Tranxene

Generic name: Clorazepate
Drug class: Benzodiazepines

Usage of Tranxene

Clorazepate is used to relieve symptoms of anxiety and alcohol withdrawal. It is also 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.

Tranxene 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

Agitation

change in consciousness

changes in patterns and rhythms of speech

drowsiness

loss of consciousness

loss of strength or energy

mood or mental changes

nightmares

shakiness and unsteady walk

sleepiness

slurred speech

talkativeness

trouble speaking

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

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual excitement, nervousness, restlessness, or irritability

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

stomach pain, fullness, or discomfort

trouble with concentrating

trouble with sleeping

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.

Before taking Tranxene

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, 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.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Flumazenil

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

Alprazolam

Amobarbital

Aripiprazole

Benzhydrocodone

Bromazepam

Bromopride

Buprenorphine

Butabarbital

Butalbital

Butorphanol

Calcium Oxybate

Cannabis

Cetirizine

Chloral Hydrate

Chlorzoxazone

Clobazam

Clonazepam

Codeine

Dantrolene

Daridorexant

Dexmedetomidine

Dihydrocodeine

Doxylamine

Esketamine

Ethchlorvynol

Fentanyl

Flibanserin

Fospropofol

Gabapentin

Gabapentin Enacarbil

Hydrocodone

Hydromorphone

Ivacaftor

Ketamine

Lacosamide

Lemborexant

Levocetirizine

Levorphanol

Lofexidine

Loxapine

Magnesium Oxybate

Meclizine

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methadone

Methocarbamol

Methohexital

Metoclopramide

Midazolam

Mirtazapine

Morphine

Morphine Sulfate Liposome

Nalbuphine

Olanzapine

Omeprazole

Orlistat

Oxycodone

Oxymorphone

Pentazocine

Pentobarbital

Periciazine

Phenobarbital

Potassium Oxybate

Pregabalin

Primidone

Propofol

Remimazolam

Ropeginterferon Alfa-2b-njft

Scopolamine

Secobarbital

Sodium Oxybate

Sufentanil

Tapentadol

Thiopental

Topiramate

Tramadol

Trazodone

Zolpidem

Zuranolone

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

Rifapentine

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.

Relate drugs

How to use Tranxene

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. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

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 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.

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.

Warnings

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.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

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, including hallucinations, nausea or vomiting, seizures, 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), thoughts of killing oneself, and unusual excitement, nervousness, or irritability.

Symptoms of an overdose include: change in consciousness, changes in patterns and rhythms of speech, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, mood or mental changes, muscle pain or weakness, nightmares, sleepiness or unusual drowsiness, shakiness and unsteady walk, slurred speech, trouble in speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

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.

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