Suicidal Thoughts or Behaviors per 1,000 Patients Treated Table 1 Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Rangeĭrug-Placebo Difference in Number of Patients of There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. No suicides occurred in any of the pediatric studies. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The full bisected side of tablet is debossed with '8' on one side of bisect and '08' on other bisect segment.ĥ.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients Trazodone hydrochloride tablets USP, 300 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments. Trazodone hydrochloride tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect. Trazodone hydrochloride tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '05' on lower side of bisect. Trazodone hydrochloride tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. Trazodone hydrochloride tablets, USP are available in the following strengths: Gradually reduce the dosage rather than stopping trazodone abruptly whenever possible. Ģ.6 Discontinuation of Treatment with TrazodoneĪdverse reactions may occur upon discontinuation of trazodone. Ĭoadministration with Strong CYP3A4 InducersĬonsider increasing trazodone dose based on therapeutic response when trazodone is coadministered with a strong CYP3A4 inducer. Ģ.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or InducersĬoadministration with Strong CYP3A4 InhibitorsĬonsider reducing trazodone dose based on tolerability when trazodone is coadministered with a strong CYP3A4 inhibitor. In addition, at least 14 days must elapse after stopping trazodone hydrochloride tablets before starting an MAOI antidepressant. Ģ.4 Switchning to or from Monoamine Oxidase Inhibitor AntidepressantĪt least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of trazodone hydrochloride tablets. Prior to initiating treatment with trazodone hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.Ģ.3 Screen for Bipolar Disorder Prior to Starting Trazodone Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.Ģ.2 Improtant Administration Instructions Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. The dose may be increased by 50 mg/day every 3 to 4 days. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. An initial dose of 150 mg/day in divided doses is suggested.
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