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Trazodone (Trazodone Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Trazodone hydrochloride is indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and out-patient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, III.a

Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

DOSAGE AND ADMINISTRATION

The dosage should be initiated at a low level and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. Trazodone hydrochloride should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within 2 weeks. Twenty-five percent of those who respond to trazodone require more than 2 weeks (up to 4 weeks) of drug administration.

Usual Adult Dosage

An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.

Maintenance

Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Although there has been no systematic evaluation of the efficacy of trazodone beyond 6 weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.

HOW SUPPLIED

Trazodone Hydrochloride Tablets USP, 50 mg are scored, round, white, film-coated tablets imprinted DAN DAN and 5600 supplied in bottles of 100 and 1000.

Trazodone Hydrochloride Tablets USP, 100 mg are scored, round, white, film-coated tablets imprinted DAN DAN and 5599 supplied in bottles of 100 and 1000.

Dispense in a tight, light-resistant container with child-resistant closure.

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

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