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    Chemistry

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    Also known as: Ketoconazole, (+)-ketoconazole, 65277-42-1, (2r,4s)-ketoconazole, 142128-59-4, Kuric
    Molecular Formula
    C26H28Cl2N4O4
    Molecular Weight
    531.4  g/mol
    InChI Key
    XMAYWYJOQHXEEK-OZXSUGGESA-N
    Ketoconazole
    Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients.
    1 2D Structure

    Ketoconazole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone
    2.1.2 InChI
    InChI=1S/C26H28Cl2N4O4/c1-19(33)31-10-12-32(13-11-31)21-3-5-22(6-4-21)34-15-23-16-35-26(36-23,17-30-9-8-29-18-30)24-7-2-20(27)14-25(24)28/h2-9,14,18,23H,10-13,15-17H2,1H3/t23-,26-/m0/s1
    2.1.3 InChI Key
    XMAYWYJOQHXEEK-OZXSUGGESA-N
    2.1.4 Canonical SMILES
    CC(=O)N1CCN(CC1)C2=CC=C(C=C2)OCC3COC(O3)(CN4C=CN=C4)C5=C(C=C(C=C5)Cl)Cl
    2.1.5 Isomeric SMILES
    CC(=O)N1CCN(CC1)C2=CC=C(C=C2)OC[C@H]3CO[C@](O3)(CN4C=CN=C4)C5=C(C=C(C=C5)Cl)Cl
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Ketoconazole

    2. Nizoral

    3. R 41400

    4. R-41400

    5. R41,400

    6. R41400

    2.2.2 Depositor-Supplied Synonyms

    1. Ketoconazole

    2. (+)-ketoconazole

    3. 65277-42-1

    4. (2r,4s)-ketoconazole

    5. 142128-59-4

    6. Kuric

    7. Ketocanazole

    8. Cpd000058460

    9. Chembl75

    10. Smr000058460

    11. Mls000069784

    12. Mls001146934

    13. 1-[4-[4-[[(2r,4s)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone

    14. 1-acetyl-4-(4-{[(2r,4s)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine

    15. Chebi:48336

    16. Dsstox_cid_9879

    17. R-41400

    18. Dsstox_rid_78829

    19. Dsstox_gsid_29879

    20. 1-(4-(4-(((2r,4s)-2-((1h-imidazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)ethanone

    21. Mfcd00058579

    22. Rac-trans-ketoconazole

    23. Ktz

    24. Sr-01000075626

    25. Sr-01000597381

    26. Ketoconazole (k)

    27. (+)-ketoconazol

    28. Ketoconazole,(s)

    29. Ncgc00016907-01

    30. Prestwick_744

    31. Cas-65277-42-1

    32. Tocris-1103

    33. Opera_id_397

    34. Prestwick0_000389

    35. Prestwick1_000389

    36. Prestwick2_000389

    37. Prestwick3_000389

    38. R 41,400

    39. Upcmld-dp138

    40. Schembl8407

    41. Lopac0_000666

    42. Bspbio_000577

    43. Mls000758224

    44. Mls001423987

    45. Mls002207053

    46. Mls002222255

    47. Bidd:gt0696

    48. Us9150527, Ketoconazole

    49. Spbio_002498

    50. Amy917

    51. Bdbm8610

    52. Bpbio1_000635

    53. Dtxsid7029879

    54. Upcmld-dp138:001

    55. Bdbm60666

    56. Hy-b0105a

    57. Ketoconazole, >=98% (hplc)

    58. Dtxsid901316748

    59. Hms1569m19

    60. Hms2051a19

    61. Hms2089n05

    62. Hms2096m19

    63. Hms2234h17

    64. Hms3262e13

    65. Hms3414j19

    66. Hms3678j17

    67. Hms3713m19

    68. Zinc643138

    69. Bcp28528

    70. Piperazine, (+/-)-1-acetyl-4-[4-[[(2r,4s)-2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, Rel-

    71. Ketoconazole 2.0 Mg/ml In Methanol

    72. Tox21_110676

    73. Tox21_300267

    74. Tox21_500666

    75. Ei-107

    76. S1353

    77. Akos007930650

    78. Ccg-100815

    79. Cs-1846

    80. Ks-1205

    81. Lp00666

    82. Nc00065

    83. Sdccgsbi-0050645.p002

    84. Ketoconazole 100 Microg/ml In Methanol

    85. Mrf-0000100

    86. 24f2-1,25(oh)d3

    87. Ncgc00025000-01

    88. Ncgc00025000-02

    89. Ncgc00025000-03

    90. Ncgc00025000-04

    91. Ncgc00025000-05

    92. Ncgc00025000-06

    93. Ncgc00025000-07

    94. Ncgc00025000-08

    95. Ncgc00025000-09

    96. Ncgc00025000-10

    97. Ncgc00025000-14

    98. Ncgc00025000-16

    99. Ncgc00025000-28

    100. Ncgc00253967-01

    101. Ncgc00261351-01

    102. ( Inverted Exclamation Marka)-ketoconazol

    103. (+/-)-cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine

    104. Ac-15957

    105. Cis-1-acetyl-4-[4-[[2-(2,4-

    106. 3-dioxolan-4-yl)-methoxy]phenyl)piperazine

    107. Ketoconazole 100 Microg/ml In Acetonitrile

    108. Eu-0100666

    109. K0045

    110. Sw196888-4

    111. Bim-0050645.0001

    112. K 1003

    113. M02048

    114. 277k421

    115. Ketoconazole, Antibiotic For Culture Media Use Only

    116. Q-201267

    117. Sr-01000075626-1

    118. Sr-01000075626-4

    119. Sr-01000597381-1

    120. Sr-01000597381-6

    121. Brd-k29113274-001-03-6

    122. Brd-k29113274-001-11-9

    123. Brd-k29113274-001-21-8

    124. Q27121163

    125. (+)-r 41400

    126. Ketoconazole, British Pharmacopoeia (bp) Reference Standard

    127. Ketoconazole, European Pharmacopoeia (ep) Reference Standard

    128. Ketoconazole, United States Pharmacopeia (usp) Reference Standard

    129. Dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-piperazine

    130. Ketoconazole, Pharmaceutical Secondary Standard; Certified Reference Material

    131. (2r,4s)-1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine

    132. 1-(4-(4-(((2r,4s)-2-((1h-imidazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)ethan-1-one

    133. Cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] Methoxy]phenyl]piperazine

    134. Kz

    135. Piperazine, (+)-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1h-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-

    2.3 Create Date
    2005-08-01
    3 Chemical and Physical Properties
    Molecular Weight 531.4 g/mol
    Molecular Formula C26H28Cl2N4O4
    XLogP34.3
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count7
    Exact Mass530.1487608 g/mol
    Monoisotopic Mass530.1487608 g/mol
    Topological Polar Surface Area69.1 Ų
    Heavy Atom Count36
    Formal Charge0
    Complexity735
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 10  
    Drug NameExtina
    PubMed HealthKetoconazole
    Drug LabelEXTINA Foam contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H-imidazol-l-ylmethyl)-1,3-di...
    Active IngredientKetoconazole
    Dosage FormAerosol, foam
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyDelcor Abet

    2 of 10  
    Drug NameKetoconazole
    PubMed HealthKetoconazole
    Drug LabelNIZORAL is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate...
    Active IngredientKetoconazole
    Dosage FormShampoo; Tablet; Cream; Aerosol, foam
    RouteOral; Topical
    Strength200mg; 2%
    Market StatusPrescription
    CompanyTeva; Taro; Fougera Pharms; Perrigo New York; Tolmar; Mylan; Perrigo Israel

    3 of 10  
    Drug NameNizoral
    PubMed HealthKetoconazole
    Drug LabelNIZORAL is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate...
    Active IngredientKetoconazole
    Dosage FormShampoo
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyJanben Pharms

    4 of 10  
    Drug NameNizoral a-d
    PubMed HealthKetoconazole (On the skin)
    Active IngredientKetoconazole
    Dosage FormShampoo
    RouteTopical
    Strength1%
    Market StatusOver the Counter
    CompanyMcneil Cons

    5 of 10  
    Drug NameXolegel
    PubMed HealthKetoconazole
    Drug LabelXOLEGEL contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.Chemically, ketoconazole is ()-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methox...
    Active IngredientKetoconazole
    Dosage FormGel
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyAqua Pharms

    6 of 10  
    Drug NameExtina
    PubMed HealthKetoconazole
    Drug LabelEXTINA Foam contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H-imidazol-l-ylmethyl)-1,3-di...
    Active IngredientKetoconazole
    Dosage FormAerosol, foam
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyDelcor Abet

    7 of 10  
    Drug NameKetoconazole
    PubMed HealthKetoconazole
    Drug LabelNIZORAL is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate...
    Active IngredientKetoconazole
    Dosage FormShampoo; Tablet; Cream; Aerosol, foam
    RouteOral; Topical
    Strength200mg; 2%
    Market StatusPrescription
    CompanyTeva; Taro; Fougera Pharms; Perrigo New York; Tolmar; Mylan; Perrigo Israel

    8 of 10  
    Drug NameNizoral
    PubMed HealthKetoconazole
    Drug LabelNIZORAL is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate...
    Active IngredientKetoconazole
    Dosage FormShampoo
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyJanben Pharms

    9 of 10  
    Drug NameNizoral a-d
    PubMed HealthKetoconazole (On the skin)
    Active IngredientKetoconazole
    Dosage FormShampoo
    RouteTopical
    Strength1%
    Market StatusOver the Counter
    CompanyMcneil Cons

    10 of 10  
    Drug NameXolegel
    PubMed HealthKetoconazole
    Drug LabelXOLEGEL contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.Chemically, ketoconazole is ()-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methox...
    Active IngredientKetoconazole
    Dosage FormGel
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyAqua Pharms

    4.2 Therapeutic Uses

    Antifungal agents

    National Library of Medicine's Medical Subject Headings. Ketoconazole. Online file (MeSH, 2014). Available from, as of August 28, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Nizoral Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Nizoral (ketoconazole) Tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Nizoral Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465

    Oral ketoconazole has been used for the palliative treatment of Cushing's syndrome (hypercortisolism), including adrenocortical hyperfunction associated with adrenal or pituitary adenoma or ectopic corticotropin-secreting tumors. Based on ketoconazole's endocrine effects, the drug has been used in the treatment of advanced prostatic carcinoma. Safety and efficacy of ketoconazole have not been established for either of these indications. Oral ketoconazole also has been used in the treatment of hypercalcemia in patients with sarcoidosis and the treatment of tuberculosis-associated hypercalcemia and idiopathic infantile hypercalcemia and hypercalciuria. /NOT included in US product label/

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Ketoconazole has been used for the treatment of sporotrichosis caused by Sporothrix schenckii; however, the drug is not recommended since it is less effective and associated with more adverse effects than some other azoles. Oral itraconazole is considered the drug of choice for the treatment of cutaneous, lymphocutaneous, or mild pulmonary or osteoarticular sporotrichosis and for follow-up therapy in more severe infections after a response has been obtained with IV amphotericin B. /NOT included in US product label/

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    For more Therapeutic Uses (Complete) data for KETOCONAZOLE (18 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ WARNING. Nizoral Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity: Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. QT Prolongation and Drug Interactions Leading to QT Prolongation: Co-administration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias such as torsades de pointes.

    NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465

    Transient increases in serum AST, ALT, and alkaline phosphatase concentrations may occur during ketoconazole therapy. Serious hepatotoxicity has occurred in patients receiving oral ketoconazole, including cases that were fatal or required liver transplantation. Hepatotoxicity may be hepatocellular (in most cases), cholestatic, or a mixed pattern of injury. Although ketoconazole-induced hepatotoxicity usually is reversible following discontinuance of the drug, recovery may take several months and rarely death has occurred. Symptomatic hepatotoxicity usually is apparent within the first few months of ketoconazole therapy, but occasionally may be apparent within the first week of therapy. Some patients with ketoconazole-induced hepatotoxicity had no obvious risk factors for liver disease. Serious hepatotoxicity has been reported in patients receiving high oral ketoconazole dosage for short treatment durations and in patients receiving low oral dosage of the drug for long durations. Many of the reported cases of hepatotoxicity occurred in patients who received the drug for the treatment of tinea unguium (onychomycosi or the treatment of chronic, refractory dermatophytoses. Ketoconazole-induced hepatitis has been reported in some children.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 521

    Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with Nizoral Tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia. Additionally, the following other drugs are contraindicated with Nizoral Tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine.

    NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465

    The use of Nizoral Tablets is contraindicated in patients with acute or chronic liver disease.

    NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465

    For more Drug Warnings (Complete) data for KETOCONAZOLE (46 total), please visit the HSDB record page.

    4.4 Drug Indication

    Ketoconazole HRA is indicated for the treatment of endogenous Cushings syndrome in adults and adolescents above the age of 12 years.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Cytochrome P-450 CYP3A Inhibitors

    Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP3A. (See all compounds classified as Cytochrome P-450 CYP3A Inhibitors.)

    14-alpha Demethylase Inhibitors

    Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)

    Antifungal Agents

    Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Azoles [CS]; Cytochrome P450 3A4 Inhibitors [MoA]; Cytochrome P450 3A5 Inhibitors [MoA]; P-Glycoprotein Inhibitors [MoA]; Azole Antifungal [EPC]
    5.3 ATC Code

    J02AB02

    D01AC08

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    D - Dermatologicals

    D01 - Antifungals for dermatological use

    D01A - Antifungals for topical use

    D01AC - Imidazole and triazole derivatives

    D01AC08 - Ketoconazole

    G - Genito urinary system and sex hormones

    G01 - Gynecological antiinfectives and antiseptics

    G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

    G01AF - Imidazole derivatives

    G01AF11 - Ketoconazole

    H - Systemic hormonal preparations, excl. sex hormones and insulins

    H02 - Corticosteroids for systemic use

    H02C - Antiadrenal preparations

    H02CA - Anticorticosteroids

    H02CA03 - Ketoconazole

    J - Antiinfectives for systemic use

    J02 - Antimycotics for systemic use

    J02A - Antimycotics for systemic use

    J02AB - Imidazole derivatives

    J02AB02 - Ketoconazole

    5.4 Absorption, Distribution and Excretion

    Ketoconazole is rapidly absorbed from the GI tract. Following oral administration, ketoconazole is dissolved in gastric secretions and converted to the hydrochloride salt prior to absorption from the stomach.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    The effect of food on the rate and extent of GI absorption of ketoconazole has not been clearly determined. Some clinicians have reported that administration of ketoconazole to fasting individuals results in higher plasma concentrations of the drug than does administration with food. However, the manufacturer states that administration of ketoconazole with food increases the extent of absorption and results in more consistent plasma concentrations of the drug. The manufacturer suggests that food increases absorption of ketoconazole by increasing the rate and/or extent of dissolution of ketoconazole (e.g., by increasing bile secretions) or by delaying stomach emptying.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption.

    NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465

    The bioavailability of oral ketoconazole depends on the pH of the gastric contents in the stomach; an increase in the pH results in decreased absorption of the drug. Decreased bioavailability of ketoconazole has been reported in patients with acquired immunodeficiency syndrome (AIDS), probably because of gastric hypochlorhydria associated with this condition; concomitant administration of dilute hydrochloric acid solution normalized absorption of the drug in these patients.198 Concomitant administration of an acidic beverage may increase bioavailability of oral ketoconazole in some individuals with achlorhydria.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    For more Absorption, Distribution and Excretion (Complete) data for KETOCONAZOLE (19 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Ketoconazole is partially metabolized, in the liver, to several inactive metabolites by oxidation and degradation of the imidazole and piperazine rings, by oxidative O-dealkylation, and by aromatic hydroxylation.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    5.6 Biological Half-Life

    Plasma concentrations of ketoconazole appear to decline in a biphasic manner with a half-life of approximately 2 hours in the initial phase and approximately 8 hours in the terminal phase.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    Elimination from plasma is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter.

    NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465

    5.7 Mechanism of Action

    Ketoconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14alpha-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane.

    NIH; DailyMed. Current Medication Information for Nizoral (Ketoconazole) Tablet (Revised: March 2014). Available from, as of November 11, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=090660c1-6e6d-457f-adb5-046ddfcd1465

    Like other azole antifungal agents, ketoconazole presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition. Although the exact mechanism of action of ketoconazole has not been fully determined, it has been suggested that the fungistatic activity of the drug may result from interference with ergosterol synthesis, probably via inhibition of C-14 demethylation of sterol intermediates (e.g., lanosterol). The fungicidal activity of ketoconazole at high concentrations may result from a direct physiochemical effect of the drug on the fungal cell membrane.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 200MG **Federal Regist...DOSAGE - TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 18533

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    DOSAGE - SHAMPOO;TOPICAL - 2% **Federal Regis...DOSAGE - SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19927

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    DOSAGE - SHAMPOO;TOPICAL - 1%

    USFDA APPLICATION NUMBER - 20310

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    DOSAGE - AEROSOL, FOAM;TOPICAL - 2% **Federal...DOSAGE - AEROSOL, FOAM;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21738

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    DOSAGE - GEL;TOPICAL - 2%

    USFDA APPLICATION NUMBER - 21946

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    ABOUT THIS PAGE

    Looking for 65277-42-1 / Ketoconazole API manufacturers, exporters & distributors?

    Ketoconazole manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Ketoconazole 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 Ketoconazole manufacturer or Ketoconazole supplier for your needs.

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

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

    API | Excipient name

    Ketoconazole

    Synonyms

    (+)-ketoconazole, 65277-42-1, (2r,4s)-ketoconazole, 142128-59-4, Kuric, Ketocanazole

    Cas Number

    65277-42-1

    About Ketoconazole

    Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients.

    Ketoconazolum Manufacturers

    A Ketoconazolum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketoconazolum, including repackagers and relabelers. The FDA regulates Ketoconazolum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketoconazolum 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 Ketoconazolum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Ketoconazolum Suppliers

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

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

    Ketoconazolum USDMF

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

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

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

    Ketoconazolum JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Ketoconazolum Drug Master File in Japan (Ketoconazolum JDMF) empowers Ketoconazolum API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Ketoconazolum JDMF during the approval evaluation for pharmaceutical products. At the time of Ketoconazolum JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Ketoconazolum suppliers with JDMF on PharmaCompass.

    Ketoconazolum KDMF

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

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

    After submitting a Ketoconazolum 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 Ketoconazolum API can apply through the Korea Drug Master File (KDMF).

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

    Ketoconazolum CEP

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

    A Ketoconazolum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketoconazolum 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 Ketoconazolum suppliers with CEP (COS) on PharmaCompass.

    Ketoconazolum WC

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

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

    Ketoconazolum 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 Ketoconazolum as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Ketoconazolum 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 Ketoconazolum 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 Ketoconazolum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ketoconazolum NDC to their finished compounded human drug products, they may choose to do so.

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

    Ketoconazolum GMP

    Ketoconazolum 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 Ketoconazolum 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 Ketoconazolum GMP manufacturer or Ketoconazolum GMP API supplier for your needs.

    Ketoconazolum CoA

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

    Ketoconazolum CoA mostly includes findings from lab analyses of a specific batch. For each Ketoconazolum 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.

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