Pregnancy: (Pregnancy Category B). Reproduction studies have been performed in mice and rats using oral doses of cefalexin monohydrate 1 and 1.5 times the maximum daily human dose based upon mg/m2, and have revealed no harmful effects to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, cefalexin should be used only if clearly needed.
Lactation: The excretion of cefalexin in human milk increased up to 4 hours after a 500 mg dose; the drug reached a maximum level of 4 mcg/mL, then decreased gradually, and disappeared 8 hours after administration. Cefalexin should be used with caution during breastfeeding.