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Trazodone (Trazodone Hydrochloride) - Indications and Dosage

 
 



INDICATIONS & USAGE SECTION

Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies].

DOSAGE & ADMINISTRATION SECTION

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. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.

Dose Selection

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

  • Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.
  • Patients should be monitored for withdrawal symptoms when discontinuing treatment with trazodone hydrochloride tablets. The dose should be gradually reduced whenever possible [see Warnings andPrecautions].

Maintenance Treatment

The efficacy of trazodone hydrochloride tablets for the maintenance treatment of MDD has not been evaluated. While there is no body of evidence available to answer the question of how long a patient treated with trazodone hydrochloride tablets should continue the drug, it is generally recommended that treatment be continued for several months after an initial response. Patients should be maintained on the lowest effective dose and be periodically reassessed to determine the continued need for maintenance treatment.

Important Administration Instructions

Trazodone hydrochloride tablets are scored to provide flexibility in dosing.

Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.

DOSAGE FORMS & STRENGTHS SECTION

Trazodone hydrochloride tablets are available in the following strengths:

50 mg- White, round, compressed tablet, debossed “PLIVA 433” on one side and scored on the other side.

100 mg- White, round, compressed tablets, debossed “PLIVA 434” on one side and scored on the other side.

150 mg- White, trapezoid, flat-face, beveled edge tablet, scored and debossed as “PLIVA” and “441” on one side and tri-scored and debossed as “50” in each section on the other side.

HOW SUPPLIED SECTION

Trazodone hydrochloride tablets USP are available as follows:

50 mg: White, round, compressed tablet, debossed “PLIVA 433” on one side and scored on the other side. Available in bottles of 100, 500 and 1000.

100 mg: White, round, compressed tablets, debossed “PLIVA 434” on one side and scored on the other side. Available in bottles of 100, 500 and 1000 Tablets and Unit Dose Blisters of 100 (10 x 10) Tablets.

150 mg: White, trapezoid, flat-face, beveled edge tablet, scored and debossed as “PLIVA” and “441” on one side and tri-scored and debossed as “50” in each section on the other side. Available in bottles of 100 and 500 Tablets.

Directions for using the correct score when breaking the tablet please refer to the following:

- For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet).

- For 75 mg, break the score down the middle of the tablet (one-half of a tablet).

- For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet).

- For 150 mg, use the entire tablet.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

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