![]() ![]() O rthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.9).įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Schizophrenia 2.2 Depressive Episodes Associated with Bipolar I Disorder 2.3 Administration Information 2.4 Dose Modifications for Renal Impairment 2.5 Dose Modifications for Hepatic Impairment 2.6 Dose Modifications Due to Drug Interactions of CYP3A4 Inhibitors and CYP3A4 Inducers 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis 5.2 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients 5.3 Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis 5.4 Neuroleptic Malignant Syndrome 5.5 Tardive Dyskinesia 5.6 Metabolic Changes 5.7 Hyperprolactinemia 5.8 Leukopenia, Neutropenia and Agranulocytosis 5.9 Orthostatic Hypotension and Syncope 5.10 Falls 5.11 Seizures 5.12 Potential for Cognitive and Motor Impairment 5.13 Body Temperature Dysregulation 5.14 Activation of Mania/Hypomania 5.15 Dysphagia 5.16 Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with Lurasidone Hydrochloride 7.2 Drugs Having No Clinically Important Interactions with Lurasidone Hydrochloride 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 8.8 Other Specific Populations 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.2 Abuse 10 OVERDOSAGE 10.1 Human Experience 10.2 Management of Overdosage 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Schizophrenia 14.2 Depressive Episodes Associated with Bipolar I Disorder 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.Ģ.2 Depressive Episodes Associated with Bipolar I DisorderĪdults The recommended starting dose of lurasidone hydrochloride tablets is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate.Consider discontinuing lurasidone hydrochloride if a clinically significant decline in WBC occurs in the absence of other causative factors ( 5.8). Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia.Hyperprolactinemia: Prolactin elevations may occur ( 5.7).Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain ( 5.6).Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5).Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4).Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) ( 5.3). ![]()
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