CLORAZEPATE DIPOTASSIUM 15 mg Tablet, 100-count
Other active recalls for Clorazepate Dipotassium (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Benzodiazepine class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Clorazepate is used to relieve anxiety. Clorazepate is also used along with other medications to treat certain types of seizures. It is also used to relieve unpleasant symptoms that may be experienced by people who have stopped drinking alcohol after drinking large amounts for a long time. Clorazepate is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.
Read the full MedlinePlus article ↗- Clorazepate is used for three things: managing anxiety disorders, helping control partial seizures as part of a broader treatment plan (alongside other seizure medications), and ea...
- Drowsiness is the most commonly reported side effect, especially when you first start taking it or after a dose increase. You may also notice some dizziness, dry mouth, or mild con...
- Will this medication make me feel drowsy or foggy?
- No — please avoid alcohol entirely while on clorazepate. This medication intensifies the effects of alcohol, and the combination puts extra strain on your breathing and nervous sys...
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 3A3U0GI71G
Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII BQN1B9B9HA
Potassium carbonate is a white crystalline salt made from potassium and carbonate compounds. It functions as a pH buffer and alkalizing agent in medicines, helping maintain proper acidity levels in liquid formulations.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.900 | $90.04 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.44 | $144.08 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clorazepate Dipotassium 15 mg 13107-0284-01 | Aurolife | 100 tablets | $0.900 | AB | Availability likely | — |
| Clorazepate Dipotassium 15 mgthis 13107-0321-01 | Aurolife | 100 tablets | $0.900 | AB | Availability likely | — |
| Clorazepate Dipotassium 15 mg 51672-4044-01 | Sun | 100 tablets | $0.900 | AB | Availability likely | — |
| Clorazepate Dipotassium 15 mg/mg 60505-4756-01 | Apotex | 100 mg | $0.900 | AB | Availability likely | — |
| Clorazepate Dipotassium 15 mg 70954-0157-10 | ANI | 100 tablets | $0.900 | AB | Availability likely | — |
| Clorazepate Dipotassium 15 mg 72603-0114-01 | NORTHSTAR | 100 tablets | $0.900 | AB | Availability likely | — |
| Clorazepate Dipotassium 15 mg 67046-1462-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Clorazepate Dipotassium 15 mg 67046-1501-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Clorazepate Dipotassium 15 mg 72789-0256-06 | PD-Rx | 6 tablets | — | AB | FDA listed | — |
| Clorazepate Dipotassium 15 mg 58118-4044-08 | Clinical | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 13107-0321-01 You're viewing this | 100 TABLET in 1 BOTTLE, PLASTIC (13107-321-01) | 1987-07-17 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS 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 ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clorazepate dipotassium tablets are indicatedfor the management of anxiety disordersorfortheshort-term relief of the symptoms of anxiety. Anxiety or tensionassociatedwith the stress of everyday life usually does not require treatmentwith an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctivetherapy in themanagement of partialseizures.
Theeffectiveness of Clorazepate dipotassium tablets in long-term management of anxiety, that is,more than 4 months, has not beenassessed by systematicclinicalstudies.Long-term studies in epilepticpatients,however, have showncontinuedtherapeuticactivity.Thephysician should reassessperiodically the usefulnessof the drug for the individualpatient. Clorazepate dipotassium tabletsare indicatedfor the symptomaticrelief of acute alcoholwithdrawal.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION FortheSymptomatic ReliefofAnxiety: Clorazepate dipotassium tablets are administeredorally in divided doses. The usual daily dose is 30mg.The dose should beadjustedgraduallywithintherange of 15 to 60 mg daily in accordancewith the response of the patient. In elderly or debilitatedpatientsit is advisable to initiate treatment at a daily dose of 7.5 to 15 mg.
Clorazepate dipotassium tabletsmay also be administeredin a singledosedaily at bedtime; the recommendedinitialdose is 15 mg.After the initial dose, the response of the patient mayrequireadjustment of subsequent dosage.Lower doses may be indicated in the elderlypatient. Drowsinessmay occur at the initiation of treatment and withdosageincrement. For the Symptomatic Relief of Acute Alcohol Withdrawal: Thefollowing dosage scheduleisrecommended: 1st 24 hours (Day 1) 30 mginitially;followed by 30 to 60 mg in divideddoses 2nd 24 hours (Day 2) 45 to 90 mg in divideddoses 3rd 24 hours (Day 3) 22.5 to 45 mg in divided doses Day 4 15 to 30 mg in divideddoses Thereafter,graduallyreduce the daily dose to 7.5 to 15 mg.Discontinuedrugtherapy as soon as patient’s condition is stable.
Themaximum recommendedtotaldailydose is 90 mg. Avoid excessive reductionsin the totalamount of drug administeredonsuccessive days. As an Adjunct to Antiepileptic Drugs: In order to minimizedrowsiness, the recommendedinitialdosages and dosageincrementsshould not be exceeded.
Adults: Themaximum recommendedinitialdose in patients over 12 years old is 7.5 mg three times a day. Dosage should be increased by no more than 7.5mg every week and should not exceed 90 mg/day. Children (9-12 years): Themaximum recommendedinitial dose is 7.5 mgtwotimes a day.
Dosage should be increased by no more than 7.5mg every week and should not exceed 60 mg/day. Discontinuation or DosageReduction of Clorazepate dipotassium tablets: To reduce the risk of withdrawalreactions,use a gradualtaper to discontinueClorazepate dipotassium tablets or reduce the dosage. If a patient develops withdrawalreactions,consider pausing the taper or increasingthe dosage to the previous tapereddosage level.
Subsequentlydecreasethedosagemoreslowly (see WARNINGS and DRUG ABUSE AND DEPENDENCE ).
⛔ Contraindications ▾
CONTRAINDICATIONS Clorazepate dipotassium tabletsare contraindicated in patientswith a knownhypersensitivityto the drug and in those withacutenarrow angle glaucoma.
⚠️ Warnings ▾
WARNINGS Risks from Concomitant Use with Opioids: Concomitant use of benzodiazepines, including Clorazepate dipotassium tablets, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe Clorazepate dipotassium tablets concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Clorazepate dipotassium tablets than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Clorazepate dipotassium tablets, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when Clorazepate dipotassium tablets is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see PRECAUTIONS: Drug Interactions ). Abuse, Misuse, and Addiction: The use of benzodiazepines, including Clorazepate dipotassium tablets, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
Abuse and misuse of benzodiazepines often (but not always) involve the 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 (see DRUG ABUSE AND DEPENDENCE: Abuse ). Before prescribing Clorazepate dipotassium tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).
Use of Clorazepate dipotassium tablets, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Clorazepate dipotassium tablets along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.
Dependence and Withdrawal Reactions: To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Clorazepate dipotassium tablets or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION: Discontinuation of Dosage Reduction of Clorazepate dipotassium tablets ). 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.
Acute Withdrawal Reactions The continued use of benzodiazepines, including Clorazepate dipotassium tablets, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of Clorazepate dipotassium tablets after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: Dependence ). Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The side effectmostfrequentlyreported wasdrowsiness.Lesscommonlyreported (in descending order of occurrence)were:dizziness, various gastrointestinal complaints,nervousness, blurred vision, dry mouth,headache, and mentalconfusion.Other side effects included insomnia,transientskinrashes,fatigue,ataxia,genitourinarycomplaints,irritability,diplopia,depression,tremor, and slurredspeech. There have been reports of abnormalliver and kidneyfunction tests and of decrease in hematocrit. Decrease in systolicbloodpressurehas been observed.
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
DRUG INTERACTIONS Theconcomitant use of benzodiazepines and opioidsincreases the riskof respiratorydepressionbecause of actionsatdifferentreceptor sites in the CNS that control respiration.Benzodiazepinesinteract at GABAA sites and opioidsinteractprimarilyatmu receptors. Whenbenzodiazepinesand opioids arecombined, the potentialforbenzodiazepinestosignificantlyworsenopioid-relatedrespiratorydepressionexists.Limitdosageandduration of concomitant use of benzodiazepines and opioids, and monitorpatients closelyforrespiratorydepressionandsedation.
If Clorazepate dipotassium tablets is to be combined with other drugs acting on the central nervous system, careful consideration should be given to thepharmacology of the agentsto be employed.Animalexperienceindicates that clorazepatedipotassium prolongs thesleepingtimeafterhexobarbital or afterethylalcohol,increases the inhibitoryeffects of chlorpromazine, but does not exhibitmonoamineoxidaseinhibition.Clinicalstudies have shownincreasedsedationwithconcurrent hypnotic medications.Theactions of the benzodiazepines may be potentiated by barbiturates,narcotics,phenothiazines,monoamine oxidase inhibitors or other antidepressants.
If Clorazepate dipotassium tablets are used to treatanxietyassociatedwithsomatic disease states,carefulattentionmust be paid to possible druginteractionwith concomitantmedication. In bioavailabilitystudieswithnormalsubjects,theconcurrentadministration of antacidsattherapeuticlevelsdid not significantlyinfluencethebioavailability of Clorazepate dipotassium tablets.
🤰 Pregnancy ▾
Pregnancy: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including Clorazepate dipotassium tablets, during pregnancy. Healthcare providers are encouraged to register patients calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome and Clinical Considerations ).
Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Clorazepate dipotassium during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems.
Monitor neonates exposed to Clorazepate dipotassium during pregnancy for signs of withdrawal. Manage these neonates accordingly (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome ). Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects.
Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings. Animal Data In animal reproduction studies, oral administration of clorazepate to pregnant rats and rabbits at doses up to 150 and 15 mg/kg, respectively, did not cause fetal toxicities or malformation.
However, the sedative effects of high dose clorazepate interfered with the maternal care of the offspring.
🧒 Pediatric Use ▾
Pediatric Use: See WARNINGS .
🧓 Geriatric Use ▾
Geriatric Use: Clinical studies of Clorazepate dipotassium tablets were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects. Elderly or debilitated patients may be especially sensitive to the effects of all benzodiazepines, including Clorazepate dipotassium. In general, elderly or debilitated patients should be started on lower doses of Clorazepate dipotassium and observed closely, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.
Dose adjustments should also be made slowly, and with more caution in this patient population (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur.
In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Dependence and Withdrawal Reactions ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage.
In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency.
The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage.
See the flumazenil injection Prescribing Information. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacologically, clorazepate dipotassium has the characteristics of the benzodiazepines. It has depressant effects on the central nervous system. The primary metabolite, nordiazepam, quickly appears in the blood stream.
The serum half-life is about 2 days. The drug is metabolized in the liver and excreted primarily in the urine. Studies in healthy men have shown that clorazepate dipotassium has depressant effects on the central nervous system.
Prolonged administration of single daily doses as high as 120 mg was without toxic effects. Abrupt cessation of high doses was followed in some patients by nervousness, insomnia, irritability, diarrhea, muscle aches, or memory impairment. Since orally administered clorazepate dipotassium is rapidly decarboxylated to form nordiazepam, there is essentially no circulating parent drug.
Nordiazepam, the primary metabolite, quickly appears in the blood and is eliminated from the plasma with an apparent half-life of about 40 to 50 hours. Plasma levels of nordiazepam increase proportionally with Clorazepate dipotassium tablets dose and show moderate accumulation with repeated administration. The protein binding of nordiazepam in plasma is high (97-98%).
Within 10 days after oral administration of a 15 mg (50 µCi) dose of 14 C-Clorazepate dipotassium tablets to two volunteers, 62-67% of the radioactivity was excreted in the urine and 15-19% was eliminated in the feces. Both subjects were still excreting measurable amounts of radioactivity in the urine (about 1% of the 14 C-dose) on day ten. Nordiazepam is further metabolized by hydroxylation.
The major urinary metabolite is conjugated oxazepam (3-hydroxynordiazepam), and smaller amounts of conjugated p-hydroxynordiazepam and nordiazepam are also found in the urine.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clorazepate Dipotassium Tablets, USP are available containing 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP. The 3.75 mg tablets are blue, round, scored tablets debossed with M above the score and 30 below the score on one side of the tablet and blank on the other side. They are available as follows: Bottles of 100 NDC 13107-319-01 Bottles of 500 NDC 13107-319-05 The 7.5 mg tablets are peach, round, scored tablets debossed with M above the score and 40 below the score on one side of the tablet and blank on the other side.
They are available as follows: Bottles of 100 NDC 13107-320-01 Bottles of 500 NDC 13107-320-05 The 15 mg tablets are white, round, scored tablets debossed with M above the score and 70 below the score on one side of the tablet and blank on the other side. They are available as follows: Bottles of 100 NDC 13107-321-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
PHARMACIST: Dispense a Medication Guide with each prescription. 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
📋 Description ▾
DESCRIPTION Chemically, Clorazepate dipotassium is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1 H -1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2,3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows: The compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water.
Aqueous solutions are unstable, clear, light yellow, and alkaline. Clorazepate dipotassium tablets, USP contain 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP for oral administration. Inactive ingredients for Clorazepate dipotassium tablets: 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.
CHemical Structure
💬 Information for Patients ▾
Information for Patients Advise thepatient to read theFDA-approvedpatientlabeling ( Medication Guide ).
💬 Medication Guide ▾
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 patientwhohasepilepsycancausese…