CLORAZEPATE DIPOTASSIUM- clorazepate dipotassium tablet 
Mylan Pharmaceuticals Inc.

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Medication Guide Clorazepate Dipotassium Tablets, USP CIV

(klor azʹ e pate dyeʺ poe tasʹ ee um)

What is the most important information I should know about clorazepate dipotassium tablets?

Do not stop taking clorazepate dipotassium tablets without first talking to your healthcare provider. Stopping clorazepate dipotassium tablets suddenly can cause serious side effects.
Clorazepate dipotassium is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
Clorazepate dipotassium tablets can make you sleepy or dizzy and can slow your thinking and motor skills.
 
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Do not drive, operate heavy machinery, or do other dangerous activities until you know how clorazepate dipotassium tablets affect you.
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Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clorazepate dipotassium tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clorazepate dipotassium tablets may make your sleepiness or dizziness much worse.
Clorazepate dipotassium tablets can cause abuse and dependence.
 
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Do not stop taking clorazepate dipotassium tablets all of a sudden. Stopping clorazepate dipotassium tablets suddenly can cause seizures that do not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps.
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Talk to your healthcare provider about slowly stopping clorazepate dipotassium tablets to avoid withdrawal symptoms.
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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 are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep clorazepate dipotassium tablets in a safe place to prevent misuse and abuse. Selling or giving away clorazepate dipotassium tablets 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.
Clorazepate dipotassium tablets may harm your unborn or developing baby. Medicines like clorazepate dipotassium tablets 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. Your healthcare provider should decide if you will take clorazepate dipotassium tablets 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.
 
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If you become pregnant while taking clorazepate dipotassium tablets, 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.
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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. You and your healthcare provider should decide if you will take clorazepate dipotassium tablets or breastfeed. You should not do both.
Like other antiepileptic drugs, clorazepate dipotassium tablets 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.

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?

Clorazepate dipotassium tablets are a prescription medicine used:

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

It is not known if clorazepate dipotassium tablets are safe and effective in children less than 9 years of age.

Do not take clorazepate dipotassium tablets if you:

are allergic to clorazepate dipotassium or any of the ingredients in clorazepate dipotassium tablets. See the end of this Medication Guide for a complete list of ingredients in clorazepate 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 history of abnormal thinking and behavior (psychotic reactions)

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

Taking clorazepate dipotassium tablets with certain other medicines can cause side effects or affect how well clorazepate dipotassium tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

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 you how much clorazepate dipotassium tablets to take and when to take it.
Your healthcare provider may change your dose if needed. Do not change your dose of clorazepate dipotassium tablets without talking to your healthcare provider.
Do not stop taking clorazepate dipotassium tablets without first talking to your healthcare provider. Stopping clorazepate dipotassium tablets suddenly can cause serious problems.
If you take too many clorazepate dipotassium tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

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 should know about clorazepate dipotassium tablets?”

The most common side effects of clorazepate dipotassium tablets include:

drowsiness
dizziness
upset stomach
blurred vison
dry mouth

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

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?

Store clorazepate dipotassium tablets between 20º to 25ºC (68º to 77ºF).
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 they were not prescribed. Do not give clorazepate dipotassium tablets to other people, even if they have the same symptoms that you have. They 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, 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.

Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

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

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

Revised: 11/2019
CZPT:R19mmh/MG:CZPT:R2m/MG:CZPT:R2mh

Revised: 11/2019
Mylan Pharmaceuticals Inc.