fluoxetine tablet film coated
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) ] .
aurobindo pharma limited
OVAL WHITE FL 1 0
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fluoxetine tablet film coated
aurobindo pharma limited
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
FLUOXETINE Tablets, USP are available containing
FLUOXETINE hydrochloride, USP equivalent to 10 mg or 20 mg of
FLUOXETINE.
FLUOXETINE Tablets USP, 10 mg are white, film-coated, oval shaped biconvex, scored (functional) tablets debossed with “1†on the left of the score and “0†on the right of the score on one side of the tablet and “FL†on the other side. They are available as follows: Bottles of 30 NDC 59651-308-30 Bottles of 100 NDC 59651-308-01
FLUOXETINE Tablets USP, 20 mg are white, film-coated, oval shaped biconvex, scored (functional) tablets debossed with “2†on the left of the score and “0†on the right of the score on one side of the tablet and “FL†on the other side. They are available as follows: Bottles of 30 NDC 59651-309-30 Bottles of 100 NDC 59651-309-01 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. 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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