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    Chemistry

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    Also known as: 124750-99-8, Cozaar, Erythropoietin, Losartan potassium salt, Lorzaar, Losacar
    Molecular Formula
    C22H22ClKN6O
    Molecular Weight
    461.0  g/mol
    InChI Key
    OXCMYAYHXIHQOA-UHFFFAOYSA-N
    FDA UNII
    3ST302B24A
    Losartan Potassium
    An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.
    1 2D Structure

    Losartan Potassium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol
    2.1.2 InChI
    InChI=1S/C22H22ClN6O.K/c1-2-3-8-20-24-21(23)19(14-30)29(20)13-15-9-11-16(12-10-15)17-6-4-5-7-18(17)22-25-27-28-26-22;/h4-7,9-12,30H,2-3,8,13-14H2,1H3;/q-1;+1
    2.1.3 InChI Key
    OXCMYAYHXIHQOA-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCC1=NC(=C(N1CC2=CC=C(C=C2)C3=CC=CC=C3C4=NN=N[N-]4)CO)Cl.[K+]
    2.2 Other Identifiers
    2.2.1 UNII
    3ST302B24A
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-butyl-4-chloro-1-((2'-(1h-etrazol-5-yl) (1,1'-biphenyl)-4-yl)methyl)-1h-imidazole-5-methanol

    2. Cozaar

    3. Dup 753

    4. Dup-753

    5. Dup753

    6. Losartan

    7. Losartan Monopotassium Salt

    8. Mk 954

    9. Mk-954

    10. Mk954

    11. Monopotassium Salt, Losartan

    12. Potassium, Losartan

    13. Salt, Losartan Monopotassium

    2.3.2 Depositor-Supplied Synonyms

    1. 124750-99-8

    2. Cozaar

    3. Erythropoietin

    4. Losartan Potassium Salt

    5. Lorzaar

    6. Losacar

    7. Losaprex

    8. Hyzaar

    9. Dup 753

    10. Nu-lotan

    11. Mk 954

    12. Lortaan

    13. Losata

    14. Tancin

    15. Mk-0954

    16. Losartanpotassium

    17. Losartan Potassium (dup 753)

    18. Mk0954

    19. L-158086

    20. Losartan Monopotassium Salt

    21. 3st302b24a

    22. Aradois

    23. Zaart

    24. Dup-753

    25. Presartan-50

    26. E-3340

    27. 2-butyl-4-chloro-1-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)imidazole-5-methanol, Monopotassium Salt

    28. 124750-99-8 (ka+)

    29. Potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol

    30. Lifezar

    31. Lorzaan

    32. Losacor

    33. Tenopres

    34. Lotim

    35. Niten

    36. Ocsaar

    37. Du Pont-753

    38. Neo Lotan

    39. 1h-imidazole-5-methanol, 2-butyl-4-chloro-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Monopotassium Salt

    40. 2-butyl-4-chloro-1-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-imidazole-5-methanol, Monopotassium Salt

    41. Mfcd09850721

    42. Mk-954

    43. Du Pont 753

    44. Losartan Potassium [usan]

    45. Covance

    46. Unii-3st302b24a

    47. Losartan Potassium [usan:usp]

    48. Potassium 5-(4'-((2-butyl-4-chloro-5-(hydroxymethyl)-1h-imidazol-1-yl)methyl)biphenyl-2-yl)tetrazol-1-ide

    49. Cozaar (tn)

    50. Dup-753 Potassium

    51. Mk 0954

    52. Losartan Potassium,(s)

    53. Schembl42079

    54. Mls001401407

    55. Ex-89

    56. Dtxsid3044209

    57. Losartan Potassium [jan]

    58. Losartan Potassium (jp17/usp)

    59. Losartan Potassium [hsdb]

    60. Hms2051m12

    61. Hms2090o22

    62. Hms2235f20

    63. Hms3369f08

    64. Hms3393m12

    65. Losartan Potassium [vandf]

    66. Losartan Potassium [mart.]

    67. Act02618

    68. Bcp05332

    69. Bcp29397

    70. Losartan Potassium [usp-rs]

    71. Losartan Potassium [who-dd]

    72. Akos015955543

    73. Akos025310168

    74. Ac-1072

    75. Ccg-100869

    76. Losartan Potassium, Analytical Standard

    77. Nc00119

    78. 2-butyl-4-chloro-1-(2'-(tetrazol-5-yl)biphenyl-4-ylmethyl)-1h-imidazole-5-methanol Potassium

    79. Losartan Monopotassium Salt [mi]

    80. Losartan Potassium [orange Book]

    81. Losartan Potassium [ep Monograph]

    82. 2-butyl-4-chloro-1-[[2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl]imidazole-5-methanol Potassium Salt

    83. Bl164642

    84. Epo

    85. Hyzaar Component Losartan Potassium

    86. Losartan Potassium [usp Monograph]

    87. Smr000469593

    88. Ft-0625705

    89. L-185

    90. L0232

    91. Losartan Potassium Component Of Hyzaar

    92. D00357

    93. Ab01275507-01

    94. 750l998

    95. A805291

    96. Sr-05000001514

    97. Sr-05000001514-1

    98. Q27257991

    99. Losartan Potassium, European Pharmacopoeia (ep) Reference Standard

    100. Losartan Potassium Is Known As A Potent, Synthetic At1 Receptor Antagonist.

    101. Losartan Potassium, United States Pharmacopeia (usp) Reference Standard

    102. Losartan Potassium, Pharmaceutical Secondary Standard; Certified Reference Material

    103. [2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol; Potassium;losartan Potassium

    104. 1h-imidazole-5-methanol, 2-butyl-4-chloro-1-((2-(1h-tetrazol-5-yl)(1,1-biphenyl)-4-yl)methyl)-, Monopotassium Salt

    105. Potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol.

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 461.0 g/mol
    Molecular Formula C22H22ClKN6O
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count8
    Exact Mass460.1180685 g/mol
    Monoisotopic Mass460.1180685 g/mol
    Topological Polar Surface Area77.7 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity526
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameCozaar
    PubMed HealthLosartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelCOZAAR1(losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.Its...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    2 of 4  
    Drug NameLosartan potassium
    Drug LabelLosartan potassium tablets USP are an angiotensin II receptor (type AT1) antagonist. Losartan potassium, USP a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyUpsher Smith; Teva; Apotex; Alembic Pharms; Aurobindo Pharma; Torrent Pharms; Lupin; Sandoz; Prinston; Roxane; Watson Labs; Macleods Pharms; Ipca Labs; Vivimed Labs; Micro Labs Ltd India; Cadista Pharms; Zydus Pharms Usa; Mylan

    3 of 4  
    Drug NameCozaar
    PubMed HealthLosartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelCOZAAR1(losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.Its...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    4 of 4  
    Drug NameLosartan potassium
    Drug LabelLosartan potassium tablets USP are an angiotensin II receptor (type AT1) antagonist. Losartan potassium, USP a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyUpsher Smith; Teva; Apotex; Alembic Pharms; Aurobindo Pharma; Torrent Pharms; Lupin; Sandoz; Prinston; Roxane; Watson Labs; Macleods Pharms; Ipca Labs; Vivimed Labs; Micro Labs Ltd India; Cadista Pharms; Zydus Pharms Usa; Mylan

    4.2 Drug Indication

    Indicated in adult and paediatric patients for the: - treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. - treatment of anemia due to zidovudine in patients with HIV-infection. - treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. - reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

    FDA Label

    Proteinuria, Treatment of heart failure, Treatment of hypertension

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Erythropoietin and epoetin alfa are involved in the regulation of erythrocyte differentiation and the maintenance of a physiological level of circulating erythrocyte mass. It is reported to increase the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. Depending on the dose administered, the rate of hemoglobin increase may vary. In patients receiving hemodialysis, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly. Epoetin alfa serves to restore erythropoietin deficiency in pathological and other clinical conditions where normal production of erythropoietin is impaired or compromised. In anemic patients with chronic renal failure (CRF), administration with epoetin alfa stimulated erythropoiesis by increasing the reticulocyte count within 10 days, followed by increases in the red cell count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. Epoetin alfa was shown to be effective in increasing hematocrit in zidovudine-treated HIV-infected patients and anemic cancer patients undergoing chemotherapy.

    5.2 MeSH Pharmacological Classification

    Angiotensin II Type 1 Receptor Blockers

    Agents that antagonize ANGIOTENSIN II TYPE 1 RECEPTOR. Included are ANGIOTENSIN II analogs such as SARALASIN and biphenylimidazoles such as LOSARTAN. Some are used as ANTIHYPERTENSIVE AGENTS. (See all compounds classified as Angiotensin II Type 1 Receptor Blockers.)

    Anti-Arrhythmia Agents

    Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

    Antihypertensive Agents

    Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Angiotensin 2 Receptor Blocker [EPC]; Angiotensin 2 Receptor Antagonists [MoA]
    5.4 ATC Code

    B - Blood and blood forming organs

    B03 - Antianemic preparations

    B03X - Other antianemic preparations

    B03XA - Other antianemic preparations

    B03XA01 - Erythropoietin

    5.5 Absorption, Distribution and Excretion

    Absorption

    The time to reach peak concentration is slower via the subcutaneous route than the intravenous route which ranges from 20 to 25 hours, and the peak is always well below the peak achieved using the intravenous route (510% of those seen with IV administration). The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenously administered product and is approximately 20-40%. **Adult and paediatric patients with CRF:** Following subcutaneous administration, the peak plasma levels are achieved within 5 to 24 hours. **Cancer patients receiving cyclic chemotherapy:** The average time to reach peak plasma concentration was approximately 13.3 12.4 hours after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing. The Cmax is expected be 3- to 7- fold higher and the Tmax is expected to be 2- to 3-fold longer in patients receiving a 40,000 Units SC weekly dosing regimen.

    Route of Elimination

    Erythropoietin and epoetin alfa are cleared via uptake and degradation via the EPO-R-expressing cells, and may also involve other cellular pathways in the interstitium, probably via cells in the reticuloendothelial scavenging pathway or lymphatic system. Only a small amount of unchanged epoetin alfa is found in the urine.

    Volume of Distribution

    In healthy volunteers, the volume of distribution of intravenous epoetin alfa was generally similar to the plasma volume (range of 4063.80 mL/kg), indicating limited extravascular distribution.

    Clearance

    **Healthy volunteers: *

    In male volunteers receiving intravenous epoetin alfa, the total body clearance was approximately 8.12 1.00 mL/h/kg. **Cancer patients receiving cyclic chemotherapy:*

    The average clearance was approximately 20.2 15.9 mL/h/kg after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing. The patients receiving a 40,000 Units SC weekly dosing regimen display a lower clearance (9.2 4.7 mL/h/kg).

    5.6 Metabolism/Metabolites

    Binding of erythropoietin and epoetin alfa to EPO-R leads to cellular internalization, which involves the degradation of the ligand. Erythropoietin and epoetin alfa may also be degraded by the reticuloendothelial scavenging pathway or lymphatic system.

    5.7 Biological Half-Life

    **Healthy volunteers:*

    The half life is approximately 4 hours in healthy volunteers receiving an intravenous injection. A half-life of approximately 6 hours has been reported in children. **Adult and paediatric patients with CRF:*

    The elimination half life following intravenous administration ranges from 4 to 13 hours, which is about 20% longer in CRF patients than that in healthy subjects. The half life is reported to be similar between adult patients receiving or not receiving dialysis. **Cancer patients receiving cyclic chemotherapy:*

    Following subcutaneous administration, the average half life is 40 hours with range of 16 to 67 hours.

    5.8 Mechanism of Action

    Erythropoietin or exogenous epoetin alfa binds to the erythropoietin receptor (EPO-R) and activates intracellular signal transduction pathways. The affinity (Kd) of EPO for its receptor on human cells is 100 to 200 pM. Upon binding to EPO-R on the surface of erythroid progenitor cells, a conformational change is induced which brings EPO-R-associated Janus family tyrosine protein kinase 2 (JAK2) molecules into close proximity. JAK2 molecules are subsequently activated via phosphorylation, then phosphorylate tyrosine residues in the cytoplasmic domain of the EPO-R that serve as docking sites for Src homology 2-domain-containing intracellular signaling proteins. The signalling proteins include STAT5 that once phosphorylated by JAK2, dissociates from the EPO-R, dimerizes, and translocates to the nucleus where they serve as transcription factors to activate target genes involved in cell division or differentiation, including the apoptosis inhibitor Bcl-x. The inhibition of apoptosis by the EPO-activated JAK2/STAT5/Bcl-x pathway is critical in erythroid differentiation. Via JAK2-mediated tyrosine phosphorylation, erythropoietin and epoetin alfa also activates other intracellular proteins involved in erythroid cell proliferation and survival, such as Shc , phosphatidylinositol 3-kinase (PI3K), and phospholipase C-1.

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    01-Jan-2021
    30-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    DOSAGE - TABLET;ORAL - 100MG

    USFDA APPLICATION NUMBER - 20386

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    DOSAGE - TABLET;ORAL - 12.5MG;50MG

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