Category C—No reports describing the use of paliperidone in human pregnancy have been located. Developmental toxicity, in the absence of maternal toxicity, was not observed in two animal species. Risperidone was carcinogenic in rodents, but the relationship of this effect to humans has not been studied. Although there are no human pregnancy data with paliperidone, there are limited data for risperidone. However, the absence of specific information for paliperidone prevents a better assessment of the embryo-fetal risk. Nevertheless, if the mother's disease requires the use of paliperidone, the benefits to her probably outweigh any fetal risk.
No reports describing the use of paliperidone during breastfeeding have been located.
All atypicals may increase mortality in elderly patients by 1.7 times greater than placebo.
2019 BEE℞S Recommendation: Avoid, except in schizophrenia or bipolar disorder. Increased risk of CVA and greater rate of cognitive decline and mortality in persons with dementia. Avoid antipsychotics for behavioral problems of dementia or delirium unless nonpharmacological options have failed or are not possible and the older adult is threatening substantial harm to self or others.
Max recommended dose 3 mg/day in moderate or severe renal impairment (CrCl < 50 mL/ min). Dose reduction (max 6 mg/day) is recommended with mild renal impairment (CrCl ≥50 mL/ min to <80 mL/ min)
No dose adjustment is required in patients with mild or moderate hepatic impairment.
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Last updated March 25 2019 15:25:58. Disclaimer: This website does not provide medical advice, nor is it a substitute for clinical judgment.