Category C—The limited human pregnancy data and the absence of relevant animal data prevents a better assessment of the embryo-fetal risk. Nevertheless, most of the evidence for the phenothiazine agents suggest that these drugs are low risk. However, use of antipsychotic drugs during the 3rd trimester can cause extrapyramidal and/ or withdrawal symptoms in the newborn.
No reports describing the use of thioridazine during human lactation have been located. It is not known if the drug is excreted into breast milk, but the molecular weight (about 407) suggests that it will be present in breast milk. Moreover, other phenothiazines are present in milk and have caused toxicity. Sedation is a possible effect in nursing infants.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic function, concomitant disease or other drug therapy.
No dosage adjustment necessary.
Use with caution in patients with hepatic impairment.