TRANXENE (clorazepate dipotassium) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

TRANXENE (clorazepate dipotassium) tablets are indicated as adjunctive therapy in the management of partial seizures.

The effectiveness of TRANXENE (clorazepate dipotassium) tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient.

TRANXENE (clorazepate dipotassium) tablets are indicated for the symptomatic relief of acute alcohol withdrawal.

For the symptomatic relief of anxiety: TRANXENE (clorazepate dipotassium) T-TAB tablets are administered orally in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the range of 15 to 60 mg daily in accordance with the response of the patient. In elderly or debilitated patients it is advisable to initiate treatment at a daily dose of 7.5 to 15 mg.

TRANXENE (clorazepate dipotassium) tablets may also be administered in a single dose daily at bedtime; the recommended initial dose is 15 mg. After the initial dose, the response of the patient may require adjustment of subsequent dosage. Lower doses may be indicated in the elderly patient. Drowsiness may occur at the initiation of treatment and with dosage increment.

For the symptomatic relief of acute alcohol withdrawal:

The following dosage schedule is recommended:

Thereafter, gradually reduce the daily dose to 7.5 to 15 mg. Discontinue drug therapy as soon as patient's condition is stable.

The maximum recommended total daily dose is 90 mg. Avoid excessive reductions in the total amount of drug administered on successive days.

As an Adjunct to Antiepileptic Drugs: In order to minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded.

Adults: The maximum recommended initial dose in patients over 12 years old is 7.5 mg three times a day. Dosage should be increased by no more than 7.5 mg every week and should not exceed 90 mg/day.

Children (9-12 years): The maximum recommended initial dose is 7.5 mg two times a day. Dosage should be increased by no more than 7.5 mg every week and should not exceed 60 mg/day.

TRANXENE (clorazepate dipotassium) 3.75 mg scored T-TAB tablets are supplied as blue-colored tablets bearing the letters OV, the distinctive T shape and a two-digit designation, 31: Bottles of 100 (NDC 67386-301-01).

7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letters OV, the distinctive T shape and a two-digit designation, 32: Bottles of 100 (NDC 67386-302-01).

15 mg scored T-TAB tablets are supplied as lavender-colored tablets bearing the letters OV, the distinctive T shape and a two-digit designation, 33: Bottles of 100 (NDC 67386-303-01).

Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.

Manufactured by: Abbott Pharmaceuticals PR Ltd. Barceloneta, PR 00617. For: Lundbeck Inc., Deerfield IL, 60015, U.S.A. Revised: May 2010

Last reviewed on RxList: 7/2/2010
This monograph has been modified to include the generic and brand name in many instances.