Clorazepate

Clorazepate is a prescription medication used for treating anxiety, seizures, and symptoms of alcohol withdrawal.

• Clorazepate  is available under various brand names: Tranxene SD, Tranxene T-Tab

Common side effects of Clorazepate include:

• dizziness, drowsiness.
• blurred vision.
• upset stomach; or
• dry mouth.

Serious side effects of Clorazepate include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• shallow or paused breathing,
• mood or behavior changes, anxiety, panic attacks, trouble sleeping, or  feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting.
• severe drowsiness.
• confusion, unusual thoughts, or behavior; or
• problems with urination.

Rare side effects of Clorazepate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet: Schedule IV

• 3.75 mg
• 7.5 mg
• 15 mg

Anxiety

Adult dosage

• 30 mg/day orally in divided doses; adjust dose gradually within range of 15-60 mg/day

Geriatric dosage

• 7.5 mg orally every day or every 12 hours

Seizure

Adult dosage

• 7.5 mg orally every 8 hours; increase by less than 7.5 mg/week; 90 mg/day maximum

Partial seizure

Pediatric dosage

• Aged below 9 years: Not recommended
• Aged between 9-12 years: 7.5 mg orally twice daily initially; increase by less than 7.5 mg every week to 60 mg/day maximum
• Aged above 12 years: As in adults

Acute Alcohol Withdrawal

Adult dosage

• Day 1: Initial 30 mg orally once, THEN 30-60 mg in divided doses, no more than 90 mg
• Day 2: 45-90 mg orally in divided doses
• Day 3: 22.5-45 mg orally in divided doses
• Day 4: 15-30 mg orally in divided doses
• Day 5 onwards: 7.5-15 mg orally in divided doses
• Discontinue when stable

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Clorazepate has severe interactions with no other drugs.
  • Clorazepate has serious interactions with the following drugs:
  • abametapir
  • apalutamide
  • benzhydrocodone/acetaminophen
  • calcium/magnesium/potassium/sodium oxybates
  • conivaptan
  • enzalutamide
  • fexinidazole
  • hydrocodone
  • idelalisib
  • ivosidenib
  • lonafarnib
  • lopinavir
  • metoclopramide intranasal
  • selinexor
  • sodium oxybate
  • sufentanil SL
  • tucatinib
  • valerian
  • voxelotor
• Clorazepate has moderate interactions with at least 236 other drugs.
• Clorazepate has minor interactions with at least 14 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Narrow-angle glaucoma

Effects of drug abuse

• Overdose
• Death

Short-Term Effects

• See “What Are Side Effects Associated with Using Clorazepate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Clorazepate?”

Cautions

• Benzodiazepines expose users to risks of abuse, misuse, and addiction, which can lead to overdose or death; abuse and misuse of benzodiazepines often (but not always) involve use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death
• Use of drug, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency
• Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate
• Therapy not recommended for use in depressive neuroses or psychotic reactions
• Patients receiving therapy should be cautioned against engaging in hazardous occupations requiring mental alertness, including heavy machinery
• Therapy has central nervous system (CNS) effect; avoid simultaneous use of other CNS depressant drug; effects of alcohol may be increased
• For patients treated more frequently than recommended, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose), to reduce risk of withdrawal reactions
• Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use
• In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months
• Patients taking drug for prolonged periods should have blood counts and liver function tests done periodically; the usual precautions in treating patients with impaired renal or hepatic function should also be observed
• In elderly or debilitated patients, initial dose should be small, and increments should be made gradually, in accordance with response of patient, to preclude ataxia or excessive sedation
• Suicidal behavior and ideation
  • Antiepileptic drugs (AEDs), increase risk of suicidal thoughts or behavior in patients taking drugs for any indication
  • Monitor patients treated with any AED for any indication for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
  • Increased risk of suicidal thoughts or behavior with AEDs reported as early as one week after starting drug treatment with AEDs; epilepsy and many other illnesses for which AEDs are prescribed are associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior
  • Should suicidal thoughts and behavior emerge during treatment, prescriber needs to consider whether emergence of these symptoms in any given patient may be related to illness being treated

Pregnancy & Lactation

• Not available. An increased risk of congenital malformations associated with the use of minor tranquilizers during the first trimester of pregnancy has been suggested in several studies. Pregnant patients taking clorazepate should enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. More information can be found at http://www.aedpregnancyregistry.org.
• Lactation
  • Enters breast milk; do not nurse