Tranxene

— THERAPEUTIC CATEGORIES —
  • Addiction/dependence
  • Anxiety/OCD
  • Seizure disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tranxene Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Clorazepate dipotassium 7.5mg; scored tabs.

    Pharmacological Class

    Benzodiazepine.

    How Supplied

    Tabs—100

    Manufacturer

    Recordati Rare Diseases, Inc.

    Generic Availability

    YES

    Tranxene Indications

    Indications

    Symptomatic relief of acute alcohol withdrawal.

    Tranxene Dosage and Administration

    Adult

    First 24hrs (Day 1): initially 30mg, followed by 30–60mg in divided doses. Second 24hrs (Day 2): 45–90mg in divided doses. Third 24hrs (Day 3): 22.5–45mg in divided doses. Day 4: 15–30mg in divided doses. Then gradually reduce daily dose to 7.5–15mg; discontinue therapy as soon as condition is stable. Maximum total daily dose: 90mg. Avoid excessive reductions in the total amount of drug given on successive days.

    Children

    <9yrs: not recommended.

    Tranxene Contraindications

    Contraindications

    Acute narrow-angle glaucoma.

    Tranxene Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Tranxene Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Use in depressive neuroses or in psychotic reactions: not recommended. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Renal or hepatic impairment. Monitor CBCs, LFTs during prolonged use. Assess patient’s risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Reevaluate periodically. Drug or alcohol abusers. Elderly. Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

    Tranxene Pharmacokinetics

    Distribution

    97–98% plasma protein bound.

    Metabolism

    Hepatic.

    Elimination

    Renal (62–67%), fecal (15–19%). Half-life: ~2 days.

    Tranxene Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiation of CNS depression with alcohol and other CNS depressants (eg, hypnotics, barbiturates, narcotics, phenothiazines, MAOIs, or other antidepressants).

    Tranxene Adverse Reactions

    Adverse Reactions

    Drowsiness, dizziness, GI disorders, nervousness, blurred vision, dry mouth, headache, mental confusion, insomnia, rash, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, slurred speech, hypotension, abnormal hepatic and renal tests, decreased hematocrit; withdrawal reactions.

    Tranxene Clinical Trials

    See Literature

    Tranxene Note

    Not Applicable

    Tranxene Patient Counseling

    See Literature

    Tranxene Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Clorazepate dipotassium 7.5mg; scored tabs.

    Pharmacological Class

    Benzodiazepine.

    How Supplied

    Tabs—100

    Manufacturer

    Recordati Rare Diseases, Inc.

    Generic Availability

    YES

    Tranxene Indications

    Indications

    Anxiety.

    Tranxene Dosage and Administration

    Adult

    Usually 30mg daily in divided doses or may administer initially at 15mg as a single daily dose at bedtime; adjust gradually in range 15–60mg daily. Elderly, debilitated: initially 7.5–15mg daily in divided doses.

    Children

    <9yrs: not recommended.

    Tranxene Contraindications

    Contraindications

    Acute narrow-angle glaucoma.

    Tranxene Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Tranxene Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Use in depressive neuroses or in psychotic reactions: not recommended. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Renal or hepatic impairment. Monitor CBCs, LFTs during prolonged use. Assess patient’s risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Reevaluate periodically. Drug or alcohol abusers. Elderly. Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

    Tranxene Pharmacokinetics

    Distribution

    97–98% plasma protein bound.

    Metabolism

    Hepatic.

    Elimination

    Renal (62–67%), fecal (15–19%). Half-life: ~2 days.

    Tranxene Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiation of CNS depression with alcohol and other CNS depressants (eg, hypnotics, barbiturates, narcotics, phenothiazines, MAOIs, or other antidepressants).

    Tranxene Adverse Reactions

    Adverse Reactions

    Drowsiness, dizziness, GI disorders, nervousness, blurred vision, dry mouth, headache, mental confusion, insomnia, rash, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, slurred speech, hypotension, abnormal hepatic and renal tests, decreased hematocrit; withdrawal reactions.

    Tranxene Clinical Trials

    See Literature

    Tranxene Note

    Not Applicable

    Tranxene Patient Counseling

    See Literature

    Tranxene Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Clorazepate dipotassium 7.5mg; scored tabs.

    Pharmacological Class

    Benzodiazepine.

    How Supplied

    Tabs—100

    Manufacturer

    Recordati Rare Diseases, Inc.

    Generic Availability

    YES

    Tranxene Indications

    Indications

    Adjunct therapy in partial seizures.

    Tranxene Dosage and Administration

    Adult

    Initially 7.5mg three times daily; may increase by max 7.5mg weekly. Max 90mg/day.

    Children

    <9yrs: not recommended. 9–12yrs: initially 7.5mg two times daily; may increase by max 7.5mg weekly. Max 60mg/day.

    Tranxene Contraindications

    Contraindications

    Acute narrow-angle glaucoma.

    Tranxene Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Tranxene Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Use in depressive neuroses or in psychotic reactions: not recommended. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Renal or hepatic impairment. Monitor CBCs, LFTs during prolonged use. Assess patient’s risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Reevaluate periodically. Drug or alcohol abusers. Elderly. Debilitated. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

    Tranxene Pharmacokinetics

    Distribution

    97–98% plasma protein bound.

    Metabolism

    Hepatic.

    Elimination

    Renal (62–67%), fecal (15–19%). Half-life: ~2 days.

    Tranxene Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiation of CNS depression with alcohol and other CNS depressants (eg, hypnotics, barbiturates, narcotics, phenothiazines, MAOIs, or other antidepressants).

    Tranxene Adverse Reactions

    Adverse Reactions

    Drowsiness, dizziness, GI disorders, nervousness, blurred vision, dry mouth, headache, mental confusion, insomnia, rash, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, slurred speech, hypotension, abnormal hepatic and renal tests, decreased hematocrit; withdrawal reactions.

    Tranxene Clinical Trials

    See Literature

    Tranxene Note

    Not Applicable

    Tranxene Patient Counseling

    See Literature

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