Fluoxetine 10 MG Oral Tablet

1 INDICATIONS & USAGE Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) Indication Adult Pediatric MDD (2.1) 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD (2.2) 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa (2.3) 60 mg/day in am Panic Disorder (2.4) 10 mg/day (initial dose) A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications (2.7) 1.1 Major Depressive Disorder Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)] . The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)] . 1.2 Obsessive Compulsive Disorder Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)] . The effectiveness of fluoxetine in long‑term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo‑controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)] . 1.3 Bulimia Nervosa Fluoxetine is indicated for the acute and maintenance treatment of binge‑eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . The physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)] . 1.4 Panic Disorder Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)] . The effectiveness of fluoxetine in long‑term use, i.e., for more than 12 weeks, has not been established in placebo‑controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)] .

Par Pharmaceutical, Inc.

FDA Reported Adverse Reactions
[1] fatigue    [2] drug ineffective    [3] pain    [4] nausea    [5] off label use    [6] dyspnoea    [7] headache    [8] diarrhoea    [9] vomiting    [10] pneumonia