trazodone hydrochloride tablet

1 INDICATIONS AND USAGE Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of Trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see Clinical Studies ( 14 )]. Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder ( 1 ). • Efficacy was established in trials of trazodone immediate release formulation in patients with major depressive disorder ( 14 ).

avkare, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] granulocytopenia` `[4] dyspnoea` `[5] death` `[6] off label use` `[7] drug interaction` `[8] dizziness` `[9] tremor` `[10] headache`

6 years ago

ROUND WHITE Pliva 433

6 years ago

Pliva 433 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 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 90 tablets (42291-833-90) and 1,000 tablets (42291-833-10). 100 mg: white, round, compressed tablets, debossed “PLIVA 434” on one side and scored on the other side. Available in bottles of 90 tablets (42291-834-90) and 1,000 tablets (42291-834-10). 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 90 tablets (42291-835-90) and 500 tablets (42291-835-50). 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. 300 mg: white, oval, flat-faced, beveled-edge tablet with one side scored with a full bisect and having two partial trisects. debossed with stylized barr/733 on one side and 100 100 100 on the other side with the middle 100 perpendicular to the others. Available in bottles of 100 tablets (42291-836-01). Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Image 1 Image 2 Image 3 Image 4 half one half 3/4 full

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