Summary of Use during Lactation

Because of the low levels of nizatidine in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required. Histamine H2-antagonists with more extensive use might be preferred in newborns.

Drug Levels

Maternal Levels. Three women who had been breastfeeding for 3 to 8 months were given nizatidine 150 mg orally every 12 hours for 5 doses. Milk nizatidine was measured at several times after the first and fifth doses. Peak milk levels of about 1.2 mg/L occurred about 2 hours after the dose. The mothers excreted a combined average of 96 mcg (range 55 to 137 mcg) of nizatidine into breast milk over the 12 hours after the first and last doses which was less than 0.1% of the mothers' total dose. The half-life in milk averaged less than 2 hours.[1]

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.[2] No reports of hyperprolactinemia, galactorrhea or effects on breastfeeding women caused by nizatidine were found as of the revision date. The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Antacids, Cimetidine, Famotidine, Omeprazole, Pantoprazole, Sucralfate

References

1.

Obermeyer BD, Bergstrom RF, Callaghan JT, et al. Secretion of nizatidine into human breast milk after single and multiple doses. Clin Pharmacol Ther. 1990;47:724–30. [PubMed: 1972674]

2.

Knigge UP. Histaminergic regulation of prolactin secretion. Dan Med Bull. 1990;37:109–24. [PubMed: 2188799]

Substance Name

Nizatidine

CAS Registry Number

76963-41-2

Drug Class

Breast Feeding

Lactation

Anti-Ulcer Agents

Histamine H2 Antagonists

Gastrointestinal Agents