Clorazepate (Oral route)
- Tranxene T-Tab
- Tablet, Extended Release
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, or death. Reserve use for patients for whom alternative therapies are inadequate and limit use to lowest possible dose and shortest possible duration. Monitor for signs or symptoms of respiratory depression and sedation .
Benzodiazepine, Long Acting
Uses of This Medicine:
Clorazepate is used to relieve symptoms of anxiety and alcohol withdrawal. This medicine may also be used with other medicines 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 This Medicine:
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clorazepate in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving clorazepate.
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.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
- Chloral Hydrate
- Morphine Sulfate Liposome
- Sodium Oxybate
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.
- St John's Wort
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.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, or history of or
- Depression, history of or
- Drug abuse or dependence, or history of or
- Lung or breathing problems (eg, respiratory depression) or
- Mental health problems, history of—Use with caution. May make these conditions worse.
- Glaucoma, narrow angle—Should not be used in patients with this condition.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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.
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 adjust 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 partial seizures:
- Adults and children 13 years of age and older—At first, 7.5 milligrams (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mg per day.
- Children 9 to 12 years of age—The starting dose is up to 7.5 mg 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
- Children up to 9 years of age—Use is not recommended.
- For anxiety:
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.
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 This Medicine:
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.
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 hay fever, allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, benzodiazepines, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. 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 be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Clorazepate may cause confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine.
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.
Side Effects of This Medicine:
- 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
- Symptoms of overdose
- Change in consciousness
- loss of consciousness
- relaxed and calm
- Less common
- Blurred vision
- double vision
- dry mouth
- feeling sad or empty
- loss of appetite
- loss of interest or pleasure
- mental confusion
- nausea or vomiting
- passing of gas
- seeing double
- skin rash
- stomach pain, fullness, or discomfort
- trouble with concentrating
- trouble with sleeping
- unusual tiredness or weakness
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 9/4/2017