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Флуоксетин

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Флуоксетин

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Флуоксетин

What is Флуоксетин? (Fluoxetine)

Флуоксетин (Fluoxetine) is an internationally recognized active ingredient and a commonly prescribed medication used to treat major depressive disorder and various anxiety-related conditions. It is known worldwide under its generic name and various brand names, the most famous being Prozac.

Quick Facts

Property Description
Active ingredient Fluoxetine hydrochloride
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
Rx Status Prescription-only (Rx)
Common uses Major Depressive Disorder, OCD, Bulimia Nervosa, Panic Disorder
Distinctive feature Longest half-life among common SSRIs

Overview and Clinical Recognition

Fluoxetine is classified as a Selective Serotonin Reuptake Inhibitor (SSRI). This means it works primarily by increasing the levels of the neurotransmitter serotonin in the brain, a chemical messenger crucial for regulating mood and emotional stability.

It is clinically recognized for its use in a broad range of psychiatric conditions, not limited to depression. Approved applications include Obsessive-Compulsive Disorder (OCD), Bulimia Nervosa, Panic Disorder, and Premenstrual Dysphoric Disorder (PMDD).

One of the drug's differentiating features is its unusually long elimination half-life. This means the active substance persists in the body for an extended period, which can be an advantage as it may help mitigate abrupt discontinuation effects if a patient occasionally misses a dose. Because fluoxetine is a prescription-only (Rx) medication, its use, suitability, and dosage must always be overseen by a qualified healthcare professional.

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What side effects are possible with Флуоксетин?

Possible Side Effects and Safety Information

The safety profile of Флуоксетин (Fluoxetine) is officially defined in government regulatory documents by categorizing all documented adverse effects and necessary safety restrictions. This section details the officially reported side effects, their frequency, serious risks, and specific population constraints, without providing usage or dosing instructions.


Documented Adverse Reactions and Frequencies

Adverse reactions are classified based on their frequency of occurrence as reported in regulatory documents (e.g., EMA/ICH standards):

Classification Examples of Officially Listed Side Effects
Very Common (Affects ge 1 in 10) Diarrhoea, Nausea, Insomnia, Headache, Fatigue (Asthenia).
Common (Affects ge 1 in 100) Anxiety, Nervousness, Decreased appetite, Tremor, Dizziness, Somnolence, Sexual dysfunction.
Rare (Affects ge 1 in 10,000) Serotonin syndrome, Convulsion, Ventricular arrhythmia (Torsades de pointes), Stevens-Johnson syndrome.

Serious Adverse Reactions and Safety Constraints

Regulatory agencies document rare but clinically significant risks and formal usage limitations:

  • Serious Adverse Reactions: Official labels highlight risks such as Suicidal thoughts and behaviour (particularly in children, adolescents, and young adults), Serotonin Syndrome, QT prolongation, and severe allergic reactions.
  • Contraindications: Use is formally restricted. Флуоксетин is Contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs) and certain anti-psychotic medications (e.g., Pimozide, Thioridazine) due to the risk of serious adverse consequences.

Population-Specific Safety Notes

Official documents include warnings for specific groups:

  • Pediatric and Young Adult Use: The label notes an increased risk of Suicidal thoughts and behaviour in this age group during initial treatment or dose changes.
  • Hepatic Impairment: Lower or less frequent dosing is required because the liver's reduced capacity affects the drug's elimination rate.
  • Geriatric Use: Older adults may be more susceptible to conditions like Hyponatremia (low sodium levels).
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Overdose and Emergency Response

Overdose and When to Seek Help

This information details the officially documented clinical manifestations of fluoxetine overdose and the required emergency actions as specified in government regulatory labeling.


Documented Overdose Manifestations

System Documented Signs/Symptoms (Regulatory Sources)
Central Nervous System (CNS) Somnolence, tremor, and seizures
Gastrointestinal Nausea and vomiting
Cardiovascular Tachycardia (rapid heart rate) and QT prolongation

In severe cases, or when other drugs are co-ingested, officially documented serious outcomes may include cardiac arrest, ventricular arrhythmia (including Torsades de Pointes), and death. Furthermore, regulatory documentation notes the risk of severe conditions such as Serotonin Syndrome and rhabdomyolysis in overdose contexts.


Required Emergency Action

Immediate medical attention is required for any suspected overdose. Regulatory labeling mandates that a physician or individual contact a Poison Control Center or emergency medical care immediately.

Antidote Status: Regulatory information states that no specific antidote is known for fluoxetine overdose.

Supportive Management: The primary management approach is symptomatic and supportive. Due to the medication's long half-life, extended observation and continuous cardiac monitoring in a hospital setting may be required. Officially described supportive procedures include managing the airway and considering activated charcoal, while gastric lavage is generally not recommended.

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Therapeutic Uses of Флуоксетин

What Флуоксетин Treats: Main Uses and Benefits

Fluoxetine is commonly used across conditions presenting with symptoms that may intensify temporarily in several key therapeutic domains. It provides supportive relief that helps ease the overall burden of symptoms associated with severe mood and anxiety patterns, and is often applied during phases when symptoms become more noticeable.

Alleviating Persistent Mood and Symptoms

Fluoxetine is relevant in clinical settings that involve Major Depressive Disorder (MDD), addressing the symptoms that interfere with daily functioning, such as profound sadness, severe fatigue, and the loss of interest (anhedonia). It may assist with maintaining a sense of emotional stability during symptomatic periods, helping patients cope more steadily with symptom fluctuations. Furthermore, it is commonly used to help manage the symptoms of Obsessive-Compulsive Disorder (OCD), Panic Disorder, Bulimia Nervosa, and Premenstrual Dysphoric Disorder (PMDD).


Quick Fact: Symptom Support
Therapeutic Scope Used for conditions characterized by symptoms of increased neurological or physiological activity.
Symptom Focus Helps address groups of symptoms that cluster into patterns requiring supportive management, such as intrusive thoughts and severe mood swings.
Patient Benefit Contributes to improved comfort and assists with maintaining functional stability during episodes of heightened discomfort.
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Eligibility and Restrictions for Use

Eligibility Scope

Category Official Regulatory Status
Populations for whom use is allowed Adults are approved for all monotherapy indications. Children are eligible for Major Depressive Disorder (MDD) from age 8 and Obsessive-Compulsive Disorder (OCD) from age 7.
Populations for whom use is contraindicated Use is strictly prohibited with psychiatric MAOIs, Pimozide, Thioridazine, Linezolid, or intravenous Methylene Blue. Contraindicated in patients with known hypersensitivity to the drug substance or excipients.

Condition-Specific Eligibility and Restrictions

Category Official Regulatory Status
Age-Related Rules Use is not established for MDD in children younger than 8 years. Lower or less frequent dosage may be required for the elderly (geriatric population).
Comorbidity Rules Use requires caution in patients with a history of seizures or risk factors for QT prolongation. Patients must be screened for Bipolar Disorder risk before starting treatment.
Organ Function/Reproductive Status A lower or less frequent dosage may be appropriate in patients with significant hepatic impairment. During pregnancy, use is conditional, permitted only if the potential benefit justifies the potential risks. Breastfeeding is not recommended.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Флуоксетин (Fluoxetine)'s official interaction profile is structured around distinct pharmacokinetic and pharmacodynamic constraints documented by regulatory authorities.

Regulatory Interaction Constraints

Classification Interacting Agents Official Regulatory Description
Contraindicated Combinations MAOIs, Pimozide, Thioridazine Prohibited due to the high risk of Serotonin Syndrome or elevated plasma levels leading to QTc prolongation.
Pharmacodynamic Risk Serotonergic Agents, NSAIDs, Warfarin Increased risk of Serotonin Syndrome when combined with other serotonergic agents; increased risk of abnormal bleeding with agents that interfere with hemostasis.

Fluoxetine is officially documented as a potent inhibitor of the CYP2D6 enzyme pathway. This pharmacokinetic effect reduces the metabolism and clearance of co-administered CYP2D6 substrates, such as certain Tricyclic Antidepressants and Antipsychotics, potentially leading to their elevated plasma concentrations.

Mandatory timing separation is required when switching between Fluoxetine and MAOIs: a 5-week washout period must elapse after discontinuing Fluoxetine before starting an MAOI. Conversely, a 14-day washout period is required after stopping an MAOI before initiating Fluoxetine. Additionally, caution is noted for use in patients with hepatic impairment, as this condition can result in increased drug exposure and associated interaction risk.

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Mechanism of Action

Флуоксетин, a bicyclic phenyl-alkyl-amine compound, acts primarily in the central nervous system by targeting the serotonin transporter (SERT, or SLC6A4). It functions as a selective inhibitor of SERT, blocking the reuptake of the neurotransmitter 5-hydroxytryptamine (5-HT), also known as serotonin, into the presynaptic neuron.

This blockade increases the extracellular concentration of 5-HT within the synaptic cleft, prolonging its residence time and thereby enhancing serotonergic neurotransmission. Subsequent intracellular cascades involve the modulation of receptor sensitivity, notably the downregulation of presynaptic 5-HT1A autoreceptors.

Chronic administration leads to more complex neuroadaptive changes, including the activation of the TrkB-CREB pathway and increased expression of brain-derived neurotrophic factor (BDNF). These downstream cellular consequences modulate neuroplasticity, dendritic branching, and synaptogenesis in brain regions such as the hippocampus and prefrontal cortex, resulting in a system-level physiological change in monoamine signaling and neuronal connectivity.

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Dosage and Administration Information

Флуоксетин is administered solely by the oral route, available as immediate-release capsules or tablets, a liquid solution, and a 90 mg delayed-release capsule for weekly maintenance dosing. For most conditions, the standard regimen involves taking the medicine once daily, typically in the morning, which may be done with or without food.

The dosing schedule is highly specific to the condition. Treatment typically starts at a low dose, such as 20 mg for Major Depressive Disorder or 10 mg for Panic Disorder, and the dose is gradually titrated over several weeks to reach a defined maintenance range. Dosage adjustments must be made slowly, as the full effect of the medicine may require four weeks or longer of continuous use. When taken for maintenance, the 90 mg delayed-release capsule is taken once weekly.

Established Administration Patterns

Regimen Component Instruction
Route Oral (capsules, tablets, solution)
Standard Frequency Once daily, usually in the morning.
PMDD Use Approved for both continuous and cyclic administration.
Preparation Oral solution must be measured with a marked device; delayed-release capsules must be swallowed whole.
Adjustments Lower or less frequent dosing is necessary for older adults and patients with hepatic impairment.

The administration protocol requires the dose to be adjusted based on clinical guidance to maintain the lowest effective amount, with continuation treatment often required for several months.

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Recent Clinical Evidence

Recent Clinical Evidence for Fluoxetine

Clinical research continues to affirm the role of fluoxetine (a selective serotonin reuptake inhibitor or SSRI) in treating a range of psychiatric conditions, while also exploring new applications and its mechanism of action.

Core Indications

Fluoxetine remains an established treatment for conditions including Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Bulimia Nervosa, and Panic Disorder. Efficacy is well-documented in adults for these approved uses. In adolescents and children (aged 8 and older, depending on the indication), fluoxetine is one of the few antidepressants with consistent evidence of short-term efficacy for moderate-to-severe MDD and OCD, although the balance of risks, particularly the rare risk of increased suicidal thoughts and behaviors in those under 25, necessitates careful monitoring.

Specific Patient Groups and Formulations

  • Bulimia Nervosa: Clinical evidence supports fluoxetine, typically at a dose higher than that used for depression, to reduce binge eating and purging behaviors.
  • Pediatric Use: While fluoxetine shows benefit in youth depression and OCD, ongoing research highlights the need for continued investigation into its long-term effects on the developing brain.
  • Once-Weekly Dosing: The development of a 90 mg delayed-release, once-weekly formulation offers a convenient alternative for some patients in the maintenance phase of treatment for MDD, OCD, and Panic Disorder, potentially improving long-term adherence.

Emerging Research

Recent scientific studies suggest fluoxetine's effects may extend beyond its primary action on serotonin. Researchers are exploring its potential to enhance neural plasticity—the brain's ability to adapt and rewire its circuits—which may contribute to its long-term therapeutic benefits. Furthermore, new clinical trials are investigating fluoxetine's potential use in a variety of other conditions, including certain neurological disorders and even in the management of complications related to viral infections, based on its molecular actions.

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Frequently Asked Questions (FAQ)

Common questions about Флуоксетин (FAQ)

Q: Does it make you sleepy?

A: Official product information indicates that dizziness, lightheadedness, vertigo, weakness, and restlessness are reported adverse effects. Since these effects can impact your level of alertness and concentration, caution is advised. These effects are reported in official labeling and may vary between individuals.

Q: Is it safe long-term?

A: Official drug safety updates have reported an increased, dose-dependent risk of non-melanoma skin cancer with cumulative long-term use of this medication. The safety information notes that limiting UV exposure (sunlight and sunbeds) and regularly checking the skin for any new or changing lesions are important considerations associated with this warning.

Q: Can children 2 years old use it?

A: Official product labeling contains specific dosage recommendations and indications for use in the pediatric population, including children 2 to 12 years of age. Eligibility for use depends on the specific condition and formulation. Always follow the indications approved for the specific product.

Q: Does it have a warning about alcohol?

A: According to the official product information, using this medication with alcohol may increase the risk of orthostatic hypotension. This is a sudden drop in blood pressure when standing up, which can cause symptoms like dizziness or fainting.

Q: What are the storage instructions for this medicine?

A: The official labeling provides specific storage conditions to maintain the medicine's quality. These instructions typically include requirements to store the product below a specific temperature limit and to protect it from exposure to moisture or light.

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How should Флуоксетин be stored and disposed of?

How to Store and Dispose of Fluoxetine

The storage and disposal of fluoxetine must strictly follow the conditions detailed in government-approved regulatory labeling to maintain the product's stability.

Storage Requirements

Fluoxetine products must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C. Official instructions require the medication to be protected from light and stored in a tight, light-resistant container that is kept tightly closed.

Child Safety and Disposal

It is a mandatory regulatory requirement that fluoxetine, like all medicines, be kept out of the sight and reach of children.

For disposal, unused or expired fluoxetine must be managed according to local regulations. The regulatory guidance explicitly states that the product should not be disposed of via household waste or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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