Label: CLORAZEPATE DIPOTASSIUM tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 28, 2025

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  • SPL UNCLASSIFIED SECTION
    CIV - Rx only
  • BOXED WARNING (What is this?)

    WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

    • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGSand PRECAUTIONS).
    • The use of benzodiazepines, including clorazepate dipotassium, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clorazepate dipotassium and throughout out treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS).
    • The continued use of benzodiazepines, including clorazepate dipotassium, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clorazepate dipotassium after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (see DOSAGE AND ADMINISTRATIONand WARNINGS).
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  • DESCRIPTION
    Chemically, clorazepate dipotassium USP is a benzodiazepine. The empirical formula is C - 16H - 11ClK - 2N - 2O - 4; the molecular weight is 408.92; 1 - H-1, 4-Benzodiazepine-3-carboxylic ...
  • CLINICAL PHARMACOLOGY
    Pharmacologically, clorazepate dipotassium has the characteristics of the benzodiazepines. It has depressant effects on the central nervous system. The primary metabolite, nordiazepam, quickly ...
  • INDICATIONS AND USAGE
    Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life ...
  • CONTRAINDICATIONS
    Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.
  • WARNINGS
    Risks from Concomitant Use with Opioids - Concomitant use of benzodiazepines, including clorazepate dipotassium, and opioids may result in profound sedation, respiratory depression, coma, and ...
  • PRECAUTIONS
    In those patients in which a degree of depression accompanies the anxiety, suicidal tendencies may be present and protective measures may be required. The least amount of drug that is feasible ...
  • ADVERSE REACTIONS
    The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance - Clorazepate dipotassium tablets contain clorazepate, a Schedule IV controlled substance. Abuse - Clorazepate dipotassium is a benzodiazepine and a CNS depressant with a ...
  • OVERDOSAGE
    Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion ...
  • DOSAGE AND ADMINISTRATION
    For the Symptomatic Relief of Anxiety - Clorazepate dipotassium tablets are administered orally in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the ...
  • ANIMAL PHARMACOLOGY AND TOXICOLOGY
    Studies in rats and monkeys have shown a substantial difference between doses producing tranquilizing, sedative and toxic effects. In rats, conditioned avoidance response was inhibited at an oral ...
  • HOW SUPPLIED
    Clorazepate Dipotassium Tablets USP are available as tablets containing 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP. The 3.75 mg tablets are round flat beveled edge, pale violet ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 - Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 - Revised: September ...
  • MEDICATION GUIDE
    This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2024 - 5200400-0924-07 - MEDICATION GUIDE - CLORAZEPATE ...
  • PRINCIPAL DISPLAY PANEL
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  • INGREDIENTS AND APPEARANCE
    Product Information