FLUOXETINE - fluoxetine hydrochloride capsule
Lake Erie Medical DBA Quality Care Products LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use fluoxetine safely and effectively. See full prescribing information for fluoxetine capsules.
Fluoxetine Capsules, USP for Oral Use Initial U.S. Approval: 1987 WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for Major Depressive Disorder (MDD) and other psychiatric disorders (5.1). When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax. RECENT MAJOR CHANGES
Indications and Usage, Fluoxetine Capsules and Olanzapine in Combination: Revised: 1/2017 |
FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS11 DESCRIPTION
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Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NO•HCl. Its molecular weight is 345.79. The structural formula is:
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch, colloidal silicon dioxide, FD&C Blue #1, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, and gelatin. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide and shellac.
FLUOXETINE
fluoxetine hydrochloride capsule |
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Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Lake Erie Medical DBA Quality Care Products LLC | 831276758 | repack(49999-362) |