clorazepate (Tranxene SD, Tranxene T-Tab)
Classes: Anticonvulsants, Other; Antianxiety Agents; Anxiolytics, Benzodiazepines
Dosing and uses of Tranxene SD, Tranxene T-Tab (clorazepate)
Adult dosage forms and strengths
tablet: Schedule IV
- 3.75mg
- 7.5mg
- 15mg
Anxiety
30 mg/day PO in divided doses; adjust dose gradually within range of 15-60 mg/day
When administered as single daily HS dose, initial dosage is 15 mg; after initial dose, response of patient may require subsequent dosage adjustment
Seizure
7.5 mg PO q8hr; increase by < 7.5 mg/week; 90 mg/day maximum
Acute Alcohol Withdrawal
Day 1: Initial 30 mg PO once, THEN 30-60 mg in divided doses, no more than 90 mg
Day 2: 45-90 mg PO in divided doses
Day 3: 22.5-45 mg PO in divided doses
Day 4: 15-30 mg PO in divided doses
Day 5 onwards: 7.5-15 mg PO in divided doses
Discontinue when stable
Pediatric dosage forms and strengths
tablet: Schedule IV
- 3.75mg
- 7.5mg
- 15mg
Partial Seizures
<9 years: Not recommended
9-12 years: 7.5 mg PO BID initially; increase by <7.5 mg qWeek to 60 mg/day maximum
>12 years: As in adults
Geriatric dosage forms and strengths
Not drug of choice in elderly because of long-acting metabolite; long-acting benzodiazepines associated with falls in elderly
Anxiety
7.5 mg PO qDay or q12hr
Tranxene SD, Tranxene T-Tab (clorazepate) adverse (side) effects
Frequency not defined
Drowsiness
Dizziness
Nervousness
Headache
Confusion
GI complaints
Dry mouth
Blurred vision
Warnings
Contraindications
Documented hypersensitivity
Breastfeeding
Narrow-angle glaucoma
Caution
Anterograde amnesia may occur
May cause CNS depression
May experience aggressive behavior
Caution in patients with a history of drug abuse; tolerance, psychological, and physical dependence may occur with prolonged use
Caution in patients with gag reflex
Caution in patients with respiratory disease
Caution in hepatic impairment
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. Pregnant patients taking clorazepate should enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. More information can be found at https://www.aedpregnancyregistry.org
Lactation: enters breast milk; do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Tranxene SD, Tranxene T-Tab (clorazepate)
Mechanism of action
Enhances the inhibitory effect of GABA on neuronal excitability by increasing neuronal membrane permeability to chloride ions
Pharmacokinetics
Half-Life: 50-70 hr
Time to peak: ~ 1 hr
Protein Bound: 97-98%
Metabolism: Hydroxylation, glucuronic acid conjugation
Metabolites: Desmethyldiazepam (nordiazepam), oxazepam
Excretion: Urine
Onset of action: 1-2 hr
Duration: Variable 8-24 hr
