Fluoxetine 10 MG Oral Capsule

INDICATIONS AND USAGE Fluoxetine capsules, USP are indicated for the treatment of premenstrual dysphoric disorder (PMDD). The efficacy of fluoxetine in the treatment of PMDD was established in three placebo-controlled trials (see CLINICAL TRIALS ). The essential features of PMDD, according to the DSM-IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of fluoxetine capsules in long-term use, that is, for more than 6 months, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use fluoxetine capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
[1] drug ineffective    [2] pain    [3] off label use    [4] pyrexia    [5] infusion related reaction    [6] dyspnoea    [7] fatigue    [8] pruritus    [9] rash    [10] nausea