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DESYREL (trazodone hydrochloride) is indicated for the treatment of depression. The efficacy of DESYREL (trazodone hydrochloride) has been demonstrated in both inpatient and outpatient 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, III1.
Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two 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. DESYREL (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 two weeks. Twenty-five percent of those who respond to DESYREL (trazodone hydrochloride) require more than two weeks (up to four 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 three to four days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (ie, more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
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 DESYREL (trazodone hydrochloride) beyond six weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.
DESYREL® (trazodone hydrochloride)
Tablets, 150 mg—orange, in the Dividose® tablet design (debossed with MJ and 778 on front; “50,” “50,” “50” on reverse)
NDC 0087-0778-43 Bottles of 100
Tablets, 300 mg—yellow, in the Dividose® tablet design (debossed with MJ and 796 on front; “100,”“100,”“100” on reverse)
NDC 0087-0796-41 Bottles of 100
Store at room temperature. Protect from temperatures above 104°F (40°C).
Dispense in tight, light-resistant container (USP).
1. Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders-III, American Psychiatric Association May, 1980.
Bristol-Myers Squibb Company Princeton, NJ 08543-4500, USA. Rev February 2009This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/13/2011
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