Label: DIAZEPAM tablet

  • NDC Code(s): 11534-199-01, 11534-199-03, 11534-199-04, 11534-202-01, view more
  • Packager: Sunrise Pharmaceutical, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 9, 2024

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  • SPL UNCLASSIFIED SECTION
    Sunrise Pharmaceutical, Inc. CIV - Diazepam Tablets, USP - 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 WARNINGS and PRECAUTIONS).
    • The use of benzodiazepines, including diazepam 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 diazepam tablets and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS).
    • The continued use of benzodiazepines, including diazepam 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 diazepam 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 diazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS).

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  • DESCRIPTION
    Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-chloro-1, 3-dihydro-1- methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one. It is a colorless to light yellow crystalline ...
  • CLINICAL PHARMACOLOGY
    Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action ...
  • INDICATIONS
    Diazepam tablets are 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
    Diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age ...
  • WARNINGS
    Risks from Concomitant Use with Opioids - Concomitant use of benzodiazepines, including diazepam tablets, and opioids may result in profound sedation, respiratory depression, coma, and death ...
  • PRECAUTIONS
    General - If diazepam tablets are to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed ...
  • ADVERSE REACTIONS
    Side effects most commonly reported were drowsiness, fatigue, muscle weakness, and ataxia. The following have also been reported: Central Nervous System: confusion, depression, dysarthria ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance - Diazepam is a Schedule IV controlled substance. Abuse - Diazepam tablets are a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse ...
  • 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
    Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In ...
  • HOW SUPPLIED
    Diazepam Tablets, USP 2 mg are white to off-white, round-shaped, flat-face, beveled edge tablets, debossed "N41" on one side, scored and plain on the other side. Supplied in bottles of 100 (NDC ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - DIAZEPAM (dye az' e pam) TABLETS, C-IV - What is the most important information I should know about Diazepam Tablets? Diazepam tablets are a ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    2 mg Tablet Bottle Label (100 counts) 2 mg Tablet Bottle Label (500 counts) 2 mg Tablet Bottle Label (1000 counts) 5 mg Tablet Bottle Label (100 counts) 5 mg Tablet Bottle Label ...
  • INGREDIENTS AND APPEARANCE
    Product Information