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Fluoxetine (trade names include Prozac, Sarafem, Flunil, Prozac Weekly, Fluoxetina Sandoz, Pragmaten, Adofen, Apo-Fluoxetine, Deprex, Floxet, Fludac, Fluoxeren, Fluoxetin Neuraxpharm, Fluoxetine Biogaran, Fluxet, Fluxil, Lovan, Motivest, Mylan-Fluoxetine, Oxactin, Prozac Dispersable, Fluoxetine Actavis, Salipax, Sandoz Fluoxetine, Seromex, Seronil, Teva-Fluoxetine) is an antidepressant medication from selective serotonin reuptake inhibitors (SSRI) pharmacological group. This medicine is used for the treatment of major depressive disorder, depressive disorder in adults, adolescents and children 8 years of age and over; obsessive–compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), bulimia nervosa (an eating disorder), trichotillomania, premature ejaculation, cataplexy, obesity, alcohol dependence, binge eating disorder, adult autism. Prozac and Sarafem are also indicated to treat premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS). Fluoxetine Hydrochloride is one of the world's most widely prescribed antidepressants. This medicine helps patients with depression and anxiety by increasing the availability of serotonin in the brain.
Related medications:
Alaproclate (Alaproclate)
Amitriptyline (Elavil, Endep)
Aripiprazole (Abilify)
Citalopram (Celexa)
Doxepin (Sinequan)
Duloxetine (Cymbalta)
Escitalopram (Lexapro)
Etoperidone (Depraser)
Fluvoxamine (Faverin)
Gabapentin (Neurontin)
Imipramine (Tofranil)
Mirtazapine (Remeron)
Nortriptyline (Pamelor)
Paroxetine (Paxil)
Quetiapine (Seroquel)
Sertraline (Zoloft)
Trazodone (Desyrel)
Venlafaxine (Effexor)
Zimeldine (Normud)
Pharmacological and medical categories:
Antidepressants
Anti-anxiety medications
Selective serotonin reuptake inhibitors (SSRI)
ATC codes:
N - Nervous system
N06 - Psychoanaleptics
N06A - Antidepressants
N06AB - Selective serotonin reuptake inhibitors
N06AB03 - Fluoxetine
ICD-10 codes:
Overweight and obesity - E66
Alcohol related disorders - F10
Alcohol dependence - F10.2
Mood [affective] disorders - F30-F39
Bipolar affective disorder - F31
Major depressive disorder, single episode - F32
Premenstrual dysphoric disorder - F32.81
Major depressive disorder, recurrent - F33
Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders - F40-F48
Other anxiety disorders - F41
Panic disorder [episodic paroxysmal anxiety] - F41.0
Obsessive-compulsive disorder - F42
Reaction to severe stress, and adjustment disorders - F43
Post-traumatic stress disorder (PTSD) - F43.1
Eating disorders - F50
Bulimia nervosa - F50.2
Binge eating disorder - F50.81
Sexual dysfunction not due to a substance or known physiological condition - F52
Premature ejaculation - F52.4
Impulse disorders - F63
Trichotillomania - F63.3
Pervasive developmental disorders - F84
Autistic disorder - F84.0
Sleep disorders - G47
Narcolepsy and cataplexy - G47.4
Pain and other conditions associated with female genital organs and menstrual cycle - N94
Indications and usage:
Prozac (Fluoxetine Hydrochloride) is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of major depressive disorder (MDD).
Acute and maintenance treatment of obsessive compulsive disorder (OCD).
Acute and maintenance treatment of bulimia nervosa.
Acute treatment of panic disorder, with or without agoraphobia.
Prozac and olanzapine in combination for treatment of:
Acute depressive episodes associated with bipolar I disorder.
Treatment resistant depression.
Dosage and administration:
Take Prozac exactly as prescribed. Your healthcare provider may need to change the dose of this medication until it is the right dose for you.
Fluoxetine capsules may be taken with or without food.
If you miss a dose of Prozac, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine at the same time.
If you take too much of this drug, call your healthcare provider or poison control center right away, or get emergency treatment.
A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications.
Dosage forms and strengths:
Prozac (Fluoxetine Hydrochloride) capsules or pulvules: 10 mg, 20 mg, 40 mg, 60 mg.
Sarafem (Fluoxetine Hydrochloride) tablets: 10 mg, 15 mg, 20 mg.
Overdosage:
For current information on the management of Prozac overdose, contact your local certified poison control center. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multi-drug overdose.
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use general supportive and symptomatic measures. Induction of emesis is not recommended.
Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for fluoxetine are known.
A specific caution involves patients who are taking or have recently taken fluoxetine and might ingest excessive quantities of a TCA. In such a case, accumulation of the parent tricyclic and/or an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation.
Contraindications:
Serotonin Syndrome and MAOIs: do not use MAOIs intended to treat psychiatric disorders with Prozac or within 5 weeks of stopping treatment with Fluoxetine. Do not use this medicines within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Prozac in a patient who is being treated with linezolid or intravenous methylene blue.
Pimozide: do not use. Risk of QT prolongation and drug interaction.
Thioridazine: do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing Fluoxetine HCl. Do not use thioridazine within 5 weeks of discontinuing Prozac.
Warnings and precautions:
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: monitor for clinical worsening and suicidal thinking and behavior.
Serotonin Syndrome: serotonin syndrome has been reported with SSRIs and SNRIs, including Prozac, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such symptoms occur, discontinue Prozac and initiate supportive treatment. If concomitant use of Fluoxetine capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Allergic Reactions and Rash: discontinue upon appearance of rash or allergic phenomena.
Activation of Mania/Hypomania: screen for bipolar disorder and monitor for mania/hypomania.
Seizures: use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
Altered Appetite and Weight: significant weight loss has occurred.
Abnormal Bleeding: may increase the risk of bleeding. Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding.
Angle-Closure Glaucoma: angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
Hyponatremia: has been reported with Prozac in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing if symptomatic hyponatremia occurs.
Anxiety and Insomnia: may occur.
QT Prolongation: QT prolongation and ventricular arrhythmia including Torsades de Pointes have been reported with Prozac use. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patientswith risk factors for QT prolongation.
Potential for Cognitive and Motor Impairment: has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery.
Long Half-Life: changes in dose will not be fullyreflected in plasma for several weeks.
Side effects, adverse reactions:
Most common adverse reactions ( >= 5% and at least twice that for placebo) associated with major depressive disorder, obsessive compulsive disorder, bulimia, and panic disorder: 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.
To report suspected adverse reactions, contact Eli Lilly pharmaceutical company or your local FDA.
Drug interactions:
Monoamine Oxidase Inhibitors (MAOIs).
Drugs Metabolized by CYP2D6: fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway.
Tricyclic Antidepressants (TCAs): monitor TCA levels during coadministration with Prozac or when Fluoxetine HCl has been recently discontinued.
CNS Acting Drugs: caution should be used when taken in combination with other centrally acting drugs.
Benzodiazepines: diazepam - increased T1/2, alprazolam - further psychomotor performance decrement due to increased levels.
Antipsychotics: potential for elevation of haloperidol and clozapine levels.
Anticonvulsants: potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity.
Serotonergic drugs.
Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin, Warfarin): may potentiate the risk of bleeding.
Drugs Tightly Bound to Plasma Proteins: may cause a shift in plasma concentrations.
Olanzapine: when used in combination with Prozac, also refer to the Drug Interactions section of the package insert for Symbyax.
Drugs that Prolong the QT Interval: do not use Prozac with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval.
Use in specific populations:
Pregnancy
SSRI use, particularlylater in pregnancy, may increase risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate.
Pediatric Use
Safety and effectiveness of Prozac pills in patients < 8 years of age with Major Depressive Disorder and < 7 years of age with OCD have not been established. Safety and effectiveness of Prozac and olanzapine in combination in patients < 10 years of age for depressive episodes associated with Bipolar I Disorder have not been established.
Hepatic impairment
Lower or less frequent dosing may be appropriate in patients with cirrhosis.
Pregnancy categories:
C - Australia
C - United States (Risk cannot be ruled out)
Salts and other forms:
Fluoxetine Base
Fluoxetine Hydrochloride
Synonyms, international and chemical names:
3-(p-Trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine
Benzenepropamine, N-methyl-gamma-(4-(trifluoromethyl)phenoxy)-
Clorhidrato de Fluoxetina
DL-3-(P-Trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine
Fluoksetiini
Fluoksetin
Fluoksetino
Fluoksetyna
Fluoxetene
Fluoxetin
Fluoxetina
Fluoxetine HCl
Fluoxetinum
Methyl-[3-phenyl-3-(4-trifluoromethyl-phenoxy)-propyl]-amine
N-Methyl-3-(p-trifluoromethylphenoxy)-3-phenylpropylamine
Brands, generics, trade names:
Actan - Saval Laboratorios, Eurolab
Adofen - Ferrer Farma
Alental - Soubeiran Chobet
Andepin - Synteza Przedsiebiorstwo Farmaceutyczno-Chemiczne
Anisimol - Medipharm
Anoxen - Roemmers Laboratorios
Antiprestin - Pharos Indonesia
Apo-Fluoxetine - Apotex, Pharmaforte
Auscap - Sigma Pharmaceuticals
CO Fluoxetine - Dr. Reddy's Laboratories
Dawnex - Micro Labs
Deprex - Zentiva
Deprozan - Meridian Pharma
Digassim - Vitoria Laboratorios
Farmaxetina - Investigacion Farmaceutica
Floxet - Egis, Mekim
Fluctine - Eli Lilly, Alpharma Laboratorios
Fludac - Cadila Pharmaceuticals
Flunil - Intas Pharmaceuticals
Fluocim - Cimex Pharmazeutika, Siegfried CMS, Teva
Flutinol - Sun Pharmaceutical Industries
Fluox - AbZ-Pharma, Basics, Pacific Pharmaceuticals
Fluoxac - Psicofarma Laboratorio
Fluoxeren - Menarini
Fluoxetin - Actavis, Azupharma, Betapharm Arzneimittel, CT-Arzneimittel, Helvepharm, Mepha, Neuraxpharm Arzneimittel, Ratiopharm, Sandoz, Stada, TAD Pharma, Teva
Fluoxetina - Chile Laboratorios, Sandoz, Sanitas Laboratorio Chimico Farmaceutico
Fluoxetine - Actavis, Alphapharm, Alpharma, Arrow Generiques, Biogaran, Dr. Reddy's Laboratories, Eon Labs, Genpharm, Hexal, IVAX, Mallinckrodt, Merck, Mutual Pharmaceuticals, Mylan, Pliva, Pro Doc, Ranbaxy, Ratiopharm, Recordati, Sandoz, Sanofi-Aventis, Teva, Wockhardt
Flutin - Gulf Pharmaceutical Industries, Julphar, East West Pharma, Orion Pharma
Flutine - Teva
Fluxene - Eurofarma Laboratorios
Fluxet - Krewel Meuselbach
Fluxil - Aegis
Foxetin - Gador, The Government Pharmaceutical Organization
Hapilux - Novartis, Sandoz
Indozul - Degort's Chemical
Ladose - Eli Lilly
Lovan - Alphapharm, Eli Lilly
Magrilan - Medochemie, Derek Marketing, Medline, Thailand, Star Medical Supplies
Motivest - Medichem Pharmaceuticals, United Laboratories
Mylan-Fluoxetine - Mylan
Nuzak - Cipla
Nycoflox - Nycomed
Oxactin - Discovery Pharmaceuticals
Pragmaten - Sanofi-Aventis
Prosac - Eli Lilly
Prozac - Eli Lilly
Prozac Dispersable - Eli Lilly
Prozac Weekly - Eli Lilly
Prozamel - Clonmel Healthcare
Psiquial - Merck
Salipax - Mepha, Mepharm Malaysia
Sandoz Fluoxetine - Sandoz
Sarafem - Eli Lilly, Warner Chilcott
Seromex - Ratiopharm
Seronil - Sandoz, Orion Pharma
Stressless - Faran Laboratories
Teva-Fluoxetine - Teva
Tuneluz - Baldacci Farmoquimica
Verotina - Libbs Farmaceutica
Xeredien - Valeas
Zactin - Alphapharm, Merck, Serono, Zuellig Pharma
APIs used in medicine in combinations with fluoxetine:
Alprazolam
Olanzapine
Here is a list of popular medications containing fluoxetine as a main active pharmaceutical ingredient; their trade names, forms, doses, companies - manufacturers, distributors, suppliers, researchers and developers:
Trade name of the drug |
Pharmaceutical forms and doses |
Companies |
Fluoxetine |
Capsules; Oral; Fluoxetine Hydrochloride 10 mgCapsules; Oral; Fluoxetine Hydrochloride 20 mgCapsules; Oral; Fluoxetine Hydrochloride 40 mgTablets, Dispersible; Oral; Fluoxetine Hydrochloride 20 mg |
Mylan |
Flutine |
Capsules; Oral; Fluoxetine Hydrochloride 20 mgSyrup; Oral; Fluoxetine Hydrochloride 20 mg / 5 ml |
TevaCentral Poly TradingPharmasant LaboratoriesReliance |
Prozac |
Capsules; Oral; Fluoxetine Hydrochloride 10 mgCapsules; Oral; Fluoxetine Hydrochloride 20 mgCapsules; Oral; Fluoxetine Hydrochloride 40 mgCapsules; Oral; Fluoxetine Hydrochloride 60 mgCapsules; Oral; Fluoxetine Hydrochloride 90 mgSolution; Oral; Fluoxetine Hydrochloride 20 mg / 5 mlTablets, Dispersible; Oral; Fluoxetine Hydrochloride 20 mgTablets, Soluble; Oral; Fluoxetine Hydrochloride 20 mgTablets; Oral; Fluoxetine Hydrochloride 10 mgTablets; Oral; Fluoxetine Hydrochloride 20 mg |
Eli LillyAktuapharmaDiethelmDistaDKSHFour StarOlympo PharmaPatheonY.C. WooZuellig Pharma |
Sarafem |
Capsules; Oral; Fluoxetine Hydrochloride 10 mgCapsules; Oral; Fluoxetine Hydrochloride 20 mgTablets; Oral; Fluoxetine Hydrochloride 10 mgTablets; Oral; Fluoxetine Hydrochloride 15 mgTablets; Oral; Fluoxetine Hydrochloride 20 mg |
Eli LillyWarner Chilcott |
References:
Fluoxetine main article on Wikipedia: https://en.wikipedia.org/wiki/Fluoxetine
Fluoxetine compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Fluoxetine
Fluoxetine Hydrochloride compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Fluoxetine-hydrochloride
Fluoxetine medicine on DrugBank: https://go.drugbank.com/drugs/DB00472
Fluoxetine Hydrochloride on DrugBank: https://go.drugbank.com/salts/DBSALT000087
Fluoxetine FAQ on MedlinePlus (revised 03/15/2020): https://medlineplus.gov/druginfo/meds/a689006.html
Prozac (Fluoxetine Hydrochloride) capsules drug label on DailyMed (revised October 27, 2009): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Sarafem (Fluoxetine Hydrochloride) tablets drug label on DailyMed (revised January 1, 2017): https://dailymed.nlm.nih.gov/dailymed/lookup...
Fluoxetine Hydrochloride capsules drug label on DailyMed (revised February 4, 2019): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Fluoxetine containing drugs on Drugs-About.com: https://drugs-about.com/ing/fluoxetine.html
Fluoxetine for sale on Pharma Doctor: https://pharma-doctor.com/fluoxetine.html
Prozac (Fluoxetine Hydrochloride) capsules and delayed-release capsules for oral use official prescribing information and medication guide from the U.S. FDA (revised 01/2017): https://www.accessdata.fda.gov/drugsatfda_docs/label/...
Sarafem (Fluoxetine Hydrochloride) tablets for oral use official prescribing information and medication guide from the U.S. FDA (revised 01/2017): https://www.accessdata.fda.gov/drugsatfda_docs/label/...
Prozac (Fluoxetine Hydrochloride) capsules for oral use official prescribing information from Eli Lilly pharmaceutical company (revised 04/2020): https://pi.lilly.com/us/prozac.pdf
Prozac (Fluoxetine Hydrochloride) capsules for oral use official medication guide from Eli Lilly pharmaceutical company (revised April 2020): http://pi.lilly.com/us/Prozac-Medguide.pdf
Fluoxetine Accord Healthcare 20 mg capsules patient information leaflet from Medicines.org.uk (revised 12/2020): https://www.medicines.org.uk/emc/files/pil.6013.pdf
Revised: April 2021
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