Venlafaxine Hydrochloride venlafaxine 75 MG Oral Tablet
INDICATIONS AND USAGE Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine 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 four of the following eight 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 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 tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Mylan Pharmaceuticals Inc.
ROUND YELLOW M V4
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HOW SUPPLIED Venlafaxine Tablets, USP are available containing venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of venlafaxine. The 25 mg tablets are yellow, round, scored tablets debossed with V above the score and 1 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4881-01 bottles of 100 tablets The 37.5 mg tablets are yellow, round, scored tablets debossed with V above the score and 2 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4882-01 bottles of 100 tablets The 50 mg tablets are yellow, round, scored tablets debossed with V above the score and 3 below the score on one side of the tablet and M on the other side. They are available as follows: NDC 0378-4883-01 bottles of 100 tablets The 75 mg tablets are yellow, round, scored tablets debossed with M above the score and V4 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4884-01 bottles of 100 tablets The 100 mg tablets are yellow, round, scored tablets debossed with M above the score and V5 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4885-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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