Famotidine use while Breastfeeding

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Famotidine Levels and Effects while Breastfeeding

Summary of Use during Lactation

Famotidine is used in newborn infants in higher dosages than are transmitted in breastmilk.[1] Famotidine would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.

Drug Levels

Maternal Levels. Eight women who had "recently given birth" (not defined, but apparently within a few days postpartum) were given famotidine 40 mg orally. An average peak breastmilk level of 72 mcg/L occurred 6 hours after the dose.[2] Using the peak milk level data from this study, an exclusively breastfed infant would receive an estimated maximum of 0.01 mg/kg daily with this maternal dosage regimen or less than 2% of the maternal weight-adjusted dosage.

Seven women were given oral famotidine 40 mg daily in 2 or 4 divided doses for 3 days at 12 to 16 weeks postpartum. Average concentrations of famotidine in breastmilk were 53 and 55 mcg/L at 3 and 6 hours after a dose, respectively.[3]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

Histamine H2-receptor blockade is known to stimulate prolactin secretion.[4] Oral famotidine usually does not affect serum prolactin levels, but rare cases of hyperprolactinemia and galactorrhea have been reported.[5][6] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Cimetidine, Nizatidine, Omeprazole, Pantoprazole, Ranitidine, Sucralfate

References

1. Orenstein SR, Shalaby TM, Devandry SN et al. Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial. Aliment Pharmacol Ther. 2003; 17(9):1097-107. PMID: 12752346

2. Courtney TP, Shaw RW, Cedar E et al. Excretion of famotidine in breast milk. Br J Clin Pharmacol. 1988;26:639P. Abstract. PMC: PMC1386642

3. Wang X, Zhan Y, Hankins GD et al. Pharmacokinetics of famotidine in pregnant women. Am J Obstet Gynecol. 2011;204:S72-3. Abstract.

4. Knigge UP. Histaminergic regulation of prolactin secretion. Dan Med Bull. 1990;37:109-24. PMID: 2188799

5. Delpre G, Lapidot M, Lipchitz A et al. Hyperprolactinaemia during famotidine therapy. Lancet. 1993;342:868. Letter. PMID: 8104296

6. Guven K, Kelestimur F. Hyperprolactinemia and galactorrhea with standard-dose famotidine therapy. Ann Pharmacother. 1995;29:788. Letter. PMID: 8520102

Famotidine Identification

Substance Name

Famotidine

CAS Registry Number

76824-35-6

Drug Class

Anti-Ulcer Agents

Histamine H2 Antagonists

Administrative Information

LactMed Record Number

398

Last Revision Date

20130907

Disclaimer

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