N06AB03 fluoxetine

1 INDICATIONS AND 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 ) 1.1 Major Depressive Disorder Fluoxetine tablets are 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 tablets for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1) ] . 1.2 Obsessive Compulsive Disorder Fluoxetine tablets are 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 tablets 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 tablets 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 tablets are 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 tablets 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 tablets are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4) ] . The effectiveness of fluoxetine tablets 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 tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4) ] .