32 weeks gestation was breastfed exclusively from day 7 to day 20 postpartum. The infant's mother was taking amlodipine and labetalol in unspecified dosages for hypertension. After 4 days of breastfeeding, the infant's blood amlodipine level was unmeasurable (lower limit of assay not specified).
Eight infants whose mothers were taking amlodipine 5 mg daily during pregnancy were breastfed. Infant serum amlodipine concentrations were unmeasurable (<0.1 mcg/L), although it is unclear from the report whether mothers continued taking amlodipine postpartum.
Effects in Breastfed Infants
A woman took amlodipine for hypertension 5 mg daily beginning 2 weeks postpartum. Her exclusively breastfed infant was examined regularly and at 3 months of age was healthy and had normal physical and neurological development.
One woman received amlodipine 2.5 mg orally twice daily during pregnancy for hypertension associated with glomerulonephritis. The dose was increased to 5 mg twice daily on day 2 postpartum. Her exclusively breastfed infant's growth was normal throughout the first year of life and no adverse effects were noted.
A preterm infant of 32 weeks gestation was breastfed exclusively from day 7 to day 20 postpartum. The infant's mother was taking amlodipine and labetalol in unspecified dosages for hypertension. The infant had apnea episodes unrelated to amlodipine. Growth at 2 months of age was slightly low.
Thirty-one women with pregnancy-induced hypertension postpartum received amlodipine 5 mg daily by mouth, with the dosage increased as needed to maintain blood pressure of 140/90 mm Hg or less. Their breastfed (extent not stated) infants exhibited no observed adverse cardiovascular effects within 3 weeks postpartum, although exact measurement methods were not stated.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
1. Naito T, Kubono N, Deguchi S et al. Amlodipine passage into breast milk in lactating women with pregnancy-induced hypertension and its estimation of infant risk for breastfeeding. J Hum Lact. 2015;31:301-6. PMID: 25447596
2. Vasa R, Martha Ramirez M. Amlodipine exposure through breastfeeding in a 32 week preterm newborn. Breastfeeding Med. 2013;8 (Suppl 1):S15. Abstract. DOI: doi:10.1089/bfm.2013.9982
3. Morgan JL, Kogutt BK, Meek C et al. Pharmacokinetics of amlodipine besylate during pregnancy-how much infant exposure occurs? Am J Obstet Gynecol. 2017;216:S515-S516.
4. Ahn HK, Nava-Ocampo AA, Han JY et al. Exposure to amlodipine in the first trimester of pregnancy and during breastfeeding. Hypertens Pregnancy. 2007;26:179-87. PMID: 17469008
5. Szucs KA, Axline SE, Rosenman MB. Maternal membranous glomerulonephritis and successful exclusive breastfeeding. Breastfeed Med. 2010;5:123-6. PMID: 20491564
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Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
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