venlafaxine 75 mg
INDICATIONS & USAGE Venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS ). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
REMEDYREPACK INC.
ROUND WHITE OS 302
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HOW SUPPLIED Venlafaxine Extended Release Tablets 37.5 mg are round, biconvex, white coated tablets with OS301 printed on one side. They are supplied as follows: Unit of Use Bottles of 30 Tablets NDC 65580-301-03 Unit of Use Bottles of 90 Tablets NDC 65580-301-09 Venlafaxine Extended Release Tablets 75 mg are round, biconvex, white coated tablets with OS302 printed on one side. They are supplied as follows: Unit of Use Bottles of 30 Tablets NDC 65580-302-03 Unit of Use Bottles of 90 Tablets NDC 65580-302-09 Venlafaxine Extended Release Tablets 150 mg are round, biconvex, white coated tablets with OS303 printed on one side. They are supplied as follows: Unit of Use Bottles of 30 Tablets NDC 65580-303-03 Unit of Use Bottles of 90 Tablets NDC 65580-303-09 Venlafaxine Extended Release Tablets 225 mg are round, biconvex, white coated tablets with OS304 printed on one side. They are supplied as follows: Unit of Use Bottles of 30 Tablets NDC 65580-304-03 Unit of Use Bottles of 90 Tablets NDC 65580-304-09
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