Tablet (generic clorazepate dipotassium)
- Strengths
- 3.75, 7.5, 15 mg
- Product note
- Representative generic source.
Clorazepate
Tranxene T-Tab · generic clorazepate dipotassium
DailyMed-verified antiseizure indications
Indication / use
- Label / evidence summary
- Adjunctive treatment of focal (partial) seizures. Use is not recommended in children younger than 9 years.
- Role
- Maintenance
- Class
- 1,4-benzodiazepine prodrug
Indications checked 27 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.
- Clorazepate dipotassium tablets U.S. label
Focal seizures · 9 years and older; label does not recommend use below 9 · MaintenanceAdjunctive therapy only; dosing differs at ages 9–12 and over 12.
Formulations & strengths
U.S. product labels; strengths per dosage unit.
Tablet (Tranxene T-Tab)
- Strengths
- 3.75, 7.5, 15 mg
- Product note
- Brand package insert lists these strengths; FDA product marketing status varies by strength.
Brand & formulation labels
Each link names the product and formulation it covers. Archived labels do not establish current availability.
Dosing & administration
- Adult / product-specific schedule
- Adults and children over 12 years: initial dose no more than 7.5 mg three times daily. Increase the total daily dose by no more than 7.5 mg each week; maximum 90 mg/day.
- Pediatric
- Ages 9–12 years: initial dose no more than 7.5 mg twice daily. Increase the total daily dose by no more than 7.5 mg each week; maximum 60 mg/day. Not recommended below age 9.
- Titration / repeat dosing
- Use a gradual, individualized taper when reducing or stopping; abrupt cessation can cause life-threatening withdrawal, including seizures. Lower initial doses are advised in older or debilitated patients.
Practical administration
- Product instructions
- Oral tablets. The seizure schedule uses divided dosing; do not substitute the once-daily anxiety schedule.
Dose adjustment & concentrations
- Renal impairment
- Use with caution in impaired renal function; no numeric adjustment algorithm in the cited label.
- Hepatic impairment
- Use with caution in impaired hepatic function; no numeric adjustment algorithm in the cited label.
- Serum reference information
- No established therapeutic serum range is supplied in the cited label.
Safety
- Boxed warning
- Opioid coadministration can cause profound sedation, respiratory depression, coma or death. Abuse, misuse, addiction, physical dependence and potentially life-threatening withdrawal are additional boxed warnings.
- Contraindications
- Known hypersensitivity to clorazepate; acute narrow-angle glaucoma.
- Serious precautions & monitoring
- Sedation, respiratory depression, dependence and withdrawal seizures. Monitor for misuse, mood changes and suicidal thoughts. Avoid abrupt discontinuation.
Common / selected adverse effects
- Drowsiness
- Dizziness
- Ataxia
- Gastrointestinal symptoms
- Blurred vision / dry mouth
Selected label-reported effects; frequencies cannot be compared across drugs.
Drug interactions: toxicity & clinical action
| Partner / combination | Clinical effect | Clinical action |
|---|---|---|
| Opioids | Additive sedation and potentially fatal respiratory depression. | Reserve combined use for appropriate clinical circumstances and use close monitoring. |
| Alcohol / other CNS depressants | Increased sedation and impaired coordination. | Avoid alcohol; review combined depressant exposure. |
Selected interactions; consult the full label and complete medication list.
Pregnancy & contraception
- Fetal / neonatal risk
- Late-pregnancy benzodiazepine exposure can cause neonatal sedation, respiratory depression, hypotonia and withdrawal. The label discusses observational data without a clear association with major birth defects; individualized assessment is required. Breastfeeding is not recommended.
Clinical evidence
Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.
Product-label evidence
Trial summary
- Study design / duration
- No modern pivotal randomized trial is summarized in the cited label.
- Primary endpoint
- No quantified pivotal endpoint supplied in the cited label.
This profile uses product-label evidence; no pivotal journal publication is asserted.
Comparative evidence
- Findings
- No head-to-head efficacy comparison is summarized.
Mechanism of action
- Rapidly decarboxylated to nordiazepam, an active benzodiazepine.
- The brand label describes benzodiazepine activity through GABA-A receptor binding and increased GABA-mediated inhibition.
Pharmacology
Adult values unless specified. Vd/F denotes apparent oral distribution volume.
Pharmacokinetics
- Bioavailability
- Absolute bioavailability is not quantified in the cited product label.
- Elimination half-life
- Parent: essentially absent from circulating blood after oral dosing because of rapid conversion. Active nordiazepam: approximately 40–50 hours.
- Volume of distribution
- Not quantified in the cited product label.
- Active metabolite(s)
- Nordiazepam (active); further hydroxylation produces oxazepam before conjugation.
- Active-metabolite half-life
- Nordiazepam: approximately 40–50 hours. An oxazepam half-life is not quantified in the cited clorazepate labels.
- Protein binding
- Nordiazepam: 97–98%; this is not a measured parent-clorazepate value.
- Metabolism / elimination
- Rapid decarboxylation to nordiazepam, followed by hepatic hydroxylation and conjugation. Major urinary product is conjugated oxazepam.
Values reflect the cited product and study population; they are not interchangeable across formulations.
Molecular structure
NIH PubChem structure and record ↗
Product history
- Initial U.S. approval
- June 23, 1972 — Tranxene (NDA 017105)
- Market / formulation history
- FDA lists Tranxene products with strength-specific marketing status; representative generic tablet labels remain available.
- Brands
- Tranxene T-Tab · generic clorazepate dipotassium
- Manufacturer / marketer
- ANI (representative generic); Tranxene brand insert linked separately
- Generic availability
- Yes — representative generic tablet label linked.
- Related drugs
- Nordiazepam is also an active metabolite of diazepam.
Sources & review status
The ANI clorazepate label is a representative generic source. The Tranxene brand-name insert is linked separately.
Brand reference: Tranxene T-Tab ↗
Indications and DailyMed PDFs checked: 2026-09-27. Other profile sources reviewed: 2026-09-27 · label revision noted at that review: Representative DailyMed label reviewed September 2026; Tranxene FDA insert 2023.. This is a draft reference; final review is pending.