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Fluoxetine Hydrochloride - Uses, Precautions, Warnings, and Side Effects

Published on Nov 14, 2022 and last reviewed on Jan 25, 2023   -  14 min read

Abstract

Fluoxetine is used to manage depression, obsessive-compulsive disorder, and panic disorder. Refer to this article to know more in detail.

Overview:

Fluoxetine is a selective serotonin reuptake inhibitor meant for oral administration. It is also used for the management of premenstrual dysphoric conditions. FDA (Food and Drug Administration) approved it on 10 July 1999. Fluoxetine delivers its results by obstructing the reuptake of serotonin into presynaptic serotonin neurons by blocking the reuptake transporter protein found in the presynaptic terminal. Fluoxetine also has little action at the 5HT2A and 5HT2C receptors. It manages major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and bulimia nervosa.

How Does Fluoxetine Work?

Fluoxetine manages depression, obsessive-compulsive disorder, certain eating disorders, and panic attacks. Fluoxetine alleviates premenstrual dysphoric disorder, involving mood swings, irritability, and breast aches. It is also utilized with Olanzapine to manage depression that does not relieve or react to certain medications and sequences of depression in patients with bipolar I disorder. Fluoxetine is in a category of drugs known as selective serotonin reuptake inhibitors (SSRIs). It improves the quantity of serotonin, a natural material in the brain that allows for maintaining mental balance.

What Are the Uses of Fluoxetine?

Fluoxetine is also periodically utilized to manage alcohol intake, attention-deficit disease, borderline personality disease, sleep disturbances, mental disease, posttraumatic stress disturbance, Tourette's syndrome, sexual issues, and phobias. Discuss with the doctor the probable hazards of utilizing this medication for the condition.

Indications and Usage:

Fluoxetine is indicated for the following:

  • Acute management and maintenance therapy of major depressive disorder.
  • Acute treatment and maintenance therapy of obsessions and compulsions in obsessive-compulsive disorder (OCD) cases.
  • Acute treatment and maintenance therapy of binge-eating and vomiting manners in cases with medium to intense bulimia nervosa.
  • Acute therapy for panic conditions, with or without agoraphobia.

Fluoxetine and Olanzapine in combination are suggested for the therapy of

  • Acute therapy of depressive episodes connected with bipolar one disorder.
  • Therapy-resistant depression.
  • Fluoxetine monotherapy is not used for treating depressive episodes connected with bipolar one disorder or the therapy of medicine-resistant depression.

Contraindications:

Monoamine Oxidase Inhibitors - The usage of Monoamine Oxidase Inhibitors planned to manage psychiatric disorders with Fluoxetine or within five weeks of discontinuing therapy with Fluoxetine is contraindicated due to the improved hazard of serotonin syndrome. The usage of Fluoxetine within 14 days of discontinuing monoamine oxidase inhibitors is planned to manage psychiatric disorders is contraindicated. Initiating Fluoxetine in cases already being given with monoamine oxidase inhibitors like Linezolid or Intravenous methylene blue is contraindicated due to the augmented hazard of serotonin syndrome. Fluoxetine can improve the levels of Pimozide and Thioridazine via the inhibition of CYP2D6. Fluoxetine can extend the QT interval.

Warnings and Precautions

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

Adults and pediatric patients might experience a major depressive disorder. In addition, they may experience aggravated depression or the emergence of suicidal imagination and manners if they are intaking antidepressant medicines or not, and this hazard might continue until effective remission happens.

Suicide is an understood hazard of depression and specific additional psychiatric conditions, and these conditions are the most potent suicide predictors. There has been a prolonged problem, nevertheless, that antidepressants might have a part in causing the deterioration of depression and the emergence of suicidality in specific cases in the earlier stages of therapy.

All cases being managed with antidepressants for any user should be adequately observed for clinical worsening and uncommon differences in manners, particularly at the initial months of drug treatment or at periods of dose differences, either additions or reductions. The subsequent manifestation, anxiety, panic attack, aggressiveness, akathisia, hypomania, and mania, have been notified in grown-up and pediatric cases being managed with antidepressants for Major Depressive Disorder as well as for other uses, both psychiatric and nonpsychiatric. A causal connection between such manifestations and either the deterioration of depression or the event of suicidal impulses has not been demonstrated. There is the problem that such manifestations may describe predecessors to occurring suicidality.

Serotonin Syndrome

The evolution of a potentially life-threatening serotonin syndrome has been notified with serotonin and norepinephrine reuptake inhibitors SNRIs and SSRIs, Fluoxetine alone, but especially with simultaneous usage of additional serotonergic medications and with medications that damage serotonin metabolism.

Serotonin syndrome manifestations may possess mental status differences such as agitation, hallucinations, delirium, autonomic fluctuation, neuromuscular symptoms like tremors, and gastrointestinal manifestations.

Allergic Reactions and Rash

Anaphylactoid responses involving bronchospasm, angioedema, laryngospasm, and urticaria, independently and together, are declared. Pulmonary responses involving inflammatory methods of altering histopathology or fibrosis have been notified infrequently. These responses have emerged with dyspnea as the only preceding manifestation. Death has been declared to appear in connection with these systemic responses.

Screening Patients for Bipolar Disorder and Monitoring for Mania or Hypomania - A significant depressive episode might be the first manifestation of bipolar disorder. It is commonly thought that managing such an episode with an antidepressant alone may improve the probability of precipitation of a mixed sequence.

Altered Appetite and Weight - Substantial loss of weight, mainly in malnourished depressed, or bulimic cases, maybe an unpleasant outcome of therapy with Fluoxetine.

Abnormal Bleeding - Serotonin, norepinephrine reuptake inhibitors (SNRIs), and SSRIs, involving Fluoxetine may improve the hazard of bleeding responses. Simultaneous usage of Aspirin, nonsteroidal anti-inflammatory drugs, and additional anticoagulants may also induce the risk.

Angle-Closure Glaucoma - The pupillary dilation that happens to pursue usage of multiple antidepressant medications involving Fluoxetine might initiate an angle closure attack in cases with anatomically narrow angles if they do not contain patent iridectomy.

Hyponatremia

Hyponatremia has been informed at the time of therapy with SNRIs and SSRIs involving Fluoxetine. In many circumstances, this hyponatremia affects the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Patients with a serum sodium less than 110 mmol/L have been informed, and it seemed reversible when Fluoxetine was stopped. Older patients have a higher chance of generating hyponatremia with SNRIs and SSRIs. Furthermore, intaking diuretics or volume depletion might be a higher risk. Stoppage of Fluoxetine should be assessed in cases with symptomatic hyponatremia, and proper medical intervention should be initiated.

Use in Patients With Concomitant Illness:

1) Cardiovascular- Fluoxetine has not been assessed or utilized to any noticeable degree in cases with a current record of myocardial infarction or unstable heart disorder.

2) Glycemic Control - In diabetic patients, Fluoxetine may change glycemic control. Hypoglycemia has emerged during treatment with Fluoxetine and after stopping the medicine.

3) Potential for Cognitive and Motor Impairment- Fluoxetine can alter decision-making, assuming, or motor abilities.

Long Elimination Half-Life

Due to the prolonged removal of half-lives of the parent medicine and its primary functional metabolite, transformations in dosage will not be seen entirely in plasma for a few weeks, involving both procedures for titration to the last dosage and withdrawal from therapy.

Discontinuation Adverse Reactions

There is unexpected information of adverse reactions happening upon stoppage of these medications, incredibly when short, involving dysphoric attitude, irritability, and sensory disruptions.

Adverse Reactions:

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults.

Serotonin Syndrome.

Allergic Reactions and Rash.

  • Screening persons for bipolar disorder and assessing for mania or hypomania.
  • Seizure.
  • Changes in appetite.
  • Irregular bleeding.
  • Angle-closure glaucoma.
  • Anxiety.
  • QT Prolongation.
  • Possibility for Cognitive Alteration and Motor Impairment.
  • Stoppage of adverse reactions.

Dosage and Administration:

Major Depressive Disorder:

Initial Treatment:

Adult

Start Fluoxetine 20 mg per day orally administered in the dawn. Take a dosage exceeding 20 mg may be issued once per day. The highest Fluoxetine dosage should not be more than 80 mg daily. In controlled practices utilized to sustain the effectiveness of Fluoxetine, cases were allocated morning dosages varying from 20 mg daily to 80 mg daily. Analyses approximating Fluoxetine 20, 40, and 60 mg daily to placebo suggest that 20 mg daily is adequate to acquire a sufficient reaction in major depressive disorder in most patients.

Pediatric Cases

Begin Fluoxetine 10 mg daily or 20 mg daily. After one week at 10 mg daily, improve the dosage to 20 mg daily. Nevertheless, due to more elevated plasma levels in more low-weight children, the starting dose and target dosage in this class may be 10 mg daily. Assume a dosage addition to 20 mg daily after multiple weeks if incomplete clinical advancement is monitored. The short-term controlled clinical tests of Fluoxetine reinforce its efficacy in treating major depressive disorder. Cases were allocated Fluoxetine dosages of 10 mg daily to 20 mg.

In all cases, as with additional drugs efficacious in the therapy of Major Depressive Disorder, the full impact may be postponed until four weeks of therapy or more extended. Occasionally reassess to define the demand for maintaining therapy.

Weekly Dosage

Start Fluoxetine per week capsules seven days after the final daily dosage of Fluoxetine 20 mg. If the adequate reaction is not sustained with Fluoxetine per week, assume reestablishing a daily dosage regimen.

Changing patients to a Tricyclic Antidepressant (TCA)

The dosage of a TCA may require to be decreased, and plasma TCA concentrations may need to be observed when Fluoxetine is co-administered or has been stopped recently.

Obsessive-Compulsive Disorder:

Initial Treatment

Adult

Start Fluoxetine 20 mg daily by oral administration in the morning. Assume a dosage addition after some weeks if inadequate clinical progress is watched. The total therapeutic result may be hindered until five weeks of therapy or more prolonged. Intake of more than 20 mg daily once in the morning or twice daily. A dose range of 20 mg to 60 mg daily is suggested.

Nevertheless, dosages of around 80 mg daily have been well-accepted in studies of OCD. The highest Fluoxetine dosage should not be more than 80 mg/day. In the controlled clinical trials of Fluoxetine supporting its effectiveness in treating OCD, patients took fixed daily doses of 20 mg, 40 mg, or 60 mg of Fluoxetine.

In Children and Adolescents

Start therapy with 10 mg daily in higher-weight kids. After two weeks, improve the dosage to 20 mg daily. Assume extra dose additions if incomplete clinical progress is heeded after some weeks. A dosage degree of 20mg to 60 mg daily is suggested. Start therapy with a dose of 10 mg daily in lower-weight kids. Assume extra dosage additions if inadequate clinical improvement is followed after some weeks. A dosage range of 20 mg to 30 mg daily is suggested. Knowledge of daily doses of more than 20 mg is less, and there is no knowledge of doses of more than 60 mg.

Bulimia Nervosa:

Initial Treatment

Take Fluoxetine 60 mg daily at dawn. For some cases, it is suggested to titrate up to this dose over some days. Fluoxetine doses of more than 60 mg daily have not been systematically examined in cases with Bulimia. In the controlled clinical trials of Fluoxetine reinforcing its efficacy in treating Bulimia Nervosa, individuals were delivered fixed daily Fluoxetine doses of 20 mg or 60 mg, or placebo.

Panic Disorder:

Initial Treatment

Start therapy with Fluoxetine 10 mg daily. Following one week, improve the dosage to 20 mg daily. Assume a dose addition after some weeks if no clinical advancement is marked. Fluoxetine doses of more than 60 mg daily have not been systematically assessed in cases with panic disorder.

In the controlled clinical trials of Fluoxetine reinforcing its efficacy in treating panic disorder, individuals took Fluoxetine doses in the range of 10 mg to 60 mg daily. The most continually taken dosage in the two flexible-dose clinical trials was 20 mg daily. Occasionally reassess to define the demand for continued therapy.

Prozac and Olanzapine in Combination: Depressive Episodes Associated With Bipolar I Disorder:

Adult

Take Fluoxetine with oral Olanzapine once per day without consideration of meals, typically starting with 5 mg of oral Olanzapine and 20 mg of Fluoxetine. Create dosage adjustments if needed.

Children and Adolescents

Take Olanzapine and Fluoxetine combination once daily, starting with 2.5 mg of Olanzapine and 20 mg of Fluoxetine. Create dosage corrections, if needed, based on effectiveness and tolerability.

Prozac and Olanzapine in Combination

Treatment Resistant Depression:

Take Fluoxetine with oral Olanzapine once daily in the evening, without consideration to feeds, typically commencing with 5mg of oral Olanzapine and 20 mg of Fluoxetine.

Dosing in Specific Populations:

Treatment of Pregnant Women

While managing pregnant women with Fluoxetine, the doctor should evaluate the therapy's possible risks and advantages. Neonates disclosed to SSRIs or SNRIs delinquent in the third trimester have created complications demanding extended hospitalization, respiratory assistance, and feeding through a tube.

Geriatric - Assume a more inferior or small frequent dose for the elderly.

Hepatic Impairment - Like additional medications, utilize a lower dose in cases with hepatic impairment.

Concomitant Illness - Cases with a concurrent disorder or on multiple concomitant drugs may need dosage corrections.

Discontinuation of Treatment

Manifestations connected with the stoppage of Fluoxetine, SNRIs, and SSRIs have been noted.

Changing a Case to or From a Monoamine Oxidase Inhibitor Planned to Treat Psychiatric Disorders:

Atleast 14 days should elapse between stopping an MAOI planned to manage psychiatric conditions and starting treatment with Fluoxetine. Contrarily, at least five weeks should be permitted after stopping Fluoxetine before beginning an MAOI planned to manage psychiatric disorders.

Use of Fluoxetine With Other MAOIs like Linezolid or Methylene Blue:

Do not begin Fluoxetine in a case managed with Linezolid or intravenous Methylene blue due to the raised hazard of serotonin syndrome. Other interventions involving hospitalization should be evaluated for an individual who needs more critical therapy for a psychiatric disorder.

For Patients:

What Is Obsessive-Compulsive Disorder (OCD)?

Obsessive-compulsive disorder (OCD) is a mental condition in which patients have thoughts called obsessions and routines called compulsions repeatedly. . They interrupt life. Still, they cannot handle or prevent them. The reason for obsessive-compulsive disorder (OCD) is not known. Characteristics like genetics, chemistry, and biology of the brain and the atmosphere have a role.

What Are the Symptoms of Obsessive-Compulsive Disorder (OCD)?

People with Obsessive-Compulsive Disorder may have manifestations of obsessions, compulsions, or both:

Obsessions - They have replicated thoughts, demands, or mental pictures that induce anxiety. These include-

  • Fear of contamination.
  • Fear of misplacing anything.
  • Fears about harm arriving towards them.
  • Undesirable forbidden thoughts.
  • Fierce reflections toward themselves or any other people.

Compulsions - They are manners that feel like they are in need to do again and again to attempt to decrease anxiety or eliminate obsessive reflections. Certain typical compulsions involve -

  • Excessive hand washing.
  • Continually reviewing something, like if the gate is closed.
  • Obsessive counting.
  • Arrangement of items in a particular, specific way.

What Is the Most Important Information That the Patient Should Know About Fluoxetine?

Fluoxetine and additional antidepressant medications may induce severe bad outcomes, involving:

Suicidal Thoughts or Actions - It may raise suicidal reflections or activities in kids, teenagers, or grown-ups within the foremost few months of therapy or when the dosage is altered.

Depression or mental illnesses are the most significant reasons for suicidal thoughts or activities.

Monitor for these alterations and inform the healthcare provider immediately if:

  • New or impulsive transitions in attitude, manners, activities, views, or emotions, particularly if extreme.
  • When Fluoxetine is initiated, or the dosage is modified, give special attention to such modifications. Maintain all follow-up visits to the healthcare provider and inform the provider between visits if stressed about manifestation. Contact the healthcare provider immediately in case of the following symptoms, especially if they are unknown, more harmful, trying to commit suicide, performing destructive notions, performing assertive thoughts about suicide, more harmful depression, more harmful anxiety, feeling restless, furious or unruly, problem in sleeping, an expansion in activity more than normal, other uncommon transitions in behavior.

Serotonin Syndrome - It is a life-threatening condition that involves,

Hallucinations, comas, or other differences in the mental situation. Coordination difficulties or muscle twitching, running heartbeat, altered blood pressure, sweating, and gastrointestinal disturbances.

Severe Allergic Reactions involve difficulty breathing, inflammation, and rashes.

4) Another reaction involves altered bleeding, altered visual functions, seizures, manic attacks, transition in weight, reduced level of salt in the blood, and Transformations in the electrical activity of the heart, which involves QT prolongation and ventricular arrhythmia involving Torsades de Pointes. This situation can be life-threatening.

Can a Patient Stop Fluoxetine Promptly?

Ceasing Fluoxetine too fast may induce severe manifestations involving:

  • Anxiety.
  • Grumpiness.
  • Altered mood. Transformations in sleep habits.
  • Headache. Nausea.
  • Dizziness.
  • Confusion.

Who Should Not Take Fluoxetine?

Do not take Fluoxetine if allergic to Fluoxetine hydrochloride or its components. Take a monoamine oxidase inhibitor (MAOI). Discuss with the healthcare provider if there is any doubt regarding the intake of an MAOI involving the antibiotic Linezolid. Do not take an MAOI within five weeks of quitting Fluoxetine unless required to do so by a physician. Do not initiate Fluoxetine if you stop taking an MAOI in the last two weeks unless required to do so by a physician.

What Should Be Discussed With Healthcare Providers Before Taking Fluoxetine?

Inform the healthcare provider if taking particular drugs or therapies like

SSRIs, MAOIs, or antipsychotics would be safe. Consult the doctor to know whether medications like Amphetamines, Tramadol, and Fentanyl can be taken.

Inform the doctor in case of the following medical conditions:

  • Liver problems.
  • Kidney problems.
  • Heart issues.
  • Seizures or convulsions.
  • Bipolar disorder.
  • Reduced sodium levels in the blood.
  • Abnormal bleeding.
  • Pregnancy.
  • Breastfeeding.

How Should Fluoxetine Be Taken?

Take Fluoxetine precisely as specified. The healthcare provider may alter the dosage of Fluoxetine for each patient. Fluoxetine may be intaken with food or without food. In case of a skipped or missed dose of Fluoxetine, have the skipped dosage of the drug immediately when recalled. If it is near the time for the subsequent dose, ignore the forgotten dose and have the next dose at the normal time. Do not take two doses of Fluoxetine at an identical time. If Fluoxetine is taken over quantity, immediately contact a healthcare provider or poison control center or get emergency therapy.

What Should Be Avoided While Taking Fluoxetine?

Fluoxetine can induce sleepiness or influence the ability to make decisions, assume clearly, or respond promptly. The patient should not drive, function in heavy machinery, or do other risky actions until the patient gets to know how Fluoxetine impacts them. Do not drink alcohol while using Fluoxetine.

How Should Fluoxetine Be Stored?

Store Fluoxetine at room temperature between 59°F (Fahrenheit) and 86°F. Keep Fluoxetine away from light. Keep the Fluoxetine bottle sealed tightly.

For Doctors:

Description:

Fluoxetine is a selective serotonin reuptake inhibitor for oral administration. It is also sold for the management of premenstrual dysphoric conditions. It is established (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy] propylamine hydrochloride and its empirical formula of C17H18F3NO•HCl. Its molecular weight is 345.79. Fluoxetine hydrochloride is a white color to off-white color crystalline solid with a solubility of 14 mg per mL in water.

Clinical Pharmacology:

Pharmacodynamics

Analysis at clinically appropriate dosage in males has shown that Fluoxetine obstructs serotonin uptake into platelets. Animal investigations also indicate Fluoxetine is a more powerful serotonin uptake inhibitor than norepinephrine. The antagonism of muscarinic receptors, histaminergic receptors, and α1-adrenergic receptors has been hypothesized to be connected with different anticholinergic effects, sedative effects, and cardiovascular effects of classical tricyclic antidepressant (TCA) drugs. Fluoxetine connects to these and additional membrane receptors from brain tissue considerably undersized potently in vitro than do the tricyclic medications.

Pharmacokinetics:

Systemic Bioavailability

In males, after a single oral 40 mg dosage, elevated plasma concentrations of Fluoxetine from 15ng/mL to 55 ng/mL are seen after six to eight hours. Food does not seem to influence the systemic bioavailability of Fluoxetine, even though it may slow its absorption by around one to two hours, presumably not clinically substantial. Thus, Fluoxetine may be taken with food or without food. Fluoxetine weekly capsules, a delayed-release formulation, comprise enteric-coated pellets that fight dissolution until getting a part of the gastrointestinal tract where the pH overextends 5.5. The enteric coating slows the commencement of absorption of Fluoxetine one to two hours compared to the rapid-release formulations.

Protein Binding - On an average of 200 to 1000 ng/mL concentration, around 94.5 % of Fluoxetine is attached in vitro to serum proteins, involving albumin and α1 (alpha 1)-glycoprotein. The relationship between Fluoxetine and other high protein-bound medication has not been fully assessed, but it may be significant.

Enantiomers

Fluoxetine is a racemic mixture of R-Fluoxetine and S-Fluoxetine enantiomers. The S-fluoxetine enantiomer is removed gradually and is the dominant enantiomer in plasma at a stable condition.

Metabolism

Fluoxetine is considerably metabolized in the liver to Norfluoxetine and several additional unidentified metabolites. The determined active metabolite, Norfluoxetine, is created by the demethylation of Fluoxetine.

Accumulation and Slow Elimination

The moderately gradual removal of Fluoxetine and its active metabolite, Norfluoxetine, direct to an important collection of these active species in chronic usage and slows the achievement of a stable state, even when a specified dosage is utilized.

Specific Populations

Liver Disease - As might be expected from its primary area of metabolism, liver impairment can impact the removal of Fluoxetine. The removal half-life of Fluoxetine was extended in a study of cirrhotic cases, with a standard of 7.6 days corresponding with the degree of two to three days' notice in cases without liver conditions. Norfluoxetine removal was also delayed.

Renal Disease - In depressed cases on dialysis, Fluoxetine intake of 20 mg once a day for two months created steady-state Fluoxetine and Norfluoxetine plasma concentrations similar to those noticed in patients with normal renal processes.

Geriatric Pharmacokinetics - The disposition of a single dosage of Fluoxetine in healthful aged cases did not vary significantly from that in more youthful standard cases.

Pediatric Pharmacokinetics (Children and Adolescents) - More increased steady-state Fluoxetine and Norfluoxetine concentrations have seemed in kids relative to grown-ups; nevertheless, these concentrations were within the range of concentrations seen in the grown-up population. As in adults, Fluoxetine and Norfluoxetine were collected considerably by observing multiple oral dosing. Steady-state concentrations were attained within three to four weeks of everyday dosage.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenicity- The dietary administration of Fluoxetine to rats and mice for two years at doses of around 10 and 12 mg/kg/day, respectively, created no proof of carcinogenicity.

Mutagenicity – Fluoxetine and Norfluoxetine have been demonstrated to have no genotoxic consequences established based on certain studies.

Impairment of Fertility - Based on certain studies done in rats, it is shown that there is no impact on fertility.

Animal Toxicology and Pharmacology - Phospholipids are advanced in specific tissues of mice, rats, and dogs given Fluoxetine chronically. This impact is reversible after the termination of Fluoxetine therapy. Phospholipid collection in animals has been seen with many cationic amphiphilic medications involving Fenfluramine, Imipramine, and Ranitidine. The importance of this result in humans is unspecified.

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Last reviewed at:
25 Jan 2023  -  14 min read

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