clorazepate (Rx)

Brand and Other Names:Tranxene SD, Tranxene T-Tab

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

Next:

Interactions

Interaction Checker

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              Serious - Use Alternative (26)

              • apalutamide

                apalutamide will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • benzhydrocodone/acetaminophen

                benzhydrocodone/acetaminophen, clorazepate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

                benzhydrocodone/acetaminophen and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • buprenorphine subdermal implant

                buprenorphine subdermal implant and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • buprenorphine transdermal

                buprenorphine transdermal and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • buprenorphine, long-acting injection

                buprenorphine, long-acting injection and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • calcium/magnesium/potassium/sodium oxybates

                clorazepate, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • conivaptan

                conivaptan will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • enzalutamide

                enzalutamide will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • fentanyl

                fentanyl and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • fentanyl intranasal

                fentanyl intranasal and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • fentanyl iontophoretic transdermal system

                fentanyl iontophoretic transdermal system and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • fentanyl transdermal

                fentanyl transdermal and clorazepate both increase sedation. Avoid or Use Alternate Drug. Limit use to patients for whom alternative treatment options are inadequate

              • fexinidazole

                fexinidazole will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • hydrocodone

                hydrocodone, clorazepate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • idelalisib

                idelalisib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • ivosidenib

                ivosidenib will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

              • lonafarnib

                lonafarnib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              • lopinavir

                lopinavir will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • metoclopramide intranasal

                clorazepate, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              • olopatadine intranasal

                clorazepate and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.

              • selinexor

                selinexor, clorazepate. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

              • sodium oxybate

                clorazepate, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • sufentanil SL

                sufentanil SL, clorazepate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • tucatinib

                tucatinib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

              • valerian

                valerian and clorazepate both increase sedation. Avoid or Use Alternate Drug.

              • voxelotor

                voxelotor will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (246)

              • acrivastine

                acrivastine and clorazepate both increase sedation. Use Caution/Monitor.

              • albuterol

                clorazepate increases and albuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • alfentanil

                clorazepate and alfentanil both increase sedation. Use Caution/Monitor.

              • alprazolam

                alprazolam and clorazepate both increase sedation. Use Caution/Monitor.

              • amisulpride

                amisulpride and clorazepate both increase sedation. Use Caution/Monitor.

              • amitriptyline

                clorazepate and amitriptyline both increase sedation. Use Caution/Monitor.

              • amobarbital

                amobarbital and clorazepate both increase sedation. Use Caution/Monitor.

                amobarbital will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • amoxapine

                clorazepate and amoxapine both increase sedation. Use Caution/Monitor.

              • apomorphine

                clorazepate and apomorphine both increase sedation. Use Caution/Monitor.

              • arformoterol

                clorazepate increases and arformoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • aripiprazole

                clorazepate and aripiprazole both increase sedation. Use Caution/Monitor.

              • armodafinil

                clorazepate increases and armodafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • asenapine

                asenapine and clorazepate both increase sedation. Use Caution/Monitor.

              • asenapine transdermal

                asenapine transdermal and clorazepate both increase sedation. Use Caution/Monitor.

              • atazanavir

                atazanavir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Use alternatives if available. Consider lowering benzodiazepine dose.

              • avapritinib

                avapritinib and clorazepate both increase sedation. Use Caution/Monitor.

              • azelastine

                azelastine and clorazepate both increase sedation. Use Caution/Monitor.

              • baclofen

                clorazepate and baclofen both increase sedation. Use Caution/Monitor.

              • belladonna and opium

                clorazepate and belladonna and opium both increase sedation. Use Caution/Monitor.

              • belzutifan

                belzutifan will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

              • benperidol

                clorazepate and benperidol both increase sedation. Use Caution/Monitor.

              • benzphetamine

                clorazepate increases and benzphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • bosentan

                bosentan will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • brexanolone

                brexanolone, clorazepate. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • brexpiprazole

                brexpiprazole and clorazepate both increase sedation. Use Caution/Monitor.

              • brimonidine

                brimonidine and clorazepate both increase sedation. Use Caution/Monitor.

              • brivaracetam

                brivaracetam and clorazepate both increase sedation. Use Caution/Monitor.

              • brompheniramine

                brompheniramine and clorazepate both increase sedation. Use Caution/Monitor.

              • buprenorphine

                clorazepate and buprenorphine both increase sedation. Use Caution/Monitor.

              • buprenorphine buccal

                clorazepate and buprenorphine buccal both increase sedation. Use Caution/Monitor.

              • buprenorphine subdermal implant

                clorazepate increases toxicity of buprenorphine subdermal implant by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Studies have shown that the combination of benzodiazepines and buprenorphine altered the usual ceiling effect on buprenorphine-induced respiratory depression, making the respiratory effects of buprenorphine appear similar to those of full opioid agonists. There have been postmarketing reports of coma and death with coadministration of buprenorphine and benzodiazepines. In many, but not all of these cases, buprenorphine was misused by self-injection. If a benzodiazepine must be used for an indication other than seizures, lower the benzodiazepine initial dose and cautiously titrate to clinical response.

              • buprenorphine, long-acting injection

                clorazepate increases toxicity of buprenorphine, long-acting injection by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of buprenorphine and benzodiazepines or other CNS depressants increases risk of adverse reactions including overdose, respiratory depression, and death. Cessation of benzodiazepines or other CNS depressants is preferred in most cases. In some cases, monitoring at a higher level of care for tapering CNS depressants may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate.

              • butabarbital

                butabarbital and clorazepate both increase sedation. Use Caution/Monitor.

              • butalbital

                butalbital and clorazepate both increase sedation. Use Caution/Monitor.

              • butorphanol

                clorazepate and butorphanol both increase sedation. Use Caution/Monitor.

              • caffeine

                clorazepate increases and caffeine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • carbamazepine

                carbamazepine will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • carbinoxamine

                carbinoxamine and clorazepate both increase sedation. Use Caution/Monitor.

              • carisoprodol

                clorazepate and carisoprodol both increase sedation. Use Caution/Monitor.

              • cenobamate

                cenobamate will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

                cenobamate, clorazepate. Either increases effects of the other by sedation. Use Caution/Monitor.

              • ceritinib

                ceritinib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • chloral hydrate

                clorazepate and chloral hydrate both increase sedation. Use Caution/Monitor.

              • chlordiazepoxide

                chlordiazepoxide and clorazepate both increase sedation. Use Caution/Monitor.

              • chlorpheniramine

                chlorpheniramine and clorazepate both increase sedation. Use Caution/Monitor.

              • chlorpromazine

                clorazepate and chlorpromazine both increase sedation. Use Caution/Monitor.

              • chlorzoxazone

                clorazepate and chlorzoxazone both increase sedation. Use Caution/Monitor.

              • cimetidine

                cimetidine increases levels of clorazepate by decreasing metabolism. Use Caution/Monitor.

              • cinnarizine

                cinnarizine and clorazepate both increase sedation. Use Caution/Monitor.

              • clarithromycin

                clarithromycin will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • clemastine

                clemastine and clorazepate both increase sedation. Use Caution/Monitor.

              • clobazam

                clorazepate, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

              • clomipramine

                clorazepate and clomipramine both increase sedation. Use Caution/Monitor.

              • clonazepam

                clonazepam and clorazepate both increase sedation. Use Caution/Monitor.

              • clonidine

                clonidine, clorazepate. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration enhances CNS depressant effects.

              • clozapine

                clorazepate and clozapine both increase sedation. Use Caution/Monitor.

              • cobicistat

                cobicistat will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dose of clorazepate if necessary

              • codeine

                clorazepate and codeine both increase sedation. Use Caution/Monitor.

              • crofelemer

                crofelemer increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

              • cyclizine

                cyclizine and clorazepate both increase sedation. Use Caution/Monitor.

              • cyclobenzaprine

                clorazepate and cyclobenzaprine both increase sedation. Use Caution/Monitor.

              • cyproheptadine

                cyproheptadine and clorazepate both increase sedation. Use Caution/Monitor.

              • dabrafenib

                dabrafenib will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • dantrolene

                clorazepate and dantrolene both increase sedation. Use Caution/Monitor.

              • daridorexant

                clorazepate and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.

              • darunavir

                darunavir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternatives if available. Consider lowering benzodiazepine dose.

              • desflurane

                desflurane and clorazepate both increase sedation. Use Caution/Monitor.

              • desipramine

                clorazepate and desipramine both increase sedation. Use Caution/Monitor.

              • deutetrabenazine

                clorazepate and deutetrabenazine both increase sedation. Use Caution/Monitor.

              • dexchlorpheniramine

                dexchlorpheniramine and clorazepate both increase sedation. Use Caution/Monitor.

              • dexfenfluramine

                clorazepate increases and dexfenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dexmedetomidine

                clorazepate and dexmedetomidine both increase sedation. Use Caution/Monitor.

              • dexmethylphenidate

                clorazepate increases and dexmethylphenidate decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dextroamphetamine

                clorazepate increases and dextroamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dextromoramide

                clorazepate and dextromoramide both increase sedation. Use Caution/Monitor.

              • diamorphine

                clorazepate and diamorphine both increase sedation. Use Caution/Monitor.

              • diazepam

                clorazepate and diazepam both increase sedation. Use Caution/Monitor.

              • diazepam intranasal

                diazepam intranasal, clorazepate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may potentiate the CNS-depressant effects of each drug.

              • diethylpropion

                clorazepate increases and diethylpropion decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • difelikefalin

                difelikefalin and clorazepate both increase sedation. Use Caution/Monitor.

              • difenoxin hcl

                clorazepate and difenoxin hcl both increase sedation. Use Caution/Monitor.

              • dimenhydrinate

                dimenhydrinate and clorazepate both increase sedation. Use Caution/Monitor.

              • diphenhydramine

                diphenhydramine and clorazepate both increase sedation. Use Caution/Monitor.

              • diphenoxylate hcl

                clorazepate and diphenoxylate hcl both increase sedation. Use Caution/Monitor.

              • dipipanone

                clorazepate and dipipanone both increase sedation. Use Caution/Monitor.

              • disulfiram

                disulfiram increases levels of clorazepate by decreasing metabolism. Use Caution/Monitor.

              • dobutamine

                clorazepate increases and dobutamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dopamine

                clorazepate increases and dopamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dopexamine

                clorazepate increases and dopexamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dosulepin

                clorazepate and dosulepin both increase sedation. Use Caution/Monitor.

              • doxepin

                clorazepate and doxepin both increase sedation. Use Caution/Monitor.

              • doxylamine

                clorazepate and doxylamine both increase sedation. Use Caution/Monitor.

              • droperidol

                clorazepate and droperidol both increase sedation. Use Caution/Monitor.

              • efavirenz

                efavirenz will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • elagolix

                elagolix will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; consider benzodiazepine dose reduction.

              • encorafenib

                encorafenib, clorazepate. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

              • ephedrine

                clorazepate increases and ephedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • epinephrine

                clorazepate increases and epinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • epinephrine racemic

                clorazepate increases and epinephrine racemic decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • esketamine intranasal

                esketamine intranasal, clorazepate. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • estazolam

                clorazepate and estazolam both increase sedation. Use Caution/Monitor.

              • ethanol

                clorazepate and ethanol both increase sedation. Use Caution/Monitor.

              • etomidate

                etomidate and clorazepate both increase sedation. Use Caution/Monitor.

              • etravirine

                etravirine will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fedratinib

                fedratinib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fenfluramine

                clorazepate increases and fenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • flibanserin

                clorazepate and flibanserin both increase sedation. Modify Therapy/Monitor Closely. Risk for sedation increased if flibanserin is coadministration with other CNS depressants.

              • fluphenazine

                clorazepate and fluphenazine both increase sedation. Use Caution/Monitor.

              • flurazepam

                clorazepate and flurazepam both increase sedation. Use Caution/Monitor.

              • formoterol

                clorazepate increases and formoterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • fosamprenavir

                fosamprenavir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternatives if available. Consider lowering benzodiazepine dose.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • gabapentin

                gabapentin, clorazepate. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • gabapentin enacarbil

                gabapentin enacarbil, clorazepate. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • ganaxolone

                clorazepate and ganaxolone both increase sedation. Use Caution/Monitor.

              • haloperidol

                clorazepate and haloperidol both increase sedation. Use Caution/Monitor.

              • hydromorphone

                clorazepate and hydromorphone both increase sedation. Use Caution/Monitor.

              • hydroxyzine

                hydroxyzine and clorazepate both increase sedation. Use Caution/Monitor.

              • iloperidone

                clorazepate and iloperidone both increase sedation. Use Caution/Monitor.

                iloperidone increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

              • imipramine

                clorazepate and imipramine both increase sedation. Use Caution/Monitor.

              • indinavir

                indinavir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Potential for increased toxicity. Use alternatives if available. Consider lowering benzodiazepine dose.

              • isoniazid

                isoniazid will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • isoproterenol

                clorazepate increases and isoproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • istradefylline

                istradefylline will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • itraconazole

                itraconazole will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ketamine

                ketamine and clorazepate both increase sedation. Use Caution/Monitor.

              • ketoconazole

                ketoconazole will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • ketotifen, ophthalmic

                clorazepate and ketotifen, ophthalmic both increase sedation. Use Caution/Monitor.

              • lasmiditan

                lasmiditan, clorazepate. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

              • lemborexant

                lemborexant, clorazepate. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

              • lenacapavir

                lenacapavir will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir (a moderate CYP3A4 inhibitor) may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.

              • letermovir

                letermovir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • levalbuterol

                clorazepate increases and levalbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • levoketoconazole

                levoketoconazole will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • levorphanol

                clorazepate and levorphanol both increase sedation. Use Caution/Monitor.

              • lisdexamfetamine

                clorazepate increases and lisdexamfetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • lofepramine

                clorazepate and lofepramine both increase sedation. Use Caution/Monitor.

              • lofexidine

                clorazepate and lofexidine both increase sedation. Use Caution/Monitor.

              • loprazolam

                clorazepate and loprazolam both increase sedation. Use Caution/Monitor.

              • lorazepam

                clorazepate and lorazepam both increase sedation. Use Caution/Monitor.

              • lormetazepam

                clorazepate and lormetazepam both increase sedation. Use Caution/Monitor.

              • loxapine

                clorazepate and loxapine both increase sedation. Use Caution/Monitor.

              • loxapine inhaled

                clorazepate and loxapine inhaled both increase sedation. Use Caution/Monitor.

              • lurasidone

                lurasidone, clorazepate. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

              • maprotiline

                clorazepate and maprotiline both increase sedation. Use Caution/Monitor.

              • marijuana

                clorazepate and marijuana both increase sedation. Use Caution/Monitor.

              • melatonin

                clorazepate and melatonin both increase sedation. Use Caution/Monitor.

              • meperidine

                clorazepate and meperidine both increase sedation. Use Caution/Monitor.

              • meprobamate

                clorazepate and meprobamate both increase sedation. Use Caution/Monitor.

              • metaproterenol

                clorazepate increases and metaproterenol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • metaxalone

                clorazepate and metaxalone both increase sedation. Use Caution/Monitor.

              • methadone

                clorazepate and methadone both increase sedation. Use Caution/Monitor.

              • methamphetamine

                clorazepate increases and methamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • methocarbamol

                clorazepate and methocarbamol both increase sedation. Use Caution/Monitor.

              • methylenedioxymethamphetamine

                clorazepate increases and methylenedioxymethamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • methylphenidate transdermal

                methylphenidate transdermal will increase the level or effect of clorazepate by decreasing metabolism. Modify Therapy/Monitor Closely. Consider decreasing the dose of these drugs when given coadministered with methylphenidate. Monitor for drug toxiticities when initiating or discontinuing methylphenidate.

              • midazolam

                clorazepate and midazolam both increase sedation. Use Caution/Monitor.

              • midazolam intranasal

                midazolam intranasal, clorazepate. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • midodrine

                clorazepate increases and midodrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • mirtazapine

                clorazepate and mirtazapine both increase sedation. Use Caution/Monitor.

              • mitotane

                mitotane decreases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • modafinil

                clorazepate increases and modafinil decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • morphine

                clorazepate and morphine both increase sedation. Use Caution/Monitor.

              • motherwort

                clorazepate and motherwort both increase sedation. Use Caution/Monitor.

              • moxonidine

                clorazepate and moxonidine both increase sedation. Use Caution/Monitor.

              • nabilone

                clorazepate and nabilone both increase sedation. Use Caution/Monitor.

              • nafcillin

                nafcillin will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nalbuphine

                clorazepate and nalbuphine both increase sedation. Use Caution/Monitor.

              • nefazodone

                nefazodone will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nelfinavir

                nelfinavir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternatives if available. Consider lowering benzodiazepine dose.

              • norepinephrine

                clorazepate increases and norepinephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • nortriptyline

                clorazepate and nortriptyline both increase sedation. Use Caution/Monitor.

              • olanzapine

                clorazepate and olanzapine both increase sedation. Use Caution/Monitor.

              • oliceridine

                oliceridine, clorazepate. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • opium tincture

                clorazepate and opium tincture both increase sedation. Use Caution/Monitor.

              • orlistat

                orlistat decreases levels of clorazepate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • orphenadrine

                clorazepate and orphenadrine both increase sedation. Use Caution/Monitor.

              • oxazepam

                clorazepate and oxazepam both increase sedation. Use Caution/Monitor.

              • oxycodone

                clorazepate and oxycodone both increase sedation. Use Caution/Monitor.

              • oxymorphone

                clorazepate and oxymorphone both increase sedation. Use Caution/Monitor.

              • paliperidone

                clorazepate and paliperidone both increase sedation. Use Caution/Monitor.

              • papaveretum

                clorazepate and papaveretum both increase sedation. Use Caution/Monitor.

              • papaverine

                clorazepate and papaverine both increase sedation. Use Caution/Monitor.

              • pentazocine

                clorazepate and pentazocine both increase sedation. Use Caution/Monitor.

              • pentobarbital

                pentobarbital and clorazepate both increase sedation. Use Caution/Monitor.

              • perampanel

                perampanel and clorazepate both increase sedation. Use Caution/Monitor.

              • perphenazine

                clorazepate and perphenazine both increase sedation. Use Caution/Monitor.

              • phendimetrazine

                clorazepate increases and phendimetrazine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • phenobarbital

                phenobarbital and clorazepate both increase sedation. Use Caution/Monitor.

                phenobarbital will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • phentermine

                clorazepate increases and phentermine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • phenylephrine

                clorazepate increases and phenylephrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • phenylephrine PO

                clorazepate increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

              • phenytoin

                phenytoin will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • pholcodine

                clorazepate and pholcodine both increase sedation. Use Caution/Monitor.

              • pimozide

                clorazepate and pimozide both increase sedation. Use Caution/Monitor.

              • pirbuterol

                clorazepate increases and pirbuterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • posaconazole

                posaconazole will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • pregabalin

                pregabalin, clorazepate. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • primidone

                primidone and clorazepate both increase sedation. Use Caution/Monitor.

                primidone will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • prochlorperazine

                clorazepate and prochlorperazine both increase sedation. Use Caution/Monitor.

              • promethazine

                promethazine and clorazepate both increase sedation. Use Caution/Monitor.

              • propofol

                propofol and clorazepate both increase sedation. Use Caution/Monitor.

              • propylhexedrine

                clorazepate increases and propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • protriptyline

                clorazepate and protriptyline both increase sedation. Use Caution/Monitor.

              • quazepam

                clorazepate and quazepam both increase sedation. Use Caution/Monitor.

              • quetiapine

                clorazepate and quetiapine both increase sedation. Use Caution/Monitor.

              • ramelteon

                clorazepate and ramelteon both increase sedation. Use Caution/Monitor.

              • remimazolam

                remimazolam, clorazepate. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

              • ribociclib

                ribociclib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifabutin

                rifabutin will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifampin

                rifampin will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifapentine

                rifapentine will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • risperidone

                clorazepate and risperidone both increase sedation. Use Caution/Monitor.

              • rucaparib

                rucaparib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • salmeterol

                clorazepate increases and salmeterol decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • saquinavir

                saquinavir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternatives if available. Consider lowering benzodiazepine dose.

              • scullcap

                clorazepate and scullcap both increase sedation. Use Caution/Monitor.

              • secobarbital

                secobarbital and clorazepate both increase sedation. Use Caution/Monitor.

                secobarbital will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. May also enhance CNS depressant effect of clorazepate

              • sevoflurane

                sevoflurane and clorazepate both increase sedation. Use Caution/Monitor.

              • shepherd's purse

                clorazepate and shepherd's purse both increase sedation. Use Caution/Monitor.

              • stiripentol

                stiripentol, clorazepate. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

                stiripentol, clorazepate. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

              • sufentanil

                clorazepate and sufentanil both increase sedation. Use Caution/Monitor.

              • suvorexant

                suvorexant and clorazepate both increase sedation. Modify Therapy/Monitor Closely. Dosage adjustments of suvorexant and concomitant CNS depressants may be necessary

              • tapentadol

                clorazepate and tapentadol both increase sedation. Use Caution/Monitor.

              • tazemetostat

                tazemetostat will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • teduglutide

                teduglutide increases levels of clorazepate by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.

              • temazepam

                clorazepate and temazepam both increase sedation. Use Caution/Monitor.

              • terbutaline

                clorazepate increases and terbutaline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • thioridazine

                clorazepate and thioridazine both increase sedation. Use Caution/Monitor.

              • thiothixene

                clorazepate and thiothixene both increase sedation. Use Caution/Monitor.

              • tipranavir

                tipranavir increases levels of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Use alternatives if available. Consider lowering benzodiazepine dose.

              • topiramate

                clorazepate and topiramate both increase sedation. Modify Therapy/Monitor Closely.

              • tramadol

                clorazepate and tramadol both increase sedation. Use Caution/Monitor.

              • trazodone

                clorazepate and trazodone both increase sedation. Use Caution/Monitor.

              • triazolam

                clorazepate and triazolam both increase sedation. Use Caution/Monitor.

              • triclofos

                clorazepate and triclofos both increase sedation. Use Caution/Monitor.

              • trifluoperazine

                clorazepate and trifluoperazine both increase sedation. Use Caution/Monitor.

              • trimipramine

                clorazepate and trimipramine both increase sedation. Use Caution/Monitor.

              • triprolidine

                triprolidine and clorazepate both increase sedation. Use Caution/Monitor.

              • voriconazole

                voriconazole will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • xylometazoline

                clorazepate increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • yohimbine

                clorazepate increases and yohimbine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • ziconotide

                clorazepate and ziconotide both increase sedation. Use Caution/Monitor.

              • ziprasidone

                clorazepate and ziprasidone both increase sedation. Use Caution/Monitor.

              • zotepine

                clorazepate and zotepine both increase sedation. Use Caution/Monitor.

              Minor (18)

              • acetazolamide

                acetazolamide will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • anastrozole

                anastrozole will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • brimonidine

                brimonidine increases effects of clorazepate by pharmacodynamic synergism. Minor/Significance Unknown. Increased CNS depression.

              • ciprofloxacin

                ciprofloxacin increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • cyclophosphamide

                cyclophosphamide will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • eucalyptus

                clorazepate and eucalyptus both increase sedation. Minor/Significance Unknown.

              • fleroxacin

                fleroxacin increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • gemifloxacin

                gemifloxacin increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • green tea

                green tea decreases effects of clorazepate by pharmacodynamic antagonism. Minor/Significance Unknown. Caffeine component of green tea may decrease sedative effects of benzodiazepines.

              • larotrectinib

                larotrectinib will increase the level or effect of clorazepate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • levofloxacin

                levofloxacin increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • moxifloxacin

                moxifloxacin increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • ofloxacin

                ofloxacin increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • omeprazole

                omeprazole increases levels of clorazepate by decreasing metabolism. Minor/Significance Unknown.

              • rifabutin

                rifabutin decreases levels of clorazepate by increasing metabolism. Minor/Significance Unknown.

              • sage

                clorazepate and sage both increase sedation. Minor/Significance Unknown.

              • vinpocetine

                clorazepate increases effects of vinpocetine by unspecified interaction mechanism. Minor/Significance Unknown. Desirable interaction enhanced memory improvement (based on preliminary trial).

              • zolpidem

                zolpidem, clorazepate. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Additive CNS depression.

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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

              There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including TRANXENE, during pregnancy; healthcare providers are encouraged to register patients calling the National Pregnancy Registry for PsychiatricMedications at 1-866-961-2388 or visiting online athttps://womensmentalhealth.org/pregnancyregistry/

              Neonates born to mothers using benzodiazepines late in pregnancy have reported experiencing symptoms of sedation and/or neonatal withdrawal

              Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects

              Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates; monitor neonates exposed during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems; monitor neonates exposed during pregnancy for signs of withdrawal; manage these neonates accordingly

              Lactation

              Clorazepate and its active metabolite, nordiazepam, are present in breast milk; there are reports of sedation, poor feeding, and poor weight gain in infants exposed to benzodiazepines through breast milk; the effects of clorazepate on milk production are unknown

              Because of potential for serious adverse reactions, including sedation and withdrawal symptoms ininfants, advise patients that breastfeeding is not recommended during treatment

              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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              clorazepate dipotassium oral
              -
              15 mg tablet
              clorazepate dipotassium oral
              -
              7.5 mg tablet
              clorazepate dipotassium oral
              -
              15 mg tablet
              clorazepate dipotassium oral
              -
              3.75 mg tablet
              clorazepate dipotassium oral
              -
              3.75 mg tablet
              clorazepate dipotassium oral
              -
              7.5 mg tablet
              clorazepate dipotassium oral
              -
              3.75 mg tablet
              clorazepate dipotassium oral
              -
              15 mg tablet
              clorazepate dipotassium oral
              -
              7.5 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              clorazepate dipotassium oral

              CLORAZEPATE - ORAL

              (klor-AZ-e-pate)

              COMMON BRAND NAME(S): Tranxene

              WARNING: Clorazepate has a risk for abuse and addiction, which can lead to overdose and death. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of clorazepate that works, and take it for the shortest possible time. Be sure you know how to take clorazepate and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, trouble sleeping, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

              USES: Clorazepate is used to treat anxiety, acute alcohol withdrawal, and seizures. This medication belongs to a class of drugs called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).

              HOW TO USE: See also Warning section.Read the Medication Guide provided by your pharmacist before you start taking clorazepate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor. The dosage is based on your age, medical condition, and response to treatment.When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.Tell your doctor if your condition lasts or gets worse.

              SIDE EFFECTS: See also Warning section.Drowsiness, dizziness, tiredness, dry mouth, upset stomach, constipation, blurred vision, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: trouble speaking, clumsiness, trouble walking, decreased/increased interest in sex, tremor, trouble urinating, sleep disturbances, signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine), sore throat or fever that doesn't go away.A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, lung/breathing problems (such as COPD, sleep apnea), drug or alcohol abuse.This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially drowsiness, which can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: antacids, certain anti-depressants (such as fluoxetine, fluvoxamine, nefazodone), cimetidine, clozapine, digoxin, disulfiram, kava, orlistat, sodium oxybate.The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slowed/reduced reflexes, slowed breathing, loss of consciousness.

              NOTES: Do not share this medication with others. Sharing it is against the law.If this drug is used for an extended period of time, lab and/or medical tests (such as liver function, complete blood count) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. If you are taking this medication for seizures, take it if remembered within 1 hour of the missed dose, but skip it if more than 1 hour has passed.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              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.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.