Rifampicin Reduces Plasma Concentrations of Moxifloxacin in Patients with Tuberculosis
Background. The long duration of the current tuberculosis (TB) treatment is demanding and warrants the development of new drugs. Moxifloxacin shows promising results and may be combined with rifampicin to shorten the duration of TB treatment. Rifampicin induces the phase II metabolic enzymes that ar...
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| Veröffentlicht in: | Clinical infectious diseases 2007-10, Vol.45 (8), p.1001-1007 |
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| creator | Nijland, H. M. J. Ruslami, R. Suroto, A. Juwono Burger, D. M. Alisjahbana, B. van Crevel, R. Aarnoutse, R. E. |
| description | Background. The long duration of the current tuberculosis (TB) treatment is demanding and warrants the development of new drugs. Moxifloxacin shows promising results and may be combined with rifampicin to shorten the duration of TB treatment. Rifampicin induces the phase II metabolic enzymes that are involved in the biotransformation of moxifloxacin. Therefore, the interaction between rifampicin and moxifloxacin should be investigated. Patients and methods. Nineteen Indonesian patients with pulmonary TB who were in the last month of their TB treatment completed a 1-arm, 2-period, fixed-order pharmacokinetic study. In phase 1 of the study, they received 400 mg of moxifloxacin every day for 5 days in addition to 450 mg of rifampicin and 600 mg of isoniazid 3 times per week. In phase 2 of the study, after a 1-month washout period, patients received moxifloxacin for another 5 days (without rifampicin and isoniazid). A 24-h pharmacokinetic curve for moxifloxacin was recorded on the last day of both study periods, and its pharmacokinetic parameters were evaluated for an interaction with rifampicin, using a bioequivalence approach. Results. Coadministration of moxifloxacin with rifampicin and isoniazid resulted in an almost uniform decrease in moxifloxacin exposure (in 18 of 19 patients). The geometric means for the ratio of phase 1 area under the curve to phase 2 area under the curve and for the ratio of phase 1 peak plasma concentration to phase 2 peak plasma concentration were 0.69 (90% confidence interval, 0.65–0.74) and 0.68 (90% confidence interval, 0.64–0.73), respectively. The median time to reach peak plasma concentration for moxifloxacin was prolonged from 1 h to 2.5 h when combined with rifampicin and isoniazid (P = .003). Conclusions. Coadministration of moxifloxacin with intermittently administered rifampicin and isoniazid results in reduced moxifloxacin plasma concentrations, which is most likely the result of induced glucuronidation or sulphation by rifampicin. Further studies are warranted to evaluate the impact of the interaction on the outcome of TB treatment. |
| doi_str_mv | 10.1086/521894 |
| format | Article |
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M. J. ; Ruslami, R. ; Suroto, A. Juwono ; Burger, D. M. ; Alisjahbana, B. ; van Crevel, R. ; Aarnoutse, R. E.</creator><creatorcontrib>Nijland, H. M. J. ; Ruslami, R. ; Suroto, A. Juwono ; Burger, D. M. ; Alisjahbana, B. ; van Crevel, R. ; Aarnoutse, R. E.</creatorcontrib><description>Background. The long duration of the current tuberculosis (TB) treatment is demanding and warrants the development of new drugs. Moxifloxacin shows promising results and may be combined with rifampicin to shorten the duration of TB treatment. Rifampicin induces the phase II metabolic enzymes that are involved in the biotransformation of moxifloxacin. Therefore, the interaction between rifampicin and moxifloxacin should be investigated. Patients and methods. Nineteen Indonesian patients with pulmonary TB who were in the last month of their TB treatment completed a 1-arm, 2-period, fixed-order pharmacokinetic study. In phase 1 of the study, they received 400 mg of moxifloxacin every day for 5 days in addition to 450 mg of rifampicin and 600 mg of isoniazid 3 times per week. In phase 2 of the study, after a 1-month washout period, patients received moxifloxacin for another 5 days (without rifampicin and isoniazid). A 24-h pharmacokinetic curve for moxifloxacin was recorded on the last day of both study periods, and its pharmacokinetic parameters were evaluated for an interaction with rifampicin, using a bioequivalence approach. Results. Coadministration of moxifloxacin with rifampicin and isoniazid resulted in an almost uniform decrease in moxifloxacin exposure (in 18 of 19 patients). The geometric means for the ratio of phase 1 area under the curve to phase 2 area under the curve and for the ratio of phase 1 peak plasma concentration to phase 2 peak plasma concentration were 0.69 (90% confidence interval, 0.65–0.74) and 0.68 (90% confidence interval, 0.64–0.73), respectively. The median time to reach peak plasma concentration for moxifloxacin was prolonged from 1 h to 2.5 h when combined with rifampicin and isoniazid (P = .003). Conclusions. Coadministration of moxifloxacin with intermittently administered rifampicin and isoniazid results in reduced moxifloxacin plasma concentrations, which is most likely the result of induced glucuronidation or sulphation by rifampicin. Further studies are warranted to evaluate the impact of the interaction on the outcome of TB treatment.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1086/521894</identifier><identifier>PMID: 17879915</identifier><identifier>CODEN: CIDIEL</identifier><language>eng</language><publisher>Chicago, IL: The University of Chicago Press</publisher><subject>Adolescent ; Adult ; Antibacterial agents ; Antibiotics ; Antibiotics, Antitubercular - pharmacokinetics ; Antibiotics, Antitubercular - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Articles and Commentaries ; Aza Compounds - administration & dosage ; Aza Compounds - antagonists & inhibitors ; Aza Compounds - pharmacokinetics ; Bacterial diseases ; Biological and medical sciences ; Blood plasma ; Clinical trials ; Dosage ; Drug Interactions ; Enzymes ; Female ; Fluoroquinolones ; Geometric mean ; Human bacterial diseases ; Humans ; Indonesia ; Infectious diseases ; Isoniazid - therapeutic use ; Male ; Medical sciences ; Medical treatment ; Medications ; Middle Aged ; Mycobacterium ; Mycobacterium tuberculosis ; Pharmacokinetics ; Pharmacology. Drug treatments ; Plasma ; Plasma - chemistry ; Pulmonary tuberculosis ; Quinolines - administration & dosage ; Quinolines - antagonists & inhibitors ; Quinolines - pharmacokinetics ; Quinolones ; Rifampin - administration & dosage ; Rifampin - therapeutic use ; Studies ; Tuberculosis ; Tuberculosis and atypical mycobacterial infections ; Tuberculosis, Pulmonary - drug therapy</subject><ispartof>Clinical infectious diseases, 2007-10, Vol.45 (8), p.1001-1007</ispartof><rights>Copyright 2007 The Infectious Diseases Society of America</rights><rights>2007 of the Infectious Diseases Society of America 2007</rights><rights>2008 INIST-CNRS</rights><rights>Copyright University of Chicago, acting through its Press Oct 15, 2007</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c507t-d1653d42e803def36f5705732d36994cbf1cec855dd0b4059e27a604bbe6c9e03</citedby><cites>FETCH-LOGICAL-c507t-d1653d42e803def36f5705732d36994cbf1cec855dd0b4059e27a604bbe6c9e03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/4485628$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/4485628$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>315,782,786,805,27933,27934,58026,58259</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20289789$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17879915$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nijland, H. M. J.</creatorcontrib><creatorcontrib>Ruslami, R.</creatorcontrib><creatorcontrib>Suroto, A. Juwono</creatorcontrib><creatorcontrib>Burger, D. M.</creatorcontrib><creatorcontrib>Alisjahbana, B.</creatorcontrib><creatorcontrib>van Crevel, R.</creatorcontrib><creatorcontrib>Aarnoutse, R. E.</creatorcontrib><title>Rifampicin Reduces Plasma Concentrations of Moxifloxacin in Patients with Tuberculosis</title><title>Clinical infectious diseases</title><addtitle>Clinical Infectious Diseases</addtitle><addtitle>Clinical Infectious Diseases</addtitle><description>Background. The long duration of the current tuberculosis (TB) treatment is demanding and warrants the development of new drugs. Moxifloxacin shows promising results and may be combined with rifampicin to shorten the duration of TB treatment. Rifampicin induces the phase II metabolic enzymes that are involved in the biotransformation of moxifloxacin. Therefore, the interaction between rifampicin and moxifloxacin should be investigated. Patients and methods. Nineteen Indonesian patients with pulmonary TB who were in the last month of their TB treatment completed a 1-arm, 2-period, fixed-order pharmacokinetic study. In phase 1 of the study, they received 400 mg of moxifloxacin every day for 5 days in addition to 450 mg of rifampicin and 600 mg of isoniazid 3 times per week. In phase 2 of the study, after a 1-month washout period, patients received moxifloxacin for another 5 days (without rifampicin and isoniazid). A 24-h pharmacokinetic curve for moxifloxacin was recorded on the last day of both study periods, and its pharmacokinetic parameters were evaluated for an interaction with rifampicin, using a bioequivalence approach. Results. Coadministration of moxifloxacin with rifampicin and isoniazid resulted in an almost uniform decrease in moxifloxacin exposure (in 18 of 19 patients). The geometric means for the ratio of phase 1 area under the curve to phase 2 area under the curve and for the ratio of phase 1 peak plasma concentration to phase 2 peak plasma concentration were 0.69 (90% confidence interval, 0.65–0.74) and 0.68 (90% confidence interval, 0.64–0.73), respectively. The median time to reach peak plasma concentration for moxifloxacin was prolonged from 1 h to 2.5 h when combined with rifampicin and isoniazid (P = .003). Conclusions. Coadministration of moxifloxacin with intermittently administered rifampicin and isoniazid results in reduced moxifloxacin plasma concentrations, which is most likely the result of induced glucuronidation or sulphation by rifampicin. Further studies are warranted to evaluate the impact of the interaction on the outcome of TB treatment.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antibacterial agents</subject><subject>Antibiotics</subject><subject>Antibiotics, Antitubercular - pharmacokinetics</subject><subject>Antibiotics, Antitubercular - therapeutic use</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Articles and Commentaries</subject><subject>Aza Compounds - administration & dosage</subject><subject>Aza Compounds - antagonists & inhibitors</subject><subject>Aza Compounds - pharmacokinetics</subject><subject>Bacterial diseases</subject><subject>Biological and medical sciences</subject><subject>Blood plasma</subject><subject>Clinical trials</subject><subject>Dosage</subject><subject>Drug Interactions</subject><subject>Enzymes</subject><subject>Female</subject><subject>Fluoroquinolones</subject><subject>Geometric mean</subject><subject>Human bacterial diseases</subject><subject>Humans</subject><subject>Indonesia</subject><subject>Infectious diseases</subject><subject>Isoniazid - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Medications</subject><subject>Middle Aged</subject><subject>Mycobacterium</subject><subject>Mycobacterium tuberculosis</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Plasma</subject><subject>Plasma - chemistry</subject><subject>Pulmonary tuberculosis</subject><subject>Quinolines - administration & dosage</subject><subject>Quinolines - antagonists & inhibitors</subject><subject>Quinolines - pharmacokinetics</subject><subject>Quinolones</subject><subject>Rifampin - administration & dosage</subject><subject>Rifampin - therapeutic use</subject><subject>Studies</subject><subject>Tuberculosis</subject><subject>Tuberculosis and atypical mycobacterial infections</subject><subject>Tuberculosis, Pulmonary - drug therapy</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10F2L1DAUBuAiiruu-gtEqqB31Xx_XMqgjjLquruKeBPSNMGMbTPmtDj-e7N0mAVBCCTwPpwc3qp6iNELjJR4yQlWmt2qTjGnshFc49vljbhqmKLqpLoHsEUIY4X43eoESyW1xvy0-noRgx120cWxvvDd7DzU572FwdarNDo_TtlOMY1Qp1B_SPsY-rS317qc8xIVAfXvOP2or-bWZzf3CSLcr-4E24N_cLjPqi9vXl-t1s3m09t3q1ebxnEkp6bDgtOOEa8Q7XygInCJuKSko0Jr5tqAnXeK865DLUNceyKtQKxtvXDaI3pWPV_m7nL6NXuYzBDB-b63o08zGIIUU0SQAp_-A7dpzmPZzRCstaKF3UxzOQFkH8wux8HmPwYjc12zWWou8PFh2twOvrthh14LeHYAFpztQ7aji3B0BBGlpdLFPVlcmnf__-zRYrYwpXxUjCkuiCpxs8QRJr8_xjb_NEJSyc3623ejLj9-vlyjjXlP_wK7XKZ1</recordid><startdate>20071015</startdate><enddate>20071015</enddate><creator>Nijland, H. M. J.</creator><creator>Ruslami, R.</creator><creator>Suroto, A. Juwono</creator><creator>Burger, D. M.</creator><creator>Alisjahbana, B.</creator><creator>van Crevel, R.</creator><creator>Aarnoutse, R. E.</creator><general>The University of Chicago Press</general><general>University of Chicago Press</general><general>Oxford University Press</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>P64</scope></search><sort><creationdate>20071015</creationdate><title>Rifampicin Reduces Plasma Concentrations of Moxifloxacin in Patients with Tuberculosis</title><author>Nijland, H. M. J. ; Ruslami, R. ; Suroto, A. Juwono ; Burger, D. M. ; Alisjahbana, B. ; van Crevel, R. ; Aarnoutse, R. E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c507t-d1653d42e803def36f5705732d36994cbf1cec855dd0b4059e27a604bbe6c9e03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antibacterial agents</topic><topic>Antibiotics</topic><topic>Antibiotics, Antitubercular - pharmacokinetics</topic><topic>Antibiotics, Antitubercular - therapeutic use</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Articles and Commentaries</topic><topic>Aza Compounds - administration & dosage</topic><topic>Aza Compounds - antagonists & inhibitors</topic><topic>Aza Compounds - pharmacokinetics</topic><topic>Bacterial diseases</topic><topic>Biological and medical sciences</topic><topic>Blood plasma</topic><topic>Clinical trials</topic><topic>Dosage</topic><topic>Drug Interactions</topic><topic>Enzymes</topic><topic>Female</topic><topic>Fluoroquinolones</topic><topic>Geometric mean</topic><topic>Human bacterial diseases</topic><topic>Humans</topic><topic>Indonesia</topic><topic>Infectious diseases</topic><topic>Isoniazid - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Medications</topic><topic>Middle Aged</topic><topic>Mycobacterium</topic><topic>Mycobacterium tuberculosis</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Plasma</topic><topic>Plasma - chemistry</topic><topic>Pulmonary tuberculosis</topic><topic>Quinolines - administration & dosage</topic><topic>Quinolines - antagonists & inhibitors</topic><topic>Quinolines - pharmacokinetics</topic><topic>Quinolones</topic><topic>Rifampin - administration & dosage</topic><topic>Rifampin - therapeutic use</topic><topic>Studies</topic><topic>Tuberculosis</topic><topic>Tuberculosis and atypical mycobacterial infections</topic><topic>Tuberculosis, Pulmonary - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nijland, H. M. J.</creatorcontrib><creatorcontrib>Ruslami, R.</creatorcontrib><creatorcontrib>Suroto, A. Juwono</creatorcontrib><creatorcontrib>Burger, D. M.</creatorcontrib><creatorcontrib>Alisjahbana, B.</creatorcontrib><creatorcontrib>van Crevel, R.</creatorcontrib><creatorcontrib>Aarnoutse, R. E.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nijland, H. M. J.</au><au>Ruslami, R.</au><au>Suroto, A. Juwono</au><au>Burger, D. M.</au><au>Alisjahbana, B.</au><au>van Crevel, R.</au><au>Aarnoutse, R. E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rifampicin Reduces Plasma Concentrations of Moxifloxacin in Patients with Tuberculosis</atitle><jtitle>Clinical infectious diseases</jtitle><stitle>Clinical Infectious Diseases</stitle><addtitle>Clinical Infectious Diseases</addtitle><date>2007-10-15</date><risdate>2007</risdate><volume>45</volume><issue>8</issue><spage>1001</spage><epage>1007</epage><pages>1001-1007</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><coden>CIDIEL</coden><abstract>Background. The long duration of the current tuberculosis (TB) treatment is demanding and warrants the development of new drugs. Moxifloxacin shows promising results and may be combined with rifampicin to shorten the duration of TB treatment. Rifampicin induces the phase II metabolic enzymes that are involved in the biotransformation of moxifloxacin. Therefore, the interaction between rifampicin and moxifloxacin should be investigated. Patients and methods. Nineteen Indonesian patients with pulmonary TB who were in the last month of their TB treatment completed a 1-arm, 2-period, fixed-order pharmacokinetic study. In phase 1 of the study, they received 400 mg of moxifloxacin every day for 5 days in addition to 450 mg of rifampicin and 600 mg of isoniazid 3 times per week. In phase 2 of the study, after a 1-month washout period, patients received moxifloxacin for another 5 days (without rifampicin and isoniazid). A 24-h pharmacokinetic curve for moxifloxacin was recorded on the last day of both study periods, and its pharmacokinetic parameters were evaluated for an interaction with rifampicin, using a bioequivalence approach. Results. Coadministration of moxifloxacin with rifampicin and isoniazid resulted in an almost uniform decrease in moxifloxacin exposure (in 18 of 19 patients). The geometric means for the ratio of phase 1 area under the curve to phase 2 area under the curve and for the ratio of phase 1 peak plasma concentration to phase 2 peak plasma concentration were 0.69 (90% confidence interval, 0.65–0.74) and 0.68 (90% confidence interval, 0.64–0.73), respectively. The median time to reach peak plasma concentration for moxifloxacin was prolonged from 1 h to 2.5 h when combined with rifampicin and isoniazid (P = .003). Conclusions. Coadministration of moxifloxacin with intermittently administered rifampicin and isoniazid results in reduced moxifloxacin plasma concentrations, which is most likely the result of induced glucuronidation or sulphation by rifampicin. Further studies are warranted to evaluate the impact of the interaction on the outcome of TB treatment.</abstract><cop>Chicago, IL</cop><pub>The University of Chicago Press</pub><pmid>17879915</pmid><doi>10.1086/521894</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical infectious diseases, 2007-10, Vol.45 (8), p.1001-1007 |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; JSTOR Archive Collection A-Z Listing; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adolescent Adult Antibacterial agents Antibiotics Antibiotics, Antitubercular - pharmacokinetics Antibiotics, Antitubercular - therapeutic use Antibiotics. Antiinfectious agents. Antiparasitic agents Articles and Commentaries Aza Compounds - administration & dosage Aza Compounds - antagonists & inhibitors Aza Compounds - pharmacokinetics Bacterial diseases Biological and medical sciences Blood plasma Clinical trials Dosage Drug Interactions Enzymes Female Fluoroquinolones Geometric mean Human bacterial diseases Humans Indonesia Infectious diseases Isoniazid - therapeutic use Male Medical sciences Medical treatment Medications Middle Aged Mycobacterium Mycobacterium tuberculosis Pharmacokinetics Pharmacology. Drug treatments Plasma Plasma - chemistry Pulmonary tuberculosis Quinolines - administration & dosage Quinolines - antagonists & inhibitors Quinolines - pharmacokinetics Quinolones Rifampin - administration & dosage Rifampin - therapeutic use Studies Tuberculosis Tuberculosis and atypical mycobacterial infections Tuberculosis, Pulmonary - drug therapy |
| title | Rifampicin Reduces Plasma Concentrations of Moxifloxacin in Patients with Tuberculosis |
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