New Drug Update 2009-2010 - LAFP

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Other warnings and precautions are typical for the class and include suicide risk, neuroleptic malignant syndrome, tardive dyskinesia, disruption of body temperature regulation, dysphagia, and the potential for cognitive and motor impairment. The safety and effectiveness of iloperidone have not been established in children. Iloperidone is in Pregnancy Category C. In animal models, iloperidone caused developmental toxicity but was not teratogenic. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Iloperidone was excreted in milk of rats during lactation. It is not known whether iloperidone or its metabolites are excreted in human milk. It is recommended that women receiving iloperidone not breastfeed. Table 4. Contraindications, Warnings, and Precautions of the Benzisoxazole Antipsychotics Contraindications Iloperidone Paliperidone Risperidone Ziprasidone Hypersensitivity X X X X QT prolongation Black Box Warnings Increased mortality in elderly patients with dementiarelated psychoses Warnings and Precautions Cerebrovascular events in elderly patients with dementiarelated psychoses X X X X X X X X QT prolongation X X X Neuroleptic malignant syndrome X X X X Tardive dyskinesia X X X X Hyperglycemia/ diabetes mellitus Weight gain X X X X X Seizures X X X X Orthostatic hypotension X X X X Hyperprolactinemia X X X X Body temperature regulation X X X X Dysphagia X X X X Suicide X X X X X 88
Priapism X X X X Cognitive and motor impairment Potential for GI obstruction X X X X X Antiemetic effects X X Leukopenia, neutropenia, agranulocytosis X Thrombotic thrombocytopenic purpura X X Rash Special Populations Hepatic impairment Not recommended Renal impairment Pharmacokinetics not affected Not affected in mild to moderate impairment; not studied in severe impairment Reduced dose in moderate to severe impairment Reduced dose in severe impairment Reduced dose in severe impairment X Dosage adjustments not necessary Elderly Caution Caution Caution Caution Pharmacokinetics not affected Children Not established Not established 5 y and older Not established Pregnancy Category C; use only if clearly needed Breast-feeding mothers Not recommended Category C; use only if clearly needed Caution Category C; use only if clearly needed Not recommended Category C; use only if clearly needed Not recommended ADVERSE REACTIONS: The most common adverse effects have included dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and increased weight.Other common adverse effects have included nausea, headache, anxiety, and insomnia. Administration with food reduced the incidence of many common adverse events, including orthostatic hypotension, dizziness, and nausea. Iloperidone has been associated with an increase in heart rate and reduction in blood pressure. Reductions in blood pressure were most commonly observed during the first week of therapy and were generally not sustained. The incidence of sustained orthostatic hypotension was 2.4% of patients treated with iloperidone, compared with 0.8% treated with haloperidol and no patients treated with placebo or risperidone in 3 of the clinical trials. Sustained orthostatic hypotension was observed in 4.8% of patients treated with iloperidone 20 to 24 mg/day. 89
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New Drug Update 2009-2010 C. Wayne
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FDA MedWatch Information 9/9/2006 C
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Add-on to Metformin and Thiazolidin
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New Drug Update 2009-2010 - LAFP

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