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    Synopsis

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    Chemistry

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    Also known as: 103577-45-3, Prevacid, Agopton, Limpidex, Lanzor, Bamalite
    Molecular Formula
    C16H14F3N3O2S
    Molecular Weight
    369.4  g/mol
    InChI Key
    MJIHNNLFOKEZEW-UHFFFAOYSA-N
    FDA UNII
    0K5C5T2QPG
    Lansoprazole
    A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.
    Lansoprazole is a Proton Pump Inhibitor. The mechanism of action of lansoprazole is as a Proton Pump Inhibitor. The physiologic effect of lansoprazole is by means of Inhibition Gastric Acid Secretion.
    1 2D Structure

    Lansoprazole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1H-benzimidazole
    2.1.2 InChI
    InChI=1S/C16H14F3N3O2S/c1-10-13(20-7-6-14(10)24-9-16(17,18)19)8-25(23)15-21-11-4-2-3-5-12(11)22-15/h2-7H,8-9H2,1H3,(H,21,22)
    2.1.3 InChI Key
    MJIHNNLFOKEZEW-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C=CN=C1CS(=O)C2=NC3=CC=CC=C3N2)OCC(F)(F)F
    2.2 Other Identifiers
    2.2.1 UNII
    0K5C5T2QPG
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)benzimidazole

    2. Ag 1749

    3. Ag-1749

    4. Ag1749

    5. Agopton

    6. Bamalite

    7. Lansol

    8. Lansoprazol

    9. Lansoprazole Sodium

    10. Lansoprazoles

    11. Lanzor

    12. Monolitum

    13. Ogast

    14. Ogastro

    15. Opiren

    16. Prevacid

    17. Prezal

    18. Pro Ulco

    19. Promeco

    20. Sodium, Lansoprazole

    21. Takepron

    22. Ulpax

    23. Zoton

    2.3.2 Depositor-Supplied Synonyms

    1. 103577-45-3

    2. Prevacid

    3. Agopton

    4. Limpidex

    5. Lanzor

    6. Bamalite

    7. Monolitum

    8. Takepron

    9. Ogastro

    10. Lansoprazol

    11. Opiren

    12. Zoton

    13. Prevacid Solutab

    14. Lanzopral

    15. Ag-1749

    16. Lanproton

    17. Lansopep

    18. Lasoprol

    19. Mesactol

    20. Aprazol

    21. Blason

    22. Ketian

    23. Lancid

    24. Lanston

    25. Ogast

    26. Lanz

    27. Lanzoprazole

    28. Lansoprazolum

    29. Lansox

    30. Prevacid Iv

    31. Prevonco

    32. Ag 1749

    33. A-65006

    34. Lanzo

    35. Prevacid 24hr

    36. Ogastoro

    37. 2-[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1h-benzimidazole

    38. Chebi:6375

    39. Prezal

    40. Pro Ulco

    41. 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)benzimidazole

    42. Compraz

    43. Ilsatec

    44. Prosogan

    45. Suprecid

    46. Dakar

    47. Promp

    48. Zoprol

    49. Nsc-758638

    50. Tak-390mr

    51. 0k5c5t2qpg

    52. Mls000069705

    53. 1261394-42-6

    54. Lanzol-30

    55. 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

    56. 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole

    57. 2-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1h-benzimidazole

    58. Ncgc00015615-02

    59. Smr000058469

    60. Lansoprazol [inn-spanish]

    61. Lansoprazolum [inn-latin]

    62. Cas-103577-45-3

    63. Dsstox_cid_3200

    64. Mls-0003247.0001

    65. Prevacid Naprapac

    66. 1h-benzimidazole, 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-

    67. 1h-benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-

    68. 2-({[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl}sulfinyl)-1h-benzimidazole

    69. 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole

    70. Dsstox_rid_76922

    71. Dsstox_gsid_23200

    72. Prevacid I.v.

    73. Tak 390mr

    74. Lansophed

    75. Lanzol

    76. Lanzul

    77. 2-((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methylsulfinyl)-1h-benzo[d]imidazole

    78. 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole

    79. Prevacid (tn)

    80. 2-({3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl} Sulphinylbenzimidazole;2-({3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl} Sulphinylbenzimidazole

    81. Hsdb 7204

    82. Sr-01000000169

    83. A 65006

    84. Unii-0k5c5t2qpg

    85. Brn 4333393

    86. Lanfast

    87. Lapraz

    88. 2-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl}-1h-benzimidazole

    89. Abt-006

    90. Lansoprazole,(s)

    91. 2-(((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzimidazole

    92. Lansoprazole [usan:usp:inn:ban]

    93. Mfcd00866873

    94. Cg-4801

    95. Spectrum_001580

    96. Cpd000058469

    97. Prevacid Delayed Release

    98. Opera_id_1676

    99. Prestwick0_001072

    100. Prestwick1_001072

    101. Prestwick2_001072

    102. Prestwick3_001072

    103. Spectrum2_000444

    104. Spectrum3_000295

    105. Spectrum4_000856

    106. Spectrum5_001521

    107. Dexlansoprazole-[13c6]

    108. Lansoprazole [mi]

    109. Lopac-l-8533

    110. Lansoprazole [inn]

    111. Lansoprazole [jan]

    112. Chembl480

    113. L 8533

    114. Lansoprazole [hsdb]

    115. Lansoprazole [usan]

    116. Cid_3883

    117. Lansoprazole [vandf]

    118. Lopac0_000709

    119. Schembl22365

    120. Bspbio_001084

    121. Bspbio_001830

    122. Kbiogr_001491

    123. Kbioss_002060

    124. Lansoprazole [mart.]

    125. Lansoprazole Impurity Standard

    126. Mls000759405

    127. Mls001074170

    128. Mls001424235

    129. (+/-)-lansoprazole

    130. Bidd:gt0006

    131. Divk1c_000920

    132. Lansoprazole [usp-rs]

    133. Lansoprazole [who-dd]

    134. Spectrum1503926

    135. Spbio_000488

    136. Spbio_002992

    137. Bpbio1_001194

    138. Gtpl7208

    139. Dtxsid4023200

    140. Bdbm47032

    141. Hms502n22

    142. Kbio1_000920

    143. Kbio2_002060

    144. Kbio2_004628

    145. Kbio2_007196

    146. Kbio3_001330

    147. Lansoprazole (jp17/usp/inn)

    148. 2-[(r)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1h-benzimidazole

    149. 2-[(s)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1h-benzimidazole

    150. Levolansoprazole;(-)-lansoprazole

    151. Ninds_000920

    152. Hms1571g06

    153. Hms1922m04

    154. Hms2052f05

    155. Hms2093m07

    156. Hms2098g06

    157. Hms2234b10

    158. Hms3262m19

    159. Hms3264e12

    160. Hms3269d15

    161. Hms3371e21

    162. Hms3394f05

    163. Hms3413j05

    164. Hms3654j17

    165. Hms3677j05

    166. Hms3715g06

    167. Lansoprazole [orange Book]

    168. Pharmakon1600-01503926

    169. Pharmakon1600-01504282

    170. Lansoprazole [ep Monograph]

    171. Act03358

    172. Bcp22331

    173. Bcp34129

    174. Lansoprazole For Peak Identification

    175. Lansoprazole [usp Monograph]

    176. Tox21_110184

    177. Tox21_301023

    178. Tox21_500709

    179. Bbl029072

    180. Bdbm50070208

    181. Ccg-39952

    182. Nsc758638

    183. Nsc758710

    184. Prevpac Component Lansoprazole

    185. S1354

    186. Stk621169

    187. Akos005554811

    188. Tox21_110184_1

    189. Ac-1233

    190. Cs-1847

    191. Db00448

    192. Ks-1075

    193. Lansoprazole, >=98% (tlc), Powder

    194. Lp00709

    195. Nc00411

    196. Nsc 758638

    197. Sb19127

    198. Sdccgsbi-0050687.p004

    199. 2-[({3-methyl-4-[(2,2,2-trifluoroethyl)oxy]pyridin-2-yl}methyl)sulfinyl]-1h-benzimidazole

    200. 2-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methanesulfinyl}-1h-1,3-benzodiazole

    201. Idi1_000920

    202. Lansoprazole Component Of Prevpac

    203. Ncgc00015615-01

    204. Ncgc00015615-03

    205. Ncgc00015615-04

    206. Ncgc00015615-05

    207. Ncgc00015615-06

    208. Ncgc00015615-07

    209. Ncgc00015615-08

    210. Ncgc00015615-09

    211. Ncgc00015615-10

    212. Ncgc00015615-11

    213. Ncgc00015615-12

    214. Ncgc00015615-14

    215. Ncgc00015615-15

    216. Ncgc00023826-03

    217. Ncgc00023826-04

    218. Ncgc00023826-05

    219. Ncgc00023826-06

    220. Ncgc00023826-07

    221. Ncgc00254925-01

    222. Ncgc00261394-01

    223. Ncgc00381720-13

    224. Bl166173

    225. Hy-13662

    226. Sbi-0050687.p003

    227. Ab00052388

    228. Eu-0100709

    229. Ft-0610894

    230. Ft-0670721

    231. Ft-0670722

    232. L0233

    233. Sw197226-4

    234. D00355

    235. F20528

    236. Ab00052388-17

    237. Ab00052388_18

    238. Ab00052388_19

    239. 577l453

    240. A800764

    241. A921066

    242. Q254296

    243. J-007154

    244. Sr-01000000169-2

    245. Sr-01000000169-6

    246. Sr-01000000169-9

    247. Brd-a49172652-001-05-7

    248. Brd-a49172652-001-13-1

    249. F2173-0222

    250. Lansoprazole, British Pharmacopoeia (bp) Reference Standard

    251. Lansoprazole, European Pharmacopoeia (ep) Reference Standard

    252. Lansoprazole, United States Pharmacopeia (usp) Reference Standard

    253. (+)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole

    254. 2-({[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methane}sulfinyl)-1h-1,3-benzodiazole

    255. 2-[[ [3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1h-benzimidazole

    256. 2-[[[3-methyl-4-(2,2,2-trifluoro-ethoxy)-2-pyridinyl]methyl]-sulfinyl]1h-benzimidazole

    257. 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]benzimidazole

    258. 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1h-benzimidazole

    259. 2-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylsulfinyl]-1h-benzimidazole

    260. 2-[[3-methyl-4-(2,2,2-trifluoroethoxy)pyrid-2-yl]methylsulfinyl]benzimidazole

    261. 2-[[3-methyl-4-[2,2,2-tris(fluoranyl)ethoxy]pyridin-2-yl]methylsulfinyl]-1h-benzimidazole

    262. 2-[3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethanesulfinyl]-1h-benzimidazole

    263. 2-[3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethanesulfinyl]-benzimidazole

    264. 2-[3-methyl-4-(2,2,2-trifluoro-ethoxy)pyridin-2-ylmethanesulfinyl]-benzimidazole

    265. 2-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl-methanesulfinyl]-1h-benzimidazole

    266. 2-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-ylmethanesulfinyl]-1h-benzimidazole

    267. Lansoprazole For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    268. 1h-benzimidazole, 2-[(s)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-

    269. 2-[[[3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-yl]methyl]sulfinyl]-1h-benzo[d]imidazole

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 369.4 g/mol
    Molecular Formula C16H14F3N3O2S
    XLogP32.8
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count5
    Exact Mass369.07588236 g/mol
    Monoisotopic Mass369.07588236 g/mol
    Topological Polar Surface Area87.1 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity480
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameLansoprazole
    PubMed HealthLansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in lansoprazole delayed-release capsules USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Lansop...
    Active IngredientLansoprazole
    Dosage FormCapsule, delayed rel pellets
    RouteOral
    Strength30mg; 15mg
    Market StatusOver the Counter; Prescription
    CompanyWockhardt; Mylan Pharms; Krka Tovarna Zdravil; Natco Pharma; Sandoz; Sun Pharma Global; Perrigo R And D; Teva Pharms; Zydus Hlthcare; Dr Reddys Labs; Wockhardt Usa

    2 of 4  
    Drug NamePrevacid
    PubMed HealthNaproxen (By mouth)
    Drug ClassesAnalgesic, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
    Drug LabelThe active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimida...
    Active IngredientLansoprazole
    Dosage FormCapsule, delayed rel pellets; Tablet, delayed release, orally disintegrating
    RouteOral
    Strength30mg; 15mg
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    3 of 4  
    Drug NameLansoprazole
    PubMed HealthLansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in lansoprazole delayed-release capsules USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Lansop...
    Active IngredientLansoprazole
    Dosage FormCapsule, delayed rel pellets
    RouteOral
    Strength30mg; 15mg
    Market StatusOver the Counter; Prescription
    CompanyWockhardt; Mylan Pharms; Krka Tovarna Zdravil; Natco Pharma; Sandoz; Sun Pharma Global; Perrigo R And D; Teva Pharms; Zydus Hlthcare; Dr Reddys Labs; Wockhardt Usa

    4 of 4  
    Drug NamePrevacid
    PubMed HealthNaproxen (By mouth)
    Drug ClassesAnalgesic, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
    Drug LabelThe active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimida...
    Active IngredientLansoprazole
    Dosage FormCapsule, delayed rel pellets; Tablet, delayed release, orally disintegrating
    RouteOral
    Strength30mg; 15mg
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    4.2 Therapeutic Uses

    Antiulcerative

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 961

    Lansoprazole is indicated for the short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD). Lansoprazole is indicated for the short-term (up to 8 weeks) treatment for symptom relief and healing of all grades of erosive esophagitis (associated with GERD). Lansoprazole may be indicated for an additional 8 weeks of treatment of patients in whom healing has not occurred. If erosive esophagitis recurs, an additional course of lansoprazole treatment may be considered. Lansoprazole also is indicated to maintain healing of erosive esophagitis. /Included in US product labeling/

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1724

    Lansoprazole is indicated for short-term (up to 8 weeks) treatment in patients with active benign gastric ulcer. /Included in US product labeling/

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1724

    Lansoprazole is indicated for short-term (up to 4 weeks) treatment for symptom relief and healing in patients with active duodenal ulcer. Lansoprazole also is indicated to maintain healing of duodenal ulcers. /Included in US product labeling/

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1724

    For more Therapeutic Uses (Complete) data for LANSOPRAZOLE (6 total), please visit the HSDB record page.

    4.3 Drug Warning

    Worldwide, over 10,000 patients have been treated with lansoprazole in Phase 2-3 trials involving various dosages and durations of treatment. The adverse reaction profiles for prevacid delayed-release capsules and prevacid for delayed-release oral suspension are similar. In general, lansoprazole treatment has been well-tolerated in both short-term and long-term trials. ... The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

    Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 3211

    An 85-year-old white man presented with an upper gastrointestinal hemorrhage from a gastric ulcer. His platelet count was normal on admission. He was started on oral lansoprazole 60 mg twice daily and, on hospital day 2, his platelet count decreased to 102 x 10(3)/mm(3); on hospital day 3, the platelet count was 36 x 10(3)/mm(3). Lansoprazole was discontinued, and the platelet count returned to normal. He has not had any further episodes of thrombocytopenia to date. After exclusion of other causes, the onset of thrombocytopenia after administration of lansoprazole, the resolution of the adverse reaction after discontinuation of the drug, and the fact that no other medicines were introduced during this time frame lead us to believe that this was most likely an idiosyncratic thrombocytopenic response to lansoprazole. To date, this is the first reported case of what appears to be isolated thrombocytopenia associated with lansoprazole.

    Zlabek JA, Anderson CG: Ann Pharmacother 36 (5): 809-11 (2002)

    Studies in elderly patients indicate that the clearance of lansoprazole is decreased in the elderly, resulting in a 50 to 100% increase in the elimination half-life. Because the mean half-life in the elderly remains between 1.9 and 2.9 hours, repeated once-daily dosing does not result in accumulation of lansoprazole. However, subsequent doses higher than 30 mg a day should not be administered unless additional gastric acid suppression is necessary.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1725

    Diarrhea is one of the most frequently reported adverse events during proton pump inhibitor use in any setting. Because of the limited available information, this study was set up with the aim of assessing the incidence and characteristics of diarrhea and to investigate possible associated co-factors in proton pump inhibitor users in daily practice. Data were used from a prospective, observational study in which 10,008 lansprazole users were followed over time (1994-1998). The study was designed according to the SAMM guidelines. A nested case-control design was used to compare proton pump inhibitor users reporting diarrhea with those reporting no diarrhea. The frequency of diarrhea was 3.7% and the incidence density 10.7 per 1000 patients months of proton pump inhibitor use. The diarrhea was most commonly loose and occurred on average 4.4 times per day. The analysis of co-factors revealed that patients with concomitant use of oral antibiotics and patients reporting neurological and/or dermatological adverse events, were at risk of developing diarrhea during proton pomp inhibitor use.

    PMID:12512247 Claessens AA et al; Pharmacoepidemiol Drug Saf 11 (8): 703-8 (2002)

    For more Drug Warnings (Complete) data for LANSOPRAZOLE (8 total), please visit the HSDB record page.

    4.4 Drug Indication

    Lansoprazole is used to reduce gastric acid secretion and is approved for short term treatment of active gastric ulcers, active duodenal ulcers, erosive reflux oesophagitis, symptomatic gastroesophageal reflux disease, and non-steroidal anti-inflammatory drug (NSAID) induced gastric and duodenal ulcers. It may be used in the maintenance and healing of several gastric conditions including duodenal ulcers, NSAID related gastric ulcers, and erosive esophagitis. Lansoprazole prevents recurrence of gastric ulcers in patients who have a documented history of gastric ulcers who also use NSAIDs chronically. Predictably, it is also useful in the management of hypersecretory conditions including Zollinger-Ellison syndrome. Lansoprazole is effective at eradicating H. pylori when used in conjunction with amoxicillin and clarithromycin (triple therapy) or with amoxicillin alone (dual therapy).

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Lansoprazole decreases gastric acid secretion by targeting H+,K+-ATPase, which is the enzyme that catalyzes the final step in the acid secretion pathway in parietal cells. Conveniently, lansoprazole administered any time of day is able to inhibit both daytime and nocturnal acid secretion. The result is that lansoprazole is effective at healing duodenal ulcers, reduces ulcer-related pain, and offers relief from symptoms of heartburn Lansoprazole also reduces pepsin secretion, making it a useful treatment option for hypersecretory conditions such as Zollinger-Ellison syndrome.

    5.2 MeSH Pharmacological Classification

    Proton Pump Inhibitors

    Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    LANSOPRAZOLE
    5.3.2 FDA UNII
    0K5C5T2QPG
    5.3.3 Pharmacological Classes
    Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]; Inhibition Gastric Acid Secretion [PE]
    5.4 ATC Code

    A02BC03

    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

    A - Alimentary tract and metabolism

    A02 - Drugs for acid related disorders

    A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

    A02BC - Proton pump inhibitors

    A02BC03 - Lansoprazole

    5.5 Absorption, Distribution and Excretion

    Absorption

    The oral bioavailability of lansoprazole is reported to be 80-90% and the peak plasma concentration(Cmax) is achieved about 1.7 hours after oral dosing. Food reduces the absorption of lansoprazole (both Cmax and AUC are reduced by 50-70%); therefore, patients should be instructed to take lansoprazole before meals.

    Route of Elimination

    A reported 14-23% of a lansoprazole is eliminated in the urine with this percentage range including both conjugated and unconjugated hydroxylated metabolites.

    Volume of Distribution

    The apparent volume of distribution of lansoprazole is 0.4 L/kg.

    Clearance

    The reported clearance of lansoprazole is 400-650 mL/min.

    Very high (around 97%) /protein binding/; protein binding remains constant over the concentration range of 0.05 to 5 ug/mL. In patient with renal function impairment, protein binding may be decreased by 1 to 1.5%.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1725

    Distributed in tissue, particularly gastric parietal cells. Apparent oral volume of distribution following administration of 30 mg of lansoprazole is about 0.5 L/kg.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1725

    Since lansoprazole is acid-labile, it is administered as a capsule containing enter-coated granules to prevent gastric decomposition and to increase bioavailability. Once lansoprazole has left the stomach, absorption is rapid and relatively complete, with absolute bioavailability over 80%. Bioavailability may be decreased if lansoprazole is administered within 30 minutes of food intake as compared to that of a fasting state. Absorption may be delayed in patients with hepatic cirrhosis.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1725

    Elimination: Renal: Approximately 14 to 25% of a dose of lansoprazole is excreted in the urine, as conjugated and unconjugated hydroxylated metabolites. Less than 1% of unchanged lansoprazole is detectable in the urine. Biliary/fecal: Approximately two-thirds of a dose of lansoprazole is detected as metabolites in the feces. In dialysis: Lansoprazole and its metabolites are not significantly dialyzed; no appreciable fraction is removed by hemodialysis. Note: Elimination is prolonged in healthy elderly subjects, in adult and elderly patient with mild renal impairment, and in patients with severe liver disease.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1725

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

    5.6 Metabolism/Metabolites

    Lansoprazole is predominantly metabolized in the liver by CYP3A4 and CYP2C19. The resulting major metabolites are 5-hydroxy lansoprazole and the sulfone derivative of lansoprazole.

    Lansoprazole is extensively metabolized in the liver to two main excretory metabolites that are inactive. In the acidic environment of the gastric parietal cell, lansoprazole is converted to two active compounds that inhibit acid secretion by (H+,K+)-ATPase within the parietal cell canaliculus, but that are not present in the systemic circulation.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1725

    5.7 Biological Half-Life

    One source reports the half life of lansoprazole to be 0.9 - 1.6 hours, while another source cites 0.9 - 2.1 hours. The general consensus is that lansoprazole has a short half life and is approximately 2 hours or less. These numbers may be misleading since it suggests that lansoprazole has a short duration of action when in practice, lansoprazole can effectively inhibit acid secretion for ~24 hours due to it's mechanism of action.

    Elimination: Normal renal function: Approximately 1.5 hours. Renal function impairment: Shortened elimination half-life. Elderly patients: 1.9 to 2.9 hours. Hepatic function impairment: 3.2 to 7.2 hours.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1725

    5.8 Mechanism of Action

    As a PPI, lansoprazole is a prodrug and requires protonation via an acidic environment to become activated. Once protonated, lansoprazole is able to react with cysteine residues, specifically Cys813 and Cys321, on parietal H+,K+-ATPase resulting in stable disulfides. PPI's in general are able to provide prolonged inhibition of acid secretion due to their ability to bind covalently to their targets.

    Lansoprazole is a selective and irreversible proton pump inhibitor. In the acidic environment of the gastric parietal cell, lansoprazole is converted to active sulphenamide derivatives that bind to the sulfhydryl group of (H+, K+)-adenosine triphosphatase ((H+,K+)-ATPase), also known as the proton pump (H+,K+)-ATPase catalyzes the final step in the gastric acid secretion pathway. Lansoprazole's inhibition of (H+,K+)-ATPase results in inhibition of both centrally and peripherally mediated gastric acid secretion. The inhibitory effect is dose-related. Lansoprazole inhibits both basal and stimulated gastric acid secretion regardless of the stimulus.

    Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1724

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

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    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

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    DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20406

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    DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 30MG

    USFDA APPLICATION NUMBER - 20406

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