Revision as of 14:32, 24 November 2011 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Saving copy of the {{drugbox}} taken from revid 457178026 of page Ofloxacin for the Chem/Drugbox validation project (updated: 'DrugBank'). |
Latest revision as of 05:30, 23 December 2024 edit Whywhenwhohow (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers49,185 edits infobox |
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{{Short description|Antibiotic to treat bacterial infections}} |
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{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}} |
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{{Infobox drug |
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{{Drugbox |
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| Verifiedfields = changed |
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| Watchedfields = changed |
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| verifiedrevid = 419048432 |
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| verifiedrevid = 462264606 |
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| IUPAC_name = (''RS'')-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclotrideca-5(13),6,8,11-tetraene-11-carboxylic acid |
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| image = Ofloxacin.svg |
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| image = Ofloxacin.svg |
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| width = 200px |
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| width = 240 |
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| imagename = 1 : 1 mixture (racemate) |
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| alt = |
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| chirality = ] |
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| drug_name = Ofloxacin |
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| image2 = Ofloxacin zwitterion ball from xtal.png |
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| alt2 = |
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<!--Clinical data--> |
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<!-- Clinical data --> |
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| pronounce = |
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| tradename = Floxin, Ocuflox |
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| tradename = Floxin, Ocuflox, others |
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| Drugs.com = {{drugs.com|monograph|ofloxacin}} |
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| Drugs.com = {{drugs.com|monograph|ofloxacin}} |
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| MedlinePlus = a691005 |
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| MedlinePlus = a691005 |
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| DailyMedID = Ofloxacin |
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| pregnancy_US = C |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_AU_comment = |
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| pregnancy_category = |
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| routes_of_administration = ], ], ] (]s and ]s) |
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| class = |
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| ATC_prefix = J01 |
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| ATC_suffix = MA01 |
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| ATC_supplemental = {{ATC|J01|RA17}}, {{ATC|J01|RA18}}, {{ATC|S01|AE01}}, {{ATC|S02|AA16}} |
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<!-- Legal status --> |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> |
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| legal_AU_comment = |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> |
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| legal_BR_comment = |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_CA_comment = |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
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| legal_DE_comment = |
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| legal_NZ = <!-- Class A, B, C --> |
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| legal_NZ_comment = |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> |
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| legal_UK_comment = |
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| legal_US = Rx-only |
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| legal_US = Rx-only |
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| legal_US_comment = |
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| routes_of_administration = Oral, ], ] (]s and ]s) |
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| legal_EU = |
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| legal_EU_comment = |
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> |
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| legal_UN_comment = |
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| legal_status = <!-- For countries not listed above --> |
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<!--Pharmacokinetic data--> |
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<!-- Pharmacokinetic data --> |
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| bioavailability = 85% - 95% |
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| bioavailability = 85% – 95% |
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| protein_bound = 32% |
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| protein_bound = 32% |
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| metabolism = |
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| metabolites = |
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| onset = |
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| elimination_half-life = 8–9 hours |
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| elimination_half-life = 8–9 hours |
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| duration_of_action = |
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| excretion = |
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<!--Identifiers--> |
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<!-- Identifiers --> |
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| CASNo_Ref = {{cascite|correct|CAS}} |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| CAS_number = 82419-36-1 |
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| CAS_number = 82419-36-1 |
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| CAS_supplemental = |
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| ATC_prefix = J01 |
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| ATC_suffix = MA01 |
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| ATC_supplemental =  ,{{ATC|S01|AX11}}, {{ATC|S02|AA16}} |
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| PubChem = 4583 |
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| PubChem = 4583 |
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| IUPHAR_ligand = |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = DB01165 |
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| DrugBank = DB01165 |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII = A4P49JAZ9H |
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| UNII = A4P49JAZ9H |
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| KEGG_Ref = {{keggcite|changed|kegg}} |
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| KEGG_Ref = {{keggcite|correct|kegg}} |
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| KEGG = D00453 |
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| KEGG = D00453 |
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| ChEBI_Ref = {{ebicite|changed|EBI}} |
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| ChEBI_Ref = {{ebicite|correct|EBI}} |
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| ChEBI = 7731 |
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| ChEBI = 7731 |
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| ChEMBL_Ref = {{ebicite|correct|EBI}} |
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| ChEMBL_Ref = {{ebicite|correct|EBI}} |
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| ChEMBL = 4 |
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| ChEMBL = 4 |
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| NIAID_ChemDB = |
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| PDB_ligand = |
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| synonyms = <small>(±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7''H''-pyridobenzoxazine-6-carboxylic acid</small> |
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<!--Chemical data--> |
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<!-- Chemical and physical data --> |
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| IUPAC_name = (''RS'')-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclotrideca-5(13),6,8,11-tetraene-11-carboxylic acid |
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| C=18 | H=20 | F=1 | N=3 | O=4 |
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| C=18 | H=20 | F=1 | N=3 | O=4 |
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| molecular_weight = 361.368 g/mol |
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| smiles = Fc4cc1c2N(/C=C(\C1=O)C(=O)O)C(COc2c4N3CCN(C)CC3)C |
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| SMILES = Fc4cc1c2N(/C=C(\C1=O)C(=O)O)C(COc2c4N3CCN(C)CC3)C |
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| InChI = 1/C18H20FN3O4/c1-10-9-26-17-14-11(16(23)12(18(24)25)8-22(10)14)7-13(19)15(17)21-5-3-20(2)4-6-21/h7-8,10H,3-6,9H2,1-2H3,(H,24,25) |
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| InChIKey = GSDSWSVVBLHKDQ-UHFFFAOYAU |
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| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChI_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChI = 1S/C18H20FN3O4/c1-10-9-26-17-14-11(16(23)12(18(24)25)8-22(10)14)7-13(19)15(17)21-5-3-20(2)4-6-21/h7-8,10H,3-6,9H2,1-2H3,(H,24,25) |
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| StdInChI = 1S/C18H20FN3O4/c1-10-9-26-17-14-11(16(23)12(18(24)25)8-22(10)14)7-13(19)15(17)21-5-3-20(2)4-6-21/h7-8,10H,3-6,9H2,1-2H3,(H,24,25) |
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| StdInChI_comment = |
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| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} |
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| StdInChIKey = GSDSWSVVBLHKDQ-UHFFFAOYSA-N |
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| StdInChIKey = GSDSWSVVBLHKDQ-UHFFFAOYSA-N |
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| density = |
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| synonyms = <small>(±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7''H''-pyridobenzoxazine-6-carboxylic acid</small> |
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| density_notes = |
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| melting_point = 250–257 |
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| melting_high = |
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| boiling_point = |
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| boiling_notes = |
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| solubility = |
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| sol_units = |
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| specific_rotation = |
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}} |
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}} |
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'''Ofloxacin''' is a ] useful for the treatment of a number of ]s.<ref name=AHFS2016/> When taken ] or ], these include ], ], ], ], ], and certain types of ].<ref name="AHFS2016">{{cite web|title=Ofloxacin|url=https://www.drugs.com/monograph/ofloxacin.html|publisher=The American Society of Health-System Pharmacists|access-date=8 December 2016|url-status=live|archive-url=https://web.archive.org/web/20161228200053/https://www.drugs.com/monograph/ofloxacin.html|archive-date=28 December 2016}}</ref><ref name="BNF69" /> Other uses, along with other medications, include treating ].<ref name="WHO2008">{{cite book | title = WHO Model Formulary 2008 | year = 2009 | isbn = 9789241547659 | vauthors = ((World Health Organization)) | veditors = Stuart MC, Kouimtzi M, Hill SR | hdl = 10665/44053 | author-link = World Health Organization | publisher = World Health Organization |page=140 }}</ref> An ] may be used for a ] and an ] may be used for ] when a hole in the ] is present.<ref name="BNF69">{{cite book|title=British national formulary: BNF 69|date=2015|publisher=British Medical Association|isbn=9780857111562|pages=409, 757, 782|edition=69}}</ref> |
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<!-- Side effects and mechanisms --> |
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When taken by mouth, common side effects include vomiting, diarrhea, headache, and rash.<ref name=AHFS2016/> Other serious side effect include ], numbness due to nerve damage, ], and ].<ref name=AHFS2016/> Use in ] is typically not recommended.<ref>{{cite web|title=Ofloxacin Use During Pregnancy {{!}} Drugs.com|url=https://www.drugs.com/pregnancy/ofloxacin.html|website=www.drugs.com|access-date=28 December 2016|url-status=live|archive-url=https://web.archive.org/web/20161228200042/https://www.drugs.com/pregnancy/ofloxacin.html|archive-date=28 December 2016}}</ref> Ofloxacin is in the ] family of medications.<ref name=AHFS2016/> It works by interfering with the bacterium's ].<ref name=AHFS2016/> |
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<!-- History and culture --> |
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Ofloxacin was patented in 1980 and approved for medical use in 1985.<ref name=Fis2006>{{cite book| vauthors = Fischer J, Ganellin CR |title=Analogue-based Drug Discovery|date=2006|publisher=John Wiley & Sons|isbn=9783527607495|page=500|url=https://books.google.com/books?id=FjKfqkaKkAAC&pg=PA500|language=en|url-status=live|archive-url=https://web.archive.org/web/20161229100150/https://books.google.ca/books?id=FjKfqkaKkAAC&pg=PA500|archive-date=2016-12-29}}</ref> It is on the ].<ref name="WHO21st">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}</ref> Ofloxacin is available as a ].<ref name=AHFS2016/> In 2022, it was the 206th most commonly prescribed medication in the United States, with more than 1{{nbsp}}million prescriptions.<ref name="Top 300 of 2022">{{cite web | title=The Top 300 of 2022 | url=https://clincalc.com/DrugStats/Top300Drugs.aspx | website=ClinCalc | access-date=30 August 2024 | archive-date=30 August 2024 | archive-url=https://web.archive.org/web/20240830202410/https://clincalc.com/DrugStats/Top300Drugs.aspx | url-status=live }}</ref><ref>{{cite web | title = Ofloxacin Drug Usage Statistics, United States, 2013 - 2022 | website = ClinCalc | url = https://clincalc.com/DrugStats/Drugs/Ofloxacin | access-date = 30 August 2024 }}</ref> |
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==Medical uses== |
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Ofloxacin is used in the treatment of bacterial infections such as: |
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*Acute bacterial exacerbations of ] (COPD) |
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*Community-acquired ] |
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*Uncomplicated skin and skin structure infections |
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*Nongonococcal ] and ] |
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*] |
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*Mixed Infections of the ] and ] |
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*Acute ] |
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*Uncomplicated ] |
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*Complicated ] |
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*] |
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*Acute, uncomplicated urethral and cervical ] |
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Ofloxacin has not been shown to be effective in the treatment of ].<ref name="Ofloxacin label">{{cite web | title=Ofloxacin tablet, film coated | website=DailyMed | date=4 September 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c677b35c-0432-4ee5-af57-1f95449c48b6 | access-date=6 January 2020}}</ref> |
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Fluoroquinolones, the class of drug ofloxacin belongs to, were the drug of choice for treating gonorrhea in the 1980s; However, due to the development of fluoroquinolone-resistant '']'', fluoroquinolones were no longer used to treat gonorrhea by the late 1990s.<ref name="Bodoev2015">{{Cite journal | vauthors = Bodoev IN, Il'Ina EN |date= July 2015 |title=Molecular mechanisms of formation of drug resistance in Neisseria gonorrhoeae: History and prospects |journal=Molecular Genetics, Microbiology and Virology |language=en |volume=30 |issue=3 |pages=132–140 |doi=10.3103/S0891416815030027 |s2cid= 255433752 |issn=0891-4168}}</ref> As of 2004, the failure of single dose ofloxacin to treat gonorrhea has been reported in the ], ], ], and ]. <ref name="pmid15102567">{{cite journal | vauthors = Dan M | title = The use of fluoroquinolones in gonorrhoea: the increasing problem of resistance | journal = Expert Opinion on Pharmacotherapy | volume = 5 | issue = 4 | pages = 829–854 | date = April 2004 | pmid = 15102567 | doi = 10.1517/14656566.5.4.829 | s2cid = 1706114 }}</ref> |
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===Susceptible bacteria=== |
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According to the product package insert, ofloxacin is effective against these microorganisms:<ref name="pmid6960805">{{cite journal | vauthors = Sato K, Matsuura Y, Inoue M, Une T, Osada Y, Ogawa H, Mitsuhashi S | title = In vitro and in vivo activity of DL-8280, a new oxazine derivative | journal = Antimicrobial Agents and Chemotherapy | volume = 22 | issue = 4 | pages = 548–553 | date = October 1982 | pmid = 6960805 | pmc = 183791 | doi = 10.1128/aac.22.4.548 }}</ref> |
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Aerobic Gram-positive microorganisms: |
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*'']'' (]-susceptible strains) |
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*'']'' (]-susceptible strains) |
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*'']'' |
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Aerobic Gram-negative microorganisms |
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*'']'' (''Citrobacter diversus'') |
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*'']'' |
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*'']'' |
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*'']'' |
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*'']'' |
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*'']'' |
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*'']'' |
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*'']'' |
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Other microorganisms: |
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*'']'' |
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==Adverse effects== |
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{{See also|Adverse effects of fluoroquinolones|Levofloxacin#Adverse effects}} |
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In general, fluoroquinolones are well tolerated, with most side effects being mild to moderate.<ref name="Owens RC, Ambrose PG 2005 S144–57">{{cite journal | vauthors = Owens RC, Ambrose PG | title = Antimicrobial safety: focus on fluoroquinolones | journal = Clinical Infectious Diseases | volume = 41 | issue = Suppl 2 | pages = S144–S157 | date = July 2005 | pmid = 15942881 | doi = 10.1086/428055 | doi-access = free }}</ref> On occasion, serious ]s occur.<ref name="pmid11172695">{{cite journal | vauthors = De Sarro A, De Sarro G | title = Adverse reactions to fluoroquinolones. an overview on mechanistic aspects | journal = Current Medicinal Chemistry | volume = 8 | issue = 4 | pages = 371–384 | date = March 2001 | pmid = 11172695 | doi = 10.2174/0929867013373435 }}</ref> Common side effects include gastrointestinal effects such as nausea, vomiting, and diarrhea, as well as headache and insomnia. |
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The overall rate of adverse events in patients treated with fluoroquinolones is roughly similar to that seen in patients treated with other antibiotic classes.<ref>{{cite web |url=https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4266s1-01-06-FDA-Levine.ppt |title=Data Mining Analysis of Multiple Antibiotics in AERS |publisher=U.S. ] (FDA) |url-status=dead |archive-url=https://web.archive.org/web/20160310193444/https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4266s1-01-06-FDA-Levine.ppt |archive-date=2016-03-10 }}</ref><ref>{{cite journal | vauthors = Skalsky K, Yahav D, Lador A, Eliakim-Raz N, Leibovici L, Paul M | title = Macrolides vs. quinolones for community-acquired pneumonia: meta-analysis of randomized controlled trials | journal = Clinical Microbiology and Infection | volume = 19 | issue = 4 | pages = 370–378 | date = April 2013 | pmid = 22489673 | doi = 10.1111/j.1469-0691.2012.03838.x | doi-access = free }}</ref><ref>{{cite journal | vauthors = Falagas ME, Matthaiou DK, Vardakas KZ | title = Fluoroquinolones vs beta-lactams for empirical treatment of immunocompetent patients with skin and soft tissue infections: a meta-analysis of randomized controlled trials | journal = Mayo Clinic Proceedings | volume = 81 | issue = 12 | pages = 1553–1566 | date = December 2006 | pmid = 17165634 | doi = 10.4065/81.12.1553 }}</ref><ref>{{cite journal | vauthors = Van Bambeke F, Tulkens PM | title = Safety profile of the respiratory fluoroquinolone moxifloxacin: comparison with other fluoroquinolones and other antibacterial classes | journal = Drug Safety | volume = 32 | issue = 5 | pages = 359–378 | year = 2009 | pmid = 19419232 | doi = 10.2165/00002018-200932050-00001 | s2cid = 19026852 }}</ref> A U.S. Centers for Disease Control study found patients treated with fluoroquinolones experienced adverse events severe enough to lead to an emergency department visit more frequently than those treated with ]s or ]s, but less frequently than those treated with ]s, ], ]s, or ].<ref>{{cite journal | vauthors = Shehab N, Patel PR, Srinivasan A, Budnitz DS | title = Emergency department visits for antibiotic-associated adverse events | journal = Clinical Infectious Diseases | volume = 47 | issue = 6 | pages = 735–743 | date = September 2008 | pmid = 18694344 | doi = 10.1086/591126 | doi-access = free }}</ref> |
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Postmarketing surveillance has revealed a variety of relatively rare but serious adverse effects associated with all members of the fluoroquinolone antibacterial class. Among these, tendon problems and exacerbation of the symptoms of the neurological disorder ] are the subject of "black box" warnings in the United States. The most severe form of tendonopathy associated with fluoroquinolone administration is tendon rupture, which in the great majority of cases involves the Achilles tendon. Younger people typically experience good recovery, but permanent disability is possible, and is more likely in older patients.<ref>{{cite journal | vauthors = Kim GK | title = The Risk of Fluoroquinolone-induced Tendinopathy and Tendon Rupture: What Does The Clinician Need To Know? | journal = The Journal of Clinical and Aesthetic Dermatology | volume = 3 | issue = 4 | pages = 49–54 | date = April 2010 | pmid = 20725547 | pmc = 2921747 }}</ref> The overall frequency of fluoroquinolone-associated Achilles tendon rupture in patients treated with ciprofloxacin or levofloxacin has been estimated at 17 per 100,000 treatments.<ref>{{cite journal | vauthors = Sode J, Obel N, Hallas J, Lassen A | title = Use of fluroquinolone and risk of Achilles tendon rupture: a population-based cohort study | journal = European Journal of Clinical Pharmacology | volume = 63 | issue = 5 | pages = 499–503 | date = May 2007 | pmid = 17334751 | doi = 10.1007/s00228-007-0265-9 | s2cid = 3330687 }}</ref><ref>{{cite journal | vauthors = Owens RC, Ambrose PG | title = Antimicrobial safety: focus on fluoroquinolones | journal = Clinical Infectious Diseases | volume = 41 | issue = Suppl 2 | pages = S144–S157 | date = July 2005 | pmid = 15942881 | doi = 10.1086/428055 | doi-access = free }}</ref> Risk is substantially elevated in the elderly and in those with recent exposure to topical or systemic corticosteroid therapy. Simultaneous use of ] is present in almost one-third of quinolone-associated tendon rupture.<ref name="pmid16139623">{{cite journal | vauthors = Khaliq Y, Zhanel GG | title = Musculoskeletal injury associated with fluoroquinolone antibiotics | journal = Clinics in Plastic Surgery | volume = 32 | issue = 4 | pages = 495–502, vi | date = October 2005 | pmid = 16139623 | doi = 10.1016/j.cps.2005.05.004 }}</ref> Tendon damage may manifest during and up to a year after fluoroquinolone therapy has been completed.<ref name="pmid10970974">{{cite journal | vauthors = Saint F, Gueguen G, Biserte J, Fontaine C, Mazeman E | title = | language = fr | journal = Revue de Chirurgie Orthopedique et Reparatrice de l'Appareil Moteur | volume = 86 | issue = 5 | pages = 495–497 | date = September 2000 | pmid = 10970974 | url = http://www.masson.fr/masson/MDOI-RCO-09-2000-86-5-0035-1040-101019-ART7 }}</ref> |
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Fluoroquinolones prolong the ] by blocking voltage-gated potassium channels.<ref>{{cite journal | vauthors = Heidelbaugh JJ, Holmstrom H | title = The perils of prescribing fluoroquinolones | journal = The Journal of Family Practice | volume = 62 | issue = 4 | pages = 191–197 | date = April 2013 | pmid = 23570031 }}</ref> Prolongation of the QT interval can lead to '']'', a life-threatening arrhythmia, but in practice, this appears relatively uncommon in part because the most widely prescribed fluoroquinolones (ciprofloxacin and levofloxacin) only minimally prolong the QT interval.<ref name= "Rubinstein">{{cite journal | vauthors = Rubinstein E, Camm J | title = Cardiotoxicity of fluoroquinolones | journal = The Journal of Antimicrobial Chemotherapy | volume = 49 | issue = 4 | pages = 593–596 | date = April 2002 | pmid = 11909831 | doi = 10.1093/jac/49.4.593 | doi-access = free }}</ref> |
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'']''-associated diarrhea may occur in connection with the use of any antibacterial drug, especially those with a broad spectrum of activity such as clindamycin, cephalosporins, and fluoroquinolones. Fluoroquinoline treatment is associated with risk similar to<ref>{{cite journal | vauthors = Deshpande A, Pasupuleti V, Thota P, Pant C, Rolston DD, Sferra TJ, Hernandez AV, Donskey CJ | display-authors = 6 | title = Community-associated Clostridium difficile infection and antibiotics: a meta-analysis | journal = The Journal of Antimicrobial Chemotherapy | volume = 68 | issue = 9 | pages = 1951–1961 | date = September 2013 | pmid = 23620467 | doi = 10.1093/jac/dkt129 | doi-access = free }}</ref> or less<ref>{{cite journal | vauthors = Slimings C, Riley TV | title = Antibiotics and hospital-acquired Clostridium difficile infection: update of systematic review and meta-analysis | journal = The Journal of Antimicrobial Chemotherapy | volume = 69 | issue = 4 | pages = 881–891 | date = April 2014 | pmid = 24324224 | doi = 10.1093/jac/dkt477 | doi-access = free }}</ref><ref>{{cite web |url=https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4266s1-01-06-FDA-Levine.ppt |title=Data Mining Analysis of Multiple Antibiotics in AERS |website=] |url-status=dead |archive-url=https://web.archive.org/web/20160310193444/https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4266s1-01-06-FDA-Levine.ppt |archive-date=2016-03-10 }}</ref> than that associated with broad spectrum cephalosporins. Fluoroquinolone administration may be associated with the acquisition and outgrowth of a particularly virulent ''Clostridium'' strain.<ref>{{cite journal | vauthors = Vardakas KZ, Konstantelias AA, Loizidis G, Rafailidis PI, Falagas ME | title = Risk factors for development of Clostridium difficile infection due to BI/NAP1/027 strain: a meta-analysis | journal = International Journal of Infectious Diseases | volume = 16 | issue = 11 | pages = e768–e773 | date = November 2012 | pmid = 22921930 | doi = 10.1016/j.ijid.2012.07.010 | doi-access = free }}</ref> |
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The US prescribing information contains a warning regarding uncommon cases of peripheral neuropathy, which can be permanent.<ref>{{cite web |url=https://www.fda.gov/Drugs/DrugSafety/ucm365050.htm |title=FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection |publisher=U.S. ] (FDA) |url-status=dead |archive-url=https://web.archive.org/web/20160528231716/https://www.fda.gov/Drugs/DrugSafety/ucm365050.htm |archive-date=2016-05-28 }}</ref> Other nervous system effects include insomnia, restlessness, and rarely, seizure, convulsions, and psychosis<ref>{{cite journal | vauthors = Galatti L, Giustini SE, Sessa A, Polimeni G, Salvo F, Spina E, Caputi AP | title = Neuropsychiatric reactions to drugs: an analysis of spontaneous reports from general practitioners in Italy | journal = Pharmacological Research | volume = 51 | issue = 3 | pages = 211–216 | date = March 2005 | pmid = 15661570 | doi = 10.1016/j.phrs.2004.08.003 }}</ref> Other rare and serious adverse events have been observed with varying degrees of evidence for causation.<ref name="babar">{{cite journal | vauthors = Babar SM | title = SIADH associated with ciprofloxacin | journal = The Annals of Pharmacotherapy | volume = 47 | issue = 10 | pages = 1359–1363 | date = October 2013 | pmid = 24259701 | doi = 10.1177/1060028013502457 | df = dmy-all | s2cid = 36759747 }}</ref><ref name="Rouveix-">{{cite journal | vauthors = Rouveix B | title = | journal = Médecine et Maladies Infectieuses | volume = 36 | issue = 11–12 | pages = 697–705 | date = Nov–Dec 2006 | pmid = 16876974 | doi = 10.1016/j.medmal.2006.05.012 | doi-access = free }}</ref><ref name="pmid17911203">{{cite journal | vauthors = Mehlhorn AJ, Brown DA | title = Safety concerns with fluoroquinolones | journal = The Annals of Pharmacotherapy | volume = 41 | issue = 11 | pages = 1859–1866 | date = November 2007 | pmid = 17911203 | doi = 10.1345/aph.1K347 | s2cid = 26411679 }}</ref><ref>{{cite journal | vauthors = Jones SE, Smith RH | title = Quinolones may induce hepatitis | journal = BMJ | volume = 314 | issue = 7084 | pages = 869 | date = March 1997 | pmid = 9093098 | pmc = 2126221 | doi = 10.1136/bmj.314.7084.869 }}</ref> |
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Events that may occur in acute overdose are rare, and include ] and ].<ref name=Gold2006>{{Cite book | vauthors = Nelson LH, Flomenbaum N, Goldfrank LR, Hoffman RL, Howland MD, Lewin NA |title=Goldfrank's toxicologic emergencies |publisher=McGraw-Hill, Medical Pub. Division |location=New York |year=2006 |isbn=978-0-07-143763-9 |url=https://books.google.com/books?id=cvJuLqBxGUcC&q=goldfranks+Fluoroquinolone+toxicity&pg=PA849 |url-status=live |archive-url=https://web.archive.org/web/20140612171741/http://books.google.com/books?id=cvJuLqBxGUcC&pg=PA849&dq=goldfranks+Fluoroquinolone+toxicity |archive-date=2014-06-12 }}</ref> Susceptible groups of patients, such as children and the elderly, are at greater risk of adverse reactions during therapeutic use.<ref name="Owens RC, Ambrose PG 2005 S144–57"/><ref name="pmid17559736">{{cite journal | vauthors = Iannini PB | title = The safety profile of moxifloxacin and other fluoroquinolones in special patient populations | journal = Current Medical Research and Opinion | volume = 23 | issue = 6 | pages = 1403–1413 | date = June 2007 | pmid = 17559736 | doi = 10.1185/030079907X188099 | s2cid = 34091286 }}</ref><ref>{{Cite web | vauthors = Farinas ER | work = Public Health Service Food and Drug Administration Center for Drug Evaluation and Research |title=Consult: One-Year Post Pediatric Exclusivity Postmarketing Adverse Events Review |url=https://www.fda.gov/OHRMS/DOCKETS/AC/05/briefing/2005-4152b1_03_01_Cipro%20AE.pdf |publisher=U.S. ] (FDA) |date=1 March 2005 |access-date=31 August 2009 |url-status=dead |archive-url=https://web.archive.org/web/20091021063641/https://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4152b1_03_01_Cipro%20AE.pdf |archive-date=21 October 2009 }}</ref> |
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Ofloxacin, like some other fluoroquinolones, may inhibit drug-metabolizing enzymes, and thereby increase blood levels of other drugs such as cyclosporine, theophylline, and warfarin, among others. These increased blood levels may result in a greater risk of side effects. |
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Careful monitoring of serum glucose is advised when ofloxacin or other fluorquinolones are used by people who are taking sulfonylurea antidiabetes drugs. |
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The concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone, including ofloxacin, may increase the risk of central nervous system stimulation and convulsive seizures. |
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The fluoroquinolones have been shown to increase the anticoagulant effect of ], ], and ]. Additionally, the risk of cardiotoxicity and arrhythmias is increased when co-administered with drugs such as ] barbiturate, ], and quinidine barbiturate.<ref name="drugbank.ca">{{cite web |title=Showing drug card for Ofloxacin (DB01165) |url=http://www.drugbank.ca/drugs/DB01165 |publisher=DrugBank |location=Canada |date=February 19, 2009 |url-status=live |archive-url=https://web.archive.org/web/20160514063359/http://www.drugbank.ca/drugs/DB01165 |archive-date=May 14, 2016 }}</ref> |
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Current or past treatment with oral corticosteroids is associated with an increased risk of Achilles tendon rupture, especially in elderly patients who are also taking the fluoroquinolones.<ref>{{cite journal | vauthors = van der Linden PD, Sturkenboom MC, Herings RM, Leufkens HM, Rowlands S, Stricker BH | title = Increased risk of achilles tendon rupture with quinolone antibacterial use, especially in elderly patients taking oral corticosteroids | journal = Archives of Internal Medicine | volume = 163 | issue = 15 | pages = 1801–1807 | date = August 2003 | pmid = 12912715 | doi = 10.1001/archinte.163.15.1801 | doi-access = free }}</ref> |
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==Contraindications== |
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As noted above, under licensed use, ofloxacin is now considered to be ] for the treatment of certain sexually transmitted diseases by some experts due to bacterial resistance.<ref name="nycms.org">{{cite web | vauthors = Blank S, Schillinger J |title=DOHMH ALERT #8:Fluoroquinolone-resistant gonorrhea, NYC |url=http://www.nycms.org/article_view.php3?view=947&part=1 |publisher=New York County Medical Society |location=USA |date=May 14, 2004 |access-date=July 22, 2009 |url-status=dead |archive-url=https://web.archive.org/web/20110722022617/http://www.nycms.org/article_view.php3?view=947&part=1 |archive-date=July 22, 2011 }}</ref> Caution should be used in people with ].<ref>{{cite journal | vauthors = Coban S, Ceydilek B, Ekiz F, Erden E, Soykan I | title = Levofloxacin-induced acute fulminant hepatic failure in a patient with chronic hepatitis B infection | journal = The Annals of Pharmacotherapy | volume = 39 | issue = 10 | pages = 1737–1740 | date = October 2005 | pmid = 16105873 | doi = 10.1345/aph.1G111 | s2cid = 26688176 }}</ref> The excretion of ofloxacin may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). Ofloxacin is also considered to be contraindicated within the pediatric population, ], nursing mothers, patients with psychiatric illnesses and in patients with ] or other seizure disorders. |
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===Pregnancy=== |
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Ofloxacin has not been shown to have any teratogenic effects at oral doses as high as 810 mg/kg/day (11 times the recommended maximum human dose based on mg/m<sup>2</sup> or 50 times based on mg/kg) and 160 mg/kg/day (four times the recommended maximum human dose based on mg/m<sup>2</sup> or 10 times based on mg/kg) when administered to pregnant rats and rabbits, respectively. Additional studies in rats with oral doses up to 360 mg/kg/day (five times the recommended maximum human dose based on mg/m2 or 23 times based on mg/kg) demonstrated no adverse effect on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. Doses equivalent to 50 and 10 times the recommended maximum human dose of ofloxacin (based on mg/kg) were fetotoxic (i.e., decreased fetal body weight and increased fetal mortality) in rats and rabbits, respectively. Minor skeletal variations were reported in rats receiving doses of 810 mg/kg/day, which is more than 10 times higher than the recommended maximum human dose based on mg/m<sup>2</sup>.<ref>Pharmacotherapy: Official Journal of the American College of Clinical Pharmacy Print {{ISSN|0277-0008}} Volume: 25 | Issue: 1 Cover date: January 2005 Page(s): 116–118</ref><ref>{{cite journal | vauthors = Nardiello S, Pizzella T, Ariviello R | title = | journal = Le Infezioni in Medicina | volume = 10 | issue = 1 | pages = 8–15 | date = March 2002 | pmid = 12700435 | name-list-style = vanc }}</ref> |
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There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.<ref name="Ofloxacin label" /> |
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===Children=== |
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Oral and intravenous ofloxacin are not licensed for use in children, except as noted above, due to the risk of musculoskeletal injury. In one study,<ref>{{cite web | title=Levaquin- levofloxacin tablet, film coated | website=DailyMed | date=12 July 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a1f01e8e-97e9-11de-b91d-553856d89593 | access-date=6 January 2020}}</ref><ref name="Noel GJ, Bradley JS, Kauffman RE 2007 879–91">{{cite journal | vauthors = Noel GJ, Bradley JS, Kauffman RE, Duffy CM, Gerbino PG, Arguedas A, Bagchi P, Balis DA, Blumer JL | display-authors = 6 | title = Comparative safety profile of levofloxacin in 2523 children with a focus on four specific musculoskeletal disorders | journal = The Pediatric Infectious Disease Journal | volume = 26 | issue = 10 | pages = 879–891 | date = October 2007 | pmid = 17901792 | doi = 10.1097/INF.0b013e3180cbd382 | s2cid = 26457648 }}</ref> 1534 juvenile patients (age 6 months to 16 years) treated with levofloxacin as part of three efficacy trials were followed up to assess all musculoskeletal events occurring up to 12 months after treatment. At 12 months' follow-up, the cumulative incidence of musculoskeletal adverse events was 3.4%, compared to 1.8% among 893 patients treated with other antibiotics. In the levafloxacin-treated group, about two-thirds of these musculoskeletal adverse events occurred in the first 60 days, 86% were mild, 17% were moderate, and all resolved without long-term sequelae. |
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In a study comparing the safety and efficacy of levofloxacin to that of ] or ] in 712 children with community-acquired pneumonia, adverse events were experienced by 6% of those treated with levofloxacin and 4% of those treated with comparator antibiotics. Most of these adverse events were thought to be unrelated or doubtfully related to the levofloxacin. Two deaths were observed in the levofloxacin group, neither of which was thought to be treatment-related. Spontaneous reports to the FDA Adverse Effects Reporting System at the time of the 20 September 2011 FDA Pediatric Drugs Advisory Committee include musculoskeletal events (39, including five cases of tendon rupture) and ] events (19, including five cases of seizures) as the most common spontaneous reports between April 2005 and March 2008. An estimated 130,000 pediatric prescriptions for levofloxacin were filled on behalf of 112,000 pediatric patients during that period.<ref>{{cite web |title=Adverse Event Review: Levaquin (levofloxacin)|url=https://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4399s1-06%20%28Levofloxacin%29.pdf |publisher=U.S. ] (FDA) |url-status=dead |archive-url=https://web.archive.org/web/20160307233555/https://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4399s1-06%20(Levofloxacin).pdf |archive-date=2016-03-07 }}</ref> |
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==Overdose== |
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Limited information is available on overdose with ofloxacin. Advice for the management of an acute overdose of ofloxacin is emptying of the stomach, along with close observation, and making sure that the patient is appropriately hydrated. Hemodialysis or peritoneal dialysis is of only limited effectiveness.<ref name="Ofloxacin label"/> Overdose may result in ] toxicity, ] toxicity, tendon/] toxicity, and ] toxicity<ref name=Gold2006 /> as well as kidney failure and seizure.<ref name=Gold2006/> Both seizures and severe psychiatric reactions have, however, been reported to occur at therapeutic dosage.<ref name="ijsa.rsmjournals.com">{{cite journal | vauthors = Hall CE, Keegan H, Rogstad KE | title = Psychiatric side effects of ofloxacin used in the treatment of pelvic inflammatory disease | journal = International Journal of STD & AIDS | volume = 14 | issue = 9 | pages = 636–637 | date = September 2003 | pmid = 14511503 | doi = 10.1258/095646203322301121 | s2cid = 7676548 }}</ref><ref name="chestjournal.org">{{cite journal | vauthors = Amsden GW, Graci DM, Cabelus LJ, Hejmanowski LG | title = A randomized, crossover design study of the pharmacology of extended-spectrum fluoroquinolones for pneumococcal infections | journal = Chest | volume = 116 | issue = 1 | pages = 115–119 | date = July 1999 | pmid = 10424513 | doi = 10.1378/chest.116.1.115 }}</ref><ref name="randomhouse.com">{{cite web |url=http://www.randomhouse.com/author/results.pperl?authorid=9367 |title= randomhouse author search|access-date=2009-04-20 |url-status=live |archive-url=https://web.archive.org/web/20110307035325/http://www.randomhouse.com/author/results.pperl?authorid=9367 |archive-date=2011-03-07}}</ref> |
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== Pharmacokinetics == |
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]s of the ofloxacin molecule, levofloxacin or ''S''-ofloxacin (top) and dextrofloxacin or ''R''-ofloxacin (bottom). Only levofloxacin is biologically active, and is thus solely responsible for the effects of the drug.]] |
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The ] of ofloxacin in the tablet form is roughly 98% following oral administration, reaching maximum serum concentrations within one to two hours. Between 65% and 80% of an administered oral dose of ofloxacin is excreted unchanged via the kidneys within 48 hours of dosing. Therefore, elimination is mainly by ] excretion. However, 4-8% of an ofloxacin dose is excreted in the feces. This would indicate a small degree of ] excretion, as well. Plasma ] is around 4 to 5 hours in patients and 6.4 to 7.4 hours in elderly patients.<ref name="Ofloxacin label"/> |
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Ofloxacin is a ] mixture, which consists of 50% ] (the biologically active component) and 50% of its “mirror image” or ] dextrofloxacin.<ref>{{cite web |url=http://www.wvnd.uscourts.gov/Opinions/orthoorder.pdf |title=Ortho-McNeill, Johnson & Johnson, Daichi v. Mylan |access-date=2009-10-25 |url-status=dead |archive-url=https://web.archive.org/web/20080916193351/http://www.wvnd.uscourts.gov/Opinions/orthoorder.pdf |archive-date=2008-09-16 }}</ref> |
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"After multiple-dose administration of 200 mg and 300 mg doses, peak serum levels of 2.2 and 3.6 μg/ml, respectively, are predicted at steady-state. ''In vitro'', approximately 32% of the drug in plasma is protein bound. Floxin is widely distributed to body tissues. Ofloxacin has been detected in blister fluid, cervix, lung tissue, ovary, prostatic fluid, prostatic tissue, skin, and sputum. Pyridobenzoxazine ring appears to decrease the extent of parent compound metabolism. Less than 5% is eliminated by the kidneys as desmethyl or N-oxide metabolites; 4% to 8% by feces."<ref name="Ofloxacin label"/><ref>{{cite web |author=Drugs.com |title=Complete Ofloxacin information from Drugs.com |url=https://www.drugs.com/ppa/ofloxacin.html |url-status=live |archive-url=https://web.archive.org/web/20160303192327/http://www.drugs.com/ppa/ofloxacin.html |archive-date=2016-03-03 }}</ref> |
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A number of the endogenous compounds have been reported to be affected by ofloxacin as inhibitors, alteraters, and depletors. See the latest package insert for ofloxacin for additional details.<ref name="Ofloxacin label"/> |
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==Mode of action== |
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Ofloxacin is a ] that is active against both ] and ] bacteria. It functions by inhibiting two bacterial ]s, ] and ].<ref>{{cite journal | vauthors = Drlica K, Zhao X | title = DNA gyrase, topoisomerase IV, and the 4-quinolones | journal = Microbiology and Molecular Biology Reviews | volume = 61 | issue = 3 | pages = 377–392 | date = September 1997 | pmid = 9293187 | pmc = 232616 | doi = 10.1128/mmbr.61.3.377-392.1997 }}</ref> Topoisomerase IV is an enzyme necessary to separate (mostly in prokaryotes, in bacteria in particular) replicated DNA, thereby inhibiting bacterial cell division. |
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==History== |
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Ofloxacin is a ], being a broader-spectrum analog of ], and was synthesized and developed by scientists at ].<ref name=Sneader2005>{{cite book| vauthors = Sneader W |title=Drug Discovery: A History|url=https://books.google.com/books?id=jglFsz5EJR8C&pg=PA395|date=31 October 2005|publisher=John Wiley & Sons|isbn=978-0-470-01552-0|pages=295|url-status=live|archive-url=https://web.archive.org/web/20170908191512/https://books.google.com/books?id=jglFsz5EJR8C&pg=PA395|archive-date=8 September 2017}}</ref><ref name=Mouton>{{cite journal | vauthors = Mouton Y, Leroy O | title = Ofloxacin | journal = International Journal of Antimicrobial Agents | volume = 1 | issue = 2–3 | pages = 57–74 | year = 1991 | pmid = 18611493 | doi = 10.1016/0924-8579(91)90001-T }}</ref> |
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It was first approved for marketing in Japan in 1985, for oral administration, and Daiichi marketed it there under the brand name Tarvid.<ref name=Atarashi>{{cite web | vauthors = Atarashi S | work = Daiichi | url = http://www.infectweb.com/only/03_SpeFeature.pdf | title = Research and Development of Quinolones in Daiichi Sankyo Co., Ltd. | archive-url = https://web.archive.org/web/20161012025535/http://www.infectweb.com/only/03_SpeFeature.pdf | archive-date= 12 October 2016 | access-date = 25 August 2016 }}</ref> Daiichi, working with ], obtained FDA approval in December 1990, under the brand name Floxin, labelled for use in adults with lower respiratory tract infections, skin and skin structure infections, urinary tract infections, prostatitis, and sexually transmitted diseases.<ref>{{cite web | title = LEVAQUIN Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceutical, Inc. C.A. No. 06-04999-GEB-TJB May 1, 2009 Memorandum Opinion| publisher = Fish & RichaRdson P.C. | url = http://www.fr.com/files/Uploads/attachments/memoranda/memorANDAQ209.pdf | work = memorANDA | date = April 2009 | archive-url = https://web.archive.org/web/20160827002405/http://www.fr.com/files/Uploads/attachments/memoranda/memorANDAQ209.pdf | archive-date = 2016-08-27 | page = VIII }} Cites {{cite patent | country = US | number = 4382892 | title = Benzoxazine derivatives | assign1 = Daiichi Pharmaceutical Co. Ltd. | inventor = Hayakawa I, Hiramitsu T, Tanaka Y | gdate = 10 May 1983 | url = https://www.google.com/patents/US4382892 }}</ref><ref name=Pink>{{cite web | work = The Pink Sheet | date = 7 January 1991 | url = https://pink.pharmamedtechbi.com/PS018598/JOHNSON-amp-JOHNSON-GOING-INTO-1991-WITH-AT-LEAST-FOUR-NEW-PRODUCT-LAUNCHES-FLOXIN-VASCOR-PROCRIT-AND-DURAGESIC-JampJ-LEADING-OFF-WITH-PROCRIT-VASCOR | title = Johnson & Johnson Going Into 1991 With At Least Four New Product Launches: Floxin, Vascor, Procrit And Duragesic; J&J Leading Off With Procrit, Vascor | archive-url = https://web.archive.org/web/20160826140408/https://pink.pharmamedtechbi.com/PS018598/JOHNSON-amp-JOHNSON-GOING-INTO-1991-WITH-AT-LEAST-FOUR-NEW-PRODUCT-LAUNCHES-FLOXIN-VASCOR-PROCRIT-AND-DURAGESIC-JampJ-LEADING-OFF-WITH-PROCRIT-VASCOR | archive-date = 26 August 2016 }}</ref> By 1991, it was also marketed as Tarvid by Hoechst in the UK, Germany, Belgium, and Portugal; as Oflocet in France, Portugal, Tunisia, and several African countries by Roussel-Uclaf, as Oflocin by Glaxo in Italy, and as Flobacin by Sigma-Tau in Italy.<ref name=Mouton/> |
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The market for ofloxacin was seen as difficult from its launch; it was approved as a "1C" drug, a new molecular entity with little or no therapeutic gain over existing therapies, and ], which had a broader spectrum, was already on the market.<ref name=Pink/> |
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By 1992, an intravenous solution was approved for marketing,<ref>{{cite journal | vauthors = Flor SC, Rogge MC, Chow AT | title = Bioequivalence of oral and intravenous ofloxacin after multiple-dose administration to healthy male volunteers | journal = Antimicrobial Agents and Chemotherapy | volume = 37 | issue = 7 | pages = 1468–1472 | date = July 1993 | pmid = 8363378 | pmc = 187996 | doi = 10.1128/aac.37.7.1468 }}</ref> |
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In 1997, an indication for ] was approved by the U.S. ] (FDA) for the oral formulation,<ref>{{cite web|series=Floxin Tablets New FDA Drug Approval | work = CenterWatch|url=https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/212/floxin-tablets-ofloxacin-tablets|title=Floxin Tablets (ofloxacin tablets) |access-date=August 25, 2016|url-status=live|archive-url=https://web.archive.org/web/20160413040722/http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/212/floxin-tablets-ofloxacin-tablets|archive-date=April 13, 2016}}</ref> and in the same year, a solution for ] was approved under the brand <ref>{{cite web|title=Floxin otic New FDA Drug Approval |url= http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/368/floxin-otic |url-status=live |archive-url= https://web.archive.org/web/20160827085637/http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/368/floxin-otic|archive-date=2016-08-27}}</ref> |
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Daiichi and J&J also cannibalized its own market by introducing ], the levo-enantiomer of ofloxacin, in 1996;<ref name=Atarashi/> Johnson and Johnson's annual sales of Floxin in 2003 was about $30 million, whereas their combined sales of Levaquin/Floxin exceeded $1.15 billion in the same year.<ref>{{cite news |title=Teva Announces Approval of Ofloxacin Tablets, 200 mg, 300 mg, and 400 mg |url=http://findarticles.com/p/articles/mi_m0EIN/is_2003_Sept_2/ai_107154169/ |date=September 2, 2003 | work=Business Wire}}</ref><ref>{{cite web |author=Johnson & Johnson |author-link=Johnson & Johnson |title=Building on a foundation of health |url=http://files.shareholder.com/downloads/JNJ/0x0x180977/C0E8971E-DC6F-4DB2-AF7E-00ED716010C8/jnj_2003annual.pdf |publisher=Shareholder |year=2003 |url-status=dead |archive-url=https://web.archive.org/web/20111001135049/http://files.shareholder.com/downloads/JNJ/0x0x180977/C0E8971E-DC6F-4DB2-AF7E-00ED716010C8/jnj_2003annual.pdf |archive-date=2011-10-01 |access-date=2009-05-15 }}</ref> ] withdrew the marketing application in 2009.<ref>{{cite web |title=Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications |url=https://www.fda.gov/ohrms/dockets/98fr/E9-11628.htm |publisher=Federal Register 74(95):23407-23412 |date=May 19, 2009 |quote=see also FDA docket number FDA-2009-N-0211 |url-status=live |archive-url=https://web.archive.org/web/20160919181749/https://www.fda.gov/ohrms/dockets/98fr/E9-11628.htm |archive-date=September 19, 2016 }}</ref> |
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==Society and culture== |
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===Available forms=== |
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Ofloxacin for systemic use is available in multiple strengths as a tablet, an oral suspension, and an injectable solution. It is also used as eye drops and ear drops and is available in combination with ].<ref>{{Cite web |title=Ofloxacin |url=https://go.drugbank.com/drugs/DB01165 |access-date=2022-11-16 |website=Drugbank}}</ref> |
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===Antibiotic use and bacterial resistance=== |
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{{See also|Antibiotic abuse|Antibiotic resistance}} |
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] to ofloxacin and other fluoroquinolones may evolve rapidly, even during a course of treatment. Numerous ]s, including '']'', ], and '']'' now exhibit resistance worldwide.<ref>{{cite book | vauthors = Jacobs M | chapter = Worldwide overview of antimicrobial Resistance. | title = International Symposium on Antimicrobial Agents and Resistance. Drugs. | location = Republic of Korea | date = 2005 | pages = 542–546 }}</ref> |
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Floxacin and other fluoroquinolones had become the most commonly prescribed class of antibiotics to adults in 2002. Nearly half (42%) of these prescriptions were for conditions not approved by the US ] (FDA), such as acute bronchitis, otitis media, and acute upper respiratory tract infection.<ref name="pmid15745724">{{cite journal | vauthors = Linder JA, Huang ES, Steinman MA, Gonzales R, Stafford RS | title = Fluoroquinolone prescribing in the United States: 1995 to 2002 | journal = The American Journal of Medicine | volume = 118 | issue = 3 | pages = 259–268 | date = March 2005 | pmid = 15745724 | doi = 10.1016/j.amjmed.2004.09.015 }}</ref> |
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== References == |
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{{Reflist}} |
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{{Nucleic acid inhibitors}} |
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{{Otologicals}} |
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{{GABAergics}} |
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{{Portal bar | Medicine}} |
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