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Drugs reference index «Clorazepate Dipotassium»

Clorazepate Dipotassium

Pronunciation: (klor-AZE-uh-PATE DIE-poe-TASS-ee-uhm)Class: Benzodiazepine

Trade Names:Tranxene T-tab- Tablets 3.75 mg- Tablets 7.5 mg- Tablets 15 mg

Apo-Clorazepate (Canada)

Pharmacology

Potentiates action of GABA, inhibitory neurotransmitter, resulting in increased neuronal inhibition and CNS depression, especially in limbic system and reticular formation.

Pharmacokinetics

Absorption

T max is 1 to 2 h.

Distribution

97% to 98% protein bound.

Metabolism

Rapidly metabolized in the liver to nordiazepam.

Elimination

About 80% excreted in urine and feces. The t ½ is 40 to 50 h.

Indications and Usage

Management of anxiety disorders; relief of acute alcohol withdrawal symptoms; adjunctive therapy in management of partial seizures.

Unlabeled Uses

Treatment of irritable bowel syndrome.

Contraindications

Hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma.

Dosage and Administration

Acute Alcohol WithdrawalAdults Day 1

PO Initial dose is 30 mg, then 30 to 60 mg in divided doses.

Day 2

45 to 90 mg in divided doses.

Day 3

22.5 to 45 mg in divided doses.

Day 4

15 to 30 mg in divided doses. Then gradually reduce to 7.5 to 15 mg/day; discontinue when patient is stable.

AnxietyAdults

PO 15 to 60 mg/day in divided doses.

Single bedtime dosing

PO Initial dose is 15 mg.

Elderly or Debilitated PatientsInitial dose

PO 7.5 to 15 mg/day.

MaintenanceAdults

PO 22.5 mg/day as single dose alternative once patient is stabilized with 7.5 mg 3 times daily; do not use 22.5 mg in single dose to initiate therapy.

Partial SeizuresAdults and Children older than 12 yr of age Maximum initial dose

7.5 mg 3 times daily; increase by no more than 7.5 mg/wk (max, 90 mg/day).

Children 9 to 12 yr of age Maximum initial dose

7.5 mg twice daily; increase by no more than 7.5 mg/wk (max, 60 mg/day).

General Advice

  • Administer prescribed dose without regard to meals but administer with food if GI upset occurs.
  • Drowsiness may occur at the initiation of treatment and with dosage increment.

Storage/Stability

Store tablets below 77°F. Protect from moisture.

Drug Interactions

Alcohol and CNS depressants

Possible additive CNS depressant effects.

Azole antifungal agents (eg, itraconazole, ketoconazole), fluvoxamine, isoniazid, macrolide antibiotics (eg, erythromycin), nefazodone, non-nucleoside reverse transcriptase inhibitors (eg, delavirdine, efavirenz), protease inhibitors (eg, indinavir)

May increase diazepam plasma concentrations.

Cimetidine, oral contraceptives, disulfiram

May increase effects of clorazepate, with excessive sedation and impaired psychomotor function.

Digoxin

May increase serum digoxin concentrations.

Omeprazole

May increase clorazepate serum levels and enhance effects.

Rifamycins

May decrease diazepam plasma concentrations.

Theophyllines

May antagonize sedative effects of clorazepate.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

CV collapse; hypotension.

CNS

Drowsiness; confusion; ataxia; dizziness; lethargy; fatigue; apathy; memory impairment; disorientation; anterograde amnesia; restlessness; nervousness; headache; slurred speech; loss of voice; stupor; coma; euphoria; irritability; vivid dreams; psychomotor retardation; paradoxical reactions (eg, anger, hostility, mania, insomnia, muscle spasms); depression; tremor.

Dermatologic

Rash.

EENT

Blurred vision; diplopia.

GI

Constipation; diarrhea; dry mouth; coated tongue; nausea; anorexia; vomiting.

Hematologic

Blood dyscrasias.

Hepatic

Hepatic dysfunction, including hepatitis and jaundice; elevated LDH, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase.

Miscellaneous

Dependence/withdrawal syndrome.

Precautions

Monitor

CBC

Ensure that CBC with differential and liver enzymes are evaluated periodically in patient on prolonged therapy.

Response to treatment

Frequently assess patient for response to treatment. Notify health care provider if condition does not appear to improve or worsens.

Review therapy

Ensure that therapy is periodically reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated.

Pregnancy

Category D .

Lactation

Excreted in breast milk.

Children

Initial dose should be small and gradually increased. Not recommended in children younger than 9 yr of age.

Elderly

Initial dose should be small and gradually increased.

Renal Function

Observe caution to avoid accumulation of drug.

Hepatic Function

Observe caution to avoid accumulation of drug.

Debilitated patients

Initial dose should be small and gradually increased.

Drug dependency

Prolonged use may lead to dependence. Withdrawal syndrome has occurred within 4 to 6 wk of treatment, especially if abruptly discontinued. Use caution and taper dosage. If treatment is to be discontinued, or the dose reduced, gradually taper the dose. Monitor patient for withdrawal symptoms (eg, increased anxiety, tremor, muscle or abdominal cramps, sweating). If significant withdrawal symptoms develop, reinstitute previous dosing schedule and attempt a less rapid tapering regimen after patient has stabilized.

Psychiatric disorders

Not intended for use in patients with primary depressive disorder, psychosis, or disorders in which anxiety is not prominent.

Seizures

May occur during abrupt drug discontinuation or dose reduction.

Overdosage

Symptoms

Drowsiness, confusion, somnolence, impaired coordination, diminished reflexes, lethargy, ataxia, hypotonia, hypotension, hypnosis, coma.

Patient Information

  • Advise patient or caregiver to read the patient information leaflet before starting therapy and with each refill.
  • Instruct patient with seizure disorder to continue to take other medications for the condition unless advised otherwise by health care provider.
  • Advise patient that medication is usually started at a low dose and then gradually increased until maximum benefit is obtained.
  • Caution patient that medication may be habit forming and to take as prescribed and not to stop taking or change the dose unless advised by health care provider.
  • Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs.
  • Advise patient that if a dose is missed to skip that dose and take the next dose at the regularly scheduled time. Caution patient to never take 2 doses at the same time.
  • Advise patient that if medication needs to be discontinued it will be slowly withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal.
  • Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
  • Advise patient with anxiety to take as needed and to seek alternative methods for controlling or preventing anxiety (eg, stress reduction, counseling).
  • Instruct patient to contact health care provider if symptoms (eg, anxiety, panic attacks, seizures) do not appear to be getting better, are getting worse, or if bothersome adverse reactions (eg, drowsiness, memory impairment) occur.
  • Advise patient that drug may cause drowsiness or impair judgment, thinking, or reflexes and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Encourage patient with seizure disorder to carry identification (eg, Medi-Alert ) indicating condition and medication being used to treat.

Copyright © 2009 Wolters Kluwer Health.

  • Clorazepate Prescribing Information (FDA)
  • clorazepate Concise Consumer Information (Cerner Multum)
  • clorazepate Advanced Consumer (Micromedex) - Includes Dosage Information
  • Clorazepate MedFacts Consumer Leaflet (Wolters Kluwer)

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