아로작캡슐20밀리그램(플루옥세틴염산염)

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 …

When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax ® . Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue. ( 4.1 ) Pimozide: Do not use. Risk of QT prolongation and drug interaction. ( 4.2 , 5.11 , 7.7 , 7.8 ) Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine. ( 4.2 , 5.11 , 7.7 , 7.8 ) When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax ® . ( 4 ) 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use …

When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax ® . Clinical Worsening and Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior. ( 5.1 ) Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with fluoxetine, both when taken alone, but especially when coadministered with other serotonergic agents. If such symptoms occur, discontinue fluoxetine and serotonergic agents and initiate supportive treatment. If concomitant use of fluoxetine with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. ( 5.2 ) Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena. ( 5.3 ) Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania. ( 5.4 ) Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. ( 5.5 ) Altered Appetite and Weight: Significant weight loss has occurred. ( 5.6 ) Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding. ( 5.7 ) Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated …

8.1 Pregnancy Teratogenic Effects. Pregnancy Category C: Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. Treatment of Pregnant Women During the First Trimester: There are no adequate and well controlled clinical studies on the use of fluoxetine in pregnant women. Results of a number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent results. More than ten cohort studies and case-control studies failed to …