Label: CLONAZEPAM tablet

  • NDC Code(s): 71335-2414-0, 71335-2414-1, 71335-2414-2, 71335-2414-3, view more
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 72888-153
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 10, 2024

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  • SPL UNCLASSIFIED SECTION
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  • 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 for 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 WARNINGS and PRECAUTIONS).

    • The use of benzodiazepines, including clonazepam tablets, 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 clonazepam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction(see WARNINGS).
    • The continued use of benzodiazepines, including clonazepam tablets, 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 clonazepam tablets 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 clonazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS).

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  • DESCRIPTION
    Clonazepam Tablets, USP, a benzodiazepine, is available as scored tablet with debossing Λ containing 0.5 mg of clonazepam and unscored tablets with debossing Λ and Λ containing 1 mg or 2 mg of ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics: The precise mechanism by which clonazepam exerts its anti-seizure and anti-panic effects is unknown, although it is believed to be related to its ability to enhance the ...
  • INDICATIONS AND USAGE
    Seizure Disorders: Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with ...
  • CONTRAINDICATIONS
    Clonazepam tablets are contraindicated in patients with the following conditions: History of sensitivity to benzodiazepines - Clinical or biochemical evidence of significant liver disease - Acute ...
  • WARNINGS
    Risks from Concomitant Use With Opioids: Concomitant use of benzodiazepines, including clonazepam tablets, and opioids may result in profound sedation, respiratory depression, coma, and death ...
  • PRECAUTIONS
    General: Worsening of Seizures: When used in patients in whom several different types of seizure disorders coexist, clonazepam tablets may increase the incidence or precipitate the onset of ...
  • ADVERSE REACTIONS
    The adverse experiences for clonazepam tablets are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders: The most frequently occurring side effects ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance Class: Clonazepam tablets contain clonazepam, a Schedule IV controlled substance. Abuse: Clonazepam tablet is a benzodiazepine and a CNS depressant with a potential for ...
  • OVERDOSAGE
    Human Experience: Symptoms of clonazepam overdosage, like those produced by other CNS depressants, include somnolence, confusion, coma and diminished reflexes. Overdose Management: Treatment ...
  • DOSAGE AND ADMINISTRATION
    Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole. Seizure Disorders: The use of multiple anticonvulsants may result in an ...
  • HOW SUPPLIED
    Clonazepam Tablets USP, 1 mg are mottled blue, round, flat-faced, beveled edge tablet, debossed with Λ on one side and plain on the other side. They are supplied as follows: NDC: 71335-2414-1: 20 ...
  • MEDICATION GUIDECLONAZEPAM (kloe NAZ e pam) tablet, for oral use, C-IV
    What is the most important information I should know about clonazepam tablets? Clonazepam tablet is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other ...
  • PRINCIPAL DISPLAY PANEL
    Clonazepam 1 mg ( CIV) Tablet
  • INGREDIENTS AND APPEARANCE
    Product Information