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Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recover within hours or days without specific treatment; others may require prolonged hospitalization. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in neonates following in utero exposure to antipsychotics in the third trimester. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. No developmental toxicity studies were conducted with the 3-month paliperidone palmitate extended-release injectable suspension. No treatment-related effects on the offspring were observed when pregnant rats were injected intramuscularly with 1-month paliperidone palmitate extended-release injectable suspension during the period of organogenesis at doses up to 250 mg/kg, which is 3 times the MRHD of 819 mg of the 3-month paliperidone palmitate extended-release injectable suspension on mg/m 2 basis. No increases in fetal abnormalities were observed when paliperidone was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 8 times the MRHD of 12 mg/day of oral paliperidone on mg/m 2 basis. In rat reproduction studies with risperidone, which is extensively converted to paliperidone in rats and humans, pup deaths increased at oral doses, which are less than the MRHD of risperidone on mg/m 2 basis (see RISPERDAL ‘ package insert). Paliperidone is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. Paliperidone has been detected in plasma at very low levels up to 18 months after a single-dose administration of INVEGA TRINZA ‘ , and the clinical significance on the breastfed infant is not known [see CLINICAL PHARMACOLOGY ]. Safety and effectiveness of INVEGA TRINZA ‘ in patients less than 18 years of age have not been established. Use of INVEGA TRINZA ‘ is not recommended in pediatric patients because of the potential longer duration of an adverse event compared to shorter-acting products, buy drostan-p 100 mg injectable steroids $29.00 masteron. In clinical trials of oral paliperidone, there were notably higher incidences of dystonia, hyperkinesia, tremor, and parkinsonism in the adolescent population as compared to the adult studies. No juvenile animal studies were conducted with the 3-month paliperidone palmitate extended-release injectable suspension. Juvenile rats administered daily oral doses of paliperidone from days 24 to 73 of age had a reversible impairment of performance in a test of learning and memory in females only. The no-effect dose of 0. No other consistent effects on neurobehavior or reproductive development were seen up to the highest dose tested which produced plasma exposure to paliperidone 2 to 3 times that in adolescents. Juvenile dogs administered for 40 weeks daily oral doses of risperidone, which is extensively metabolized to paliperidone in animals and humans, at 0. In addition, delayed sexual maturation was seen at all doses in both males and females. All adverse effects showed little or no reversibility in females after a 12-week drug-free recovery period. The long-term effects of paliperidone on growth and sexual maturation have not been fully evaluated in children and adolescents. Clinical studies of INVEGA TRINZA ‘ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. undefined

 

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