DOSAGE AND ADMINISTRATION
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:
1st 24 hours
(Day 1)
|
30 mg initially; followed by 30 to
60 mg in divided doses
|
2nd 24 hours
(Day 2)
|
45 to 90 mg in divided doses
|
3rd 24 hours
(Day 3)
|
22.5 to 45 mg in divided doses
|
|
Day 4
|
15 to 30 mg in divided doses
|
|
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.
DRUG INTERACTIONS
If TRANXENE is to be combined with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of the agents to be employed. Animal experience indicates that clorazepate dipotassium prolongs the sleeping time after hexobarbital or after ethyl alcohol, increases the inhibitory effects of chlorpromazine, but does not exhibit monoamine oxidase inhibition. Clinical studies have shown increased sedation with concurrent hypnotic medications. The actions of the benzodiazepines may be potentiated by barbiturates, narcotics, phenothiazines, monoamine oxidase inhibitors or other antidepressants.
If TRANXENE tablets are used to treat anxiety associated with somatic disease states, careful attention must be paid to possible drug interaction with concomitant medication.
In bioavailability studies with normal subjects, the concurrent administration of antacids at therapeutic levels did not significantly influence the bioavailability of TRANXENE tablets.
|
