T-TAB® (clorazepate dipotassium) Tablets
Read this Medication Guide before you start taking
TRANXENE 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
Do not stop taking TRANXENE without first talking to
your healthcare provider. Stopping TRANXENE suddenly can cause serious
TRANXENE can cause serious side effects, including:
1. TRANXENE 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 affects you.
- Do not drink alcohol or take other drugs that may make
you sleepy or dizzy while taking TRANXENE without first talking to your
healthcare provider. When taken with alcohol or drugs that cause sleepiness or
dizziness, TRANXENE may make your sleepiness or dizziness much worse.
2. TRANXENE can cause abuse and dependence.
- Do not stop taking TRANXENE all of a sudden. Stopping
TRANXENE 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 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 is a federally controlled substance (C-IV)
because it can be abused or lead to dependence. Keep TRANXENE in a safe place
to prevent misuse and abuse. Selling or giving away TRANXENE 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 may harm your unborn or developing baby.
Medicines like TRANXENE 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. You and your healthcare provider should decide if you will take
TRANXENE 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, 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 can pass into breast milk. Talk to your
healthcare provider about the best way to feed your baby if you take TRANXENE.
You and your healthcare provider should decide if you will take TRANXENE or
breast feed. You should not do both.
4. Like other antiepileptic drugs, TRANXENE 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
- Pay attention to any changes, especially sudden changes,
in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider
Call your healthcare provider between visits as needed,
especially if you are worried about symptoms.
Do not stop TRANXENE without first talking to a
Stopping TRANXENE 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?
TRANXENE 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?
Do not take TRANXENE if you:
- are allergic to clorazepate dipotassium or any of the
ingredients in TRANXENE. See the end of this Medication Guide for a complete
list of ingredients in TRANXENE.
- have an eye disease called acute narrow angle glaucoma.
What should I tell my healthcare provider before
Before you take TRANXENE, 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
- have any other medical conditions
Tell your healthcare provider about all the medicines
you take, including prescription and non-prescription medicines, vitamins,
and herbal supplements. Taking TRANXENE 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?
- Take TRANXENE exactly as prescribed. Your healthcare
provider will tell you how much TRANXENE to take.
- Your healthcare provider may change your dose. Do not
change your dose of TRANXENE without talking to your healthcare provider.
- Do not stop taking TRANXENE without first talking to your
healthcare provider. Stopping TRANXENE suddenly can cause serious problems.
If you take too much TRANXENE, call your healthcare
provider or local Poison Control Center right away.
What are the possible side effects of TRANXENE?
See “What is the most important information I should
know about TRANXENE?”.
The most common side effects of TRANXENE include:
- upset stomach
- blurred vision
- dry mouth
These are not all the possible side effects of TRANXENE.
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?
- Store TRANXENE between 680F to 770F (200C to 250C).
- Keep TRANXENE in a tightly closed container.
- Keep TRANXENE out of the light.
- Keep TRANXENE tablets dry.
Keep TRANXENE and all medicines away from children.
General Information about TRANXENE
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use TRANXENE for a condition
for which it was not prescribed. Do not give TRANXENE 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. If you would like more information, talk with your healthcare
provider. You can ask your pharmacist or healthcare provider for information
about TRANXENE that is written for health professionals.
For more information about TRANXENE, go to
www.recordatirarediseases.com or call Recordati Rare Diseases Inc. at
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.
- 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.