Label: ARIPIPRAZOLE tablet

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

Drug Label Information

Updated January 22, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for ...
  • 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 WITH ANTIDEPRESSANT DRUGS


    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1)]. 
     
    Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions ( 5.3)]. 

     
    In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings andPrecautions ( 5.3)].

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  • 1 INDICATIONS AND USAGE
    Aripiprazole oral tablets are indicated for the treatment of: Schizophrenia  - Treatment of Tourette’s Disorder
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Schizophrenia - Adults  - The recommended starting and target dose for aripiprazole tablets is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Aripiprazole tablets, USP are available as described in 3.  Table 3: Aripiprazole Tablets Presentations - Tablet Strength - Tablet Color/Shape - Tablet Markings - 2 mg - Light ...
  • 4 CONTRAINDICATIONS
    Aripiprazole tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis - [see Adverse ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis - Increased Mortality  Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at ...
  • 6 ADVERSE REACTIONS
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical ...
  • 7 DRUG INTERACTIONS
    7.1 Drugs Having Clinically Important Interactions with Aripiprazole Tablets - Table 25: Clinically Important Drug Interactions with Aripiprazole: Concomitant Drug Name ...
  • 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 atypical antipsychotics, including aripiprazole ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Aripiprazole is not a controlled substance.  9.2 Abuse - Aripiprazole has not been systematically studied in humans for its potential for abuse, tolerance, or ...
  • 10 OVERDOSAGE
    MedDRA terminology has been used to classify the adverse reactions.  10.1 Human Experience - In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental ...
  • 11 DESCRIPTION
    Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of aripiprazole in schizophrenia is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis  - Lifetime carcinogenicity studies were conducted in ICR mice, F344 rats, and Sprague-Dawley (SD) rats ...
  • 14 CLINICAL STUDIES
    Efficacy of the oral formulations of aripiprazole was established in the following adequate and well-controlled trials: • Four short-term trials and one maintenance trial in adult patients ...
  • HOW SUPPLIED
    Aripiprazole tablets, USP 5 mg are light blue to blue, modified rectangular, bevel edged biconvex tablets debossed with 'I' on one side and '95' on other side. NDC: 70518-2163-00 - PACKAGING: 30 in ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling ( Medication Guide). Discuss the following issues with patients prescribed aripiprazole tablets: Clinical Worsening of ...
  • MEDICATION GUIDE
    Aripiprazole Tablets USP - (ar'' i pip' ra zole) What is the most important information I should know about aripiprazole tablets? (For other side effects, also see ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Aripiprazole - GENERIC: Aripiprazole - DOSAGE: TABLET - ADMINSTRATION: ORAL - NDC: 70518-2163-0 - COLOR: blue - SHAPE: RECTANGLE - SCORE: No score - SIZE: 8 mm - IMPRINT: I;95 - PACKAGING: 30 in 1 BLISTER ...
  • INGREDIENTS AND APPEARANCE
    Product Information