Category Not assigned.—Adequate and well-controlled studies have not been conducted in pregnant women to inform drug-associated risks. May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure
Lactation studies have not been conducted to assess the presence of in human milk, the effects on the breastfed infant, or the effects on milk production
All atypicals may increase mortality in elderly patients by 1.7 times greater than placebo.
For patients with moderate, severe or end-stage renal impairment (CLcr<60 mL/min), the max recommended dosage is 2 mg qd for patients with MDD and 3 mg qd for patients with schizophrenia
For patients with moderate to severe hepatic impairment (Child-Pugh score ≥7), the max recommended dosage is 2 mg qd for patients with MDD and 3 mg qd for patients with schizophrenia