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TRANXENE
Addiction/dependence
Anxiety/OCD
Seizure disorders
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Drug Name:

TRANXENE CIV

Generic Name and Formulations:
Clorazepate dipotassium 3.75mg, 7.5mg, 15mg; scored tabs.

Company:
Recordati Rare Diseases, Inc.

Therapeutic Use:

Indications for TRANXENE:

Symptomatic relief of acute alcohol withdrawal.

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.

Contraindications:

Acute narrow-angle glaucoma.

Warnings/Precautions:

Risks from concomitant use with opioids; see Interactions. Drug or alcohol abuse. Suicidal tendencies. Renal or hepatic impairment. Monitor blood counts and hepatic function. Change dose gradually. Avoid abrupt cessation. Reevaluate periodically. Elderly. Debilitated. Psychosis, depression, pregnancy, nursing mothers: not recommended.

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).

Pharmacological Class:

Benzodiazepine.

Adverse Reactions:

Drowsiness, dizziness, GI disorders, nervousness, blurred vision, dry mouth, headache, mental confusion, insomnia, rash, fatigue, ataxia, tremor, hypotension, abnormal hepatic and renal tests, decreased hematocrit.

How Supplied:

Tabs—100

Indications for TRANXENE:

Anxiety.

Adult:

Usually 30mg daily in divided doses; adjust gradually in range 15–60mg daily. Debilitated: initially 7.5–15mg daily in divided doses.

Children:

<9yrs: not recommended.

Contraindications:

Acute narrow-angle glaucoma.

Warnings/Precautions:

Risks from concomitant use with opioids; see Interactions. Drug or alcohol abuse. Suicidal tendencies. Renal or hepatic impairment. Monitor blood counts and hepatic function. Change dose gradually. Avoid abrupt cessation. Reevaluate periodically. Elderly. Debilitated. Psychosis, depression, pregnancy, nursing mothers: not recommended.

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).

Pharmacological Class:

Benzodiazepine.

Adverse Reactions:

Drowsiness, dizziness, GI disorders, nervousness, blurred vision, dry mouth, headache, mental confusion, insomnia, rash, fatigue, ataxia, tremor, hypotension, abnormal hepatic and renal tests, decreased hematocrit.

How Supplied:

Tabs—100

Indications for TRANXENE:

Adjunct therapy in partial seizures.

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.

Contraindications:

Acute narrow-angle glaucoma.

Warnings/Precautions:

Risks from concomitant use with opioids; see Interactions. Drug or alcohol abuse. Suicidal tendencies. Renal or hepatic impairment. Monitor blood counts and hepatic function. Change dose gradually. Avoid abrupt cessation. Reevaluate periodically. Elderly. Debilitated. Psychosis, depression, pregnancy, nursing mothers: not recommended.

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).

Pharmacological Class:

Benzodiazepine.

Adverse Reactions:

Drowsiness, dizziness, GI disorders, nervousness, blurred vision, dry mouth, headache, mental confusion, insomnia, rash, fatigue, ataxia, tremor, hypotension, abnormal hepatic and renal tests, decreased hematocrit.

How Supplied:

Tabs—100

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