Label: RISPERIDONE 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 RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS. RISPERIDONE tablets, for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

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

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  • 1 INDICATIONS AND USAGE
    1.1 Schizophrenia - Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to ...
  • 2 DOSAGE AND ADMINISTRATION
    Table 1. Recommended Daily Dosage by Indication - Initial - Dose - Titration - (Increments) Target Dose - Effective - Dose Range ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Risperidone tablets, USP are available in the following strengths and colors: 2 mg (yellow), 2 mg are circular shaped. Risperidone tablets, USP are engraved with “RI1”, “RI2”, “RI3”, “RI4”, “RI5 ...
  • 4 CONTRAINDICATIONS
    Risperidone tablets are contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone tablets formulation ...
  • 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 increased risk of death ...
  • 6 ADVERSE REACTIONS
    The following are discussed in more detail in other sections of the labeling: •  Increased mortality in elderly patients with dementia-related psychosis - [see  - Boxed Warningand ...
  • 7 DRUG INTERACTIONS
    7.1 Pharmacokinetic-related Interactions - The dose of risperidone tablets should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - PregnancyExposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Risperidone tablets are not a controlled substance. 9.2 Abuse - Risperidone tablets have not been systematically studied in animals or humans for its potential for ...
  • 10 OVERDOSAGE
    10.1 Human Experience - Premarketing experience included eight reports of acute risperidone tablets overdosage with estimated doses ranging from 20 to 300 mg and no fatalities. In general ...
  • 11 DESCRIPTION
    Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis  - Risperidone was administered in the diet at doses of 0.63, 2.5, and 10 mg/kg for 18 months to mice and for 25 months ...
  • 14 CLINICAL STUDIES
    14.1 Schizophrenia - Adults - Short-Term Efficacy - The efficacy of risperidone tablets in the treatment of schizophrenia was established in four short-term (4- to 8-week) controlled trials of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Risperidone Tablets, USP 2 mg are yellow, circular, biconvex film-coated tablets, engraved with 'RI4' on one side and plain on other and are supplied as follows: NDC: 70518-1631-00 - PACKAGING: 30 ...
  • 17 PATIENT COUNSELING INFORMATION
    Physicians are advised to discuss the following issues with patients for whom they prescribe risperidone tablets. Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: RISPERIDONE - GENERIC: RISPERIDONE - DOSAGE: TABLET - ADMINSTRATION: ORAL - NDC: 70518-1631-0 - COLOR: yellow - SHAPE: ROUND - SCORE: No score - SIZE: 8 mm - IMPRINT: RI4 - PACKAGING: 30 in 1 BLISTER PACK - ACTIVE ...
  • INGREDIENTS AND APPEARANCE
    Product Information