Fluoxetine HCL 40 mg/1
Fluoxetine HCL · CAPSULE · Direct_Rx
Fluoxetine HCL is a capsule containing fluoxetine hcl at 40 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Fluoxetine HCL
- Generic Name
- Fluoxetine HCL
- NDC Code (Product)
72189-505- Manufacturer
- Direct_Rx
- Strength
- 40 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204597
- Marketing Start
- 08/07/2023
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.
Full Prescribing Information
Indications & Usage
Fluoxetine is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see CLINICAL STUDIES (14.1)] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see CLINICAL STUDIES (14.2)] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see CLINICAL STUDIES (14.3)] . Acute treatment of Panic Disorder, with or without agoraphobia [see CLINICAL STUDIES (14.4)] . Fluoxetine and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.
Dosage & Administration
2.1 Major Depressive Disorder Initial Treatment Adult — Initiate fluoxetine 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). The maximum fluoxetine dose should not exceed 80 mg/day. In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 mg/day to 80 mg/day. Studies comparing fluoxetine 20 mg/day, 40 mg/day, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases [see CLINICAL STUDIES (14.1)]. Pediatric (children and adolescents) — Initiate Fluoxetine 10 mg/day or 20 mg/day. After 1 week at 10 mg/day, increase the dose to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed. In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectivenes…
Contraindications
When using fluoxetine capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see DOSAGE AND ADMINISTRATION (2.9) and WARNINGS AND PRECAUTIONS (5.2)]. Starting fluoxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see DOSAGE AND ADMINISTRATION (2.10) and WARNINGS AND PRECAUTIONS (5.2)]. 4.2 Other Contraindications The use of fluoxetine is contraindicated with the following: Pimozide [see WARNINGS AND PRECAUTIONS (5.11) and DRUG INTERACTIONS (7.7, 7.8)] Thioridazine [see WARNINGS AND PRECAUTIONS (5.11) and DRUG INTERACTIONS (7.7, 7.8)] Pimozide and thioridazine prolong the QT interval. Fluoxetine can increase the levels of pimozide and thior…
Drug Interactions
As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. 7.1 Monoamine Oxidase Inhibitors (MAOI) [See DOSAGE AND ADMINISTRATION (2.9, 2.10), CONTRAINDICATIONS (4.1), and WARNINGS AND PRECAUTIONS (5.2)]. 7.2 CNS Acting Drugs Caution is advised if the concomitant administration of fluoxetine and such drugs is required. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status [see CLINICAL PHARMACOLOGY (12.3)] . 7.3 Serotonergic Drugs [See DOSAGE AND ADMINISTRATION (2.9, 2.10), CONTRAINDICATIONS (4.1), and WARNINGS AND PRECAUTIONS (5.2)]. 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDS, Aspirin, Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that c…
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.2)] Allergic Reactions and Rash [see WARNINGS AND PRECAUTIONS (5.3)] Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [see WARNINGS AND PRECAUTIONS (5.4)] Seizures [see WARNINGS AND PRECAUTIONS (5.5)] Altered Appetite and Weight [see WARNINGS AND PRECAUTIONS (5.6)] Abnormal Bleeding [see WARNINGS AND PRECAUTIONS (5.7)] Angle-Closure Glaucoma [see WARNINGS AND PRECAUTIONS (5.8)] Hyponatremia [see WARNINGS AND PRECAUTIONS (5.9)] Anxiety and Insomnia [see WARNINGS AND PRECAUTIONS (5.10)] QT Prolongation [see WARNINGS AND PRECAUTIONS (5.11)] Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS (5.13)] Discontinuation Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.15)] Sexual Dysfunction [see WARNINGS AND FUNCTIONS (5.17)] When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax. 6.1 Clinic…
Frequently Asked Questions
What is Fluoxetine HCL used for?
Fluoxetine HCL contains Fluoxetine HCL. It is a capsule taken oral. Consult your doctor for specific uses.
Is Fluoxetine HCL a controlled substance?
Fluoxetine HCL is not classified as a controlled substance by the DEA.
What is the generic name for Fluoxetine HCL?
The generic name for Fluoxetine HCL is Fluoxetine HCL. There are 1 other brand versions of Fluoxetine HCL.
What is the NDC code for Fluoxetine HCL 40 mg/1?
The NDC (National Drug Code) for Fluoxetine HCL 40 mg/1 is 72189-505, listed by Direct_Rx.