CLORAZEPATE DIPOTASSIUM- clorazepate dipotassium tablet 
Taro Pharmaceuticals U.S.A., Inc.

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MEDICATION GUIDE
CLORAZEPATE DIPOTASSIUM CIV

(klor AZ e pate di∙po∙tas∙sium) TABLETS

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

  • Do not stop taking clorazepate dipotassium without first talking to your healthcare provider.
    Stopping clorazepate dipotassium 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 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 affects you.
    • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clorazepate dipotassium without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clorazepate dipotassium may make your sleepiness or dizziness much worse.
  • Clorazepate dipotassium can cause abuse and dependence.
    • Do not stop taking clorazepate dipotassium all of a sudden. Stopping clorazepate dipotassium 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.
    • Talk to your healthcare provider about slowly stopping clorazepate dipotassium to avoid 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 is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep clorazepate dipotassium in a safe place to prevent misuse and abuse. Selling or giving away 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.
  • Clorazepate dipotassium may harm your unborn or developing baby. Medicines like 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 clorazepate dipotassium. Your healthcare provider should decide if you will take 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 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.
    • 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. You and your healthcare provider should decide if you will take clorazepate dipotassium or breastfeed. You should not do both.
  • Like other antiepileptic drugs, 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
  • feeling agitated or restless
  • acting aggressive, being angry, or violent
  • attempts to commit suicide
  • panic attacks
  • acting on dangerous impulses
  • new or worse depression
  • trouble sleeping (insomnia)
  • an extreme increase in activity and talking (mania)
  • new or worse anxiety
  • new or worse irritability
  • 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 is clorazepate dipotassium?
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
It is not known if clorazepate dipotassium is safe and effective in children less than 9 years of age.
Do not take clorazepate dipotassium 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, 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 with certain other medicines can cause side effects or affect how well clorazepate dipotassium or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take clorazepate dipotassium?
  • Take clorazepate dipotassium exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much clorazepate dipotassium to take and when to take it.
  • Your healthcare provider may change your dose if needed. Do not change your dose of clorazepate dipotassium without talking to your healthcare provider.
  • Do not stop taking clorazepate dipotassium without first talking to your healthcare provider. Stopping clorazepate dipotassium suddenly can cause serious problems.
  • If you take too much clorazepate dipotassium, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of clorazepate dipotassium?
Clorazepate dipotassium may cause serious side effects, including: See "What is the most important information I should know about clorazepate dipotassium?"
The most common side effects of clorazepate dipotassium include:
  • drowsiness
  • dizziness
  • upset stomach
  • blurred vision
  • dry mouth
These are not all the possible side effects of clorazepate dipotassium. 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?
  • Store clorazepate dipotassium tablets between 68ºF to 77ºF (20ºC to 25ºC).
  • Keep clorazepate dipotassium tablets in a tightly closed container, dry, and out of the light.
  • Keep clorazepate dipotassium and all medicines out of the reach of children.
General Information about the safe and effective use of clorazepate dipotassium.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clorazepate dipotassium for a condition for which it was not prescribed. Do not give clorazepate dipotassium to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clorazepate dipotassium that is written for health professionals.
What are the ingredients in clorazepate dipotassium?
Active ingredient: clorazepate dipotassium
Inactive ingredients: colloidal silicon dioxide, magnesium oxide heavy, magnesium stearate, microcrystalline cellulose, potassium carbonate anhydrous, potassium chloride, talc and the following coloring agents:
3.75 mg - FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake
7.5 mg - D&C Red No. 6 Barium Lake and D&C Yellow No. 10 Lake
15 mg - D&C Red No. 6 Barium Lake and FD&C Red No. 40 Lake
For more information about clorazepate dipotassium, go to www.taro.com or call Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-6914.
Manufactured by:
Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

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

Revised: July 2019
78548-0719-4

Revised: 7/2019
Taro Pharmaceuticals U.S.A., Inc.