Tranxene-SD

Name: Tranxene-SD

Pharmacology

Mechanism of Action

Enhances the inhibitory effect of GABA on neuronal excitability by increasing neuronal membrane permeability to chloride ions

Pharmacokinetics

Half-Life: 50-70 hr

Time to peak: ~ 1 hr

Protein Bound: 97-98%

Metabolism: Hydroxylation, glucuronic acid conjugation

Metabolites: Desmethyldiazepam (nordiazepam), oxazepam

Excretion: Urine

Onset of action: 1-2 hr

Duration: Variable 8-24 hr

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 Tranxene-SD

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.

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 Tranxene-SD. 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 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.

Precautions While Using Tranxene-SD

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.

Tranxene-SD 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
  • 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.

For the Consumer

Applies to clorazepate: oral capsule, oral tablet, oral tablet extended release

Along with its needed effects, clorazepate (the active ingredient contained in Tranxene SD) 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 while taking clorazepate:

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 while taking clorazepate:

Symptoms of overdose
  • Change in consciousness
  • drowsiness
  • loss of consciousness
  • relaxed and calm
  • sleepiness

Some side effects of clorazepate 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

For Healthcare Professionals

Applies to clorazepate: oral tablet

General

The most commonly reported side effect was dizziness.

Psychiatric

Frequency not reported: Insomnia, suicidal ideation/behavior, irritability, depression

Nervous system

Frequency not reported: Dizziness, nervousness, headache, mental confusion, tremor, slurred speech, ataxia[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests

Renal

Frequency not reported: Abnormal kidney function tests

Hematologic

Frequency not reported: Decreased hematocrit

Other

Frequency not reported: Fatigue[Ref]

Dermatologic

Frequency not reported: Transient skin rash

Cardiovascular

Frequency not reported: Decrease in systolic blood pressure

Gastrointestinal

Frequency not reported: Gastrointestinal complaints, dry mouth

Genitourinary

Frequency not reported: Genitourinary complaints

Ocular

Frequency not reported: Blurred vision, diplopia

Some side effects of Tranxene SD may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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