WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for use in patients with dementia-related psychosis. ( 5.1 )
Adult Dosing
titration schedule. Recommended Dosage
for titration schedule. Recommended Dosage: Indication Starting Dosage Recommended Dosage Schizophrenia 1 mg twice daily 6 mg to 12 mg twice daily Bipolar Mania 1 mg twice daily 12 mg twice daily CYP2D6 Poor Metabolizers: See Full Prescribing Information for titration schedule and recommended dosage. 2.1 Recommended Dosage Titrate FANAPT to avoid orthostatic hypotension . Administer FANAPT orally with or without food. Table 1 includes dosage recommendations for FANAPT for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
FANAPT in adults who are CYP2D6 poor metabolizers. Table 2
for FANAPT in adults who are CYP2D6 poor metabolizers. Table 2: Dosage Recommendations for FANAPT in Adults with Schizophrenia or Bipolar I Disorder Who are CYP2D6 Poor Metabolizers Indication and Population Titration schedule Recommended Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Schizophrenia 1mg twice daily 2 mg twice daily 4 mg twice daily 6 mg twice daily Titration complete 3 mg to 6 mg twice daily Bipolar I Disorder Manic or Mixed Episodes 1 mg twice daily 3 mg twice daily 6 mg twice daily Titration complete 6 mg twice daily 2.3 Dosage Recommendations in Patients with Hepatic Impairment No dose adjustment for FANAPT is needed in patients with mild hepatic impairment. Patients with moderate hepatic impairment may require dose reduction, if clinically indicated.
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