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MEDICATION GUIDE

Tranxene
(TRAN-zeen) T-TAB®
(clorazepate dipotassium) Tablets

Read this Medication Guide before you start taking TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) ?

Do not stop taking TRANXENE (clorazepate dipotassium) without first talking to your healthcare provider.

Stopping TRANXENE (clorazepate dipotassium) suddenly can cause serious problems.

TRANXENE (clorazepate dipotassium) can cause serious side effects, including:

1. TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) affects you.
• Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking TRANXENE (clorazepate dipotassium) without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, TRANXENE (clorazepate dipotassium) may make your sleepiness or dizziness much worse.

2. TRANXENE (clorazepate dipotassium) can cause abuse and dependence.

• Do not stop taking TRANXENE (clorazepate dipotassium) all of a sudden. Stopping TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) 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.

TRANXENE (clorazepate dipotassium) is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep TRANXENE (clorazepate dipotassium) in a safe place to prevent misuse and abuse. Selling or giving away TRANXENE (clorazepate dipotassium) 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. TRANXENE (clorazepate dipotassium) may harm your unborn or developing baby.

Medicines like TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) . You and your healthcare provider should decide if you will take TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) , 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.
• Tranxene (clorazepate dipotassium) can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take TRANXENE (clorazepate dipotassium) . You and your healthcare provider should decide if you will take TRANXENE (clorazepate dipotassium) or breast feed. You should not do both.

4. Like other antiepileptic drugs, TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) without first talking to a healthcare provider.

Stopping TRANXENE (clorazepate dipotassium) 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 is TRANXENE (clorazepate dipotassium) ?

TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) ?

Do not take TRANXENE if you:

• are allergic to clorazepate dipotassium or any of the ingredients in TRANXENE (clorazepate dipotassium) . See the end of this Medication Guide for a complete list of ingredients in TRANXENE (clorazepate dipotassium) .
• have an eye disease called acute narrow angle glaucoma.

What should I tell my healthcare provider before taking TRANXENE (clorazepate dipotassium) ?

Before you take TRANXENE (clorazepate dipotassium) , 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 TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) ?

• Take TRANXENE (clorazepate dipotassium) exactly as prescribed. Your healthcare provider will tell you how much TRANXENE (clorazepate dipotassium) to take.
• Your healthcare provider may change your dose. Do not change your dose of TRANXENE (clorazepate dipotassium) without talking to your healthcare provider.
• Do not stop taking TRANXENE (clorazepate dipotassium) without first talking to your healthcare provider. Stopping TRANXENE (clorazepate dipotassium) suddenly can cause serious problems.

If you take too much TRANXENE (clorazepate dipotassium) , call your healthcare provider or local Poison Control Center right away.

What are the possible side effects of TRANXENE (clorazepate dipotassium) ?

See “What is the most important information I should know about TRANXENE (clorazepate dipotassium) ?”.

The most common side effects of TRANXENE (clorazepate dipotassium) include:

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

These are not all the possible side effects of TRANXENE (clorazepate dipotassium) . 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 TRANXENE (clorazepate dipotassium) ?

• Store TRANXENE (clorazepate dipotassium) between 680F to 770F (200C to 250C).
• Keep TRANXENE (clorazepate dipotassium) in a tightly closed container.
• Keep TRANXENE (clorazepate dipotassium) out of the light.
• Keep TRANXENE (clorazepate dipotassium) tablets dry.

Keep TRANXENE (clorazepate dipotassium) and all medicines away from children.

General Information about TRANXENE (clorazepate dipotassium)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRANXENE (clorazepate dipotassium) for a condition for which it was not prescribed. Do not give TRANXENE (clorazepate dipotassium) 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 TRANXENE (clorazepate dipotassium) . If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about TRANXENE (clorazepate dipotassium) that is written for health professionals.

For more information about TRANXENE (clorazepate dipotassium) , go to www.lundbeckinc.com or call Lundbeck Inc. at 1-888-514-5204.

What are the ingredients in TRANXENE?

Active ingredient: clorazepate dipotassium

Inactive ingredients: colloidal silicon dioxide, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, potassium chloride and talc.

In addition:

• the 3.75 mg tablets contain FD&C Blue No. 2
• the 7.5 mg tablets contain FD&C Yellow No. 6
• the 15 mg tablets contain FD&C Red No. 3

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

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

I. GOAL

The goal of this REMS is to inform patients about the serious risks associated with the use of Tranxene (clorazepate dipotassium).

II. REMS ELEMENTS

A Medication Guide

Lundbeck, Inc. will ensure a currently approved Medication Guide will be dispensed with each Tranxene (clorazepate dipotassium) prescription in accordance with 21 CFR 208.24.

The currently approved Medication Guide will be included at the end of each package insert and will also be available on Lundbeck's S.H.A.R.E. website (Support, Help and Resources for Epilepsy) (http://www.lundbeckshare.com/) and Lundbeck's corporate website (http://www.lundbeck.com/).

In accordance with 21 CFR 208.24(d), Lundbeck, Inc. will include a statement on the Tranxene (clorazepate dipotassium) carton/container labels to alert the authorized dispenser to provide a Medication Guide to each patient to whom the drug is dispensed.

B Timetable for Submission of Assessments

Lundbeck, Inc will submit REMS Assessments to the FDA 18 months, 3 years and 7 years from the date of approval of the REMS. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 days before the submission date for that assessment.

Lundbeck, Inc will submit each assessment so it will be received by the FDA on or before the due date.

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.