CLORAZEPATE DIPOTASSIUM- clorazepate dipotassium tablet 
Bryant Ranch Prepack

----------

MEDICATION GUIDE

CLORAZEPATE DIPOTASSIUM TABLETS, USP CIV

Read this Medication Guide before you start taking clorazepate dipotassium tablets 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?

Do not stop taking clorazepate dipotassium tablets without first talking to your healthcare provider.

Stopping clorazepate dipotassium tablets suddenly can cause serious problems.

Clorazepate dipotassium tablets can cause serious side effects, including:

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

2. Clorazepate dipotassium tablets can cause abuse and dependence.

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.

3. 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. You and 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.

4. 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:

How can I watch for early symptoms of suicidal thoughts and actions?

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

Do not stop clorazepate dipotassium tablets without first talking to a healthcare provider.

Stopping clorazepate dipotassium tablets 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?

Clorazepate dipotassium tablets are a prescription medicine used:

Who should not take clorazepate dipotassium tablets?

Do not take clorazepate dipotassium tablets if you:

What should I tell my healthcare provider before taking clorazepate dipotassium tablets?

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

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Taking clorazepate dipotassium tablets 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?

What are the possible side effects of clorazepate dipotassium tablets?

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

The most common side effects of clorazepate dipotassium tablets include:

These are not all the possible side effects of clorazepate dipotassium tablets. 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?

Keep clorazepate dipotassium tablets and all medicines away from children.

General Information about 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 it was not prescribed. Do not give clorazepate dipotassium tablets 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. 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 that is written for health professionals.

What are the ingredients in clorazepate dipotassium tablets?

Active ingredient: clorazepate dipotassium, USP

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 - D&C Blue No. 2 Lake and FD&C Red No. 40 Lake

7.5 mg - D&C Red No. 6 Lake and D&C Yellow No. 10 Lake

15 mg - D&C Red No. 6 Lake and FD&C Red No. 40 Lake

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

Manufactured by:
Taro Pharmaceutical Industries Ltd.,
Haifa Bay, Israel 26110

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.,
Hawthorne, NY 10532

Issued: December 2010

78548-1210-3

Revised: 05/2010
 
Bryant Ranch Prepack