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Medication Guide — Tranxene

Patient-friendly FDA guidance and safety information.

Last updated · May 15, 2026Source: DailyMed ↗
Boxed Warning
  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs 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 (See WARNINGS and PRECAUTIONS).
  • The use of benzodiazepines, including Clorazepate dipotassium tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. 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 Clorazepate dipotassium tablets and throughout out treatment, assess each patient’s risk for abuse, misuse, and addiction (See WARNINGS).
  • The continued use of benzodiazepines, including Clorazepate dipotassium tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Clorazepate dipotassium tablets after continued use may precipitate acute withdrawal reactions, which can be life- threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Clorazepate dipotassium tablets or reduce the dosage (See DOSAGE AND ADMINISTRATION and WARNINGS).

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

This Medication Guide has been approved by the U.S. Food and Drug Administration.


MEDICATION GUIDE
Clorazepate Dipotassium Tablets, USP
(klor azʹ e pate dyeʺ poe tasʹ ee um)

What is the most important information I shouldknowaboutClorazepate dipotassium tablets?
  • Clorazepate dipotassium tablets   is   a benzodiazepinemedicine.Takingbenzodiazepineswithopioidmedicines,alcohol,or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Getemergencyhelprightawayifanyofthefollowinghappens:
    • shalloworslowedbreathing
    • breathingstops(whichmayleadtotheheartstopping)
    • excessivesleepiness(sedation)

DonotdriveoroperateheavymachineryuntilyouknowhowtakingClorazepate dipotassium tabletsandopioidsaffectsyou.


  • Risk   of   abuse,   misuse,   and   addiction.  There is a riskofabuse,misuse,andaddictionwithbenzodiazepinesincludingClorazepate dipotassium tabletswhichcanleadtooverdoseandserioussideeffectsincludingcomaanddeath.
    • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Clorazepate dipotassium tablets. Theseserioussideeffectsmayalsoincludedelirium,paranoia,suicidalthoughtsoractions,seizures,anddifficultybreathing.Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • YoucandevelopanaddictionevenifyoutakeClorazepate dipotassium tabletsasprescribedbyyourhealthcareprovider
    • Take Clorazepate dipotassium tablets exactly as your healthcare provider prescribed.
    • DonotshareyourClorazepate dipotassium tabletswithotherpeople.
    • KeepClorazepate dipotassium tablets in a safeplaceandawayfromchildren.
  • Physical   dependence   and   withdrawal   reactions.  Clorazepate dipotassium tablets can cause physical dependence and withdrawal reactions,.
    • Do not suddenly stop taking Clorazepate dipotassium tablets. StoppingClorazepate dipotassium tabletssuddenlycancauseseriousandlife-threateningsideeffects,including,unusualmovements,responses,orexpressions,seizures,suddenandseverementalornervoussystemchanges,depression,seeingorhearingthingsthatothersdonotseeorhear,anextremeincreaseinactivityortalking,losingtouchwithreality,andsuicidalthoughtsoractions.Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
    • Some people who suddenly stop benzodiazepines have symptoms that canlast for severalweeks to more than 12 months, including,anxiety,troubleremembering,learning, or concentrating,depression,problemssleeping,feelinglikeinsects are crawlingunder your skin,weakness,shaking,muscletwitching,burning or pricklingfeelingin your hands,arms,legs or feet,andringingin your ears.
    • Physicaldependence is not the sameas drug addiction.Yourhealthcareprovidercantell you moreabout the differencesbetweenphysicaldependenceanddrugaddiction.
    • Do not take more Clorazepate dipotassium tablets than prescribed or take Clorazepate dipotassium tablets for longer than prescribed.
  • Like   other   antiepileptic   medicines,   Clorazepate dipotassium tablets   may   cause   suicidal   thoughts   or   actions   in   a verysmall number of people, about 1 in500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

How can I watchforearlysymptomsofsuicidalthoughtsandactions?
  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Callyourhealthcareproviderbetweenvisitsasneeded,especiallyifyouareworriedaboutsymptoms.



Stopping a seizuremedicinesuddenlyin a patientwhohasepilepsycancauseseizuresthatwillnotstop(statusepilepticus).



Suicidalthoughtsoractionscanbecausedbythingsotherthanmedicines.Ifyouhavesuicidalthoughtsoractions,yourhealthcareprovidermaycheckforothercauses.


What is Clorazepate dipotassium tablets?

Clorazepate dipotassium tabletsis a prescriptionmedicineused:


  • to treat anxiety disorders
  • with other medicines to treat partial seizures
  • to treat the symptoms of sudden alcohol withdrawal
Clorazepate dipotassium tablets is a federallycontrolledsubstance(C-IV)because it contains clorazepate dipotassium that can be abused or lead to dependence.

KeepClorazepate dipotassium tablets in a safeplace to preventmisuseandabuse.Selling or givingawayClorazepate dipotassium tabletsmayharmothers,and is against the law. Tell your healthcareprovider if you haveeverabused or beendependent on alcohol,prescriptionmedicines or streetdrugs.



ItisnotknownifClorazepate dipotassium tabletsissafeandeffectiveinchildrenlessthan 9 yearsofage.


Do not take Clorazepate dipotassium tablets if you:
  • areallergictoclorazepatedipotassiumoranyoftheingredientsinClorazepate dipotassium tablets.SeetheendofthisMedicationGuidefor a completelistofingredientsinClorazepate dipotassium tablets.
Before you take Clorazepate dipotassium tablets, tell your healthcare provider about all your medical conditions, including if you:
  • have liver or kidney problems
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have a historyofabnormalthinkingandbehavior(psychoticreactions)
  • are pregnant or plan to become pregnant.
    • Taking Clorazepate dipotassium tablets late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
    • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Clorazepate dipotassium tablets.
    • There is a pregnancy registry for women who take Clorazepate dipotassium tablets during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with Clorazepate dipotassium tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388-or visiting https://womensmentalhealth.org/pregnancyregistry/.
  • are breastfeeding or plan to breastfeed. Clorazepate dipotassium tablets passes into breast milk.
    • Talk to your healthcare provider about the best way to feed your baby if you take Clorazepate dipotassium tablets.
    • Breastfeeding is not recommended during treatment with Clorazepate dipotassium tablets.

Tell your healthcare provider about all the medicines you take,

includingprescriptionandover-the-countermedicines,vitamins,andherbalsupplements.



TakingClorazepate dipotassium tabletswithcertainothermedicinescancausesideeffectsoraffecthowwellClorazepate dipotassium tabletsortheothermedicineswork.Donotstartorstopothermedicineswithouttalkingtoyourhealthcareprovider.


How should I take Clorazepate dipotassium tablets?
  • Take Clorazepate dipotassium tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell youhowmuchClorazepate dipotassium tabletstotakeandwhentotakeit.
  • Your healthcare provider may change your dose if needed. Do not change your dose of Clorazepate dipotassium tablets without talkingtoyourhealthcareprovider.
  • Do not stop taking Clorazepate dipotassium tablets without first talking to your healthcare provider. Stopping Clorazepate dipotassium tablets suddenlycancauseseriousproblems.
  • IfyoutaketoomuchClorazepate dipotassium tablets,callyourhealthcareproviderorgotothenearesthospitalemergencyroomrightaway.
What are the possible side effects of Clorazepate dipotassium tablets?
Clorazepate dipotassium tablets may cause serious side effects, including: See “What is the most important information I shouldknowaboutClorazepate dipotassium tablets?”

o

Clorazepate dipotassium tablets can make you sleepy or dizzy and can slow your thinking and motor skills.

Donotdrive,operateheavymachinery,ordootherdangerousactivitiesuntilyouknowhowClorazepate dipotassium tabletsaffectsyou.


o

DonotdrinkalcoholortakeotherdrugsthatmaymakeyousleepyordizzywhiletakingClorazepate dipotassium tabletswithoutfirsttalkingtoyourhealthcareprovider.

Whentakenwithalcoholordrugsthatcausesleepinessordizziness,Clorazepate dipotassium tabletsmaymakeyoursleepinessordizzinessmuchworse.


The most common side effects of Clorazepate dipotassium tablets include:

        •    drowsiness                            •     upset stomach                       •     dry mouth


        •    dizziness                               •     blurred vision


These are not all the possible side effects of Clorazepate dipotassium tablets. For more information, ask your healthcare provider or pharmacist.



Call your d octor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Clorazepate dipotassium tablets?
  • Store Clorazepate dipotassium tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
  • Keep Clorazepate dipotassium tablets in a tightly closed container, dry, and out of the light.
  • Keep   Clorazepate dipotassium tablets   and   all   medicines   out   of   the   reach   of   children.
General Information about the safe and effective use of Clorazepate dipotassium tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use - Clorazepate dipotassium tablets for a condition for which it was not prescribed. Do not give Clorazepate dipotassium tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Clorazepate dipotassium tablets that is written for health professionals.


What are the ingredients in Clorazepate dipotassium tablets?
Active ingredient:

clorazepate dipotassium


Inactive ingredients:

croscarmellose sodium, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, sodium chloride and sodium lauryl sulfate. The 3.75  mg tablets also contain FD&C Blue No. 2 Aluminum Lake and the 7.5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake.



Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides


Manufactured by:
Alphapharm Pty Ltd
15 Garnet Street
Carole Park QLD 4300
Australia

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Revised: 04/2023

Sources

RxCUI: 197465

NDC: 3780030

Last fetched: May 15, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.