Fluoxetine 20 mg
1 INDICATIONS AND USAGE Fluoxetine is a 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 to18 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 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) ].
dr.reddy's laboratories inc.
OVAL WHITE 566 2 0
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Fluoxetine 20 mg
Dr.Reddy's Laboratories Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
FLUOXETINE Tablets USP, 10 mg* are blue, oval shaped biconvex beveled edged film coated tablets, debossed "R" on one side and 0150 other side with break line separating ‘01’ from ‘50’ and are supplied in bottles of 30, 100, 500, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-150-30 Bottles of 100 NDC 55111-150-01 Bottles of 500 NDC 55111-150-05 Bottles of 1000 NDC 55111-150-10 Unit dose packages of 100 (10 x 10) NDC 55111-150-78
FLUOXETINE Tablets USP, 20 mg* are white to off white film coated oval shaped beveled edged biconvex tablets debossed with '566' on one side and '20' on other side with breakline separating '2' from '0' and are supplied in bottles of 30's, 100's and 1000's. Bottles of 30 NDC 43598-566-30 Bottles of 100 NDC 43598-566-01 Bottles of 1000's NDC 43598-566-10 *
FLUOXETINE base equivalent 16.2 Storage and Handling Store
FLUOXETINE tablets at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect From Light. Dispense in a tight, light-resistant container.
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