Home › Drugs › Fluoxetine Hcl

Fluoxetine Hcl

FDA Drug Information • Also known as: Fluoxetine Hcl

Brand Names
Fluoxetine Hcl
Dosage Form
POWDER
Product Type
BULK INGREDIENT

⚠ Boxed Warning (Black Box)

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ( 5.1 )] .
  • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behavior. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.1 )] .
  • Fluoxetine is not approved for use in children less than 7 years of age [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning .
  • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ).
  • Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).

    • Description

    11 DESCRIPTION Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)- N -methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17 H 18 F 3 NO

  • 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 scored tablet contains fluoxetine hydrochloride equivalent to 60 mg (194 μmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: mannitol, microcrystalline cellulose, maize starch, povidone, hypromellose, magnesium stearate, titanium dioxide, sucrose, glycerol, and polysorbate. structure

    • What Is Fluoxetine Hcl Used For?

    1 INDICATIONS AND USAGE Fluoxetine tablets are indicated for the treatment of:

  • Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies ( 14.1 )] .
  • Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies ( 14.2 )] .
  • Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies ( 14.3 )] .
  • Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies ( 14.4 )] . Fluoxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of:
  • Major Depressive Disorder (MDD) ( 1 )
  • Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study ( 14.1 )
  • Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age ( 14.1 )
  • Obsessive Compulsive Disorder (OCD) ( 1 )
  • Adults: Efficacy was established in two 13-week trials ( 14.2 )
  • Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age ( 14.2 )
  • Bulimia Nervosa ( 1 )
  • Adults: Efficacy was established in two 8-week trials and one 16-week trial ( 14.3 )
  • Panic Disorder, with or without agoraphobia ( 1 )
  • Adults: Efficacy was established in two 12-week trials ( 14.4 )

    • Dosage and Administration

    2 DOSAGE AND ADMINISTRATION This product is only available in a 60 mg dosage form. A 30 mg dose may be achieved with one-half of the scored tablet. Use of this product requires initial titration with another fluoxetine product according to the dosing guidelines indicated below.

  • Use another fluoxetine product for initial doses of 10 to 20 mg/day or for doses other than 30 mg or 60 mg: Indication Adult Pediatric MDD ( 2.1 ) 20 mg/day in morning (initial dose) 20 mg/day (target dose) 80 mg/day (maximum dose studied) 10 to 20 mg/day (initial dose)* *This product has not been studied in doses greater than 20 mg/day in pediatric MDD. OCD ( 2.2 ) 20 mg/day in morning (initial dose) 20 to 60 mg/day (target dose) 10 mg/day (initial dose) 10 to 60 mg/day (target dose) Bulimia Nervosa ( 2.3 ) 60 mg/day in morning - Panic Disorder ( 2.4 ) 10 mg/day (initial dose) 20 mg/day (target dose) 60 mg/day (maximum dose studied) -
  • No additional benefits seen at higher doses above 20 mg/day in MDD ( 2.1 , 14.1 )
  • Use a lower or less frequent dosage in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications ( 2.5 , 8.6 ) 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 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in MDD in most cases [see Clinical Studies ( 14.1 )] . Pediatric (children and adolescents) —Treatment should be initiated with a dose of 10 or 20 mg/day. After 1 week at 10 mg/day, the dose should be increased 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. A dose increase to 20 mg/day may be considered after several weeks if insufficient clinical improvement is observed. In the short-term (8- to 9-week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of MDD, patients were administered fluoxetine doses of 10 to 20 mg/day [see Clinical Studies ( 14.1 )] . Doses greater than 20 mg/day have not been studied in pediatric patients with MDD. This product is only available in a 60 mg dosage form. Administration of doses with demonstrated efficacy of fluoxetine 10 to 20 mg/day in pediatric MDD requires the use of another formulation. All patients —As with other drugs effective in the treatment of MDD, the full effect may be delayed until 4 weeks of treatment or longer. Periodically reassess to determine the need for maintenance treatment....

    • Side Effects (Adverse Reactions)

    6 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 )]
  • Increased Risk of 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 )] Most common adverse reactions (≥ 5% and at least twice that for placebo): abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almatica Pharma, Inc. at 1-877-447-7979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. Multiple doses of fluoxetine have been administered to 10,782 patients with various diagnoses in US clinical trials. In addition, there have been 425 patients administered fluoxetine in panic clinical trials. The stated frequencies represent the proportion of individuals who experienced, at least once, an adverse reaction of the type listed. An adverse reaction was included if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Incidence in MDD, OCD, Bulimia, and Panic Disorder placebo-controlled clinical trials (excluding data from extensions of trials) —Table 2 enumerates the most common adverse reactions associated with the use of fluoxetine (incidence of at least 5% for fluoxetine and at least twice that for placebo within at least 1 of the indications) for the treatment of MDD, OCD, and bulimia in US controlled clinical trials and Panic Disorder in US plus non-US controlled trials. Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2 . Table 2. Most Common Adverse Reactions: Incidence in Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and Panic Disorder Placebo-controlled Clinical Trials Note: Includes US data for MDD, OCD, Bulimia, and Panic Disorder clinical trials, plus non-US data for Panic Disorder clinical trials. a = Denominator used was for males only (N = 690 fluoxetine MDD; N = 410 placebo MDD; N = 116 fluoxetine OCD; N = 43 placebo OCD; N = 14 fluoxetine Bulimia; N = 1 placebo Bulimia; N = 162 fluoxetine Panic Disorder; N = 121 placebo Panic Disorder). -- = Incidence less than 1%. Percentage of Patients Reporting Event MDD OCD Bulimia Panic Disorder Body System/ Adverse Reaction Fluoxetine (N = 1728) Placebo (N = 975) Fluoxetine (N = 266) Placebo (N = 89) Fluoxetine (N = 450) Placebo (N = 267) Fluoxetine (N = 425) Placebo (N = 342) Body as a Whole Asthenia 9 5 15 11 21 9 7 7 Flu syndrome 3 4 10 7 8 3 5 5 Cardiovascular System Vasodilatation 3 2 5 -- 2 1 1 -- Digestive System Nausea 21 9 26 13 29 11 12 7 Diarrhea 12 8 18 13 8 6 9 4 Anorexia 11 2 17 10 8 4 4 1...

    • Drug Interactions

    7 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.

  • Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.6 )
  • Tricyclic Antidepressants (TCAs): Monitor TCA levels during co-administration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.6 )
  • Benzodiazepines: Diazepam—increased t 1/2 , alprazolam—further psychomotor performance decrement due to increased levels ( 7.6 )
  • Antipsychotics: Potential for elevation of haloperidol and clozapine levels ( 7.6 )
  • Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity ( 7.6 )
  • Serotonergic Drugs: ( 2.6 , 2.7 , 4.1 , 5.2 )
  • Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval ( 4.2 , 5.11 , 7.6 , 7.7 ) 7.1 Monoamine Oxidase Inhibitors (MAOIs) [See Dosage and Administration ( 2.6 , 2.7 ), 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 Other Serotonergic Drugs The concomitant use of serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) with fluoxetine increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of fluoxetine and/or concomitant serotonergic drugs [see 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 concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SNRIs or SSRIs are co-administered with warfarin. Patients receiving warfarin therapy should be carefully monitored when fluoxetine is initiated or discontinued [see Warnings and Precautions ( 5.7 )] . 7.5 Potential for Other Drugs to Affect Fluoxetine Drugs tightly bound to plasma proteins —Because fluoxetine is tightly bound to plasma proteins,...

    • Contraindications

    4 CONTRAINDICATIONS

  • Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 , 7.1 )
  • Pimozide: ( 4.2 , 5.11 , 7.6 , 7.7 )
  • Thioridazine: Do not use concomitantly with or within 5 weeks of discontinuing fluoxetine ( 4.2 , 5.11 , 7.6 , 7.7 )
  • Known hypersensitivity to fluoxetine products ( 4.2 , 5.3 ) 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 ( 2.6 ) 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 ( 2.7 ) 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 ( 7.6 , 7.7 )]
  • Thioridazine [see Warnings and Precautions ( 5.11 ) and Drug Interactions ( 7.6 , 7.7 )] Pimozide and thioridazine prolong the QT interval. Fluoxetine can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval.
  • Known hypersensitivity to fluoxetine: Do not use this product in patients with known hypersensitivity to fluoxetine due to risk of anaphylactoid reactions, including bronchospasm, angioedema,...

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.7 ) and Clinical Considerations] . Available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. Some studies have reported an increased incidence of cardiovascular malformations; however, these studies results do not establish a causal relationship (see Data) . There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including Fluoxetine Tablets, during pregnancy (see Clinical Considerations) . In rats and rabbits treated with fluoxetine during the period of organogenesis, there was no evidence of developmental effects at doses up to 1.6 and 3.9 times, respectively, the maximum recommended human dose (MRHD) of 60 mg on a mg/m 2 given to adolescents on a mg/m 2 basis. However, in other reproductive studies in rats, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths early after birth occurred at doses that are 1.5 times (during gestation) and 0.97 times (during gestation and lactation) the MRHD given to adolescents on a mg/m 2 basis. The estimated background risk of major birth defects and...

    Overdosage

    10 OVERDOSAGE The following have been reported with fluoxetine tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, torsade de pointes, and cardiac arrest. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a fluoxetine overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine tablets, USP 60 mg, are available as 60-mg (fluoxetine base equivalent), film-coated, functional-scored, capsule-shaped, white tablets debossed with “FL 60” on one side (“FL” above the score and “60” below the score). NDC 52427-576-30 Bottle of 30 tablets 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. 16.1 How Supplied Fluoxetine tablets, USP 60 mg, are available as 60-mg (fluoxetine base equivalent), film-coated, functional-scored, capsule-shaped, white tablets debossed with “FL 60” on one side (“FL” above the score and “60” below the score). NDC 52427-576-30 Bottle of 30 tablets

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.