TRANXENE 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 tablets are indicated as adjunctive therapy in the management of partial seizures.

The effectiveness of TRANXENE 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 tablets are indicated for the symptomatic relief of acute alcohol withdrawal.

For the symptomatic relief of anxiety: TRANXENE 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 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.

TRANXENE-SD (22.5 mg) tablets may be administered as a single dose every 24 hours. This tablet is intended as an alternate dosage form for the convenience of patients stabilized on a dose of 7.5 mg tablets three times a day. TRANXENE-SD tablets should not be used to initiate therapy.

TRANXENE-SD HALF STRENGTH (11.25 mg) tablets may be administered as a single dose every 24 hours. This tablet is intended as an alternate dosage form for the convenience of patients stabilized on a dose of 3.75 mg tablets three times a day. TRANXENE-SD HALF STRENGTH should not be used to initiate therapy.

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® 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).

Bottles of 500 ...................... (NDC 67386-302-05).

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).

TRANXENE®-SD 22.5 mg single dose tablets are supplied as tan-colored tablets bearing the letters OV and a two-digit designation, 45:

Bottles of 100 ...................... (NDC 67386-405-01).

TRANXENE®-SD HALF STRENGTH 11.25 mg single dose tablets are supplied as blue-colored tablets bearing the letters OV and a two-digit designation, 44:

Bottles of 100 .................... (NDC 67386-404-01).

Recommended storage: Protect from moisture. Keep bottle tightly closed. Store below 77°F (25°C). Dispense in a USP tight, light-resistant container.

T-TAB, tablet appearance and shape are registered trademarks of Ovation Pharmaceuticals. Revised: April, 2005. Manufactured by: Abbott Pharmaceuticals PR Ltd. Barceloneta, PR 00617. for: OVATION PHARMACEUTICALS, INC. Deerfield, IL 60015. FDA Rev date: 3/13/2003

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