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    Synopsis

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    Chemistry

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    Also known as: Zithromax, 83905-01-5, Sumamed, Hemomycin, Azasite, Zitromax
    Molecular Formula
    C38H72N2O12
    Molecular Weight
    749.0  g/mol
    InChI Key
    MQTOSJVFKKJCRP-BICOPXKESA-N
    FDA UNII
    J2KLZ20U1M
    Azithromycin
    A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.
    Azithromycin anhydrous is a Macrolide Antimicrobial.
    1 2D Structure

    Azithromycin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one
    2.1.2 InChI
    InChI=1S/C38H72N2O12/c1-15-27-38(10,46)31(42)24(6)40(13)19-20(2)17-36(8,45)33(52-35-29(41)26(39(11)12)16-21(3)48-35)22(4)30(23(5)34(44)50-27)51-28-18-37(9,47-14)32(43)25(7)49-28/h20-33,35,41-43,45-46H,15-19H2,1-14H3/t20-,21-,22+,23-,24-,25+,26+,27-,28+,29-,30+,31-,32+,33-,35+,36-,37-,38-/m1/s1
    2.1.3 InChI Key
    MQTOSJVFKKJCRP-BICOPXKESA-N
    2.1.4 Canonical SMILES
    CCC1C(C(C(N(CC(CC(C(C(C(C(C(=O)O1)C)OC2CC(C(C(O2)C)O)(C)OC)C)OC3C(C(CC(O3)C)N(C)C)O)(C)O)C)C)C)O)(C)O
    2.1.5 Isomeric SMILES
    CC[C@@H]1[C@@]([C@@H]([C@H](N(C[C@@H](C[C@@]([C@@H]([C@H]([C@@H]([C@H](C(=O)O1)C)O[C@H]2C[C@@]([C@H]([C@@H](O2)C)O)(C)OC)C)O[C@H]3[C@@H]([C@H](C[C@H](O3)C)N(C)C)O)(C)O)C)C)C)O)(C)O
    2.2 Other Identifiers
    2.2.1 UNII
    J2KLZ20U1M
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Azadose

    2. Azithromycin Dihydrate

    3. Azithromycin Monohydrate

    4. Azitrocin

    5. Azythromycin

    6. Cp 62993

    7. Cp-62993

    8. Cp62993

    9. Dihydrate, Azithromycin

    10. Goxal

    11. Monohydrate, Azithromycin

    12. Sumamed

    13. Toraseptol

    14. Ultreon

    15. Vinzam

    16. Zentavion

    17. Zithromax

    18. Zitromax

    2.3.2 Depositor-Supplied Synonyms

    1. Zithromax

    2. 83905-01-5

    3. Sumamed

    4. Hemomycin

    5. Azasite

    6. Zitromax

    7. Zmax

    8. Azithromycine

    9. Azithromycinum

    10. Azenil

    11. Aziromycin

    12. Zithromac

    13. Azithromycine [french]

    14. Azithromycinum [latin]

    15. Azithromycin Dihydrate

    16. Cp 62993

    17. Cp-62993

    18. Azitromax

    19. Misultina

    20. Tromix

    21. Azithromycin Anhydrous

    22. Azithrocin

    23. Aruzilina

    24. Macrozit

    25. Trozocina

    26. Xithrone

    27. Zythromax

    28. Aziwin

    29. Durasite

    30. Xz-450

    31. Toraseptol

    32. Anhydrous Azithromycin

    33. 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin A

    34. J2klz20u1m

    35. Chebi:2955

    36. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-(((2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yl)oxy)-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

    37. Azitrocin

    38. Xz 405

    39. Xz 450

    40. Nsc-758625

    41. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

    42. Ncgc00090753-01

    43. Aritromicina

    44. Mixoterin

    45. Zithrax

    46. Zitrotek

    47. Aziwok

    48. Aztrin

    49. Setron

    50. Zitrim

    51. Tobil

    52. Zifin

    53. Cp-62,993

    54. Zeto

    55. Zmas

    56. Zithromax Iv

    57. Dsstox_cid_10760

    58. Dsstox_rid_78858

    59. Dsstox_gsid_30760

    60. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-{[3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl]oxy}-1-oxa-6-azacyclopentadecan-13-yl 2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranoside

    61. Z-pak

    62. C38h72n2o12

    63. Aritromicina [spanish]

    64. Azitromicine

    65. Azithromycin (as Dihydrate)

    66. Trulimax

    67. Zentavion

    68. Drg-0104

    69. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-{[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-2-ethyl-3,4,10-trihydroxy-13-{[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

    70. 13-[(2,6-dideoxy-3-c-methyl-3-o-methyl-?-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-?-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one

    71. Azm

    72. Smr000471864

    73. Zit

    74. Azithromycin (zithromax)

    75. Cas-83905-01-5

    76. Ccris 1961

    77. Azithromycin [inn]

    78. Hsdb 7205

    79. Z-pak (azithromycin)

    80. Azithromycin (anhydrous)

    81. Sr-05000002067

    82. Azithromycin, Antibiotic For Culture Media Use Only

    83. Unii-j2klz20u1m

    84. Brn 5387583

    85. Azithramycine

    86. Azitromicina

    87. Zithromycin

    88. Azifast

    89. Azigram

    90. Azimakrol

    91. Azitromin

    92. Azyter

    93. Azithromycin [usan:inn:ban]

    94. Nsc643732

    95. Azithromycin (aids Initiative)

    96. Azithromycin,(s)

    97. Zmax Sr

    98. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6

    99. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-{[3,4,6-trideoxy-3-(dimethylamino)-b-d-xylo-hexopyranosyl]oxy}-1-oxa-6-azacyclopentadecan-13-yl 2,6-dideoxy-3-c-methyl-3-o-methyl-a-l-ribo-hexopyranoside

    100. Zitromax Avium 600

    101. Azitromicina [spanish]

    102. Spectrum_000307

    103. Azithromycin, Unspecified

    104. Dch3

    105. Spectrum2_001582

    106. Spectrum3_000653

    107. Spectrum4_000186

    108. Spectrum5_001867

    109. Azithromycin [mi]

    110. Chembl529

    111. Azithromycin [hsdb]

    112. Ec 617-500-5

    113. Schembl23481

    114. Bspbio_002285

    115. Kbiogr_000731

    116. Kbioss_000787

    117. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-1-oxa-6-azacyclopentadecan-15-one

    118. 1-oxa-6-azacyclopentadecan-15-one, 13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-, (2r-(2r*,3s*,4r*,5r*,8r*,10r*,11r*,12s*,13s*,14r*))-

    119. Mls001055353

    120. Mls001066331

    121. Mls001201763

    122. Mls001304005

    123. Mls001332499

    124. Mls001332500

    125. Azithromycin [who-dd]

    126. Azithromycin, Unspecified Form

    127. Bidd:gt0792

    128. Divk1c_000233

    129. Spectrum1503679

    130. N-methyl-11-aza-10-deoxo-10-dihydroerythromycin A

    131. Spbio_001544

    132. Gtpl6510

    133. Dtxsid8030760

    134. Azithromycin, Analytical Standard

    135. Hms500l15

    136. Kbio1_000233

    137. Kbio2_000787

    138. Kbio2_003355

    139. Kbio2_005923

    140. Kbio3_001505

    141. Ninds_000233

    142. Hms1922g12

    143. Hms2094m11

    144. Hms2232m10

    145. Hms3259d10

    146. Act03224

    147. Azithromycin [usp Monograph]

    148. Tox21_111008

    149. Tox21_201011

    150. Bdbm50373918

    151. Ccg-39360

    152. Mfcd00873574

    153. Zinc85537026

    154. Akos015895044

    155. Db00207

    156. Nc00712

    157. Nsc 758625

    158. Azithromycin 100 Microg/ml In Methanol

    159. Idi1_000233

    160. Ncgc00090753-02

    161. Ncgc00090753-03

    162. Ncgc00090753-04

    163. Ncgc00090753-06

    164. Ncgc00258564-01

    165. Ac-16014

    166. Cp62,993

    167. Hy-17506

    168. Sbi-0206706.p001

    169. Cp-62993-3

    170. A-9940

    171. A-9941

    172. N46072

    173. Ab00698251-10

    174. Ab00698251_11

    175. 905a015

    176. A905251

    177. Q165399

    178. Sr-05000002067-1

    179. Sr-05000002067-2

    180. Brd-k74501079-001-18-1

    181. Z1563146014

    182. Azithromycin, European Pharmacopoeia (ep) Reference Standard

    183. Azithromycin Identity, United States Pharmacopeia (usp) Reference Standard

    184. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-((2s,3r,4s,6r)-

    185. Azithromycin For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    186. Azithromycin For System Suitability, European Pharmacopoeia (ep) Reference Standard

    187. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-((2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2h-pyran-2-yloxy)-2-ethyl-3,4,10-trihydroxy-13-((2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2h-pyran-2-yloxy)-3,5,6,8,10,12,14-heptamethy...

    188. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyl-tetrahydropyran-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

    189. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)-11-[(2s,3r,4s,6r)-4-dimethylamino-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2r,4r,5s,6s)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-one

    190. (2r,3s,4r,5r,8r,10r,11r,12s,13s,14r)13-((2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl)oxy)-1-oxa-6-azacyclopentadecan-15-one

    191. [2r-(2r*,3s*,4r*,5r*,8r*,10r*,11r*,12s*,13s*,14r*)]-13-[(2,6-dideoxy-3-c-methyl-3-o-methyl-.alpha.-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-

    192. 13-[(2,6-dideoxy-3-c-methyl-3-o-methyl-alpha-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-beta-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 749.0 g/mol
    Molecular Formula C38H72N2O12
    XLogP34
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count7
    Exact Mass748.50852574 g/mol
    Monoisotopic Mass748.50852574 g/mol
    Topological Polar Surface Area180 Ų
    Heavy Atom Count52
    Formal Charge0
    Complexity1150
    Isotope Atom Count0
    Defined Atom Stereocenter Count18
    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 8  
    Drug NameAzasite
    Drug LabelAzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of...
    Active IngredientAzithromycin
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyOak Pharms Akorn

    2 of 8  
    Drug NameAzithromycin
    PubMed HealthAzithromycin (Into the eye)
    Drug ClassesAntibiotic
    Drug LabelAzithromycin tablets and azithromycin for oral suspension contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12S,13S,14R)-1...
    Active IngredientAzithromycin
    Dosage FormInjectable; Tablet; Solution; For suspension
    Routeophthalmic; Injection; Oral
    Strength1%; eq 600mg base; eq 500mg base; eq 500mg base/vial; eq 100mg base/5ml; eq 250mg base; eq 200mg base/5ml
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Sagent Strides; Teva Pharms; Fresenius Kabi Usa; Hospira; Gland Pharma; Teva; Apotex; Sun Pharm Inds; Pliva; Sandoz; Mylan

    3 of 8  
    Drug NameZithromax
    PubMed HealthAzithromycin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12...
    Active IngredientAzithromycin
    Dosage FormTablet; Injectable; For suspension
    RouteInjection; Oral
    Strengtheq 500mg base; eq 100mg base/5ml; eq 250mg base; eq 1gm base/packet; eq 200mg base/5ml; eq 600mg base; eq 500mg base/vial
    Market StatusPrescription
    CompanyPfizer

    4 of 8  
    Drug NameZmax
    PubMed HealthAzithromycin
    Drug ClassesAntibiotic
    Drug LabelZmax (azithromycin extended release) for oral suspension contains the active ingredient azithromycin (as azithromycin dihydrate), an azalide, a subclass of macrolide antibiotics. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)...
    Active IngredientAzithromycin
    Dosage FormFor suspension, extended release
    RouteOral
    Strengtheq 2gm base/bot
    Market StatusPrescription
    CompanyPf Prism Cv

    5 of 8  
    Drug NameAzasite
    Drug LabelAzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of...
    Active IngredientAzithromycin
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength1%
    Market StatusPrescription
    CompanyOak Pharms Akorn

    6 of 8  
    Drug NameAzithromycin
    PubMed HealthAzithromycin (Into the eye)
    Drug ClassesAntibiotic
    Drug LabelAzithromycin tablets and azithromycin for oral suspension contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12S,13S,14R)-1...
    Active IngredientAzithromycin
    Dosage FormInjectable; Tablet; Solution; For suspension
    Routeophthalmic; Injection; Oral
    Strength1%; eq 600mg base; eq 500mg base; eq 500mg base/vial; eq 100mg base/5ml; eq 250mg base; eq 200mg base/5ml
    Market StatusTentative Approval; Prescription
    CompanyWockhardt; Sagent Strides; Teva Pharms; Fresenius Kabi Usa; Hospira; Gland Pharma; Teva; Apotex; Sun Pharm Inds; Pliva; Sandoz; Mylan

    7 of 8  
    Drug NameZithromax
    PubMed HealthAzithromycin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R, 10R,11R,12...
    Active IngredientAzithromycin
    Dosage FormTablet; Injectable; For suspension
    RouteInjection; Oral
    Strengtheq 500mg base; eq 100mg base/5ml; eq 250mg base; eq 1gm base/packet; eq 200mg base/5ml; eq 600mg base; eq 500mg base/vial
    Market StatusPrescription
    CompanyPfizer

    8 of 8  
    Drug NameZmax
    PubMed HealthAzithromycin
    Drug ClassesAntibiotic
    Drug LabelZmax (azithromycin extended release) for oral suspension contains the active ingredient azithromycin (as azithromycin dihydrate), an azalide, a subclass of macrolide antibiotics. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)...
    Active IngredientAzithromycin
    Dosage FormFor suspension, extended release
    RouteOral
    Strengtheq 2gm base/bot
    Market StatusPrescription
    CompanyPf Prism Cv

    4.2 Therapeutic Uses

    Anti-Bacterial Agents

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2012)

    Azithromycin is used orally in children for the treatment of acute otitis media (AOM) caused by Haemophilus influenzae, M. catarrhalis, or S. pneumoniae. /Included in US product labeling/

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 225

    Azithromycin is used orally for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci) in adults and children when first-line therapy (penicillins) cannot be used. /Included in US product labeling/

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 225

    Although further study is needed, azithromycin has been used in conjunction with an antimalarial agent (e.g., chloroquine, quinine, artesunate [not commercially available in the US]) for the treatment of uncomplicated malaria caused by Plasmodium falciparum, including multidrug-resistant strains. Azithromycin should not be used alone as monotherapy for the treatment of malaria. /NOT included in US product labeling/

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 229

    For more Therapeutic Uses (Complete) data for AZITHROMYCIN (52 total), please visit the HSDB record page.

    4.3 Drug Warning

    Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure; patients on drugs known to prolong the QT interval; or patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.

    US FDA; Label Information for ZITHROMAX (azithromycin tablets) and (azithromycin for oral suspension) (Last updated January 2013). Available from, as of March 15, 2013: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf

    Pregnancy risk category: B /NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absents of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility./

    Physicians Desk Reference. 58th ed. Thomson PDR. Montvale, NJ 2004., p. 2684

    The most frequent adverse effects of azithromycin involve the GI tract (i.e., diarrhea/loose stools, nausea, abdominal pain). While these adverse effects generally are mild to moderate in severity and occur less frequently than with oral erythromycin, adverse GI effects are the most frequent reason for discontinuing azithromycin therapy. Administration of conventional azithromycin tablets or oral suspension with food may improve GI tolerability.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 234

    Azithromycin has been detected in human milk. The drug should be used with caution in nursing women.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 237

    For more Drug Warnings (Complete) data for AZITHROMYCIN (30 total), please visit the HSDB record page.

    4.4 Drug Indication

    Azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria in order to prevent the development antimicrobial resistance and maintain the efficacy of azithromycin. Azithromycin is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the microorganisms listed in the specific conditions below. Recommended dosages, duration of therapy and considerations for various patient populations may vary among these infections. Refer to the FDA label and "Indications" section of this drug entry for detailed information. **Adults**: Acute bacterial exacerbations of chronic obstructive pulmonary disease due to _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Acute bacterial sinusitis due to _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Community-acquired pneumonia due to _Chlamydophila pneumoniae_, _Haemophilus influenzae_, _Mycoplasma pneumoniae_ or _Streptococcus pneumoniae_ in patients appropriate for oral therapy Pharyngitis/tonsillitis caused by _Streptococcus pyogenes_ as an alternative to first-line therapy in individuals who cannot use first-line therapy. Uncomplicated skin and skin structure infections due to _Staphylococcus aureus_, _Streptococcus pyogenes_, or _Streptococcus agalactiae_. Abscesses usually require surgical drainage. Urethritis and cervicitis due to _Chlamydia trachomatis_ or _Neisseria gonorrhoeae_. Genital ulcer disease in men due to _Haemophilus ducreyi_ (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. **Pediatric Patients** Acute otitis media caused by _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Community-acquired pneumonia due to _Chlamydophila pneumoniae_, _Haemophilus influenzae_, _Mycoplasma pneumoniae_ or _Streptococcus pneumoniae_ in patients appropriate for oral therapy. Pharyngitis/tonsillitis caused by _Streptococcus pyogenes_ as an alternative to first-line therapy in individuals who cannot use first-line therapy.

    Treatment of bacterial conjunctivitis

    Prevention of bronchopulmonary dysplasia

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Macrolides stop bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections. Azithromycin has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose.

    5.2 MeSH Pharmacological Classification

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    AZITHROMYCIN ANHYDROUS
    5.3.2 FDA UNII
    J2KLZ20U1M
    5.3.3 Pharmacological Classes
    Macrolides [CS]; Macrolide Antimicrobial [EPC]
    5.4 ATC Code

    J01FA10

    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

    J - Antiinfectives for systemic use

    J01 - Antibacterials for systemic use

    J01F - Macrolides, lincosamides and streptogramins

    J01FA - Macrolides

    J01FA10 - Azithromycin

    S - Sensory organs

    S01 - Ophthalmologicals

    S01A - Antiinfectives

    S01AA - Antibiotics

    S01AA26 - Azithromycin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Bioavailability of azithromycin is 37% following oral administration. Absorption is not affected by food. Macrolide absorption in the intestines is believed to be mediated by P-glycoprotein (ABCB1) efflux transporters, which are known to be encoded by the _ABCB1_ gene.

    Route of Elimination

    Biliary excretion of azithromycin, primarily as unchanged drug, is a major route of elimination. Over a 1 week period, approximately 6% of the administered dose is found as unchanged drug in urine.

    Volume of Distribution

    After oral administration, azithromycin is widely distributed in tissues with an apparent steady-state volume of distribution of 31.1 L/kg. Significantly greater azithromycin concentrations have been measured in the tissues rather than in plasma or serum,. The lung, tonsils and prostate are organs have shown a particularly high rate of azithromycin uptake. This drug is concentrated within macrophages and polymorphonucleocytes, allowing for effective activity against Chlamydia trachomatis. In addition, azithromycin is found to be concentrated in phagocytes and fibroblasts, shown by in vitro incubation techniques. In vivo studies demonstrate that concentration in phagocytes may contribute to azithromycin distribution to inflamed tissues.

    Clearance

    Mean apparent plasma cl=630 mL/min (following single 500 mg oral and i.v. dose)

    Biliary excretion of azithromycin, predominantly as unchanged drug is a major route of elimination following oral administration.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241

    Azithromycin is rapidly absorbed from the GI tract after oral administration; absorption of the drug is incomplete but exceeds that of erythromycin. The absolute oral bioavailability of azithromycin is reported to be approximately 34-52% with single doses of 500 mg to 1.2 g administered as various oral dosage forms. Limited evidence indicates that the low bioavailability of zithromycin results from incomplete GI absorption rather acid degradation of the drug or extensive first-pss metabolism.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 240

    Azithromycin appears to be distributed into most body tissues and fluids after oral or IV administration. The extensive tissue uptake of azithromycin has been attributed to cellular uptake of this basic antibiotic into relatively acidic lysosomes as a result of iron trapping and to an energy-dependent pathway associated with the nucleoside transport system.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 240

    Because of rapid distribution into tissues and high intracellular concentrations of azithromycin, tissue concentrations of the drug generally exceed plasma concentrations by 10- to 100-fold following single dose administration; with multiple dosing, the tissue-to-plasma ratio increases.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241

    For more Absorption, Distribution and Excretion (Complete) data for AZITHROMYCIN (10 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed, however, this drug is eliminated by the liver,.

    The principal route of biotransformation involves N-demethylation of the desosamine sugar or at the 9a position on the macrolide ring. Other metabolic pathways include O-demethylation and hydrolysis and/or hydroxylation of the cladinose and desosamine sugar moieties and the macrolide ring. Up to 10 metabolites of azithromycin have been identified, and all are microbiologically inactive. While short-term administration of azithromycin produces hepatic accumulation of the drug and increases azithromycin demethylase activity, current evidence indicates that hepatic cytochrome p450 induction of inactivation via cytochrome-metabolite complex formation does not occur. In contrast to erythromycin, azithromycin does not inhibit its own metabolism via this pathway.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241

    5.7 Biological Half-Life

    Terminal elimination half-life: 68 hours

    An elimination half-life of 54.5 hours has been reported in children 4 months to 15 years of age receiving single or multiple oral doses of azithromycin.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241

    Plasma azithromycin concentrations following a single 500-mg oral or IV dose decline in a polyphasic manner with a terminal elimination half-life averaging 68 hours. The high values for apparent steady-state volume of distribution (31.3-33.3 L/kg) and plasma clearance (630 mL/minute, 10.18 mL/minute per kg) of azithromycin suggest that the prolonged half-life is related to extensive uptake and subsequent release of the drug from tissues. The average tissue half-life of azithromycin is estimated to be 1-4 days. The half-life of the drug in peripheral leukocytes ranges from 34-57 hours.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 241

    5.8 Mechanism of Action

    In order to replicate, bacteria require a specific process of protein synthesis, enabled by ribosomal proteins. Azithromycin binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It stops bacterial protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit,. This results in the control of various bacterial infections,. The strong affinity of macrolides, including azithromycin, for bacterial ribosomes, is consistent with their broadspectrum antibacterial activities. Azithromycin is highly stable at a low pH, giving it a longer serum half-life and increasing its concentrations in tissues compared to erythromycin.

    Azithromycin usually is bacteriostatic, although the drug may be bactericidal in high concentrations against selected organisms. Bactericidal activity has been observed in vitro against Streptococcus pyogenes, S. pneumoniae, and Haemophilus influenzae. Azithromycin inhibits protein synthesis in susceptible organisms by penetrating the cell wall and binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. The site of action of azithromycin appears to be the same as that of the macrolides (i.e., erythromycin, clarithromycin), clindamycin, lincomycin, and chloramphenicol. The antimicrobial activity of azithromycin is reduced at low pH. Azithromycin concentrates in phagocytes, including polymorphonuclear leukocytes, monocytes, macrophages, and fibroblasts. Penetration of the drug into phagocytic cells is necessary for activity against intracellular pathogens (e.g., Staphylococcus aureus, Legionella pneumophila, Chlamydia trachomatis, Salmonella typhi).

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 238

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    01-Jan-2021
    31-Aug-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORA...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

    USFDA APPLICATION NUMBER - 50797

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