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(klor-AZE-uh-PATE DIE-poe-TASS-ee-uhm)
Gen-Xene, Tranxene, Tranxene-SD, Tranxene-SD Half Strength,  Novoclopate
Class: Antianxiety/Benzodiazepine

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

 Indications Management of anxiety disorders; relief of acute alcohol withdrawal symptoms; adjunctive therapy in management of partial seizures. Unlabeled use(s): Treatment of irritable bowel syndrome.

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

 Route/Dosage

Anxiety

ADULTS: PO 30–60 mg/day in divided doses. SINGLE BEDTIME DOSING: Initial dose: PO 15 mg.

Elderly or Debilitated Patients

Initial dose: PO 7.5–15 mg/day.

Maintenance

ADULTS: PO 22.5 mg/day as single dose alternative once patient is stabilized with 7.5 mg tid; do not use 22.5 mg in single dose to initiate therapy. 11.25 mg tablet may be given as single dose q 24 hr.

Acute Alcohol Withdrawal

ADULTS: DAY 1: Initial dose: PO 30 mg, then 30–60 mg in divided doses. DAY 2: 45–90 mg in divided doses. DAY 3: 22.5–45 mg in divided doses. DAY 4: 15–30 mg in divided doses. Then gradually reduce to 7.5–15 mg/day; discontinue when patient is stable.

Partial Seizures

ADULTS & CHILDREN > 12 YR: Maximum initial dose:

7.5 mg tid; increase by no more than 7.5 mg/wk (maximum 90 mg/day). CHILDREN 9–12 YR: MAXIMUM INITIAL DOSE: 7.5 mg bid; increase by no more than 7.5 mg/wk (maximum 60 mg/day).

 Interactions

Alcohol and CNS depressants: Possible additive CNS depressant effects. 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. Theophyllines: May antagonize sedative effects.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Cardiovascular 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). DERM: Rash. EENT: Blurred vision; diplopia. GI: Constipation; diarrhea; dry mouth; coated tongue; nausea; anorexia; vomiting. HEMA: Blood dyscrasias. HEPA: Hepatic dysfunction, including hepatitis and jaundice; elevated lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase. OTHER: Dependence/withdrawal syndrome.

 Precautions

Pregnancy: Pregnancy category undetermined. Lactation: Excreted in breast milk. Children: Initial dose should be small and gradually increased. Not recommended in children < 9 yr. Elderly or debilitated patients: Initial dose should be small and gradually increased. Dependence: Prolonged use may lead to dependence. Withdrawal syndrome has occurred within 4–6 wk of treatment, especially if abruptly discontinued. Use caution and taper dosage. Psychiatric disorders: Not intended for use in patients with primary depressive disorder, psychosis or disorders in which anxiety is not prominent. Renal or hepatic impairment: Observe caution to avoid accumulation of drug.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Administer drug with food or milk to avoid GI irritation.
  • Crush tablets if patient is unable to swallow tablets whole.
  • Store at room temperature.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies.
  • Assist patient with ambulation during initial therapy due to drowsiness and dizziness, especially if patient is elderly. Use siderails.
  • Assess level of anxiety, what precipitates anxiety and whether drug controls symptoms.
  • Observe for drowsiness, ataxia, and confusion, especially in elderly and debilitated.
  • Give gum, hard candy, frequent sips of water to alleviate dry mouth.
  • Monitor CBC; blood dyscrasias occur rarely with long-term use.
  • Monitor liver function throughout long-term therapy.
  • Monitor I&O and serum creatinine to assess renal function.
  • Monitor mental status: mood, sensorium, affect, sleep pattern, drowsiness, dizziness. Notify physician of changes.
  • Monitor for physical dependence and withdrawal symptoms after long-term use: increased anxiety, headache, muscle pain, weakness, nausea, vomiting. When patient is discontinuing therapy, gradually decrease dosage over 4–8 wk to prevent withdrawal symptoms, especially in patients with history of seizures or epilepsy.
  • Assess for alcohol withdrawal symptoms: hallucinations, delirium, irritability, agitation, tremors.
  • Assess for seizure control and type, duration and intensity of convulsions.
  • Monitor BP, pulse and respiratory rate frequently in treatment of alcohol withdrawal.
OVERDOSAGE: SIGNS & SYMPTOMS
  Drowsiness, confusion, somnolence, impaired coordination, diminished reflexes, lethargy, ataxia, hypotonia, hypotension, hypnosis, coma

 Patient/Family Education

  • Advise patient to take drug with food or milk to decrease GI irritation.
  • Inform patient that drug may be habit forming and advise that patient discuss use with physician.
  • Caution patient to rise slowly or fainting may occur, especially if patient is elderly. Drowsiness may be increased during initial therapy.
  • Encourage patient to carry identification (Medi-Alert) indicating medication usage if taking drug for seizure disorder.
  • Suggest to patient to keep log of seizure activity and report to physician.
  • Emphasize that medication must not be discontinued abruptly after long-term use.
  • Instruct patient to avoid intake of alcoholic beverages or other CNS depressants.
  • Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.

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