clorazepate

ROUTE	ONSET	PEAK	DURATION
PO	1–2 hr	1–2 hr	up to 24 hr‡

Contraindicated in:

Hypersensitivity;
Cross-sensitivity with other benzodiazepines may occur;
Pre-existing CNS depression;
Severe uncontrolled pain;
Angle-closure glaucoma;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

All patients (may ↑ risk of suicidal thoughts/behaviors);
Hepatic impairment;
Patients who may be suicidal or have been addicted to drugs in the past;
Severe pulmonary disease;
Geri: Appears on Beers list. ↑ risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents. If possible, avoid use in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

EENT: blurred vision

GI: constipation, diarrhea, nausea, vomiting

Neuro: dizziness, drowsiness, lethargy, ataxia, depression, hangover, headache, paradoxical excitation, slurred speech, SUICIDAL THOUGHTS

Resp: RESPIRATORY DEPRESSION

Misc: physical dependence, psychological dependence, tolerance

Interactions ⬆ ⬇

Drug-drug:

Use with opioids or other CNS depressants, including otherbenzodiazepines, non-benzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
Cimetidine, hormonal contraceptives, disulfiram, fluoxetine, isoniazid, ketoconazole, metoprolol, propranolol, or valproic acid may ↓metabolism of clorazepate, ↑ its actions.
May ↓ efficacy of levodopa.
Rifampin or barbiturates may ↓ metabolism and ↓ effectiveness of clorazepate.
Sedative effects may be ↓ by theophylline.

Drug-Natural Products:

Concomitant use of kava-kava, valerian, or chamomile↑ CNS depression.

Route/Dosage ⬆ ⬇

Prescribe largest dose at bedtime to avoid daytime sedation. Can be used on prn basis for anxiety
PO (Adults ): Anxiety: 7.5–15 mg 2–4 times daily or 15 mg at bedtime initially. Alcohol withdrawal: 30 mg initially, then 15 mg 2–4 times daily on 1st day, then gradually ↓ over subsequent days.
PO (Adults and Children >12 yr): Anticonvulsant: 7.5 mg 3 times daily; may ↑ by no more than 7.5 mg/day at weekly intervals (daily dose not to exceed 90 mg).
PO Geriatric Patients ): Anxiety: 7.5 mg 1–2 times daily; may be ↑.
PO (Children 9–12 yr): Anticonvulsant: 7.5 mg twice daily initially, may ↑ by no more than 7.5 mg/wk (not to exceed 60 mg/day).

Availability ⬆ ⬇

(Generic available)

Tablets: 3.75 mg; 7.5 mg; 15 mg

Assessment ⬆ ⬇

Assess for drowsiness, unsteadiness, and clumsiness. Symptoms are dose related and most severe during initial therapy; may decrease in severity or disappear with continued or long-term therapy.
- Prolonged high-dose therapy may lead to psychological or physical dependence. Restrict amount of drug available to patient.
Conduct regular assessments to determine continued need for therapy.
Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
Assess risk for addiction, abuse, or misuse prior to administration and periodically during therapy.
Anxiety: Assess degree and manifestations of anxiety and mental status (orientation, mood, behavior) prior to and periodically during therapy.
Alcohol Withdrawal: Assess patient experiencing alcohol withdrawal for tremors, agitation, delirium, and hallucinations. Protect from injury. Institute seizure precautions.
Seizures: Observe and record intensity, duration, and location of seizure activity.
Geri: Assess risk of falls and institute fall prevention strategies.

Lab Test Considerations:

Patients on prolonged therapy should have CBC and liver function tests evaluated periodically. May cause an ↑ in serum bilirubin, AST, and ALT.
- May cause ↓ thyroidal uptake of ¹²³I and ¹³¹I.

Toxicity and Overdose:

Flumazenil is the antidote for clorazepate toxicity or overdose (flumazenil may induce seizures in patients with a history of seizures disorder or who are on tricyclic antidepressants).

Implementation ⬆ ⬇

PO: If gastric irritation is a problem, may be administered with food or fluids.
- Avoid administration of antacids within 1 hr of medication, because absorption of clorazepate may be delayed.
- Use lowest effective dose for shortest period of time. Gradually taper to discontinue or reduce the dose to reduce risk of withdrawal reactions, increased seizure frequency, and status epilepticus. Taper by 0.5 mg every 3 days to prevent withdrawal. If patient develops withdrawal symptoms, pause taper or increase dose to previous tapered dose level; decrease dose more slowly. Some patients may require longer tapering period (weeks to >12 mo).

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed, not to skip or double up on missed doses. Abrupt withdrawal may cause status epilepticus, tremors, nausea, vomiting, and abdominal and muscle cramps. Instruct patient to read the Medication Guide before starting and with each Rx refill, changes may occur.
- Advise patient that clorazepate is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
- May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to drug is known. Instruct patient and family how to reduce falls risk at home.
- Caution patient to avoid alcohol or other CNS depressants, including opioids, concurrently with this medication, may cause respiratory depression and overdose. Advise patient to consult health care professional prior to taking OTC or herbal products.
- Instruct patient and family to notify health care professional of unusual tiredness, bleeding, sore throat, fever, clay-colored stools, yellowing of skin, or behavioral changes. Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking, other unusual changes in behavior or mood occur.
- May cause fetal harm. Advise females of reproductive potential to contact health care professional immediately if pregnancy is planned or suspected or if breastfeeding. Monitor infants exposed to clorazepate during 2nd and 3rd trimester or immediately prior to or during childbirth for decreased fetal movement and/or fetal heart rate variability, “floppy infant syndrome,” dependence, sedation (respiratory depression, lethargy, hypotonia) and symptoms of withdrawal (hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, vomiting, restlessness, inconsolable crying, and feeding difficulties); may occur shortly after delivery up to 3 wk after birth. Monitor breastfed infants for sedation, poor sucking, poor feeding and poor weight gain. Encourage pregnant patients to enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334; information is available at www.aedpregnancyregistry.org.
- Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
- Emphasize the importance of follow-up exams to determine effectiveness of the medication.
Seizures: Patients on anticonvulsant therapy should carry identification describing disease process and medication regimen at all times.

Evaluation/Desired Outcomes ⬆ ⬇

Increase in sense of well-being.
Decrease in subjective feelings of anxiety.
Control of acute alcohol withdrawal.
Decrease or cessation of seizure activity without undue sedation.

US Brand Names ⬆ ⬇

~~Gen-XENE,~~ ~~Tranxene T-Tab~~

Contr. Subst. Schedule ⬆ ⬇

Code ⬆

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-0030- Clorazepate Dipotassium
  - 0378-0030-01- 100 TABLET in 1 BOTTLE, PLASTIC (0378-0030-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0030- Clorazepate Dipotassium
  - 0378-0030-05- 500 TABLET in 1 BOTTLE, PLASTIC (0378-0030-05)

0378- Mylan Pharmaceuticals Inc.
- 0378-0040- Clorazepate Dipotassium
  - 0378-0040-01- 100 TABLET in 1 BOTTLE, PLASTIC (0378-0040-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-0040- Clorazepate Dipotassium
  - 0378-0040-05- 500 TABLET in 1 BOTTLE, PLASTIC (0378-0040-05)

0378- Mylan Pharmaceuticals Inc.
- 0378-0070- Clorazepate Dipotassium
  - 0378-0070-01- 100 TABLET in 1 BOTTLE, PLASTIC (0378-0070-01)

43063- PD-Rx Pharmaceuticals, Inc.
- 43063-030- Clorazepate Dipotassium
  - 43063-030-03- 3 TABLET in 1 BOTTLE, PLASTIC (43063-030-03)

43063- PD-Rx Pharmaceuticals, Inc.
- 43063-030- Clorazepate Dipotassium
  - 43063-030-06- 6 TABLET in 1 BOTTLE, PLASTIC (43063-030-06)

43063- PD-Rx Pharmaceuticals, Inc.
- 43063-030- Clorazepate Dipotassium
  - 43063-030-10- 10 TABLET in 1 BOTTLE, PLASTIC (43063-030-10)

43063- PD-Rx Pharmaceuticals, Inc.
- 43063-030- Clorazepate Dipotassium
  - 43063-030-12- 12 TABLET in 1 BOTTLE, PLASTIC (43063-030-12)

43063- PD-Rx Pharmaceuticals, Inc.
- 43063-893- Clorazepate Dipotassium
  - 43063-893-06- 6 TABLET in 1 BOTTLE, PLASTIC (43063-893-06)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4042- Clorazepate Dipotassium
  - 51672-4042-1- 100 TABLET in 1 BOTTLE (51672-4042-1)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4042- Clorazepate Dipotassium
  - 51672-4042-2- 500 TABLET in 1 BOTTLE (51672-4042-2)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4042- Clorazepate Dipotassium
  - 51672-4042-3- 1000 TABLET in 1 BOTTLE (51672-4042-3)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4043- Clorazepate Dipotassium
  - 51672-4043-1- 100 TABLET in 1 BOTTLE (51672-4043-1)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4043- Clorazepate Dipotassium
  - 51672-4043-2- 500 TABLET in 1 BOTTLE (51672-4043-2)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4043- Clorazepate Dipotassium
  - 51672-4043-3- 1000 TABLET in 1 BOTTLE (51672-4043-3)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4044- Clorazepate Dipotassium
  - 51672-4044-1- 100 TABLET in 1 BOTTLE (51672-4044-1)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4044- Clorazepate Dipotassium
  - 51672-4044-2- 500 TABLET in 1 BOTTLE (51672-4044-2)

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-4044- Clorazepate Dipotassium
  - 51672-4044-3- 1000 TABLET in 1 BOTTLE (51672-4044-3)

55292- RECORDATI RARE DISEASES, INC.
- 55292-304- Tranxene T-Tab
  - 55292-304-01- 100 TABLET in 1 BOTTLE (55292-304-01)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇