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Fluoxetine 20 MG Oral Capsule

1 INDICATIONS AND USAGE 1.1 Major Depressive Disorder Fluoxetine hydrochloride is 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 reevaluated [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 ) ]. 1.5 Fluoxetine and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.

Lake Erie Medical DBA Quality Care Products L


3 years ago CAPSULE WHITE GG 550 Fluoxetine 20 MG Oral Capsule

CAPSULE WHITE GG 550

3 years ago CAPSULE WHITE GG 550 Fluoxetine 20 MG Oral Capsule

GG 550 CAPSULE WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Fluoxetine capsules USP, 10 mg, 20 mg, and 40 mg are available as: 10 mg: white capsules, imprinted GG 575 with single green ink bands, filled with white powder and supplied as: NDC 0781-2823-31 bottles of 30 NDC 0781-2823-01 bottles of 100 NDC 0781-2823-10 bottles of 1000 NDC 0781-2823-13 unit dose packages of 100 20 mg: white capsules, imprinted GG 550 with green and black ink bands, filled with white powder and supplied as: NDC 0781-2822-31 bottles of 30 NDC 0781-2822-01 bottles of 100 NDC 0781-2822-10 bottles of 1000 NDC 0781-2822-13 unit dose packages of 100 40 mg: white capsules, imprinted GG 540 with single orange ink bands, filled with white powder and supplied as: NDC 0781-2824-31 bottles of 30 NDC 0781-2824-01 bottles of 100 NDC 0781-2824-10 bottles of 1000 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.


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Fluoxetine 20 MG Oral Capsule

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