Generic Name : clorazepate dipotassium
Brand Name: Apo-Clorazepate (CAN), Novo-Clopate (CAN), Tranxene-SD, Tranxene-SD Half Strength, Tranxene-T-tab
Classification: Benzodiazepine, Anxiolytic, Antiepileptic
Pregnancy Category D
Controlled Substance C-IV
Dosage & Route
- Individualize dosage; increase dosage gradually to avoid adverse effects. Drug is available only in oral forms.
- Anxiety: Usual dose is 30 mg/day PO in divided doses tid; adjust gradually within the range of 15–60 mg/day; also may be given as a single daily dose hs with a maximum starting dose of 15 mg. For maintenance, give the 22.5-mg PO tablet in a single daily dose as an alternate form for patients stabilized on 7.5 mg PO tid; do not use to initiate therapy; the 11.25-mg tablet may be given as a single daily dose.
- Adjunct to antiepileptic medication: Maximum initial dose is 7.5 mg PO tid. Increase dosage by no more than 7.5 mg every wk, do not exceed 90 mg/day.
- Acute alcohol withdrawal: Day 1: 30 mg PO initially, then 30–60 mg in divided doses. Day 2: 45–90 mg PO in divided doses. Day 3: 22.5–45 mg PO in divided doses. Day 4: 15–30 mg PO in divided doses. Thereafter, gradually reduce dose to 7.5–15 mg/day PO, and stop as soon as condition is stable.
- Adjunct to antiepileptic medication:
- > 12 yr: Use adult dosage.
- 9–12 yr: Maximum initial dose is 7.5 mg PO bid; increase dosage by no more than 7.5 mg every wk, and do not exceed 60 mg/day.
- < 9 yr: Not recommended.
Geriatric Patients or Patients with Debilitating Disease
- Anxiety: Initially, 7.5–15 mg/day PO in divided doses. Adjust as needed and tolerated.
- Exact mechanisms not understood; benzodiazepines potentiate the effects of GABA, an inhibitory neurotransmitter; anxiolytic effects occur at doses well below those necessary to cause sedation, ataxia.
- Management of anxiety disorders or for short-term relief of symptoms of anxiety
- Symptomatic relief of acute alcohol withdrawal
- Adjunctive therapy for partial seizures
- Drowsiness, muscular hypotonia, anterograde amnesia, tremor, GI upsets.
- Contraindicated with hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma; shock; coma; acute alcoholic intoxication with depression of vital signs; pregnancy (risk of congenital malformations, neonatal withdrawal syndrome); labor and delivery (“floppy infant” syndrome); lactation (infants tend to become lethargic and lose weight).
- Use cautiously with impaired liver or renal function, debilitation; elderly patients.
CLINICAL ALERT! Name confusion has occurred between clorazepate and clofibrate; use caution.
- History: Hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma; shock; coma; acute alcoholic intoxication; pregnancy; lactation; impaired liver or renal function; debilitation
- Physical: Skin color, lesions; T; orientation, reflexes, affect, ophthalmologic examination; P, BP; R, adventitious sounds; liver evaluation, abdominal examination, bowel sounds, normal output; CBC, LFTs, renal function tests
- WARNING: Taper dosage gradually after long-term therapy, especially in epileptics.
- Arrange for patients with epilepsy to wear medical alert identification, indicating disease and medication usage.
- Take drug exactly as prescribed; do not stop taking drug (long-term therapy) without consulting your health care provider.
- Avoid alcohol, sleep-inducing, or over-the-counter drugs.
- Avoid pregnancy while taking this drug; using barrier contraceptives is advised. If you become pregnant, do not stop the drug; contact your health care provider.
- You may experience these side effects: Drowsiness, dizziness (may be transient; avoid driving a car or engaging in other dangerous activities); GI upset (take with food); fatigue; depression; dreams; crying; nervousness; depression, emotional changes; bed-wetting, urinary incontinence.
- Report severe dizziness, weakness, drowsiness that persists, rash or skin lesions, difficulty voiding, palpitations, swelling in the extremities.