clorazepate (Rx)

Brand and Other Names:Tranxene SD, Tranxene T-Tab
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & 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

Dosage Forms & 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

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

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Interactions

Interaction Checker

and clorazepate

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            Frequency Not Defined

            Drowsiness

            Dizziness

            Nervousness

            Headache

            Confusion

            GI complaints

            Dry mouth

            Blurred vision

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            Warnings

            Black Box Warnings

            Risks from concomitant use with opioids

            • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death
            • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate
            • Limit dosages and durations to the minimum required
            • Follow patients for signs and symptoms of respiratory depression and sedation
            • Inform patients and caregivers that potentially fatal additive effects may occur if drug is used with opioids and that such drugs should not be used concomitantly unless supervised by a health care provider
            • Prescribers should advise caregivers that they expect to be informed immediately if a patient develops any new findings which are not typical of the patient’s characteristic seizure episode

            Addiction, abuse, and misuse

            • On September 2020, FDA addressed serious risks of benzodiazepine addiction, abuse, and misuse, which can lead to overdose and death
            • Physical dependence can occur when taken steadily for several days to weeks, even as prescribed
            • Stopping abruptly or reducing dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening
            • Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes; before prescribing and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction
            • Assess each patient’s risk prior to prescribing and monitor regularly for the development of these conditions
            • Risks of dependence and withdrawal increase with longer treatment duration and higher daily dose; although injection is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction may precipitate acute withdrawal reactions, including seizures, which can be life-threatening; use gradual taper when discontinuing therapy to reduce withdrawal reactions risk

            Contraindications

            Documented hypersensitivity

            Narrow-angle glaucoma

            Caution

            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

            Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use

            In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months

            Patients taking drug for prolonged periods should have blood counts and liver function tests done periodically; the usual precautions in treating patients with impaired renal or hepatic function should also be observed

            In elderly or debilitated patients, initial dose should be small, and increments should be made gradually, in accordance with response of patient, to preclude ataxia or excessive sedation

            Suicidal behavior and ideation

            • Antiepileptic drugs (AEDs), increase risk of suicidal thoughts or behavior in patients taking drugs for any indication
            • Monitor patients treated with any AED for any indication for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
            • Increased risk of suicidal thoughts or behavior with AEDs reported as early as one week after starting drug treatment with AEDs; epilepsy and many other illnesses for which AEDs are prescribed are associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior
            • Should suicidal thoughts and behavior emerge during treatment, prescriber needs to consider whether emergence of these symptoms in any given patient may be related to illness being treated
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            Pregnancy & 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 http://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.

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            Pharmacology

            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

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.