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.
is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and
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