Tranxene ™

[Dipotassium Clorazepate]

Tranxene

Indications

Reactional anxiety, in particular adaptation disorders with anxious mood and post-traumatic anxiety.

  • Adjunctive therapy for anxiety in neuroses (in particular hysteria, hyponchondria, phobia)
  • Anxiety associated with severe or painful somatic disorders
  • Generalized anxiety
  • Anxiety attack
  • Prevention and treatment of delirium tremens
  • Alcohol withdrawal

    Panic disorder does not constitute an indication.

    Contraindication

    Known allergy to benzodiazepines

  • Decompensated respiratory insufficiency
  • Sleep apnea

    Children:

  • 10 mg capsules are not suitable for prescription to children.
  • 5 mg capsules should not be used in children under the age of 30 months.

    Side Effects

    These are related to the dose taken and the individual sensitivity of the patient:

  • Anterograde amnesia
  • Dizziness.
  • Asthenia, drowsiness (particularly in elderly), bradypsychia,
  • Muscle hypotonia,
  • In certain patients (in particular, in children and elderly) paradoxical reactions may be observed
          - irritability, aggressivity, excitation, oniric confusion syndrome, hallucinations
  • Maculopapular and pruriginous skin rash.
  • Rebound syndrome may occur with exacerbation of anxiety which motivated the treatment.

    Prolong use (in particular, at high dosages) may lead to the development of physical dependence, and then treatment discontinuation leads to a withdrawal syndrome . This may occur more rapidly with benzodiazepines with a short half-life than with benzodiazepines with a long half-life (several days).

    Warning and Precautions

    Dependence : any treatment with benzodiazepines may lead to the development of physical and psychic drug dependence. Several factors seem to promote the development of dependence:

  • Duration of treatment,
  • Dosage,
  • Combination with other drugs: psychotropics, anxiolytics, hypnotics,
  • Combination with alcohol,
  • History of other drug or non-drug dependencies.

    This may lead to withdrawal symptoms when treatment is discontinued, including insomnia, headaches, marked anxiety, myalgia, muscle tension, occasionally irritability, agitation and even confusion. In exceptional cases, the following may be observed: trembling, hallucinations, and seizures.

    It can be useful to warn the patient immediately about the limited length of the treatment that should not exceed 4 to 12 weeks- and about the precise way the treatment should be progressively decreased (over a few days to a few weeks).

  • Tolerance may also develop during prolonged use
  • Anterograde amnesia may occur, more particularly when the benzodiazepine drug is used at bed time and when sleep duration is short (early awakening due to an outside event).
  • Anxiolytic benzodiazepines should not be used to treat depressive condition and psychotic disorders (see "Precautions").

    Dosage

    Treatment Duration:

    The duration of treatment should be as short as possible and should not exceed 4 to 12 weeks, including tapering off (see "Special Warnings and Precautions").

    Reaction:

    Reactional anxiety, adjunctive therapy for anxiety in neuroses, anxiety associated with severe or painful somatic disorders : 4 to 12 weeks, including tapering off.

    Generalized anxiety : long-term treatment upon specialist's advice.

    Anxiety attacks: short-term treatment.

    Prevention and treatment of delirium tremens: a few days.

    Alcohol withdrawal: treatment lasting 3 to 6 weeks surrounding the withdrawal period. Treatment discontinuation : progressive, with reduction over several weeks (see "Special Warnings and Precautions").

    Adults : 10 mg capsules should be used in adults only and in severe cases. Usual daily dosage is 5 to 30 mg ; higher doses may be used depending on clinical requirements.

    Children : the use should be recommended only in exceptional cases ; the dosage is about 0,5 mg/kg/day, using 5 mg capsules of Tranxenẻ, into several divided doses.

    Elderly, Patients with renal insufficiency : reduced dosage is recommended ; for example, half of the mean dosage may be enough.

    Presentations Available

    Bottle containing 30 Capsules

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