Transcription of WARNINGS AND PRECAUTIONS ----------------
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WARNINGS AND PRECAUTIONS ----------------
HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------- WARNINGS AND PRECAUTIONS ---------------------------------- These highlights do not include all the information needed to use CAPLYTA safely Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: and effectively. See full prescribing information for CAPLYTA. Increased incidence of cerebrovascular adverse reactions ( , stroke and transient CAPLYTA (lumateperone) capsules, for oral use ischemic attack). ( ). Initial Approval: 2019 Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( ). WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH Tardive Dyskinesia: Discontinue treatment if clinically appropriate. ( ). DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and See full prescribing information for complete boxed warning.
It may also occur after discontinuation of treatment. Tardive dyskinesia may remit, partially or completely, if antipsychotic treatment is : discontinued. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of …
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