TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet
Torrent Pharmaceuticals Limited
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1)] . Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4)] .
An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose 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.
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.
Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
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 [ see Warnings and Precautions ( 5.7) ].
At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of trazodone hydrochloride tablets. In addition, at least 14 days must elapse after stopping trazodone hydrochloride tablets before starting an MAOI antidepressant [ see Contraindications ( 4), Warnings and Precautions ( 5.2) ].
Consider reducing trazodone dose based on tolerability when trazodone is coadministered with a strong CYP3A4 inhibitor [ see Drug Interactions ( 7.1) ].
Coadministration with Strong CYP3A4 Inducers
Consider increasing trazodone dose based on therapeutic response when trazodone is coadministered with a strong CYP3A4 inducer [ see Drug Interactions ( 7.1) ].
Adverse reactions may occur upon discontinuation of trazodone hydrochloride tablets [ See Warnings and Precautions ( 5.8) ]. Gradually reduce the dosage rather than stopping trazodone hydrochloride tablets abruptly whenever possible.
100 mg Tablets, white to off white, round, biconvex, uncoated tablets debossed with “13” bisect “31” on one side and plain on other side.
150 mg Tablets, white to off white, oval, flat faced beveled edge uncoated tablets with a full bisect and two partial trisects. Debossed “13” bisect “32” on one side and “50 50 50” on other side.
300 mg white to off white, oval, flat faced beveled edge uncoated tablets with a full bisect and two partial trisects. Debossed “13” bisect “33” on one side and “100 100 100” on other side with middle “100” perpendicular to others.
- Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [ see Warnings and Precautions ( 5.2), Drug Interactions ( 7.1) ].
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 drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
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 Range (years)||Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated|
|Increases Compared to Placebo|
|< 18||14 additional patients|
|18 — 24||5 additional patients|
|Decreases Compared to Placebo|
|25 — 64||1 fewer patient|
|≥ 65||6 fewer patients|
It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing trazodone hydrochloride tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
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