Label: CLONAZEPAM tablet, orally disintegrating

  • NDC Code(s): 46708-364-06, 46708-365-06, 46708-366-06, 46708-367-06, view more
  • Packager: Alembic Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 27, 2023

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • 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
    Clonazepam, USP a benzodiazepine, is available as an orally disintegrating tablet containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP. Each orally disintegrating tablet also ...
  • 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 activity ...
  • INDICATIONS  AND USAGE
    Seizure Disorders: Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures ...
  • CONTRAINDICATIONS
    Clonazepam orally disintegrating tablets are contraindicated in patients with the following conditions: History of sensitivity to benzodiazepines - Clinical or biochemical evidence of significant ...
  • WARNINGS
    Risks from Concomitant Use With Opioids: Concomitant use of benzodiazepines, including clonazepam orally disintegrating tablets, and opioids may result in profound sedation, respiratory ...
  • PRECAUTIONS
    General: Worsening of Seizures: When used in patients in whom several different types of seizure disorders coexist, clonazepam orally disintegrating tablets may increase the incidence or ...
  • ADVERSE REACTIONS
    The adverse experiences for clonazepam orally disintegrating tablets are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders: The most frequently ...
  • 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 Management: Treatment ...
  • DOSAGE  AND  ADMINISTRATION
    Clonazepam is available as an orally disintegrating tablet. The orally disintegrating tablet should be administered as follows: After opening the carton, peel back the foil on the blister. Do not ...
  • HOW SUPPLIED
    Clonazepam orally disintegrating tablets, USP are available as follows: 0.125 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 523’ on one side and plain on ...
  • MEDICATION GUIDE
    Clonazepam (kloe NAZ e pam)  Orally Disintegrating Tablets, USP C-IV   What is the most important information I should know about clonazepam orally disintegrating tablets? ·         Do not ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -0.125 mg
    NDC 46708-364-06 - Clonazepam Orally Disintegrating - Tablets, USP - 0.125 mg - Pharmacist: Dispense the accompanying - Medication Guide to each patient. Rx only - 60 (10 x 6) Unit Dose ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -0.25 mg
    NDC 46708-365-06 - Clonazepam Orally Disintegrating - Tablets, USP - 0.25 mg - Pharmacist: Dispense the accompanying - Medication Guide to each patient. Rx only - 60 (10 x 6) Unit Dose ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -0.5 mg
    NDC 46708-366-06 - Clonazepam Orally Disintegrating - Tablets, USP - 0.5 mg - Pharmacist: Dispense the accompanying - Medication Guide to each patient. Rx only - 60 (10 x 6) Unit Dose ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -1 mg
    NDC 46708-367-06 - Clonazepam Orally Disintegrating - Tablets, USP - 1 mg - Pharmacist: Dispense the accompanying - Medication Guide to each patient. Rx only - 60 (10 x 6) Unit Dose ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -2 mg
    NDC 46708-368-06 - Clonazepam Orally Disintegrating - Tablets, USP - 2 mg - Pharmacist: Dispense the accompanying - Medication Guide to each patient. Rx only - 60 (10 x 6) Unit Dose ...
  • INGREDIENTS AND APPEARANCE
    Product Information