Fluoxetine: Restore Balance with Proven SSRI Efficacy
Fluoxetine
| Product dosage: 10mg | |||
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| Product dosage: 20mg | |||
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Synonyms
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Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the management of major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, bulimia nervosa, and premenstrual dysphoric disorder (PMDD). As a cornerstone of modern psychopharmacology, it functions by increasing synaptic serotonin levels, thereby ameliorating symptoms associated with serotonergic pathway dysregulation. Its well-established efficacy, favorable side-effect profile relative to older antidepressants, and extensive clinical history make it a first-line agent in numerous treatment guidelines. This product card provides a comprehensive, evidence-based overview for healthcare professionals.
Features
- Active ingredient: Fluoxetine hydrochloride
- Available formulations: Capsules (10 mg, 20 mg, 40 mg), delayed-release capsules (90 mg), oral solution (20 mg/5 mL)
- Pharmacologic class: Selective serotonin reuptake inhibitor (SSRI)
- Half-life: 2-3 days for fluoxetine; 7-9 days for its active metabolite, norfluoxetine
- Bioavailability: Approximately 72% following oral administration
- Metabolism: Hepatic, primarily via CYP2D6 and CYP2C9 isoenzymes
- Excretion: Primarily renal (80%) with some fecal elimination
Benefits
- Effective reduction of core depressive symptoms, including low mood, anhedonia, and psychomotor retardation
- Decreased frequency and intensity of obsessive thoughts and compulsive behaviors in OCD
- Reduction in the frequency of panic attacks and associated anticipatory anxiety
- Helps regulate eating patterns and reduces binge-purge cycles in bulimia nervosa
- Alleviates mood lability, irritability, and physical symptoms in PMDD
- Lower risk of anticholinergic effects and cardiotoxicity compared to tricyclic antidepressants
Common use
Fluoxetine is FDA-approved for the treatment of major depressive disorder in adults and pediatric patients aged 8 years and older. It is also indicated for obsessive-compulsive disorder (adults and children aged 7+), panic disorder with or without agoraphobia (adults), bulimia nervosa (adults), and premenstrual dysphoric disorder (adults). Off-label uses may include treatment of generalized anxiety disorder, post-traumatic stress disorder, social anxiety disorder, and certain chronic pain syndromes, though these applications should be guided by clinical evidence and professional judgment.
Dosage and direction
Dosage must be individualized based on diagnosis, patient response, and tolerability. For major depressive disorder, OCD, and panic disorder in adults: Initiate at 20 mg once daily in the morning. May be increased after several weeks if inadequate response. Maximum recommended dose is 80 mg/day. For bulimia nervosa: 60 mg/day, which may be administered as a single dose or divided doses. For PMDD: 20 mg/day continuously or during the luteal phase only. Pediatric dosing for MDD (ages 8-18): Initiate at 10-20 mg/day. For OCD (ages 7-17): Initiate at 10 mg/day; may increase to 20 mg/day after two weeks. Administer with or without food. The delayed-release formulation (90 mg) is typically administered once weekly, initiated after stabilization on daily dosing.
Precautions
Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior, particularly during initial treatment and dose adjustments. Use with caution in patients with hepatic impairment; consider lower or less frequent dosing. May increase risk of bleeding; use caution in patients taking anticoagulants or with underlying bleeding disorders. May alter glycemic control in patients with diabetes. Discontinuation syndrome may occur upon abrupt cessation; taper gradually. May cause activation or insomnia; consider morning administration. Use caution in elderly patients due to potential for hyponatremia and falls.
Contraindications
Hypersensitivity to fluoxetine or any component of the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy due to risk of serotonin syndrome. Concomitant use with pimozide or thioridazine due to risk of QT prolongation. Use of linezolid or intravenous methylene blue in patients taking fluoxetine is contraindicated due to MAOI properties of these agents.
Possible side effect
Common (>10%): Headache, insomnia, nausea, diarrhea, dry mouth, asthenia, sweating. Less common (1-10%): Anxiety, nervousness, drowsiness, tremor, anorexia, dyspepsia, rash, pharyngitis, sexual dysfunction (decreased libido, anorgasmia, erectile dysfunction). Rare (<1%): Serotonin syndrome, hyponatremia (especially in elderly), seizures, abnormal bleeding, angle-closure glaucoma, manic episodes, akathisia, syndrome of inappropriate antidiuretic hormone secretion (SIADH). Allergic reactions including angioedema may occur.
Drug interaction
MAOIs: Risk of serotonin syndrome (contraindicated). Serotonergic drugs (tramadol, triptans, other SSRIs/SNRIs): Increased serotonergic effects. Drugs metabolized by CYP2D6 (tricyclic antidepressants, antipsychotics, beta-blockers, codeine): Fluoxetine may increase their concentrations. Drugs that prolong QT interval: Additive effects possible. NSAIDs, aspirin, warfarin: Increased bleeding risk. Lithium, tryptophan: May enhance serotonergic effects. Diazepam: Increased half-life. Highly protein-bound drugs: Potential displacement interactions.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is close to the time of the next dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one. For the once-weekly formulation: If a dose is missed, take it as soon as remembered, then resume the regular weekly schedule. Do not take more than one capsule within 7 days.
Overdose
Symptoms may include nausea, vomiting, agitation, restlessness, hypomania, seizures, and drowsiness. Cardiac manifestations may include tachycardia and ECG changes. Fatalities have been reported with mixed overdoses, particularly with concomitant alcohol or other drugs. There is no specific antidote. Provide supportive care with monitoring of vital signs and cardiac rhythm. Gastric lavage may be considered if presented early. Activated charcoal may be administered. Forced diuresis, dialysis, and hemoperfusion are not likely to be beneficial due to high protein binding and large volume of distribution.
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed. Protect from light and moisture. Keep out of reach of children and pets. Do not use after expiration date printed on packaging. Oral solution should be stored in original container; do not freeze.
Disclaimer
This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something contained in this document. The prescribing physician should be thoroughly familiar with the full prescribing information before initiating therapy.
Reviews
“Fluoxetine remains a foundational agent in my practice for moderate to severe MDD. Its long half-life is particularly advantageous for patients with adherence challenges, though requires careful management during switching or discontinuation.” - Psychiatrist, 15 years experience
“In pediatric OCD, fluoxetine has demonstrated consistent efficacy in clinical trials. I appreciate the availability of liquid formulation for precise dosing in younger patients.” - Child Psychiatrist
“The delayed-release weekly formulation has improved quality of life for many of my stable patients by reducing pill burden and minimizing minor side effects associated with daily dosing.” - Primary Care Physician
“While generally well-tolerated, I monitor for activation symptoms carefully in the first two weeks, particularly in anxious patients. Starting low and going slow remains key.” - Psychiatric Nurse Practitioner
“After twenty years of use, fluoxetine continues to be a workhorse in my geriatric practice, though I maintain heightened vigilance for hyponatremia and falls in this population.” - Geriatric Psychiatrist