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Generic Name: clorazepate (Oral route)

klor-AZ-e-pate

Commonly used brand name(s)

In the U.S.

Gen-Xene

Tranxene

Tranxene-SD

Tranxene T-Tab

Available Dosage Forms:

Tablet

Tablet, Extended Release

Capsule

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Long Acting

Uses For Gen-Xene

Clorazepate is used to relieve symptoms of anxiety and alcohol withdrawal. This medicine may also be used to treat partial seizures.

Clorazepate is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using Gen-Xene

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of clorazepate in children younger than 9 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clorazepate in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of clorazepate. Elderly patients may require a lower dose to help reduce unwanted effects.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil

Amobarbital

Anileridine

Aprobarbital

Butabarbital

Butalbital

Carisoprodol

Chloral Hydrate

Chlorzoxazone

Codeine

Dantrolene

Ethchlorvynol

Fentanyl

Fospropofol

Hydrocodone

Hydromorphone

Levorphanol

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Morphine

Morphine Sulfate Liposome

Omeprazole

Oxycodone

Oxymorphone

Pentobarbital

Phenobarbital

Primidone

Propoxyphene

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Tapentadol

Thiopental

Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amprenavir

Ginkgo

St John's Wort

Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of clorazepate

This section provides information on the proper use of a number of products that contain clorazepate. It may not be specific to Gen-Xene. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine may be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For anxiety:
  - Adults—30 milligrams (mg) per day, taken in divided doses. Your doctor may adjust your dose if needed.
  - Older adults—At first, 7.5 to 15 mg per day, taken at bedtime or in divided doses. Your doctor may increase your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- For symptoms of alcohol withdrawal:
  - Adults—At first, 30 milligrams (mg), followed by 30 to 60 mg in divided doses. Your doctor will set up a schedule that will gradually reduce your dose until your symptoms improve. The dose is usually not more than 90 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For control of seizures:
  - Adults and teenagers—At first, 7.5 milligrams (mg) three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 90 mg per day.
  - Children 9 to 12 years of age—At first, up to 7.5 mg two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 60 mg per day.
  - Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Gen-Xene

It is very important that your doctor check the progress of you or your child at regular visits to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are using this medicine.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, nausea or vomiting, stomach or muscle cramps, tremors, or unusual behavior.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Gen-Xene Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

shakiness and unsteady walk

slurred speech

trembling or shaking of the hands or feet

unsteadiness, trembling, or other problems with muscle control or coordination

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in consciousness

drowsiness

loss of consciousness

relaxed and calm

sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Blurred vision

diarrhea

discouragement

dizziness

double vision

dry mouth

feeling sad or empty

headache

indigestion

irritability

loss of appetite

loss of interest or pleasure

mental confusion

nausea or vomiting

nervousness

passing of gas

seeing double

skin rash

sleeplessness

stomach pain, fullness, or discomfort

trouble with concentrating

trouble with sleeping

unable to sleep

unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Gen-Xene side effects (in more detail)

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More Gen-Xene resources

Gen-Xene Side Effects (in more detail)
Gen-Xene Use in Pregnancy & Breastfeeding
Drug Images
Gen-Xene Drug Interactions
Gen-Xene Support Group
9 Reviews for Gen-Xene - Add your own review/rating

Clorazepate Prescribing Information (FDA)

Clorazepate MedFacts Consumer Leaflet (Wolters Kluwer)

clorazepate Concise Consumer Information (Cerner Multum)

Clorazepate Dipotassium Monograph (AHFS DI)

Tranxene T-Tab Prescribing Information (FDA)

Compare Gen-Xene with other medications

Alcohol Withdrawal
Anxiety
Seizure Prevention

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Monday, September 26, 2016

Gen-Xene