Clorazepate

What is Clorazepate?

• Clorazepate (Tranxene), is a benzodiazepine.

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Clorazepate

Clorazepate

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What are the uses of this medicine?

Clorazepate (Tranxene), is a prescription medicine used:

• to treat anxiety disorders
• with other medicines to treat partial seizures
• to treat the symptoms of sudden alcohol withdrawal

How does this medicine work?

• Clorazepate (klor az' e pate) is a benzodiazepine with particular activity against spread of seizure activity in several animal models.
• The antiseizure activity of the benzodiazepines is mediated by their ability to enhance gamma-aminobutryic acid (GABA) mediated inhibition of synaptic transmission through binding to the GABA A receptor.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to clorazepate dipotassium or any of the ingredients in clorazepate dipotassium tablets, USP.
• have an eye disease called acute narrow angle glaucoma.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• barbiturates such as phenobarbital and secobarbital (Seconal)
• chlorpromazine
• cimetidine (Tagamet)
• disulfiram (Antabuse)
• levodopa (in Ritary, in Sinemet, in Stalevo)
• monoamine oxidase inhibitors such as isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• medications for depression, nausea, mental illness, and seizures
• sedatives
• sleeping pills
• tranquilizers

Is this medicine FDA approved?

• Clorazepate is used both as an anticonvulsant and anxiolytic agent.
• Clorazepate was approved in the United States in 1972 and currently more than 3 million prescriptions are filled yearly.

How should this medicine be used?

Recommended dosage:

For the symptomatic relief of anxiety:

• Clorazepate dipotassium tablets are administered orally in divided doses.
• The usual daily dose is 30 mg.
• The dose should be adjusted gradually within the range of 15 to 60 mg daily in accordance with the response of the patient.
• In elderly or debilitated patients it is advisable to initiate treatment at a daily dose of 7.5 to 15 mg.
• Clorazepate dipotassium tablets may also be administered in a single dose daily at bedtime; the recommended initial dose is 15 mg.

For the symptomatic relief of acute alcohol withdrawal: The following dosage schedule is recommended:

• 1st 24 hours (Day 1): 30 mg initially; followed by 30 to 60 mg in divided doses
• 2nd 24 hours (Day 2): 45 to 90 mg in divided doses
• 3rd 24 hours (Day 3): 22.5 to 45 mg in divided doses
• Day 4: 15 to 30 mg in divided doses
• Thereafter, gradually reduce the daily dose to 7.5 to 15 mg. Discontinue drug therapy as soon as patient's condition is stable.
• The maximum recommended total daily dose is 90 mg. Avoid excessive reductions in the total amount of drug administered on successive day.

As an Adjunct to Antiepileptic Drugs:

In Adults:

• The maximum recommended initial dose in patients over 12 years old is 7.5 mg three times a day.
• Dosage should be increased by no more than 7.5 mg every week and should not exceed 90 mg/day.

In Children (9 to 12 years):

• The maximum recommended initial dose is 7.5 mg two times a day.
• Dosage should be increased by no more than 7.5 mg every week and should not exceed 60 mg/day.

Administration:

• Clorazepate comes as a tablet to take by mouth.
• Take clorazepate dipotassium tablets, USP exactly as prescribed. Your healthcare provider will tell you how much clorazepate dipotassium tablets, USP to take.
• Your healthcare provider may change your dose. Do not change your dose of clorazepate dipotassium tablets, USP without talking to your healthcare provider.
• Do not stop taking clorazepate dipotassium tablets, USP without first talking to your healthcare provider. Stopping clorazepate dipotassium tablets, USP suddenly can cause serious problems.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Clorazepate dipotassium tablets, USP contain either 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP for oral administration.

This medicine is available in fallowing brand namesː

• Tranxene

What side effects can this medication cause?

The most common side effects of this medicine include:

• drowsiness
• dizziness
• upset stomach
• blurred vision
• dry mouth
• confusion

Less common,but serious side effects may include:

• can make you sleepy or dizzy and can slow your thinking and motor skills
• abuse and dependence
• harm your unborn or developing baby
• suicidal thoughts or actions

What special precautions should I follow?

• Patients taking clorazepate dipotassium tablets for prolonged periods should have blood counts and liver function tests periodically.
• In elderly or debilitated patients, the initial dose should be small, and increments should be made gradually, in accordance with the response of the patient, to preclude ataxia or excessive sedation.
• To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is essential that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.
• Clorazepate dipotassium tablets are not recommended for use in depressive neuroses or in psychotic reactions.
• Patients taking clorazepate dipotassium tablets should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating dangerous machinery including motor vehicles.
• Since clorazepate dipotassium has a central nervous system depressant effect, patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased.
• Withdrawal symptoms have occurred following abrupt discontinuance of clorazepate. Caution should be observed in patients who are considered to have a psychological potential for drug dependence.
• Antiepileptic drugs (AEDs), including clorazepate dipotassium, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Behaviors of concern should be reported immediately to healthcare providers.
• Therapy with clorazepate is not associated with serum aminotransferase elevations, and cases of clinically apparent liver injury from clorazepate have been reported but are very rare.
• Clorazepate dipotassium tablets should not be given to nursing mothers since it has been reported that nordiazepam is excreted in human breast milk.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• CNS depression ranging from slight sedation to coma.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• The treatment of overdosage should consist of the general measures employed in the management of overdosage of any CNS depressant.
• Gastric evacuation either by the induction of emesis, lavage, or both, should be performed immediately.
• General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.
• Hypotension, though rarely reported, may occur with large overdoses.
• In such cases the use of agents such as norepinephrine bitartrate injection, USP or metaraminol bitartrate injection, USP should be considered.
• Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected.
• Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment.
• The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

Can this medicine be used in pregnancy?

• Clorazepate dipotassium tablets, USP may harm your unborn or developing baby.
• If you become pregnant while taking clorazepate dipotassium tablets, USP, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.
• You can register by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

Can this medicine be used in children?

• Because of the lack of sufficient clinical experience, clorazepate dipotassium tablets are not recommended for use in patients less than 9 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: clorazepate dipotassium, USP
• Inactive ingredients: colloidal silicon dioxide, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, and potassium chloride.

In addition:

• the 3.75 mg tablets contain FD&C Blue No. 2 aluminum lake
• the 7.5 mg tablets contain FD&C Yellow No. 6 aluminum lake
• the 15 mg tablets contain FD&C Red No. 40 aluminum lake

Who manufactures and distributes this medicine?

Manufactured for:

• Ranbaxy Pharmaceuticals Inc.
• Jacksonville, FL USA

by: Ohm Laboratories Inc.

• North Brunswick, NJ USA

What should I know about storage and disposal of this medication?

• Store clorazepate dipotassium tablets, USP between 68○F to 77○F (20○C to 25○C).
• Keep clorazepate dipotassium tablets, USP in a tightly closed container.
• Keep clorazepate dipotassium tablets, USP out of the light.
• Keep clorazepate dipotassium tablets, USP dry.

• Dailymed label info on Clorazepate
• FDA Clorazepate

Clorazepate Resources
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Benzodiazipines

• Alprazolam
• Chlordiazepoxide
• Diazepam (Oral)
• Estazolam
• Flurazepam
• Lorazepam
• Midazolam
• Oxazepam
• Quazepam
• Temazepam
• Triazolam

Anticonvulsants Drugs

• Clobazam
• Clonazepam
• Clorazepate
• Diazepam (Intravenous)

Drug class for Clorazepate

Anticonvulsants, and Benzodiazepines]