Classes
DEA Class; Rx
Common Brand Names; Tranxene SD, Tranxene T-Tab
- Antianxiety Agents;
- Anxiolytics, Benzodiazepines;
- Anticonvulsants, Benzodiazepine
Description
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.
Indications
Indicated for the adjunctive treatment of partial seizures.
Contraindications
Documented hypersensitivity
Narrow-angle glaucoma
Adverse Effects
- Drowsiness
- Dizziness
- Nervousness
- Headache
- Confusion
- GI complaints
- Dry mouth
- Blurred vision
Warnings
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 and Lactation
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
Maximum Dosage
60 mg/day PO for anxiety; 90 mg/day PO for acute alcohol withdrawal or partial seizures.
60 mg/day PO for anxiety; 90 mg/day PO for acute alcohol withdrawal or partial seizures.
60 mg/day PO for anxiety; 90 mg/day PO for partial seizures.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Clorazepate dipotassium
tablet: Schedule IV
- 3.75mg
- 7.5mg
- 15mg