Label: LORAZEPAM tablet

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

Drug Label Information

Updated April 17, 2025

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
    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 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, includinglorazepam 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 lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS).
    • The continued use of benzodiazepines, includinglorazepam 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 lorazepam 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 lorazepam tablets or reduce the dosage ( DOSAGE AND ADMINISTRATIONand WARNINGS).
    Close
  • DESCRIPTION
    Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 - H-1,4-benzodiazepin-2-one: It is a white or practically white ...
  • CLINICAL PHARMACOLOGY
    Studies in healthy volunteers show that in single high doses lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular ...
  • INDICATIONS AND USAGE
    Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension ...
  • CONTRAINDICATIONS
    Lorazepam is contraindicated in patients with: hypersensitivity to benzodiazepines or to any components of the formulation - acute narrow-angle glaucoma.
  • WARNINGS
    Risks from Concomitant Use with Opioids - Concomitant use of benzodiazepines, including lorazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of ...
  • PRECAUTIONS
    In patients with depression, a possibility for suicide should be borne in mind; benzodiazepines should not be used in such patients without adequate antidepressant therapy. Lorazepam should be ...
  • ADVERSE REACTIONS
    Most adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses. In a sample of about 3500 ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance - Lorazepam tablets contain lorazepam, a Schedule IV controlled substance. Abuse - Lorazepam tablets are a benzodiazepine and a CNS depressant with a potential for abuse and ...
  • 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
    Lorazepam tablets are administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate ...
  • HOW SUPPLIED
    Lorazepam Tablets, USP are available in the following dosage strengths: Lorazepam tablets, USP 1 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX” above the ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Lorazepam (lor az' e pam) Tablets, USP - CIV - What is the most important information I should know about lorazepam tablets? Lorazepam tablets are a ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Lorazepam - GENERIC: Lorazepam - DOSAGE: TABLET - ADMINSTRATION: ORAL - NDC: 70518-4276-0 - NDC: 70518-4276-1 - NDC: 70518-4276-2 - NDC: 70518-4276-3 - COLOR: white - SHAPE: ROUND - SCORE: Two even pieces - SIZE ...
  • INGREDIENTS AND APPEARANCE
    Product Information