Label: LURASIDONE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 16, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LURASIDONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LURASIDONE HYDROCHLORIDE TABLETS ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

    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. Lurasidone hydrochloride tablets are not approved for the treatment of patients with dementia-related psychosis[see Warnings and Precautions (5.1)].

    Suicidal Thoughts and Behaviors

    Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2)].


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  • 1 INDICATIONS AND USAGE
    Lurasidone hydrochloride tablets are indicated for:   • Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder ...
  • 2 DOSAGE AND ADMINISTRATION
    2.2 Depressive Episodes Associated with Bipolar I Disorder - Adults - The recommended starting dose of lurasidone hydrochloride tablets is 20 mg given once daily as monotherapy or as ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Lurasidone hydrochloride tablets are available in the following shape and color (Table 1) with respective two-sided debossing: Table 1: Lurasidone Hydrochloride Tablet Presentations - Tablet ...
  • 4 CONTRAINDICATIONS
    • Known  hypersensitivity  to  lurasidone  HCl  or  any  components  in  the  formulation. Angioedema has been observed with lurasidone  - [see Adverse Reactions (6.1)]. ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis - Elderly  patients  with  dementia-related  psychosis  treated  with  antipsychotic  drugs  are  at  an ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in more detail in other sections of the labeling:  Increased Mortality in Elderly Patients with Dementia-Related Psychosis  - [seeBoxed ...
  • 7 DRUG INTERACTIONS
    7.1 Drugs Having Clinically Important Interactions with Lurasidone Hydrochloride - Table 34: Clinically Important Drug Interactions with Lurasidone Hydrochloride -   Strong CYP3A4 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy. For more ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Lurasidone hydrochloride is not a controlled substance. 9.2 Abuse - Lurasidone hydrochloride has not been systematically studied in humans for its potential for abuse ...
  • 10 OVERDOSAGE
    10.1 Human Experience - In premarketing clinical studies, accidental or intentional overdosage of lurasidone hydrochloride was identified in one patient who ingested an estimated 560 mg of ...
  • 11 DESCRIPTION
    Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives.  Its chemical name is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of lurasidone in the treatment of bipolar depression is unclear. However, its efficacy in bipolar depression could be mediated ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis:Lurasidone increased incidences of malignant mammary gland tumors and pituitary gland adenomas in female mice orally ...
  • 14 CLINICAL STUDIES
    14.2 Depressive Episodes Associated with Bipolar I Disorder - Adults - Monotherapy - The efficacy of lurasidone hydrochloride, as monotherapy, was established in a 6-week, multicenter ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Lurasidone hydrochloride tablets are available in the following strengths and package configurations. 20 mg tablets are white to off white, round shaped, film-coated tablets debossed with “351” on ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behavior - Advise patients and caregivers to look for the emergence of suicidality ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - LurasidoneHydrochloride(loo ras’ i done hye” droe klor’ ide) Tablets - What is the most important information I should know about ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Lurasidone hydrochloride - GENERIC: Lurasidone hydrochloride - DOSAGE: TABLET, FILM COATED - ADMINSTRATION: ORAL - NDC: 70518-4241-0 - COLOR: white - SHAPE: ROUND - SCORE: No score - SIZE: 6 mm - IMPRINT ...
  • INGREDIENTS AND APPEARANCE
    Product Information