Fluoxetine

Fluoxetine

Fluoxetine Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Major Depressive Disorder

Fluoxetine capsules, USP 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 for extended periods, should periodically be re-evaluated [see Dosage and Administration (2.1)].

1.2 Obsessive Compulsive Disorder

Fluoxetine capsules, USP 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 capsules, USP capsules 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 capsules, USP 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 capsules, USP 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 capsules, USP 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 capsules, USP 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 capsules, USP 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 capsules 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 Capsules and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder

When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.

Fluoxetine capsules, USP and olanzapine in combination are indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder.

Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.

History

There is currently no drug history available for this drug.

Other Information

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 structural formula

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:, colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, proplylene glycol, shellac and strong ammonia solution.

Fluoxetine Manufacturers


  • Cardinal Health
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Cardinal Health]
  • Pliva Inc.
    Fluoxetine Capsule [Pliva Inc.]
  • Proficient Rx Lp
    Fluoxetine (Fluoxetine Hydrochloride) Tablet, Film Coated [Proficient Rx Lp]
  • Proficient Rx Lp
    Fluoxetine Capsule [Proficient Rx Lp]
  • Remedyrepack Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Proficient Rx Lp]
  • Par Pharmaceutical Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Solution [Par Pharmaceutical Inc.]
  • Alphapharm Pty Ltd
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Alphapharm Pty Ltd]
  • Dr. Reddy’s Laboratories Limited
    Fluoxetine (Fluoxetine Hydrochloride) Tablet [Dr. Reddy’s Laboratories Limited]
  • Blenheim Pharmacal, Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Blenheim Pharmacal, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Contract Pharmacy Services-pa
    Fluoxetine Capsule [Contract Pharmacy Services-pa]
  • Stat Rx Usa Llc
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Stat Rx Usa Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Fluoxetine Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Rebel Distributors Corp
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Rebel Distributors Corp]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Fluoxetine (Fluoxetine Capsules) Capsule [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Rebel Distributors Corp
    Fluoxetine Capsule [Rebel Distributors Corp]
  • Legacy Pharmaceutical Packaging
    Fluoxetine Capsule [Legacy Pharmaceutical Packaging]
  • Legacy Pharmaceutical Packaging
    Fluoxetine Capsule [Legacy Pharmaceutical Packaging]
  • Contract Pharmacy Services-pa
    Fluoxetine Capsule [Contract Pharmacy Services-pa]
  • Lake Erie Medical Dba Quality Care Products Llc
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Bryant Ranch Prepack
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Bryant Ranch Prepack]
  • Pd-rx Pharmaceuticals, Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Physicians Total Care, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Life Line Home Care Services, Inc.
    Fluoxetine Capsule [Life Line Home Care Services, Inc.]
  • Med-health Pharma, Llc
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Med-health Pharma, Llc]
  • Stat Rx Usa Llc
    Fluoxetine Capsule [Stat Rx Usa Llc]
  • Dr.reddy’s Laboratories Limited
    Fluoxetine Capsule [Dr.reddy’s Laboratories Limited]
  • Mckesson Contract Packaging
    Fluoxetine Capsule [Mckesson Contract Packaging]
  • Mckesson Contract Packaging
    Fluoxetine Capsule [Mckesson Contract Packaging]
  • Prodigy Health Supplier
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Prodigy Health Supplier]
  • Unit Dose Services
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Unit Dose Services]
  • Stat Rx Usa Llc
    Fluoxetine Capsule [Stat Rx Usa Llc]
  • Medvantx, Inc.
    Fluoxetine Capsule [Medvantx, Inc.]
  • Medsource Pharmaceuticals
    Fluoxetine Capsule [Medsource Pharmaceuticals]
  • Cardinal Health
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Cardinal Health]
  • Pharmaceutical Associates, Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Solution [Pharmaceutical Associates, Inc.]
  • Rebel Distributors Corp
    Fluoxetine Capsule [Rebel Distributors Corp]
  • Remedyrepack Inc.
    Fluoxetine Capsule [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Fluoxetine Capsule [Remedyrepack Inc. ]
  • Par Pharmaceutical Companies, Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Par Pharmaceutical Companies, Inc.]
  • Remedyrepack Inc.
    Fluoxetine Capsule [Remedyrepack Inc. ]
  • Medvantx, Inc.
    Fluoxetine Capsule [Medvantx, Inc.]
  • Remedyrepack Inc.
    Fluoxetine Capsule [Remedyrepack Inc. ]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Fluoxetine Capsule [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Unit Dose Services
    Fluoxetine Capsule [Unit Dose Services]
  • Remedyrepack Inc.
    Fluoxetine Capsule [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Lake Erie Medical Dba Quality Care Products Llc]
  • Clinical Solutions Wholesale
    Fluoxetine Capsule [Clinical Solutions Wholesale]
  • Medvantx, Inc.
    Fluoxetine Capsule [Medvantx, Inc.]
  • Barr Laboratories Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Barr Laboratories Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Fluoxetine Capsule [Pd-rx Pharmaceuticals, Inc.]
  • Unit Dose Services
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Unit Dose Services]
  • Clinical Solutions Wholesale
    Fluoxetine Capsule [Clinical Solutions Wholesale]
  • Northstar Rxllc
    Fluoxetine Capsule [Northstar Rxllc]
  • Major Pharmaceuticals
    Fluoxetine Capsule [Major Pharmaceuticals]
  • American Health Packaging
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [American Health Packaging]
  • Aidarex Pharmaceuticals Llc
    Fluoxetine Capsule [Aidarex Pharmaceuticals Llc]
  • Aidarex Pharmaceuticals Llc
    Fluoxetine Capsule [Aidarex Pharmaceuticals Llc]
  • Blenheim Pharmacal, Inc.
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Blenheim Pharmacal, Inc.]
  • Heritage Pharmaceuticals Inc.
    Fluoxetine Capsule [Heritage Pharmaceuticals Inc.]
  • Aidarex Pharmaceuticals Llc
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [Aidarex Pharmaceuticals Llc]
  • Direct Rx
    Fluoxetine Capsule [Direct Rx]
  • State Of Florida Doh Central Pharmacy
    Fluoxetine Capsule [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Fluoxetine (Fluoxetine Hydrochloride) Capsule [State Of Florida Doh Central Pharmacy]