Label: CLONAZEPAM tablet

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

Drug Label Information

Updated December 17, 2024

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  • BOXED WARNING (What is this?)

    WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

    Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS).

    Reserve concomitant prescribing of these drugs for use 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.
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  • DESCRIPTION
    Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics - The precise mechanism by which clonazepam exerts its antiseizure and antipanic 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 is 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, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of ...
  • PRECAUTIONS
    General - Worsening of Seizures - When used in patients in whom several different types of seizure disorders coexist, clonazepam may increase the incidence or precipitate the onset of generalized ...
  • ADVERSE REACTIONS
    The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders - The most frequently occurring side effects of ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance Class - Clonazepam is a Schedule IV controlled substance. Physical and Psychological Dependence - Withdrawal symptoms, similar in character to those noted with ...
  • OVERDOSAGE
    Human Experience - Symptoms of clonazepam overdosage, like those produced by other CNS depressants, include somnolence, confusion, coma, and diminished reflexes. Overdose ...
  • DOSAGE AND ADMINISTRATION
    Clonazepam tablets should be administered with water by swallowing the tablet whole. Seizure Disorders - The use of multiple anticonvulsants may result in an increase of CNS depressant adverse ...
  • HOW SUPPLIED
    Clonazepam tablets USP 0.5 mg are available as yellow, round, flat beveled, single-scored tablets debossed "832" above the scored line and "TEVA" on the unscored ...
  • MEDICATION GUIDE
    Clonazepam (klo-NAY-zeh-pam) Tablets USP, for oral use, CIV - What is the most important information I should know about clonazepam tablets? • Clonazepam tablets are a benzodiazepine ...
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