venlafaxine 75 MG Oral Tablet
INDICATIONS AND USAGE Venlafaxine tablets, USP 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 HCl 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 tablets, USP immediate-release 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 tablets, USP immediate-release/venlafaxine HCl extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Aphena Pharma Solutions - Tennessee, LLC
OVAL ORANGE IP 304
IP 304 OVAL ORANGE
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HOW SUPPLIED Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Venlafaxine tablets, USP, 25 mg, are supplied as light orange, round deep convex tablets debossed “IP†bisect “301†on one side. It is available as follows: Bottles of 90: NDC 42291-892-90 Venlafaxine tablets, USP, 37.5 mg, are supplied as light orange, round deep convex tablets debossed “IP†bisect “302†on one side. It is available as follows: Bottles of 90: NDC 42291-893-90 Venlafaxine tablets, USP, 50 mg, are supplied as light orange, circular tablets debossed “IP†bisect “303†on one side. It is available as: Bottles of 90: NDC 42291-894-90 Venlafaxine tablets, USP, 75 mg, are supplied as light orange, oval tablets debossed “IP†bisect “304†on one side. It is available as: Bottles of 90: NDC 42291-895-90 Bottles of 500: NDC 42291-895-50 Venlafaxine tablets, USP, 100 mg, are supplied as light orange, oval tablets debossed “IP†bisect “305†on one side. It is available as: Bottles of 90: NDC 42291-896-90 Bottles of 500: NDC 42291-896-50 Store at 20 to 25°C (68 to 77 °F) [see USP Controlled Room Temperature] in a dry place. Dispense in a well-closed container as defined in the USP.
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