Oral Ofloxacin: A Critical Review of the New Drug Application
Ofloxacin is a fluoroquinolone with activity against gram-positive and gram-negative aerobic and facultatively anaerobic bacteria, chlamydiae, and some related organisms, such as mycoplasmas or mycobacteria. It has been administered orally to 3,903 patients described in the New Drug Application (NDA...
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Veröffentlicht in: | Clinical infectious diseases 1992-02, Vol.14 (2), p.539-554 |
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description | Ofloxacin is a fluoroquinolone with activity against gram-positive and gram-negative aerobic and facultatively anaerobic bacteria, chlamydiae, and some related organisms, such as mycoplasmas or mycobacteria. It has been administered orally to 3,903 patients described in the New Drug Application (NDA) submitted to the U.S. Food and Drug Administration. Although some components of the NDA lack scientific rigor or fail to mimic clinical practice, other components and the collective whole identify important potential advantages and limitations of the new drug. Ofloxacin was effective in the treatment of infections of the skin, soft tissues, urinary tract, and lower respiratory tract as well as in that of gonococcal and nongonococcal urethritis and prostatitis due to sensitive organisms. Adverse reactions were relatively infrequent, generally mild, and usually self-limiting. Symptoms involving the gastrointestinal tract and the central nervous system predominated. The emergence of resistance and superinfections were uncommon. Few adverse drug interactions were encountered, although antacids may diminish gastrointestinal absorption. In certain defined clinical situations, ofloxacin appears to be a useful addition to the therapeutic armamentarium. |
doi_str_mv | 10.1093/clinids/14.2.539 |
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In certain defined clinical situations, ofloxacin appears to be a useful addition to the therapeutic armamentarium.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1093/clinids/14.2.539</identifier><identifier>PMID: 1554843</identifier><language>eng</language><publisher>United States: The University of Chicago Press</publisher><subject>Administration, Oral ; Adverse drug reactions ; Antibacterials ; Antimicrobials ; Bacterial Infections - drug therapy ; Chemotherapy ; Dosage ; Humans ; Infections ; Medical cures ; Ofloxacin - administration & dosage ; Ofloxacin - adverse effects ; Ofloxacin - therapeutic use ; Quinolones ; Respiratory tract infections ; Review Articles ; Urinary tract infections</subject><ispartof>Clinical infectious diseases, 1992-02, Vol.14 (2), p.539-554</ispartof><rights>Copyright 1992 The University of Chicago</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-ffc7607f330ad70bd45e4a2264ce2d93b057f7a046c361efcf52a014daaefad63</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/4456323$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/4456323$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,778,782,801,27907,27908,58000,58233</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/1554843$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sanders, Jr, W E</creatorcontrib><title>Oral Ofloxacin: A Critical Review of the New Drug Application</title><title>Clinical infectious diseases</title><addtitle>Clinical Infectious Diseases</addtitle><description>Ofloxacin is a fluoroquinolone with activity against gram-positive and gram-negative aerobic and facultatively anaerobic bacteria, chlamydiae, and some related organisms, such as mycoplasmas or mycobacteria. 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In certain defined clinical situations, ofloxacin appears to be a useful addition to the therapeutic armamentarium.</description><subject>Administration, Oral</subject><subject>Adverse drug reactions</subject><subject>Antibacterials</subject><subject>Antimicrobials</subject><subject>Bacterial Infections - drug therapy</subject><subject>Chemotherapy</subject><subject>Dosage</subject><subject>Humans</subject><subject>Infections</subject><subject>Medical cures</subject><subject>Ofloxacin - administration & dosage</subject><subject>Ofloxacin - adverse effects</subject><subject>Ofloxacin - therapeutic use</subject><subject>Quinolones</subject><subject>Respiratory tract infections</subject><subject>Review Articles</subject><subject>Urinary tract infections</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1992</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkD1PwzAYhC0EKlDYGUDKxJbWjr8SJIaqQIuoKOJDQiyW69jgkjbBTqD8e1ylKtN7ep-7Gw6AEwR7CGa4rwq7tLnvI9JLehRnO-AAUcxjRjO0GzSkaUxSnO6DQ-_nECKUQtoBHUQpSQk-AJdTJ4toaopyJZVdXkSDaOhsbVX4Pupvq3-i0kT1h47ug7xyzXs0qKoi8NqWyyOwZ2Th9fHmdsHLzfXzcBxPpqPb4WASK5ySOjZGcQa5wRjKnMNZTqgmMkkYUTrJMzyDlBsuIWEKM6SNMjSREJFcSm1kznAXnLe9lSu_Gu1rsbBe6aKQS102XiCGOOGcByNsjcqV3jttROXsQrpfgaBYLyY2iwlERCLCYiFytuluZgud_wfaiQI_bfnc16XbYkIow8kaxy22vtarLZbuUzCOORXj1zdxN6GjB_LEBcd_u2-Aag</recordid><startdate>19920201</startdate><enddate>19920201</enddate><creator>Sanders, Jr, W E</creator><general>The University of Chicago Press</general><general>University of Chicago Press</general><scope>BSCLL</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>7U7</scope><scope>C1K</scope></search><sort><creationdate>19920201</creationdate><title>Oral Ofloxacin: A Critical Review of the New Drug Application</title><author>Sanders, Jr, W E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-ffc7607f330ad70bd45e4a2264ce2d93b057f7a046c361efcf52a014daaefad63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1992</creationdate><topic>Administration, Oral</topic><topic>Adverse drug reactions</topic><topic>Antibacterials</topic><topic>Antimicrobials</topic><topic>Bacterial Infections - drug therapy</topic><topic>Chemotherapy</topic><topic>Dosage</topic><topic>Humans</topic><topic>Infections</topic><topic>Medical cures</topic><topic>Ofloxacin - administration & dosage</topic><topic>Ofloxacin - adverse effects</topic><topic>Ofloxacin - therapeutic use</topic><topic>Quinolones</topic><topic>Respiratory tract infections</topic><topic>Review Articles</topic><topic>Urinary tract infections</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sanders, Jr, W E</creatorcontrib><collection>Istex</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>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sanders, Jr, W E</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Oral Ofloxacin: A Critical Review of the New Drug Application</atitle><jtitle>Clinical infectious diseases</jtitle><addtitle>Clinical Infectious Diseases</addtitle><date>1992-02-01</date><risdate>1992</risdate><volume>14</volume><issue>2</issue><spage>539</spage><epage>554</epage><pages>539-554</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><abstract>Ofloxacin is a fluoroquinolone with activity against gram-positive and gram-negative aerobic and facultatively anaerobic bacteria, chlamydiae, and some related organisms, such as mycoplasmas or mycobacteria. It has been administered orally to 3,903 patients described in the New Drug Application (NDA) submitted to the U.S. Food and Drug Administration. Although some components of the NDA lack scientific rigor or fail to mimic clinical practice, other components and the collective whole identify important potential advantages and limitations of the new drug. Ofloxacin was effective in the treatment of infections of the skin, soft tissues, urinary tract, and lower respiratory tract as well as in that of gonococcal and nongonococcal urethritis and prostatitis due to sensitive organisms. Adverse reactions were relatively infrequent, generally mild, and usually self-limiting. Symptoms involving the gastrointestinal tract and the central nervous system predominated. The emergence of resistance and superinfections were uncommon. Few adverse drug interactions were encountered, although antacids may diminish gastrointestinal absorption. In certain defined clinical situations, ofloxacin appears to be a useful addition to the therapeutic armamentarium.</abstract><cop>United States</cop><pub>The University of Chicago Press</pub><pmid>1554843</pmid><doi>10.1093/clinids/14.2.539</doi><tpages>16</tpages></addata></record> |
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source | MEDLINE; Oxford University Press Journals Digital Archive Legacy; Jstor Complete Legacy |
subjects | Administration, Oral Adverse drug reactions Antibacterials Antimicrobials Bacterial Infections - drug therapy Chemotherapy Dosage Humans Infections Medical cures Ofloxacin - administration & dosage Ofloxacin - adverse effects Ofloxacin - therapeutic use Quinolones Respiratory tract infections Review Articles Urinary tract infections |
title | Oral Ofloxacin: A Critical Review of the New Drug Application |
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