Clorazepate

Usual Adult Dose for Anxiety:

Initial dose: 15 mg orally at bedtime or in divided doses
Maintenance dose: 15 to 60 mg orally in divided doses

Comments:
-In elderly or debilitated patients treatment should be initiated at a daily dose of 7.5 to 15 mg.
-Drowsiness may develop at the start of treatment and with dosage increases.

Uses:
-Management of anxiety disorders
-Short-term relief of the symptoms of anxiety

Usual Adult Dose for Alcohol Withdrawal:

Day 1: 30 mg orally, followed by 30 to 60 mg in divided doses
Day 2: 45 to 90 mg orally in divided doses
Day 3: 22.5 to 45 mg orally in divided doses
Day 4: 15 to 30 mg orally in divided doses
Maximum dose: 90 mg orally per day

Comments:
-After Day 4, the daily dose should be reduced to 7.5 to 15 mg.
-Use should be discontinued as soon as patient's condition is stable.
-Excessive reductions in the total amount of drug administered on successive days should be avoided.

Use: Symptomatic relief of acute alcohol withdrawal

Usual Adult Dose for Seizure Prophylaxis:

Initial Dose: 7.5 mg orally 3 times a day
Maintenance dose: May increase by no more than 7.5 mg orally every week
Maximum dose: 90 mg orally per day

Comments:
-To minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded.

Use: Adjunct to antiepileptic drugs

Usual Pediatric Dose for Seizure Prophylaxis:

9 to 12 years:
Initial Dose: 7.5 mg orally 2 times a day
Maintenance dose: May increase by no more than 7.5 mg orally every week
Maximum dose: 60 mg orally per day

13 years or older:
Initial Dose: 7.5 mg orally 3 times a day
Maintenance dose: May increase by no more than 7.5 mg orally every week
Maximum dose: 90 mg orally per day

Comments:
-To minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded.

Use: Adjunct to antiepileptic drugs

In the U.S.

• Gen-Xene
• Tranxene
• Tranxene-SD
• Tranxene T-Tab

Available Dosage Forms:

• Tablet
• Tablet, Extended Release
• Capsule

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Long Acting

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how clorazepate affects you.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
• This medicine may be habit-forming with long-term use.
• Do not change the dose or stop clorazepate. This could cause seizures. Talk with your doctor.
• Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop clorazepate, you will want to slowly stop it as ordered by your doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking clorazepate, call your doctor right away.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time clorazepate is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take clorazepate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to clorazepate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Clorazepate dipotassium tablets, USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Clorazepate dipotassium tablets, USP are indicated as adjunctive therapy in the management of partial seizures.

The effectiveness of Clorazepate dipotassium tablets, USP in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient.

Clorazepate dipotassium tablets, USP are indicated for the symptomatic relief of acute alcohol withdrawal.

The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech.

There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit.

Decrease in systolic blood pressure has been observed.

To report SUSPECTED ADVERSE REACTIONS, contact Ranbaxy Pharmaceuticals Inc. at 1-888-Ranbaxy (726-2299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Clorazepate DIPOTASSIUM TABLETS, USP

Rx only

Read this Medication Guide before you start taking Clorazepate dipotassium tablets, USP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Clorazepate dipotassium tablets, USP?

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.

Clorazepate dipotassium tablets, USP can cause serious side effects, including:

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

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Clorazepate dipotassium tablets, USP affects you.
• Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Clorazepate dipotassium tablets, USP without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Clorazepate dipotassium tablets, USP may make your sleepiness or dizziness much worse.

2. Clorazepate dipotassium tablets, USP can cause abuse and dependence.

• Do not stop taking Clorazepate dipotassium tablets, USP all of a sudden. Stopping Clorazepate dipotassium tablets, USP suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps.
  • Talk to your doctor about slowly stopping Clorazepate dipotassium tablets, USP to avoid getting sick with withdrawal symptoms.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

Clorazepate dipotassium tablets, USP is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Clorazepate dipotassium tablets, USP in a safe place to prevent misuse and abuse. Selling or giving away Clorazepate dipotassium tablets, USP may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

3. Clorazepate dipotassium tablets, USP may harm your unborn or developing baby.

Medicines like Clorazepate dipotassium tablets, USP can cause birth defects. Talk with your healthcare provider if you are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Clorazepate dipotassium tablets, USP. You and your healthcare provider should decide if you will take Clorazepate dipotassium tablets, USP while you are pregnant. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.

• 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.
• Clorazepate dipotassium can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Clorazepate dipotassium tablets, USP. You and your healthcare provider should decide if you will take Clorazepate dipotassium tablets, USP or breast feed. You should not do both.

4. Like other antiepileptic drugs, Clorazepate dipotassium tablets, USP may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

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 watch for early symptoms of suicidal thoughts and actions?

• 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.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Clorazepate dipotassium tablets, USP without first talking to a healthcare provider.

Stopping Clorazepate dipotassium tablets, USP suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What are Clorazepate dipotassium tablets, USP?

Clorazepate dipotassium tablets, USP is a prescription medicine used:

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

Who should not take Clorazepate dipotassium tablets, USP?

Do not take Clorazepate dipotassium tablets, USP if you:

• are allergic to Clorazepate dipotassium or any of the ingredients in Clorazepate dipotassium tablets, USP. See the end of this Medication Guide for a complete list of ingredients in Clorazepate dipotassium tablets, USP.
• have an eye disease called acute narrow angle glaucoma.

What should I tell my healthcare provider before taking Clorazepate dipotassium tablets, USP?

Before you take Clorazepate dipotassium tablets, USP, tell your healthcare provider if you:

• have liver or kidney problems
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have a history of abnormal thinking and behavior (psychotic reactions)
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking Clorazepate dipotassium tablets, USP with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Clorazepate dipotassium tablets, USP?

• 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.

If you take too much Clorazepate dipotassium tablets, USP, call your healthcare provider or local Poison Control Center right away.

What are the possible side effects of Clorazepate dipotassium tablets, USP? See “What is the most important information I should know about Clorazepate dipotassium tablets, USP?”.

The most common side effects of Clorazepate dipotassium tablets, USP include:

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

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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor 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, USP?

• 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.

Keep Clorazepate dipotassium tablets, USP and all medicines away from children.

General Information about Clorazepate dipotassium tablets, USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Clorazepate dipotassium tablets, USP for a condition for which it was not prescribed. Do not give Clorazepate dipotassium tablets, USP to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Clorazepate dipotassium tablets, USP. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Clorazepate dipotassium tablets, USP that is written for health professionals.

For more information about Clorazepate dipotassium tablets, USP, go to www.ranbaxyusa.com or call Ranbaxy Pharmaceuticals Inc. at 1-888-Ranbaxy (726-2299).

What are the ingredients in Clorazepate dipotassium tablets, USP?

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

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

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

by: Ohm Laboratories Inc.

North Brunswick, NJ 08902 USA

September 2010

(klor AZ e pate)

Anxiety disorders: Oral: Initial: 7.5 to 15 mg/day

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

May administer with food or water to decrease GI upset.

Excessive CNS depression, respiratory rate, and cardiovascular status; with prolonged use: CBC, liver enzymes, renal function; signs and symptoms of suicidality (eg, anxiety, depression, behavior changes).

Applies to clorazepate: oral capsule, oral tablet, oral tablet extended release

Along with its needed effects, clorazepate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clorazepate:

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain
• shakiness and unsteady walk
• slurred speech
• trembling or shaking of the hands or feet
• unsteadiness, trembling, or other problems with muscle control or coordination

Get emergency help immediately if any of the following symptoms of overdose occur while taking clorazepate:

• Change in consciousness
• drowsiness
• loss of consciousness
• relaxed and calm
• sleepiness

Some side effects of clorazepate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision
• diarrhea
• discouragement
• dizziness
• double vision
• dry mouth
• feeling sad or empty
• headache
• indigestion
• irritability
• loss of appetite
• loss of interest or pleasure
• mental confusion
• nausea or vomiting
• nervousness
• passing of gas
• seeing double
• skin rash
• stomach pain, fullness, or discomfort
• trouble with concentrating
• trouble with sleeping
• unusual tiredness or weakness

LactMed Record Number

345

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.