publisher 1st baron verulam [40:<18 years of age. 1 Like other fluoroquinolones, gemifloxacin causes arthropathy and osteochondrosis in juvenile animals. 1 12 45 46 47 48 49 52 53 (See Musculoskeletal Effects under Cautions.) AAP states use of systemic fluoroquinolones may be justified in children> <18 years of age in special circumstances when there are no safe and effective alternatives and after careful assessment of risks and benefits for the individual patient. 110 292 Geriatric Use No overall differences in safety or efficacy relative to younger adults. 1 Risk of severe tendon disorders, including tendon rupture, is increased in older adults (usually those >60 years of age). 1 128 129 This risk is further increased in those receiving concomitant corticosteroids. 1 128 129 (See Tendinitis and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids. 1 Risk of QT interval prolongation may be increased in geriatric patients. 1 (See Prolongation of QT Interval under Cautions.) Consider age-related decreases in renal function when selecting dosage. 1 (See Renal Impairment under Dosage and Administration.) Hepatic Impairment Serum concentrations and AUC may be increased; 1 dosage adjustments not considered necessary. 1 Renal Impairment Decreased renal clearance and prolonged half-life; 1 reduce dosage in those with Cl cr 40 mL/minute. 1 (See Renal Impairment under Dosage and Administration.) Common Adverse Effects GI effects (diarrhea, nausea, abdominal pain, vomiting), rash, headache, dizziness. 1 Interactions for Factive Does not inhibit and is not metabolized by CYP isoenzymes. 1 Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely. 1 Drugs that Prolong QT Interval Potential pharmacologic interaction (additive effect on QT interval prolongation). 1 Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents. 1 Use with caution in patients receiving other drugs that prolong QT interval (e.g., cisapride [available in US only under limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants). 1 (See Prolongation of QT Interval under Cautions.) Specific Drugs Drug Interaction Comments Antacids (aluminum- or magnesium-containing) Decreased absorption of gemifloxacin 1 Administer antacids containing aluminum or magnesium at least 3 hours before or 2 hours after gemifloxacin 1 Antacids (calcium-containing); calcium supplements No clinically important pharmacokinetic interactions 1 Anticoagulants, oral (warfarin) Increased PT, INR, and/or bleeding reported 1 Closely monitor PT, INR, or other suitable coagulation tests 1 Consider that infectious disease and its accompanying inflammatory process, age, and general patient status also are risk factors for increased anticoagulation activity 1 Cimetidine Slightly increased gemifloxacin concentrations 1 Not considered clinically important 1 Corticosteroids Increased risk of tendinitis or tendon rupture, especially in patients >60 years of age 1 Use concomitantly with caution 1 Didanosine Decreased absorption of gemifloxacin if used with buffered didanosine preparations 1 Administer buffered didanosine (pediatric oral solution admixed with antacid) at least 3 hours before or 2 hours after gemifloxacin 1 Digoxin No evidence of effect on digoxin pharmacokinetics 1 Estrogens/progestins Oral contraceptives containing ethinyl estradiol and levonorgestrel: Possible decreased gemifloxacin concentrations; 1 no effect on pharmacokinetics of ethinyl estradiol and levonorgestrel 1 Not considered clinically important 1 Iron preparations Decreased absorption of gemifloxacin 1 15 Administer ferrous sulfate and dietary supplements containing iron at least 3 hours before or 2 hours after gemifloxacin 1 15 Multivitamins and mineral supplements Decreased absorption of gemifloxacin 1 Administer supplements containing iron, magnesium, zinc, or other metal cations at least 3 hours before or 2 hours after gemifloxacin 1 Omeprazole Slightly increased gemifloxacin concentrations 1 Not considered clinically important 1 Probenecid Decreased clearance of gemifloxacin resulting in increased gemifloxacin concentrations and half-life 1 Sucralfate Decreased absorption of gemifloxacin 1 15 Administer gemifloxacin at least 2 hours before sucralfate 1 15 Theophylline No evidence of effect on theophylline pharmacokinetics 1 Factive Pharmacokinetics Absorption Bioavailability 71%. 1 Rapidly absorbed from GI tract; 1 21 30 peak plasma concentrations attained within 0.5 2 hours. 1 21 30 Food Administration of 320-mg dose with a standard high-fat breakfast (2 eggs cooked in butter, 2 strips of bacon, hash brown potatoes, 2 slices of toast with butter, 300 mL whole milk) reduces peak plasma concentration and AUC by 12 and 3%, respectively; 14 this reduction in systemic exposure not considered clinically important. 1 14 Distribution Extent Widely distributed into body tissues and fluids, including lung tissue and fluids. 1 Distributed into milk in rats. 1 Plasma Protein Binding 60 70%. 1 Elimination Metabolism Metabolized to a limited extent in liver. 1 Not metabolized by CYP isoenzymes. 1 Elimination Route Eliminated by renal and nonrenal mechanisms. 1 36% of a dose eliminated in urine and 61% excreted in feces as unchanged drug and metabolites. 1 Half-life 7 hours (range 4 12 hours). 1 21 30 Special Populations Pharmacokinetics in geriatric patients similar to that in younger adults. 1 Adults with hepatic impairment: Peak plasma concentrations increased 25% in those with mild to moderate hepatic impairment (Child-Pugh class A or B) and increased 41% in those with severe hepatic impairment (Child-Pugh class C); no substantial change in plasma half-life. 1 Increased serum concentrations not considered clinically important. 1 Adults with renal impairment: Decreased clearance and prolonged half-life. 1 Stability Storage Oral Tablets 25°C (may be exposed to 15 30°C). 1 Protect from light. 1 Actions and Spectrum Usually bactericidal. 1 Like other fluoroquinolones, gemifloxacin inhibits bacterial DNA gyrase and topoisomerase IV. 1 4 12 Unlike some fluoroquinolones, gemifloxacin targets both enzymes in susceptible S. pneumoniae . 1 12 Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some other organisms (e.g., Chlamydia , Mycoplasma ). 1 4 12 22 More active in vitro than some other fluoroquinolones against S. pneumoniae , 4 12 13 22 23 but less active than ciprofloxacin in vitro against many Enterobacteriaceae and Pseudomonas aeruginosa . 4 12 Gram-positive aerobes: Active in vitro and in clinical infections against S. pneumoniae (including penicillin-resistant and multidrug-resistant strains). 1 Also active in vitro against Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains only) and S. pyogenes (group A β-hemolytic streptococci). 1 Gram-negative aerobes: Active in vitro and in clinical infections against H. influenzae , 1 H. parainfluenzae , 1 K. pneumoniae , 1 and M. catarrhalis . 1 Also active in vitro against some strains of Acinetobacter , K. oxytoca , Legionella pneumophila , and Proteus vulgaris . 1 Other organisms: Active in vitro and in clinical infections against C. pneumoniae 1 and M. pneumoniae . 1 Has some activity against Mycobacterium tuberculosis in vitro, but is considerably less active against mycobacteria than some other fluoroquinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin). 27 Some cross-resistance occurs between gemifloxacin and other fluoroquinolones. 1 Advice to Patients Advise patients to read the manufacturer s patient information (medication guide) prior to initiating gemifloxacin therapy and each time prescription refilled. 1 Advise patients that antibacterials (including gemifloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold). 1 Importance of completing full course of therapy, even if feeling better after a few days. 1 Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with gemifloxacin or other antibacterials in the future. 1 May be taken without regard to meals, 1 but should be taken with liberal amounts of fluids. 1 Importance of taking gemifloxacin at least 2 hours before or 3 hours after multivitamins containing iron, magnesium, or zinc; aluminum- or magnesium-containing antacids; or buffered didanosine (pediatric oral solution admixed with antacid). 1 Importance of taking gemifloxacin at least 2 hours before sucralfate. 1 Inform patients that systemic fluoroquinolones, including gemifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that may occur together in same patient. 1 140 145 Advise patients to immediately discontinue gemifloxacin and contact a clinician if they experience any signs or symptoms of serious adverse effects (e.g., unusual joint or tendon pain, muscle weakness, a pins and needles tingling or pricking sensation, numbness of the arms or legs, confusion, hallucinations) while taking the drug. 1 140 145 Advise patients to talk with a clinician if they have any questions or concerns. 1 140 145 Inform patients that systemic fluoroquinolones, including gemifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups and this risk is increased in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients. 1 Importance of resting and refraining from exercise at first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint) and importance of immediately discontinuing the drug and contacting a clinician. 1 (See Tendinitis and Tendon Rupture under Cautions.) Inform patients that peripheral neuropathies have been reported with systemic fluoroquinolones, including gemifloxacin, and that symptoms may occur soon after initiation of the drug and may be irreversible. 1 Importance of immediately discontinuing gemifloxacin and contacting a clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur. 1 Inform patients that systemic fluoroquinolones, including gemifloxacin, have been associated with CNS effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure, tremors, restlessness, lightheadedness, confusion, hallucinations) that can occur following first dose. 1 Importance of informing clinician of any history of convulsions, seizures, or epilepsy before initiating therapy with the drug. 1 Advise patients that gemifloxacin may cause dizziness and lightheadedness; 1 caution patients not to engage in activities requiring mental alertness and motor coordination (e.g., driving a vehicle, operating machinery) until effects of the drug on the individual are known. 1 Advise patients that systemic fluoroquinolones, including gemifloxacin, may worsen myasthenia gravis symptoms; 1 importance of informing clinician of any history of myasthenia gravis. 1 Importance of immediately contacting a clinician if any symptoms of muscle weakness, including respiratory difficulties, occur. 1 Inform patients that gemifloxacin may be associated with hypersensitivity reactions (including anaphylactic reactions), even after first dose. 1 Importance of immediately discontinuing gemifloxacin and contacting a clinician at first sign of rash, jaundice, or any other sign of hypersensitivity. 1 Advise patient that gemifloxacin has been associated with rash or hives and that rash occurs most frequently in patients> <40 years of age (especially women), in women receiving hormone replacement therapy, and in patients who receive gemifloxacin for >5 days (especially when given for >7 days). 1 Importance of discontinuing gemifloxacin and informing a clinician if rash occurs. 1 Inform patients that photosensitivity/phototoxicity reactions reported following exposure to sun or UV light in patients receiving fluoroquinolones. 1 Importance of avoiding or minimizing exposure to sunlight or artificial UV light (e.g., tanning beds, UVA/UVB treatment) and using protective measures (e.g., wearing loose-fitting clothes, sunscreen) if outdoors during gemifloxacin therapy. 1 Importance of discontinuing gemifloxacin and contacting a clinician if a sunburn-like reaction or skin eruption occurs. Advise patient that gemifloxacin may prolong QT interval and should be avoided in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents and should be used with caution in those receiving other drugs that prolong QT interval (e.g., cisapride [available in US only under limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants). 1 Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia). 1 Importance of informing a clinician if palpitations or fainting spells occur. 1 Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. 1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose. 1 Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., drugs that may affect QT interval, warfarin), as well as any concomitant illnesses. 1 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of advising patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Gemifloxacin Mesylate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets, film-coated 320 mg (of gemifloxacin)* Factive Merus Gemifloxacin Mesylate Tablets AHFS DI Essentials. Copyright 2017, Selected Revisions September 30, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Merus Labs International Inc. Factive (gemifloxacin mesylate) tablets prescribing information. Toronto, ON M5K 1H1. 2016 May. 2. File T, Schlemmer B, Garau J et al. Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. J Chemother . 2000; 12:314-25. [PubMed 10949981] 3. Wilson R, Schentag JJ, Ball P et al. A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and long-term clinical outcomes. Clin Ther . 2002; 24:639-52. [PubMed 12017408] 4. Lowe MN, Lamb HM. Gemifloxacin. Drugs . 2000; 59:1137-47. [PubMed 10852645] 5. File TM, Schlemmer B, Garau J et al. Efficacy and safety of gemifloxacin in the treatment of community-acquired pneumonia: a randomized, double-blind comparison with trovafloxacin. J Antimicrob Chemother . 2001; 48:67-74. [PubMed 11474633] 12. Zhanel GG, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs . 2002; 62:13-59. [PubMed 11790155] 13. Ball P. Quinolone generations: natural history or natural selection?. J Antimicrob Chemother . 2000; 46:17-24. [PubMed 10997595] 14. Allen A, Bygate E, Clark D et al. The effect of food on the bioavailability of oral gemifloxacin in healthy volunteers. Int J Antimicrob Agents . 2000; 16:45-50. [PubMed 11185412] 15. Allen A, Bygate E, Faessel H et al. The effect of ferrous sulphate and sucralfate on the bioavailability of oral gemifloxacin in healthy volunteers. Int J Antimicrob Agents . 2000; 16:283-9. 16. Allen A, Vousden M, Porter A et al. Effect of Maalox on the bioavailability of oral gemifloxacin in healthy volunteers. Chemotherapy . 1999; 45:504-11. [PubMed 10567782] 17. Davy M, Allen A, Bird N et al. Lack of effect of gemifloxacin on the steady-state pharmacokinetics of theophylline in healthy volunteers. Chemotherapy . 1999; 45:478-84. [PubMed 10567778] 18. Vousden M, Allen A, Lewis A et al. Lack of pharmacokinetic interaction between gemifloxacin and digoxin in healthy elderly volunteers. Chemotherapy . 1999; 45:485-90. [PubMed 10567779] 19. Davy M, Bird N, Rost KL et al. Lack of effect of gemifloxacin on the steady-state pharmacodynamics of warfarin in healthy volunteers. Chemotherapy . 1999; 45:491-5. [PubMed 10567780] 20. Allen A, Vousden M, Lewis A et al. Effect of omeprazole on the pharmacokinetics of oral gemifloxacin in healthy volunteers. Chemotherapy . 1999; 45:496-503. [PubMed 10567781] 21. Allen A, Bygate E, Vousden M et al. Multiple-dose pharmacokinetics and tolerability of gemifloxacin administered orally to healthy volunteers. Antimicrob Agents Chemother . 2001; 45:540-5. [PubMed 11158752] 22. Boswell FJ, Andrews JM, Jevons G et al. Comparison of the in vitro activities of several new fluoroquinolones against respiratory pathogens and their abilities to select fluoroquinolone resistance. J Antimicrob Chemother . 2002; 50:495-502. [PubMed 12356793] 23. Genesoft, Inc, South San Francisco, CA: Personal communication. 27. Ruiz-Serrano MJ, Alcala L, Martinez L et al. In vitro activities of six fluoroquinolones against 250 clinical isolates of Mycobacterium tuberculosis susceptible or resistant to first-line antituberculosis drugs. Antimicrob Agents Chemother . 2000; 44:2567-8. 28. Sethi S, Fogarty C, Fulambarker A. A randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days of levofloxacin in patients with acute exacerbation of chronic bronchitis. Respir Med . 2004; 98:697-707. [PubMed 15303633] 29. Leophonte P, File T, Feldman C. Gemifloxacin once daily for 7 days compared to amoxicillin/clavulanic acid thrice daily for 10 days for the treatment of community-acquired pneumonia of suspected pneumococcal origin. Respir Med . 2004; 98:708-20. [PubMed 15303634] 30. Allen A, Bygate E, Oliver S et al. Pharmacokinetics and tolerability of gemifloxacin (SB-265805) after administration of single oral doses to healthy volunteers. Antimicrob Agents Chemother . 2000; 44:1604-8. [PubMed 10817716] 31. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis . 2007; 44 Suppl 2:S27-72. Updates may be available at IDSA website at www.idsociety.org. [PubMed 17278083] 36. McDonald LC, Killgore GE, Thompson A et al. An epidemic, toxin gene-variant strain of Clostridium difficile . N Engl J Med . 2005; 353:2433-41. [PubMed 16322603] 37. Loo VG, Poirier L, Miller MA et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile -associated diarrhea with high morbidity and mortality. N Engl J Med . 2005; 353:2442-9. [PubMed 16322602] 38. McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996-2003. Emerg Infect Dis . 2006; 12:409-15. [PubMed 16704777] 39. Bartlett JG, Peri TM. The new Clostridium difficile what does it mean? 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Morphological investigation of cavity formation in articular cartilage induced by ofloxacin in rats. Fund Appl Toxicol . 1988; 11:110-9. 48. Hooper DC, Wolfson JS. Fluoroquinolone antimicrobial agents. N Engl J Med . 1991; 324:384-94. [PubMed 1987461] 49. Paton JH, Reeves DS. Fluoroquinolone antibiotics: microbiology, pharmacokinetics and clinical uses. Drugs . 1988; 36:193-228. [PubMed 3053126] 50. Maggiolo F, Caprioli S, Suter F. Risk/benefit analysis of quinolone use in children: the effect on diarthrodial joints. J Antimicrob Chemother . 1990; 26:469-71. [PubMed 2254219] 51. Pfister K, Mazur D, Vormann J et al. Diminished ciprofloxacin-induced chondrotoxicity by supplementation with magnesium and vitamin E in immature rats. Antimicrob Agents Chemother . 2007; 51:1022-7. [PubMed 17210779] 52. Stahlmann R. Safety profile of the quinolones. J Antimicrob Chemother . 1990; 26(Suppl D):31-44. [PubMed 2286589] 53. Christ W, Lehnert T, Ulbrich B. 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Bradley JS, Jackson MA, Committee on Infectious Diseases et al. The use of systemic and topical fluoroquinolones. Pediatrics . 2011; 128:e1034-45. 128. US Food and Drug Administration. FDA news. FDA requests boxed warnings on fluoroquinolone antimicrobial drugs. From the FDA website. Accessed 2008 Sept 8. 129. US Food and Drug Administration. Information for healthcare professionals. FDA alert regarding fluoroquinolone antimicrobial drugs. 2008 Jul 8. From FDA website. Accessed 2008 Sept 8. 130. US Food and Drug Administration. 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. 2013 Aug 15. From FDA website. 140. US Food and Drug Administration. FDA drug safety communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. Silver Spring, MD; 2016 May 12. From FDA website. 145. US Food and Drug Administration. FDA drug safety communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. Silver Sring, MD; 2016 Jul 26. From FDA website. 292. American Academy of Pediatrics. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015. Next Interactions Print this page Add to My Med List More about Factive (gemifloxacin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 8 Reviews Add your own review/rating Generic Availability Drug class: quinolones Consumer resources Factive Factive (Advanced Reading) Professional resources Factive (FDA) Gemifloxacin Mesylate (AHFS Monograph) Related treatment guides Bronchitis Pneumonia Strep Throat> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 10 + years Approval History FDA approved 2003 Drug Class Quinolones Related Drugs Bronchitis ciprofloxacin , amoxicillin , azithromycin , doxycycline , Augmentin , Zithromax , Levaquin , levofloxacin , Mucinex , Bactrim , sulfamethoxazole / trimethoprim , More... Pneumonia ciprofloxacin , amoxicillin , azithromycin , doxycycline , metronidazole , Augmentin , Zithromax , Levaquin , levofloxacin , clindamycin , Bactrim , More... Factive Rating 8 User Reviews 4.1 /10 8 User Reviews 4.1 Rate it! Factive Images Factive 320 mg (GE 320 GE 320) View larger images} } deliberating
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