Label: ARIPIPRAZOLE- aripiprazole orally disintegrating tablet

  • NDC Code(s): 43598-733-30, 43598-734-30
  • Packager: Dr. Reddy's Laboratories Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 26, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE ORALLY ...
  • 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 is 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; there was a reduction in risk with antidepressant use in patients aged 65 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 and Precautions (5.3)] .

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  • 1 INDICATIONS AND USAGE
    Aripiprazole orally disintegrating tablets are indicated for the treatment of: Schizophrenia - [see - Clinical Studies (14.1)] Acute Treatment of Manic and Mixed Episodes ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Schizophrenia - Adults - The recommended starting and target dose for aripiprazole is 10 mg/day or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole has ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Aripiprazole orally disintegrating tablets are available as described in Table 2. Table 2: Aripiprazole Orally Disintegrating Tablet Presentations - Tablet StrengthTablet Color/ShapeTablet ...
  • 4 CONTRAINDICATIONS
    Aripiprazole orally disintegrating tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to ...
  • 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 an ...
  • 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 trials ...
  • 7 DRUG INTERACTIONS
    7.1 Drugs Having Clinically Important Interactions with Aripiprazole - Table 22: Clinically Important Drug Interactions with Aripiprazole: Concomitant Drug Name or Drug Class - Clinical ...
  • 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, during ...
  • 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 physical ...
  • 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 an atypical antipsychotic drug that is available as Aripiprazole Orally Disintegrating Tablets. Aripiprazole is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated ...
  • 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. Aripiprazole was ...
  • 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 and one ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Aripiprazole orally disintegrating tablets, USP are round tablets with markings on either side. Aripiprazole orally disintegrating tablets, USP are available in the strengths ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling - ( Medication Guide). Discuss the following issues with patients prescribed Aripiprazole Orally Disintegrating ...
  • MEDICATION GUIDE
    Dispense the Medication Guide available at : https://www.drreddys.com/pi/medguide/Aripiprazole-od-tabs.pdf - MEDICATION GUIDE - Aripiprazole (ar" i pip' ra zole ...
  • Principal Display Panel - Container Labels
    NDC 43598-733-30 - Aripiprazole - Orally Disintegrating - Tablets, USP - 10 mg - PHARMACIST: Dispense the - enclosed Medication Guide - to each patient. Rx ...
  • INGREDIENTS AND APPEARANCE
    Product Information