<p>Pregnancy Category C. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of Promethazine hydrochloride injection . Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.<br />
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There are no adequate and well-controlled studies of Promethazine hydrochloride injection in pregnant women. Because animal reproduction studies are not always predictive of human response, Promethazine hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.</p>