TRANXENE 5MG CAPS 30S

Tranxene (clorazepate dipotassium 5 mg) is a long-acting benzodiazepine with anxiolytic, anticonvulsant, and muscle-relaxant properties.

Clorazepate itself is a prodrug; upon oral administration, it is decarboxylated in the acidic gastric environment to its active metabolite, nordiazepam (also known as desmethyldiazepam), which is then absorbed from the gastrointestinal tract. 

Nordiazepam has an exceptionally long elimination half-life of approximately 40–50 hours, meaning that significant drug accumulation occurs with repeated dosing and effects may persist well beyond the final dose.

This pharmacokinetic profile contributes to smoother, sustained plasma levels compared to shorter-acting benzodiazepines, but also to a more prolonged duration of action and greater accumulation risk, particularly in elderly patients or those with hepatic impairment.

Clorazepate is used for: the symptomatic relief of anxiety disorders and short-term management of anxiety; adjunctive treatment of partial (focal) seizures in epilepsy; and symptomatic relief of acute alcohol withdrawal. It is not intended for chronic use due to tolerance and dependence risk.

Tranxene tablets should be swallowed whole with water. They may be taken with food to reduce gastric irritation. Doses should always be the lowest effective amount for the shortest possible duration.

Anxiety Disorders

•     Adults: 15–60 mg/day in divided doses (2–4 times daily). The usual starting dose is 15 mg/day, adjusted according to response.

•     Single daily bedtime dose: 15 mg at night is an alternative for patients where sleep disruption is part of the anxiety disorder.

•     Elderly patients: Not recommended as a drug of choice due to long-acting metabolite; if used, start with the lowest available dose (3.75–5 mg once or twice daily) and monitor closely for accumulation and sedation.

Adjunctive Treatment of Partial Seizures (Epilepsy)

•     Adults and children >12 years: Initial dose 7.5 mg three times daily; increase by no more than 7.5 mg per week; maximum 90 mg/day.

•     Children 9–12 years: Maximum starting dose 7.5 mg twice daily; increase by no more than 7.5 mg per week; maximum 60 mg/day.

•     Not for use in children under 9 years for seizure control.

Acute Alcohol Withdrawal

•     Day 1: 30 mg initially, then 30–60 mg in divided doses throughout the day (maximum 90 mg Day 1).

•     Day 2: 45–90 mg in divided doses.

•     Days 3–4: 22.5–45 mg in divided doses.

•     Day 4 onwards: Gradually reduce to 7.5–15 mg/day, then discontinue as soon as stable.

Side effects vary in frequency and severity. Not every patient will experience all listed effects. Seek immediate medical attention for any serious or unexpected reactions.

•     Dependence risk: Clorazepate carries a significant risk of physical and psychological dependence with use beyond 4 weeks. Prescribers should reassess the need for continued treatment regularly. Never stop abruptly after prolonged use.

•     Long-acting metabolite: Nordiazepam has a half-life of 40–50 hours; cumulative sedation and impairment may occur, particularly in elderly patients. Falls risk is substantially increased in older adults.

•     Cognitive impairment: May affect driving ability, operating machinery, and complex cognitive tasks. Advise patients accordingly.

•     Respiratory depression: Black-box warnings in multiple jurisdictions regarding concomitant use with opioids, potentially fatal respiratory depression. Reserve combination for patients with no alternatives and monitor closely.

•     Alcohol withdrawal management: Should be conducted in a supervised clinical setting where seizures can be managed.

•     Abrupt withdrawal: Seizures, psychosis, and autonomic instability may occur if stopped suddenly after extended use. Always taper gradually.

The following interactions are clinically significant. Always inform your healthcare provider of ALL medicines, supplements, and herbal products you are taking.

•     Opioid analgesics (morphine, tramadol, codeine): Fatal respiratory depression possible; combination requires careful monitoring and dose reduction.

•     Alcohol: Profound CNS depression; avoid concurrent use.

•     Other CNS depressants (antipsychotics, antidepressants, antihistamines, barbiturates): Additive sedation.

•     MAO inhibitors: Enhanced CNS depression; avoid concurrent use.

•     Antifungals (ketoconazole, itraconazole): May increase clorazepate plasma levels.

•     Rifampicin, carbamazepine, phenytoin: Induce CYP enzymes and may reduce nordiazepam plasma levels.

•     Antacids: May reduce peak plasma concentration of nordiazepam (reduce absorption rate).

Store below 25°C. Protect from light and moisture. Keep out of reach of children. Keep in original packaging.

Clorazepate dipotassium is a Schedule IV controlled substance. Limit dispensing to prescribed quantities and duration. Counsel patients on dependence risk and the absolute need for gradual tapering on discontinuation. Flag co-prescriptions of opioids, alcohol-related medicines, or other CNS depressants to the prescriber. Elderly patients require particular caution, and nordiazepam accumulates significantly. The maximum recommended period for anxiety treatment is 4 months. Ensure documentation in the controlled drugs register.

Q1: How is Tranxene different from Valium (diazepam)?

A: Clorazepate is a prodrug that converts to nordiazepam in the stomach. Both nordiazepam and diazepam are long-acting benzodiazepines. They have similar pharmacological effects, but Tranxene is sometimes preferred for its more consistent absorption profile.

Q2: Can Tranxene be used long-term for anxiety?

A: No. Clorazepate is for short-term use only, ideally 2–4 weeks, maximum 4 months, with periodic reassessment. Long-term use causes tolerance and dependence, making it harder to cope without the medicine and exposing you to difficult withdrawal.

Q3: Why must I not stop Tranxene abruptly?

A: Sudden discontinuation after regular use can cause severe withdrawal: shaking, sweating, confusion, and sometimes life-threatening seizures. The dose must always be reduced gradually under medical supervision.

Q4: Is Tranxene safe for elderly patients?

A: Use in elderly patients is generally discouraged because the active metabolite (nordiazepam) accumulates and causes prolonged sedation and a marked increased risk of falls and fractures. If used, only very low doses with close monitoring are acceptable.

Q5: Will Tranxene help me sleep?

A: It may improve sleep as part of managing anxiety-related insomnia, but it is not primarily a sleeping medicine. Its long half-life means sedation can persist into the next day, impairing alertness and coordination.