Label: QUETIAPINE FUMARATE tablet, film coated

  • NDC Code(s): 29300-147-01, 29300-147-10, 29300-147-16, 29300-148-01, view more
  • Packager: Unichem Pharmaceuticals (USA), Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 27, 2023

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

    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 [see Warnings and Precautions (5.1)]. Quetiapine is 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 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 (5.2)]. 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 (5.2)].

    Quetiapine is not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4)].

    Close
  • 1 INDICATIONS AND USAGE
    1.1 Schizophrenia - Quetiapine tablets, USP are indicated for the treatment of schizophrenia. The efficacy of Quetiapine tablets, USP in schizophrenia was established in three 6-week trials in ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Quetiapine tablets can be taken with or without food. 2.2 Recommended Dosing - The recommended initial dose, titration, dose range and maximum ...
  • 3 DOSAGE FORMS AND STRENGTHS
    25 mg tablets are peach colored, circular, biconvex, film coated tablets, with "U" debossed on one side and "25" on the other side. 50 mg tablets are white colored, circular ...
  • 4 CONTRAINDICATIONS
    Hypersensitivity to quetiapine or to any excipients in the quetiapine tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine tablets.
  • 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 adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Other Drugs on Quetiapine - The risks of using quetiapine in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects ...
  • 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 quetiapine, during ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Quetiapine  is not a controlled substance. 9.2 Abuse - Quetiapine has not been systematically studied, in animals or humans, for its potential for abuse ...
  • 10 OVERDOSAGE
    10.1 Human Experience - In clinical trials, survival has been reported in acute overdoses of up to 30 grams of quetiapine. Most patients who overdosed experienced no adverse reactions or ...
  • 11 DESCRIPTION
    Quetiapine fumarate, USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of quetiapine in the listed indications is unclear. However, the efficacy of quetiapine in these indications could be mediated through a ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Carcinogenicity studies were conducted in C57BL mice and Wistar rats. Quetiapine was administered in the diet to mice ...
  • 14 CLINICAL STUDIES
    14.1 Schizophrenia - Short-term Trials-Adults - The efficacy of quetiapine in the treatment of schizophrenia was established in 3 short-term (6-week) controlled trials of inpatients with ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Quetiapine Tablets, USP are supplied as - 25 mg Tablets: Peach colored, circular, biconvex, film coated tablets, with "U" debossed on one side and "25" on the other side. Bottles of 60:  NDC ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Additional medication guides can be obtained by calling Unichem at 1-866-562-4616. Patients should be advised of ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Quetiapine (kwe-TYE-a-peen) Tablets, USP - Read this Medication Guide before you start taking quetiapine tablets and each time you get a refill. There may be new information ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    25 mg-60s ...
  • INGREDIENTS AND APPEARANCE
    Product Information