Clorazepate

DEA Class;  Rx

Common Brand Names; Tranxene SD, Tranxene T-Tab

  • Antianxiety Agents; 
  • Anxiolytics, Benzodiazepines; 
  • Anticonvulsants, Benzodiazepine

Oral benzodiazepine with a long half-life; essentially a prodrug for desmethyldiazepam, the primary active metabolite of diazepam.
Used primarily for partial seizures or anxiety.

Indicated for the adjunctive treatment of partial seizures.

For the treatment of generalized anxiety disorder (GAD) or for the short-term relief of anxiety symptoms.
For the treatment of acute alcohol withdrawal.

Documented hypersensitivity

Narrow-angle glaucoma

  • Drowsiness
  • Dizziness
  • Nervousness
  • Headache
  • Confusion
  • GI complaints
  • Dry mouth
  • Blurred vision

Benzodiazepines expose users to risks of abuse, misuse, and addiction, which can lead to overdose or death; abuse and misuse of benzodiazepines often (but not always) involve use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death

Use of drug, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency

Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate

Therapy not recommended for use in depressive neuroses or psychotic reactions

Patients receiving therapy should be cautioned against engaging in hazardous occupations requiring mental alertness, including heavy machinery

Therapy has central nervous system (CNS) effect; avoid simultaneous use of other CNS depressant drug; effects of alcohol may be increased

For patients treated more frequently than recommended, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose), to reduce risk of withdrawal reactions

Pregnancy Category: Not available. An increased risk of congenital malformations associated with the use of minor tranquilizers during the first trimester of pregnancy has been suggested in several studies.

Lactation: enters breast milk; do not nurse

Adults

60 mg/day PO for anxiety; 90 mg/day PO for acute alcohol withdrawal or partial seizures.

Geriatric

60 mg/day PO for anxiety; 90 mg/day PO for acute alcohol withdrawal or partial seizures.

Adolescents

60 mg/day PO for anxiety; 90 mg/day PO for partial seizures.

Children

9 to 12 years: 60 mg/day PO for partial seizures; safety and efficacy for the treatment of anxiety have not been established.
Less than 9 years: Safety and efficacy have not been established; off label use for seizures reported in literature in children as young as 3 years.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Clorazepate dipotassium

tablet: Schedule IV

  • 3.75mg
  • 7.5mg
  • 15mg

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