{"id":"gemifloxacin-mesylate","rwe":[{"pmid":"38592494","year":"2024","title":"Luminescent and time-resolved determination of gemifloxacin mesylate in pharmaceutical formulations and spiked blood plasma samples using a lanthanide complex as a probe.","finding":"","journal":"Analytical methods : advancing methods and applications","studyType":"Clinical Study"},{"pmid":"36933133","year":"2023","title":"Rapid elimination of antibiotic gemifloxacin mesylate and methylene blue over Pt nanoparticles dispersed chitosan/g-C(3)N(4) ternary visible light photocatalyst.","finding":"","journal":"Environmental science and pollution research international","studyType":"Clinical Study"},{"pmid":"36876464","year":"2023","title":"Design and evaluation of in situ gel eye drops containing nanoparticles of Gemifloxacin Mesylate.","finding":"","journal":"Drug delivery","studyType":"Clinical Study"},{"pmid":"32454688","year":"2019","title":"A Validated Reverse Phase-Ultra-Performance Liquid Chromatography Method for the Determination of Gemifloxacin Mesylate in Bulk and its Pharmaceutical Preparation.","finding":"","journal":"Turkish journal of pharmaceutical sciences","studyType":"Clinical Study"},{"pmid":"27588824","year":"2016","title":"Ingestion of the anti-bacterial agent, gemifloxacin mesylate, leads to increased gst activity and peroxidation products in hemolymph of Galleria mellonella l. (lepidoptera: pyralidae).","finding":"","journal":"Archives of insect biochemistry and physiology","studyType":"Clinical Study"}],"tags":[{"label":"Quinolone Antimicrobial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01MA15","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Acute bacterial bronchitis","category":"indication"},{"label":"Acute exacerbation of chronic bronchitis","category":"indication"},{"label":"Bacterial pneumonia","category":"indication"},{"label":"Chlamydial pneumonia","category":"indication"},{"label":"Haemophilus influenzae pneumonia","category":"indication"},{"label":"Moraxella Catarrhalis Pneumonia","category":"indication"},{"label":"Lg Chem Ltd","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Topoisomerase II Inhibitors","category":"pharmacology"},{"label":"Topoisomerase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"drugInteractions":[{"url":"/drug/high-risk-qt-prolonging-agents","drug":"High Risk QT Prolonging Agents","action":"Avoid combination","effect":"Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents","source":"DrugCentral","drugSlug":"high-risk-qt-prolonging-agents"},{"url":"/drug/dronedarone","drug":"dronedarone","action":"Monitor closely","effect":"May interact with Dronedarone, Gemifloxacin","source":"DrugCentral","drugSlug":"dronedarone"},{"url":"/drug/hydrocortisone","drug":"hydrocortisone","action":"Monitor closely","effect":"May interact with Gemifloxacin, Hydrocortisone","source":"DrugCentral","drugSlug":"hydrocortisone"},{"url":"/drug/methylprednisolone","drug":"methylprednisolone","action":"Monitor closely","effect":"May interact with Gemifloxacin, Methylprednisolone","source":"DrugCentral","drugSlug":"methylprednisolone"},{"url":"/drug/prednisolone","drug":"prednisolone","action":"Monitor closely","effect":"May interact with Gemifloxacin, Prednisolone","source":"DrugCentral","drugSlug":"prednisolone"},{"url":"/drug/prednisone","drug":"prednisone","action":"Monitor closely","effect":"May interact with Gemifloxacin, Prednisone","source":"DrugCentral","drugSlug":"prednisone"}],"commonSideEffects":[{"effect":"Headache","drugRate":"4.2%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"3.7%","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"3.5%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"2.2%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"1.6%","severity":"common","organSystem":""},{"effect":"Increased ALT","drugRate":"1.7%","severity":"common","organSystem":""},{"effect":"Increased platelets","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Increased AST","drugRate":"1.3%","severity":"common","organSystem":""},{"effect":"Urticaria","drugRate":"0.8%","severity":"common","organSystem":""},{"effect":"Increased creatine phosphokinase","drugRate":"0.7%","severity":"common","organSystem":""},{"effect":"Decreased neutrophils","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Increased neutrophils","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Increased alkaline phosphatase","drugRate":"0.4%","severity":"common","organSystem":""},{"effect":"Increased total bilirubin","drugRate":"0.4%","severity":"common","organSystem":""},{"effect":"Decreased hematocrit","drugRate":"0.3%","severity":"common","organSystem":""},{"effect":"Increased potassium","drugRate":"0.3%","severity":"common","organSystem":""},{"effect":"Increased blood urea nitrogen","drugRate":"0.3%","severity":"common","organSystem":""},{"effect":"Decreased albumin","drugRate":"0.3%","severity":"common","organSystem":""}],"contraindications":["Bradycardia","Congenital long QT syndrome","Depressive disorder","Epilepsy","Hypokalemia","Hypomagnesemia","Impaired renal function disorder","Myasthenia gravis","Peripheral nerve disease","Prolonged QT interval","Pseudomembranous enterocolitis","Tendinitis","Torsades de pointes","Transplant of kidney","Transplant of lung","Transplantation of heart"],"specialPopulations":{"Pregnancy":"...","Geriatric use":"In adult subjects, the pharmacokinetics of gemifloxacin are not affected by age.","Paediatric use":"The pharmacokinetics of gemifloxacin in pediatric subjects have not been studied.","Renal impairment":"...","Hepatic impairment":"The pharmacokinetics following single 320 mg dose of gemifloxacin were studied in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) liver disease. There was mean increase in AUC (0-inf) of 34% and mean increase in Cmax of 25% in these patients with hepatic impairment compared to healthy volunteers.The pharmacokinetics of single 320 mg dose of gemifloxacin were also studied in patients with severe hepatic impairment (Child-Pugh Class C). There was mean increase in AUC (0-inf) of 45% and mean increase in Cmax of 41% in these subjects with hepatic impairment compared to healthy volunteers.These average pharmacokinetic increases are not considered to be clinically significant. There was no"},"seriousAdverseEvents":[{"effect":"Rash (discontinuation)","drugRate":"0.8%","severity":"serious"},{"effect":"Nausea (discontinuation)","drugRate":"0.3%","severity":"serious"},{"effect":"Diarrhea (discontinuation)","drugRate":"0.3%","severity":"serious"},{"effect":"Urticaria (discontinuation)","drugRate":"0.2%","severity":"serious"},{"effect":"Vomiting (discontinuation)","drugRate":"0.2%","severity":"serious"},{"effect":"Photosensitivity/phototoxicity reactions","drugRate":"0.1%","severity":"serious"},{"effect":"Thrombocytopenia","drugRate":"0.1%","severity":"serious"},{"effect":"Granulocytopenia","drugRate":"0.1%","severity":"serious"},{"effect":"Anemia","drugRate":"0.1%","severity":"serious"},{"effect":"Eosinophilia","drugRate":"0.1%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Lg Chem Ltd","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GEMIFLOXACIN MESYLATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:39:09.568605+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Gemifloxacin Mesylate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:39:20.351021+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:39:18.546486+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GEMIFLOXACIN MESYLATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:39:19.368601+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Topoisomerase IV inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:39:20.350819+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200621/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:39:20.248110+00:00"}},"allNames":"factive","offLabel":[],"synonyms":["gemifloxacin mesilate","gemifloxacin","gemifloxacin mesylate"],"timeline":[{"date":"2002-12-27","type":"positive","source":"DrugCentral","milestone":"Korean Food and Drug Administration (KFDA) approval"},{"date":"2003-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from LG LIFE SCIENCES to Lg Chem Ltd"},{"date":"2003-04-04","type":"positive","source":"DrugCentral","milestone":"FDA approval (Lg Life Sciences)"},{"date":"2015-06-15","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Factive (Gemifloxacin mesylate) is a quinolone antimicrobial small molecule developed by LG Life Sciences and currently owned by LG Chem Ltd. It was FDA-approved in 2003 for the treatment of various bacterial infections, including pneumonia and bronchitis. Factive is off-patent and has a generic manufacturer. The drug has a half-life of 8.3 hours. It is used to treat a range of bacterial infections, including those caused by Haemophilus influenzae and Klebsiella pneumoniae.","brandName":"Factive","ecosystem":[{"indication":"Acute bacterial bronchitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefaclor","slug":"cefaclor","company":""},{"name":"cefixime","slug":"cefixime","company":""}],"globalPrevalence":null},{"indication":"Acute exacerbation of chronic bronchitis","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefditoren pivoxil","slug":"cefditoren-pivoxil","company":"Vansen Pharma"}],"globalPrevalence":null},{"indication":"Bacterial pneumonia","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Chlamydial pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"clarithromycin","slug":"clarithromycin","company":"Abbvie"},{"name":"erythromycin","slug":"erythromycin","company":"Arbor Pharms Llc"}],"globalPrevalence":null},{"indication":"Haemophilus influenzae pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Moraxella Catarrhalis Pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefdinir","slug":"cefdinir","company":""}],"globalPrevalence":null},{"indication":"Pneumococcal pneumonia","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"benzathine benzylpenicillin","slug":"benzathine-benzylpenicillin","company":"King Pharms"}],"globalPrevalence":null},{"indication":"Pneumonia due to Klebsiella pneumoniae","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"clavulanic acid","slug":"clavulanic-acid","company":"Dr Reddys Labs Inc"},{"name":"moxifloxacin","slug":"moxifloxacin","company":"Bayer Hlthcare"},{"name":"norfloxacin","slug":"norfloxacin","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Quinolone Antimicrobial","explanation":"","oneSentence":"","technicalDetail":"Gemifloxacin mesylate exerts its antibacterial effects by binding to the A subunit of DNA gyrase and the A subunit of topoisomerase IV, thereby inhibiting the enzymes' ability to relax supercoiled DNA and facilitate DNA replication and transcription."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Gemifloxacin","title":"Gemifloxacin","extract":"Gemifloxacin mesylate, sold under the brand name Factive among others, is a broad-spectrum quinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. It is taken by mouth. Vansen Pharma Inc. licensed the active ingredient from LG Life Sciences of Korea."},"commercial":{"launchDate":"2003","_launchSource":"DrugCentral (FDA 2003-04-04, LG LIFE SCIENCES)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1286","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=GEMIFLOXACIN%20MESYLATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GEMIFLOXACIN MESYLATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Gemifloxacin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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available","relationship":"same-class"},{"drugName":"trovafloxacin","drugSlug":"trovafloxacin","fdaApproval":"1997-12-18","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"moxifloxacin","drugSlug":"moxifloxacin","fdaApproval":"1999-12-10","patentExpiry":"May 29, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"gatifloxacin","drugSlug":"gatifloxacin","fdaApproval":"2003-03-28","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"delafloxacin","drugSlug":"delafloxacin","fdaApproval":"2017-06-19","patentExpiry":"Sep 23, 2029","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"gemifloxacin mesylate","indications":{"approved":[{"name":"Acute bacterial bronchitis","source":"DrugCentral","snomedId":233598009,"regulator":"FDA","eligibility":null},{"name":"Acute exacerbation of chronic bronchitis","source":"DrugCentral","snomedId":425748003,"regulator":"FDA","eligibility":"Patients who have no alternative treatment options"},{"name":"Bacterial pneumonia","source":"DrugCentral","snomedId":53084003,"regulator":"FDA","eligibility":null},{"name":"Chlamydial pneumonia","source":"DrugCentral","snomedId":233609002,"regulator":"FDA","eligibility":null},{"name":"Haemophilus influenzae pneumonia","source":"DrugCentral","snomedId":70036007,"regulator":"FDA","eligibility":null},{"name":"Moraxella Catarrhalis Pneumonia","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Pneumococcal pneumonia","source":"DrugCentral","snomedId":233607000,"regulator":"FDA","eligibility":null},{"name":"Pneumonia due to Klebsiella pneumoniae","source":"DrugCentral","snomedId":64479007,"regulator":"FDA","eligibility":null},{"name":"Pneumonia due to Mycoplasma 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Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-11-20","conditions":["Retinal Detachment","Achilles Tendon","Aneurysm, Dissecting"],"enrollment":117911,"completionDate":"2018-06-04"},{"nctId":"NCT04692623","phase":"PHASE1","title":"EFFECTS OF MOXIFLOXACIN AND GEMIFLOXACIN ON BLOOD GLUCOSE AND ECG MORPHOLOGY OF EUGLYCEMICS:A CLINICAL STUDY","status":"COMPLETED","sponsor":"Shaheed Benazir Bhutto University Sheringal Dir Upper","startDate":"2021-03-01","conditions":["Blood Glucose, Low","Hypoglycemia"],"enrollment":25,"completionDate":"2021-04-01"},{"nctId":"NCT04168099","phase":"PHASE3","title":"Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis","status":"RECRUITING","sponsor":"Tanta University","startDate":"2018-12-01","conditions":["Spontaneous Bacterial Peritonitis"],"enrollment":60,"completionDate":"2028-12-30"},{"nctId":"NCT03535558","phase":"","title":"Fluoroquinolone Associated Disability","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-05-17","conditions":["Bronchitis","Sinusitis","Urinary Tract Infections"],"enrollment":239306,"completionDate":"2018-12-31"},{"nctId":"NCT03326050","phase":"EARLY_PHASE1","title":"Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2018-02","conditions":["Rhinoscleroma"],"enrollment":60,"completionDate":"2018-10"},{"nctId":"NCT00926796","phase":"PHASE4","title":"Efficacy of Combination Therapies for Gonorrhea Treatment","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases 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international"},{"date":"2023 Dec","pmid":"36876464","title":"Design and evaluation of in situ gel eye drops containing nanoparticles of Gemifloxacin Mesylate.","journal":"Drug delivery"},{"date":"2019 Mar","pmid":"32454688","title":"A Validated Reverse Phase-Ultra-Performance Liquid Chromatography Method for the Determination of Gemifloxacin Mesylate in Bulk and its Pharmaceutical Preparation.","journal":"Turkish journal of pharmaceutical sciences"},{"date":"2016 Dec","pmid":"27588824","title":"Ingestion of the anti-bacterial agent, gemifloxacin mesylate, leads to increased gst activity and peroxidation products in hemolymph of Galleria mellonella l. (lepidoptera: pyralidae).","journal":"Archives of insect biochemistry and physiology"}],"companionDiagnostics":[],"genericManufacturers":1,"_genericFilersChecked":true,"genericManufacturerList":["Orbion Pharms"],"status":"approved","companyName":"Lg Chem Ltd","companyId":"lg-chem-ltd","modality":"Small molecule","firstApprovalDate":"2003","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2003-04-04T00:00:00.000Z","mah":"LG CHEM LTD","brand_name_local":"FACTIVE","application_number":"NDA021158"},{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":"2009-12-31T00:00:00.000Z","mah":"Menarini International Operations Luxembourg S.A.","brand_name_local":"Factive","application_number":"EMEA/H/C/000995"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2015-06-15T00:00:00.000Z","mah":"ORBION PHARMS","brand_name_local":"GEMIFLOXACIN MESYLATE","application_number":"ANDA090466"},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:39:22.134803+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}