Label: CLOBAZAM suspension

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

Drug Label Information

Updated January 10, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CLOBAZAM ORAL SUSPENSION safely and effectively. See full prescribing information for CLOBAZAM ORAL SUSPENSION. CLOBAZAM oral ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: RISKS FROM CONCOMITANT USE WllH 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 (5.1), Drug Interactions (7.1)].
    • The use of benzodiazepines, including clobazam oral suspension, 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 clobazam oral suspension and throughout treatment, assess each patient's risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2)].
    • The continued use of benzodiazepines, including clobazam oral suspension, 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 clobazam oral suspension 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 clobazam oral suspension or reduce the dosage [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)].
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  • 1 INDICATIONS AND USAGE
    Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosing Information - A daily dose of clobazam oral suspension greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Oral Suspension: 2.5 mg/mL for oral administration. An off-white suspension.
  • 4 CONTRAINDICATIONS
    Clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Risks from Concomitant Use with Opioids - Concomitant use of benzodiazepines, including clobazam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because ...
  • 6 ADVERSE REACTIONS
    Clinically significant adverse reactions that appear in other sections of the labeling include the following: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)] Abuse ...
  • 7 DRUG INTERACTIONS
    7.1 Opioids - The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as clobazam, during pregnancy. Healthcare providers ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Clobazam oral suspension contains clobazam, a Schedule IV controlled substance. 9.2 Abuse - Clobazam is a benzodiazepine and a CNS depressant with a potential for ...
  • 10 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 ...
  • 11 DESCRIPTION
    Table 4: Description - Established Name:Clobazam Oral Suspension - Dosage Forms:Oral Suspension - Route of Administration:Oral - Established Pharmacologic Class of ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The exact mechanism of action far clobazam, a 1,5-benzadiazepine, is not fully understood but is thought to involve potentiation of GABAergic neurotransmission ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - In mice, oral administration of clobazam (O, 6, 12, or 24 mg/kg/day) for 2 years did not result in an increase in ...
  • 14 CLINICAL STUDIES
    The effectiveness of clobazam for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome was established in two multicenter controlled studies (Study 1 and Study 2). Both ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Clobazam oral suspension, 2.5 mg/mL, is a berry flavored off-white liquid. Store clobazam oral suspension in an upright position. It is available as follows: NDC 68094-066-58 - 4 ml per unit dose ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Risks from Concomitant Use with Opioids - Inform patients and caregivers that ...
  • SPL UNCLASSIFIED SECTION
    Packaged by: Precision Dose, Inc. South Beloit, IL 61080 - For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com - Ll1567 Rev. 04/24
  • MEDICATION GUIDE
    MEDICATION GUIDE - Clobazam (kloe' ba zam) Oral Suspension, CIV - What is the most important information I should know about clobazam oral suspension? Clobazam oral suspension is ...
  • PRINCIPAL DISPLAY PANEL - 4 mL Syringe Label
    cloBAZam Oral Suspension CIV - 10 mg/4 mL Delivers 4 mL - Each mL Contains: clobazam 2.5 mg - Shake syringe well before each use. Store at 20-25° (68-77°F) FOR ORAL ADMINISTRATION ONLY. Pkg: Precision ...
  • INGREDIENTS AND APPEARANCE
    Product Information