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Amlodipine use while Breastfeeding

Drugs containing Amlodipine: Norvasc, Exforge, Azor, Lotrel, Tribenzor, Caduet, Exforge HCT, Twynsta, Prestalia, Amturnide, Show all 12 »Tekamlo, Amlobenz

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.

Drug Levels

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.[1]

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).[2]

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.[3]

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.[4]

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.[2]

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.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Nifedipine, Nitrendipine

References

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. 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

4. Szucs KA, Axline SE, Rosenman MB. Maternal membranous glomerulonephritis and successful exclusive breastfeeding. Breastfeed Med. 2010;5:123-6. PMID: 20491564

Amlodipine Identification

Substance Name

Amlodipine

CAS Registry Number

88150-42-9

Drug Class

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Administrative Information

LactMed Record Number

11

Last Revision Date

20150602

Disclaimer

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.

Disclaimer: This information is not intended as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. Use of this website signifies your agreement to the Terms of Use and Online Privacy Policy.

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