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    Chemistry

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    Also known as: 56296-78-7, Fluoxetine hcl, Prozac, 59333-67-4, Sarafem, Fluoxeren
    Molecular Formula
    C17H19ClF3NO
    Molecular Weight
    345.8  g/mol
    InChI Key
    GIYXAJPCNFJEHY-UHFFFAOYSA-N
    FDA UNII
    I9W7N6B1KJ
    Fluoxetine Hydrochloride
    The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.
    1 2D Structure

    Fluoxetine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine;hydrochloride
    2.1.2 InChI
    InChI=1S/C17H18F3NO.ClH/c1-21-12-11-16(13-5-3-2-4-6-13)22-15-9-7-14(8-10-15)17(18,19)20;/h2-10,16,21H,11-12H2,1H3;1H
    2.1.3 InChI Key
    GIYXAJPCNFJEHY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CNCCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    I9W7N6B1KJ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Fluoxetin

    2. Fluoxetine

    3. Lilly 110140

    4. Lilly-110140

    5. Lilly110140

    6. N-methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine

    7. Prozac

    8. Sarafem

    2.3.2 Depositor-Supplied Synonyms

    1. 56296-78-7

    2. Fluoxetine Hcl

    3. Prozac

    4. 59333-67-4

    5. Sarafem

    6. Fluoxeren

    7. Adofen

    8. Fluctin

    9. Lovan

    10. Foxetin

    11. Fontex

    12. Fluox-puren

    13. Fluoxetine (hydrochloride)

    14. Fluneurin

    15. Reconcile

    16. Fluoxetine.hcl

    17. Fluctine

    18. Fluoxac

    19. Fludac

    20. Fluxil

    21. Ly-110140

    22. Fluxet

    23. Ly110140

    24. Ly 110140

    25. Mfcd00214288

    26. Selfemra

    27. I9w7n6b1kj

    28. Hsdb 6633

    29. Fluoxetine (as Hydrochloride)

    30. Mls000069361

    31. Ly-110140 (free Base)

    32. Chembl1201082

    33. Methyl({3-phenyl-3-[4-(trifluoromethyl)phenoxy]propyl})amine Hydrochloride

    34. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine Hydrochloride

    35. Affectine

    36. Deproxin

    37. Digassim

    38. Flufran

    39. Flunirin

    40. Fluoxil

    41. Flutine

    42. Margrilan

    43. Modipran

    44. Pragmaten

    45. Proctin

    46. Rowexetina

    47. Smr000058452

    48. Erocap

    49. Flunil

    50. Flutin

    51. Fluxen

    52. Lorien

    53. Neupax

    54. Nopres

    55. Oxedep

    56. Prizma

    57. Prodep

    58. Sanzur

    59. Sinzac

    60. Zactin

    61. Nuzak

    62. Zepax

    63. Lilly 110140

    64. Prozac 20

    65. Fluoxetine Hydrochloride 100 Microg/ml In Acetonitrile

    66. Alzac 20

    67. Profluzac

    68. Prozac Weekly

    69. N-methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propan-1-amine Hydrochloride

    70. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]-1-propylamine Hydrochloride

    71. N-methyl-3-[(4-trifluoromethyl)phenoxy]-3-phenylpropylamine Hydrochloride

    72. Ccris 6150

    73. Fluoxetinehydrochloride

    74. Fluoxetine Hydrochloride [usan]

    75. Sr-01000002988

    76. Einecs 260-101-2

    77. Lilly110140

    78. Unii-i9w7n6b1kj

    79. C17h18f3no.hcl

    80. Framex

    81. Ly-110,140 Hydrochloride

    82. Fluoxetin Hcl

    83. Fluoxetine Hcl

    84. Fluoxetine, Hcl

    85. Prozac(r)

    86. Prestwick_798

    87. Sarafem (tn)

    88. Fluoxetine Hydrochloride [usan:usp]

    89. Prozac (tn)

    90. Cpd000058452

    91. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine;hydrochloride

    92. Dsstox_cid_635

    93. Opera_id_1538

    94. 3-(p-trifluoromethylphenoxy)-n-methyl-3-phenylpropylamine Hydrochloride

    95. (+-)-methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine Hydrochloride

    96. (+-)-n-methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propylamine Hydrochloride

    97. (+/-)-n-methyl-&gamma

    98. Dsstox_rid_75706

    99. Dsstox_gsid_20635

    100. Schembl33384

    101. Mls001076338

    102. Mls002222264

    103. Spectrum1504173

    104. Fluoxetine Hydrochloride, Solid

    105. Dtxsid7020635

    106. Hy-b0102a

    107. Chebi:145458

    108. Hms1569h03

    109. Hms1922f07

    110. Pharmakon1600-01504173

    111. Bcp19962

    112. Npl-2008

    113. Fluoxetine Hydrochloride (jan/usp)

    114. Tox21_200182

    115. Tox21_500558

    116. Ccg-39084

    117. Fluoxetine Hydrochloride [mi]

    118. Methyl(3-phenyl-3-(4-(trifluoromethyl)phenoxy)propyl)ammonium Chloride

    119. Nsc714457

    120. Nsc758685

    121. Prozac; Ly-110,140 Hydrochloride

    122. S1333

    123. Fluoxetine Hydrochloride [jan]

    124. Akos015894939

    125. Propylamine, N-methyl-3-phenyl-3-(p-trifluoromethylphenoxy)-, Hydrochloride

    126. Ab04860

    127. Ac-1697

    128. Cs-1838

    129. Fluoxetine Hydrochloride [hsdb]

    130. Ks-1061

    131. Lp00558

    132. Nc00715

    133. Nsc-714457

    134. Benzenepropanamine, N-methyl-gamma-(4-(trifluoromethyl)phenoxy)-, Hydrochloride

    135. Fluoxetine Hydrochloride [vandf]

    136. N-methyl-3-phenyl-3-{[4-(trifluoromethyl)phenyl]oxy}propan-1-amine Hydrochloride

    137. Fluoxetine Hydrochloride [usp-rs]

    138. Fluoxetine Hydrochloride [who-dd]

    139. Ncgc00093943-01

    140. Ncgc00093943-02

    141. Ncgc00093943-03

    142. Ncgc00093943-04

    143. Ncgc00093943-05

    144. Ncgc00257736-01

    145. Ncgc00261243-01

    146. Bf163653

    147. Sy035644

    148. Cas-56296-78-7

    149. Eu-0100558

    150. F-132

    151. F0750

    152. Fluoxetine Hydrochloride [green Book]

    153. Ft-0626490

    154. Ft-0652216

    155. Ft-0668749

    156. Ft-0668750

    157. Ft-0668751

    158. Sw196934-4

    159. Fluoxetine Hydrochloride [orange Book]

    160. D00823

    161. Fluoxetine Hydrochloride [ep Monograph]

    162. Fluoxetine Hydrochloride [usp Impurity]

    163. Fluoxetine Hydrochloride [usp Monograph]

    164. Symbyax Component Fluoxetine Hydrochloride

    165. 910f893

    166. A830990

    167. Fluoxetine Hydrochloride 100 Microg/ml In Methanol

    168. Fluoxetine Hydrochloride Component Of Symbyax

    169. J-521372

    170. Sr-01000002988-2

    171. Sr-01000002988-4

    172. Sr-01000002988-9

    173. Q27280620

    174. Z1741982921

    175. Fluoxetine Hydrochloride, Vetranal(tm), Analytical Standard

    176. Fluoxetine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    177. Fluoxetine Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    178. Fluoxetine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    179. Methyl-[(3r)-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propyl]ammonium

    180. Methyl-[3-phenyl-3-(4-trifluoromethyl-phenoxy)-propyl]-amine Hydrochloride

    181. N-methyl-3-phenyl-3-(p-trifluoromethylphenoxy)-propylaminhydrochloride

    182. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propylamine Hydrochloride

    183. Fluoxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    184. Fluoxetine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    185. N-methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propan-1-amine Hydrochloride1

    186. N-methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propan-1-aminehydrochloride1

    187. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]-1-propanamine Hydrochloride (1:1)

    188. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine;hydrochloride.

    189. (+/-)-n-methyl-3-phenyl-3-((.alpha.,.alpha.,.alpha.-trifluoro-p-tolyl)oxy)propylamine, Hydrochloride

    190. Benzenepropanamine, N-methyl-.gamma.-(4-(trifluoromethyl)phenoxy)-, Hydrochloride (1:1)

    191. Benzenepropanamine, N-methyl-.gamma.-(4-(trifluoromethyl)phenoxy)-, Hydrochloride, (+/-)-

    192. Fluoxetine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 345.8 g/mol
    Molecular Formula C17H19ClF3NO
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass345.1107264 g/mol
    Monoisotopic Mass345.1107264 g/mol
    Topological Polar Surface Area21.3 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity308
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameFluoxetine hydrochloride
    Active IngredientFluoxetine hydrochloride
    Dosage FormTablet; Capsule; Capsule, delayed rel pellets; Solution
    RouteOral
    Strengtheq 20mg base; eq 40mg base; eq 90mg base; eq 20mg base/5ml; eq 10mg base; eq 60mg base
    Market StatusPrescription
    CompanyRanbaxy; Mylan Pharms; Wockhardt; Silarx; Ani Pharms; Edgemont Pharms; Teva; Pharm Assoc; Alembic Pharms; Aurobindo Pharma; Teva Pharms Usa; Mallinckrodt; Sandoz; Par Pharm; Ivax Sub Teva Pharms; Lannett; Aurobindo Pharm; Landela Pharm; Dr Reddys Labs; My

    2 of 8  
    Drug NameProzac
    PubMed HealthFluoxetine (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent
    Drug LabelSARAFEM (fluoxetine hydrochloride tablets) is a selective serotonin reuptake inhibitor(SSRI) for oral administration. It is designated ()-N-methyl-3-phenyl-3-[(,,-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula...
    Active IngredientFluoxetine hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 20mg base; eq 40mg base; eq 10mg base
    Market StatusPrescription
    CompanyEli Lilly And

    3 of 8  
    Drug NameSarafem
    Drug LabelFluoxetine hydrochloride is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is designated ()-N-methyl-3-phenyl-3-[(a,a,a-trifluoro-p-tol...
    Active IngredientFluoxetine hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 20mg base; eq 15mg base; eq 10mg base
    Market StatusPrescription
    CompanyWarner Chilcott; Eli Lilly And

    4 of 8  
    Drug NameSelfemra
    PubMed HealthFluoxetine (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent
    Drug LabelDESCRIPTIONProzac (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is des...
    Active IngredientFluoxetine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 20mg base; eq 15mg base; eq 10mg base
    Market StatusPrescription
    CompanyTeva Pharms Usa

    5 of 8  
    Drug NameFluoxetine hydrochloride
    Active IngredientFluoxetine hydrochloride
    Dosage FormTablet; Capsule; Capsule, delayed rel pellets; Solution
    RouteOral
    Strengtheq 20mg base; eq 40mg base; eq 90mg base; eq 20mg base/5ml; eq 10mg base; eq 60mg base
    Market StatusPrescription
    CompanyRanbaxy; Mylan Pharms; Wockhardt; Silarx; Ani Pharms; Edgemont Pharms; Teva; Pharm Assoc; Alembic Pharms; Aurobindo Pharma; Teva Pharms Usa; Mallinckrodt; Sandoz; Par Pharm; Ivax Sub Teva Pharms; Lannett; Aurobindo Pharm; Landela Pharm; Dr Reddys Labs; My

    6 of 8  
    Drug NameProzac
    PubMed HealthFluoxetine (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent
    Drug LabelSARAFEM (fluoxetine hydrochloride tablets) is a selective serotonin reuptake inhibitor(SSRI) for oral administration. It is designated ()-N-methyl-3-phenyl-3-[(,,-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula...
    Active IngredientFluoxetine hydrochloride
    Dosage FormCapsule
    RouteOral
    Strengtheq 20mg base; eq 40mg base; eq 10mg base
    Market StatusPrescription
    CompanyEli Lilly And

    7 of 8  
    Drug NameSarafem
    Drug LabelFluoxetine hydrochloride is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is designated ()-N-methyl-3-phenyl-3-[(a,a,a-trifluoro-p-tol...
    Active IngredientFluoxetine hydrochloride
    Dosage FormTablet; Capsule
    RouteOral
    Strengtheq 20mg base; eq 15mg base; eq 10mg base
    Market StatusPrescription
    CompanyWarner Chilcott; Eli Lilly And

    8 of 8  
    Drug NameSelfemra
    PubMed HealthFluoxetine (By mouth)
    Drug ClassesAntidepressant, Central Nervous System Agent
    Drug LabelDESCRIPTIONProzac (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem, fluoxetine hydrochloride). It is des...
    Active IngredientFluoxetine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 20mg base; eq 15mg base; eq 10mg base
    Market StatusPrescription
    CompanyTeva Pharms Usa

    4.2 Therapeutic Uses

    Antidepressive Agents, Second-Generation; Serotonin Uptake Inhibitors

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    Fluoxetine is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder. /Included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1359

    Fluoxetine is used to relieve the symptoms of premenstrual dysphoric disorder (PMDD). PMDD was formerly known as late luteal phase dysphoric disorder (LLPDD) and is distinguishable from the cyclic changes in mood commonly known as premenstrual syndrome (PMS) by its greater severity of symptoms. (Evidence rating: B-1) /Included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1359

    Fluoxetine is indicated for the treatment of major depressive disorder. Treatment of acute depressive episodes typically requires 6 to 12 months of antidepressant therapy. Patients with recurrent or chronic depression may require long-term treatment. Fluoxetine has shown effective maintenance of antidepressant response for up to 50 weeks of treatment in a placebo-controlled trial. /Included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1359

    For more Therapeutic Uses (Complete) data for FLUOXETINE HYDROCHLORIDE (10 total), please visit the HSDB record page.

    4.3 Drug Warning

    Pregnancy risk category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

    Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 1843

    Fluoxetine potentially may alter blood glucose concentrations. Hypoglycemia has occurred in less than 1% of patients receiving fluoxetine and hypoglycemic reaction has occurred rarely. In addition, hyperglycemia has developed following discontinuance of the drug. Therefore, the possibility that insulin and/or oral sulfonylurea antidiabetic agent dosage adjustments may be necessary when fluoxetine therapy is initiated or discontinued in patients with diabetes mellitus should be considered.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2206

    The most frequent adverse effect associated with fluoxetine therapy is nausea, which occurs in about 21% of patients. Nausea generally is mild, occurs early in therapy, and usually subsides after a few weeks of continued therapy with the drug. ... Diarrhea occurs in about 12%, anorexia in about 9%, and dyspepsia in about 6% of patients receiving the drug; limited evidence suggests that the incidence of anorexia may be dose-related. Other adverse GI effects associated with fluoxetine therapy include abdominal pain and change in taste perception, which occur in approximately 3 and 2% of patients, respectively; taste loss has been reported rarely. Vomiting, melena, and flatulence reportedly occur in about 2% and gastroenteritis in about 1% of patients receiving the drug. Increased appetite has been reported in more than 1% of patients receiving fluoxetine, but has not been definitely attributed to the drug. Other adverse GI effects, including aphthous stomatitis, dysphagia, eructation, esophagitis, gastritis, gingivitis, glossitis, melena, stomatitis, and thirst, have been reported in less than 1% of fluoxetine-treated patients; however, a causal relationship to the drug has not been established. Bloody diarrhea, colitis, duodenal or gastric ulcer, enteritis, fecal incontinence, hematemesis, hyperchlorhydria, increased salivation, mouth ulceration, salivary gland enlargement, tongue discoloration, and tongue edema have occurred rarely, but have not been definitely attributed to fluoxetine.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2206

    Because of the possibility of suicide in depressed patients, close supervision of high risk patients is recommended during initial fluoxetine therapy. To reduce the risk of overdosage, the drug should be prescribed in the smallest quantity consistent with good patient management. Suicidal ideation may persist until substantial remission of the depressive disorder occurs.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2207

    For more Drug Warnings (Complete) data for FLUOXETINE HYDROCHLORIDE (14 total), please visit the HSDB record page.

    4.4 Drug Indication

    As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate behaviours (vocalisation and inappropriate defecation and / or urination) and only in combination with behavioural-modification techniques.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Cytochrome P-450 CYP2D6 Inhibitors

    Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2D6. (See all compounds classified as Cytochrome P-450 CYP2D6 Inhibitors.)

    Selective Serotonin Reuptake Inhibitors

    Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

    Antidepressive Agents, Second-Generation

    A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake. (See all compounds classified as Antidepressive Agents, Second-Generation.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin Uptake Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]
    5.3 ATC Code

    QN06AB03

    5.4 Absorption, Distribution and Excretion

    Fluoxetine hydrochloride appears to be well absorbed from the GI tract following oral administration. The oral bioavailability of fluoxetine in humans has not been fully elucidated to date, but at least 60-80% of an oral dose appears to be absorbed. However, the relative proportion of an oral dose reaching systemic circulation unchanged currently is not known. Limited data from animals suggest that the drug may undergo first-pass metabolism and extraction in the liver and/or lung following oral administration. In these animals (beagles), approximately 72% of an oral dose reached systemic circulation unchanged. Food appears to cause a slight decrease in the rate, but not the extent of absorption of fluoxetine in humans.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2214

    Distribution of fluoxetine and its metabolites into human body tissues and fluids has not been fully characterized. Limited pharmacokinetic data obtained during long term administration of fluoxetine to animals suggest that the drug and some of its metabolites, including norfluoxetine, are widely distributed in body tissues, with highest concentrations occurring in the lungs and liver. The drug crosses the blood-brain barrier in humans and animals. In animals, fluoxetine: norfluoxetine ratios reportedly were similar in the cerebral cortex, corpus striatum, hippocampus, hypothalamus, brain stem, and cerebellum 1 hr after administration of single dose of the drug.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2214

    In order to confirm embryonic/fetal exposure to fluoxetine and/or metabolites, dissection and whole-body autoradiographic techniques were utilized to determine the placental transfer and fetal distribution in 12 and 18 day pregnant Wistar rats 1, 4, 8, and 24 hr following a single oral 12.5 mg/kg dose of (14)C fluoxetine. On gestation Days 12 (organogenesis) and 18 (postorganogenesis), peak concentrations of radiocarbon occurred 4-8 hr after dose administration in the placenta, embryo/fetus, amniotic fluid, and maternal kidney, brain, and lung, and declined slightly at 24 hr postdose. Maternal lung contained the highest tissue concentration of radiocarbon at all time points. Placenta and maternal brain, kidney, and liver contained moderate levels of radioactivity, while embryonic/fetal tissue, amniotic fluid, and maternal plasma contained low levels of radioactivity. Mean fetal concentrations of radiocarbon at 4, 8, and 24 hr on gestation Day 18 were higher than mean embryonic concentrations on Day 12 of gestation. Analytical characterization of radioactivity indicated that combined fluoxetine and norfluoxetine concentrations accounted for 63-80% of the total radiocarbon concentrations in embryonic/fetal tissue. Results indicated that embryonic/fetal and maternal tissue levels of fluoxetine were greatest at early time points and declined with time, while norfluoxetine tissue levels were highest at the 24 hr time point. Whole-body autoradiographic techniques demonstrated that radioactivity associated with (14)C fluoxetine and/or its metabolites traversed the placenta and distributed throughout the 18 day fetus 4 hr following dose administration. Visual and quantitative evaluations of the autoradiograms indicated that the highest fetal concentrations of radiocarbon were associated with brain and thymus. Results from these studies indicate that fluoxetine and norfluoxetine traverse the placenta and distribute within the embryo/fetus during the periods of organogenesis and postorganogenesis and confirm embryonic/fetal exposure of parent and metabolite in previous negative rat teratology and reproductive studies.

    PMID:2785300 Pohland RC et al; Toxicol Appl Pharmacol 98 (2): 198-205 (1989)

    Elimination: Renal: 80% excreted in the urine (11.6% fluoxetine, 7.4% fluoxetine glucuronide, 6.8% norfluoxetine, 8.2% norfluoxetine glucuronide, >20% hippuric acid, 46% other); Biliary: Approximately 15% in the feces; In dialysis--Not dialyzable because of high protein binding and large volume of distribution.

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1359

    For more Absorption, Distribution and Excretion (Complete) data for FLUOXETINE HYDROCHLORIDE (6 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    The present study was designed to define the kinetic behavior of fluoxetine N-demethylation in human liver microsomes and to identify the isoforms of cytochrome p450 (CYP) involved in this metabolic pathway. The kinetics of Ne formation of norfluoxetine was determined in human liver microsomes from six genotyped CYP2C19 extensive metabolizers (EM). The correlation studies between the fluoxetine N-demethylase activity and various CYP enzyme activities were performed. Selective inhibitors or chemical probes of various cytochrome P-450 isoforms were also employed. The kinetics of norfluoxetine formation in all liver microsomes were fitted by a single-enzyme Michaelis-Menten equation (mean Km=32 umol/L +/- 7 umol/L). Significant correlations were found between N-demethylation of fluoxetine at both 25 umol/L and 100 umol/L and 3-hydroxylation of tolbutamide at 250 micromol/L (r1=0.821, P1=0.001; r2=0.668, P2=0.013), respectively, and S-mephenytoin 4'-hydroxylase activity (r=0.717, P=0.006) at high substrate concentration of 100 umol/L. S-mephenytoin (SMP) (a CYP2C19 substrate) at high concentration and sulfaphenazole (SUL) (a selective inhibitor of CYP2C9) substantially inhibited norfluoxetine formation. The reaction was minimally inhibited by coincubation with chemical probe, inhibitor of CYP3A4 (triacetyloleandomycin, TAO). The inhibition of fluoxetine N-demethylation at high substrate concentration (100 umol/L) was greater in PM livers than in EM livers (73 % vs 45 %, P < 0.01) when the microsomes were precoincubated with SUL plus TAO. Cytochrome p450 CYP2C9 is likely to be a major CYP isoform catalyzing fluoxetine N-demethylation in human liver microsomes at a substrate concentration close to the therapeutic level, while polymorphic CYP2C19 may play a more important role in this metabolic pathway at high substrate concentration.

    PMID:11730569 Liu ZQ et al; Acta Pharmacol Sin 22 (1): 85-90 (2001)

    The exact metabolic fate of fluoxetine has not been fully elucidated. The drug appears to be metabolized extensively, probably in the liver, to norfluoxetine and several other metabolites. Norfluoxetine (desmethylfluoxetine) the principal metabolite, is formed by N-demethylation of fluoxetine, which may be under polygenic control. The potency and selectivity of norfluoxetine's serotonin-reuptake inhibiting activity appear to be similar to those of the parent drug. Both fluoxetine and norfluoxetine undergo conjugation with glucuronic acid in the liver, and limited evidence from animals suggests that both the parent drug and its principal metabolite also undergo O-dealkylation to form p-trifluoromethylphenol, which subsequently appears to be metabolized to hippuric acid.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2214

    5.6 Biological Half-Life

    The half-life of fluoxetine reportedly is prolonged (to approximately 4-5 days) after administration of multiple versus single doses, suggesting a nonlinear pattern of drug accumulation during long-term administration.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2214

    Following a single oral dose of fluoxetine in healthy adults, the elimination half-life of fluoxetine reportedly averages approximately 2-3 days (range: 1-9 days) and that of norfluoxetine averages about 7-9 days (range: 3-15 days).

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2214

    The mean half-life /for fluoxetine/ was 6.6 vs 2.2 days ... for patients with cirrhosis vs normal volunteers.

    PMID:3262026 Schenker S et al; Clin Pharmacol Ther 44 (3): 353-9 (1988)

    5.7 Mechanism of Action

    The precise mechanism of antidepressant action of fluoxetine is unclear, but the drug has been shown to selectively inhibit the reuptake of serotonin (5-HT) at the presynaptic neuronal membrane. Fluoxetine-induced inhibition of serotonin reuptake causes increased synaptic concentrations of serotonin in the CNS, resulting in numerous functional changes associated with enhanced serotonergic neurotransmission.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 2212

    Monoamine oxidase-B has been determined to be the enzyme responsible for the conversion of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine into its toxic metabolite 1-methyl-4-phenylpyridine ion. Since this enzyme has been localized primarily in astrocytes and serotonergic neurons, it would appear that 1-methyl-4-phenylpyridine ion is being produced outside the dopaminergic neurons. To investigate this possibility, the administration of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine was preceded by systemically administered fluoxetine. In keeping with its demonstrated ability to inhibit uptake into serotonergic neurons and serotonin uptake into astrocytes, fluoxetine pretreatment resulted in a significant attenuation of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine induced depletions of striatal dopamine and serotonin concentration. These results support the extra-dopaminergic production of 1-methyl-4-phenylpyridine ion.

    PMID:3258013 Brooks WJ et al; J Neural Transm 71 (2): 85-90 (1988)

    Fluoxetine is a potent and selective inhibitor of the neuronal serotonin-uptake carrier and is a clinically effective antidepressant. Although fluoxetine is used therapeutically as the racemate, there appears to be a small but demonstrable stereospecificity associated with its interactions with the serotonin-uptake carrier. The goals of this study were to determine the absolute configurations of the enantiomers of fluoxetine and to examine whether the actions of fluoxetine in behavioral tests were enantiospecific. (S)-Fluoxetine was synthesized from (S)-(-)-3-chloro-1-phenylpropanol by sequential reaction with sodium iodide, methylamine, sodium hydride, and 4-fluorobenzotrifluoride. (S)-Fluoxetine is dextrorotatory (+1.60) in methanol, but is levorotatory (-10.85) in water. Fluoxetine enantiomers were derivatized with (R)-1-(1-naphthyl)ethyl isocyanate, and the resulting ureas were assayed by 1H NMR or HPLC to determine optical purities of the fluoxetine samples. Both enantiomers antagonized writhing in mice; following sc administration of (R)- and (S)-fluoxetine, ED50 values were 15.3 and 25.7 mg/kg, respectively. Moreover, both enantiomers potentiated a subthreshold analgesic dose (0.25 mg/kg) of morphine, and ED50 values were 3.6 and 5.7 mg/kg, respectively. Following ip administration to mice, the two stereoisomers antagonized p-chloroamphetamine-induced depletion of whole brain serotonin concentrations. ED50 values for (S)- and (R)-fluoxetine were 1.2 and 2.1 mg/kg, respectively. The two enantiomers decreased palatability-induced ingestion following ip administration to rats; (R)- and (S)-fluoxetine reduced saccharin-induced drinking with ED50 values of 6.1 and 4.9 mg/kg, respectively. Thus, in all biochemical and pharmacological studies to date, the eudismic ratio for the fluoxetine enantiomers is near unity.

    PMID:3260286 Robertson DW et al; J Med Chem 31 (7): 1412-7 (1988)

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    ABOUT THIS PAGE

    Looking for 56296-78-7 / Fluoxetine API manufacturers, exporters & distributors?

    Fluoxetine manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Fluoxetine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Fluoxetine manufacturer or Fluoxetine supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluoxetine manufacturer or Fluoxetine supplier.

    PharmaCompass also assists you with knowing the Fluoxetine API Price utilized in the formulation of products. Fluoxetine API Price is not always fixed or binding as the Fluoxetine Price is obtained through a variety of data sources. The Fluoxetine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Fluoxetine

    Synonyms

    56296-78-7, Fluoxetine hcl, Prozac, 59333-67-4, Sarafem, Fluoxeren

    Cas Number

    56296-78-7

    Unique Ingredient Identifier (UNII)

    I9W7N6B1KJ

    About Fluoxetine

    The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.

    Lovan Manufacturers

    A Lovan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lovan, including repackagers and relabelers. The FDA regulates Lovan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lovan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Lovan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Lovan Suppliers

    A Lovan supplier is an individual or a company that provides Lovan active pharmaceutical ingredient (API) or Lovan finished formulations upon request. The Lovan suppliers may include Lovan API manufacturers, exporters, distributors and traders.

    click here to find a list of Lovan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Lovan USDMF

    A Lovan DMF (Drug Master File) is a document detailing the whole manufacturing process of Lovan active pharmaceutical ingredient (API) in detail. Different forms of Lovan DMFs exist exist since differing nations have different regulations, such as Lovan USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Lovan DMF submitted to regulatory agencies in the US is known as a USDMF. Lovan USDMF includes data on Lovan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lovan USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Lovan suppliers with USDMF on PharmaCompass.

    Lovan KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Lovan Drug Master File in Korea (Lovan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lovan. The MFDS reviews the Lovan KDMF as part of the drug registration process and uses the information provided in the Lovan KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Lovan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lovan API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Lovan suppliers with KDMF on PharmaCompass.

    Lovan CEP

    A Lovan CEP of the European Pharmacopoeia monograph is often referred to as a Lovan Certificate of Suitability (COS). The purpose of a Lovan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lovan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lovan to their clients by showing that a Lovan CEP has been issued for it. The manufacturer submits a Lovan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lovan CEP holder for the record. Additionally, the data presented in the Lovan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lovan DMF.

    A Lovan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lovan CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Lovan suppliers with CEP (COS) on PharmaCompass.

    Lovan WC

    A Lovan written confirmation (Lovan WC) is an official document issued by a regulatory agency to a Lovan manufacturer, verifying that the manufacturing facility of a Lovan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lovan APIs or Lovan finished pharmaceutical products to another nation, regulatory agencies frequently require a Lovan WC (written confirmation) as part of the regulatory process.

    click here to find a list of Lovan suppliers with Written Confirmation (WC) on PharmaCompass.

    Lovan NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Lovan as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Lovan API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Lovan as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Lovan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lovan NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Lovan suppliers with NDC on PharmaCompass.

    Lovan GMP

    Lovan Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Lovan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Lovan GMP manufacturer or Lovan GMP API supplier for your needs.

    Lovan CoA

    A Lovan CoA (Certificate of Analysis) is a formal document that attests to Lovan's compliance with Lovan specifications and serves as a tool for batch-level quality control.

    Lovan CoA mostly includes findings from lab analyses of a specific batch. For each Lovan CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Lovan may be tested according to a variety of international standards, such as European Pharmacopoeia (Lovan EP), Lovan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lovan USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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