To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.


500 mg PO/IV once daily for 7-14 days or 750 mg PO/IV once daily for 5 days500 mg PO/IV once daily for 10-14 days or 750 mg PO/IV once daily for 5 daysLimitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitisLimitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis500 mg PO once daily for 60 days, beginning as soon as possible after exposureUncomplicated: 500 mg PO/IV once daily for 7-10 days250 mg PO/IV once daily for 10 days or 750 mg PO/IV once daily for 5 daysLimitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infectionsIndicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or olderTreatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosisTablets not for administration to pediatric patients with inhalational anthrax or plague who weigh <30 kg due to limitations of available strengths; alternative formulations of levofloxacin may be considered for pediatric patients who weigh <30 kg≥6 months and <50 kg: 8 mg/kg PO q12hr for 60 days, beginning as soon as possible after exposure; individual dose not to exceed 250 mg ≥6 months and >50 kg: 500 mg PO once daily for 60 days, beginning as soon as possible after exposureSafety in children for treatment duration >14 days has not been establishedIndicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older≥6 months and <50 kg: 8 mg/kg PO/IV q12hr for 10-14 days; individual dose not to exceed 250 mg Cardiac: Cardiac arrest, palpitation, ventricular tachycardia, arrhythmiaNervous system: Tremor, convulsions, paresthesia, vertigo, hypertonia, hyperkinesias, abnormal gait, somnolence, syncopeMetabolic: Hypoglycemia, hyperglycemia, hyperkalemiaBlood/lymphatic system: Anemia, thrombocytopenia, granulocytopeniaMusculoskeletal/connective tissue: Arthralgia, tendonitis, myalgia, skeletal painGastrointestinal (GI): Gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous/C difficile colitisHepatobiliary: Abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatasePsychiatric: Anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disorder, anorexia, abnormal dreamingOther: Immune hypersensitivity reaction, acute renal failure, urticaria, phlebitis, epistaxisCardiac: Prolonged QT interval, torsades de pointes, tachycardiaMusculoskeletal/connective tissue: Tendon rupture, muscle injury, rhabdomyolysisSkin/subcutaneous tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity/phototoxicity, leukocytoclastic vasculitisRenal and urinary disorders: Interstitial nephritisVascular disorders: Vasodilation; increased risk of aortic aneurysm and dissectionBlood/lymphatic system: Pancytopenia, aplastic anemia, leukopenia, hemolytic anemia, eosinophiliaHepatobiliary: Hepatic failure, hepatitis, jaundicePsychiatric: Psychosis, paranoia, suicidal ideation, isolated reports of suicide attemptsNervous system: Exacerbation of myasthenia gravis, anosmia, ageusia, parosmia, dysgeusia, peripheral neuropathy, abnormal electroencephalogram (EEG), dysphonia, isolated reports of encephalopathy, pseudotumor cerebriCentral nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion)Respiratory, thoracic and mediastinal disorders: Isolated reports of allergic pneumonitisImmune system disorders: Hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions, anaphylactic shock, angioneurotic edema, serum sicknessEye disorders: Uveitis, vision disturbance (including diplopia), visual acuity reduced, vision blurred, scotomaGeneral disorders and administration site conditions: Multiorgan failure, pyrexiaMay exacerbate muscle weakness in patients with myasthenia gravis; fluoroquinolones should be avoided in patients with known history of myasthenia gravisBecause the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment optionsFor some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic optionAnaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dosePeripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanentCommonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); these reactions can occur within hours to weeks after starting therapy, including in patients of any age or without pre-existing risk factors; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolonesRisk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants; other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis (see Black Box Warnings)Excessive sunlight may result in moderate-to-severe phototoxicityFatal hypoglycemia reported in elderly patients with or without diabetes; prompt treatment when symptoms are present is essentialProlonged use may result in fungal or bacterial superinfectionProlongation of QT interval and isolated cases of torsades de pointes; avoid use in patients with known QT prolongation, those with hypokalemia, and those taking other QT-prolonging drugsIn prolonged therapy, perform periodic evaluations of organ system function (eg, renal, hepatic, hematopoietic); adjust dosage in renal impairment; superinfections may occur with prolonged or repeated antibiotic therapyPediatric patients may experience increased incidence of musculoskeletal disorders (eg, arthralgia, arthritis, tendinopathy, gait abnormality)Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicatedPrescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteriaLevofloxacin has not been shown to increase risk of major birth defects, miscarriage or adverse maternal or fetal outcomesDrug is present in human milk following intravenous and oral administration; there is no information regarding effects on milk production or breastfed infant; because of potential risks of serious adverse reactions, in breastfed infants, a lactating woman may consider pumping and discarding breast milk during treatment and an additional two days (five half-lives) after last doseAlternatively, advise a lactating woman that breastfeeding is not recommended during treatment and for an additional two days (five half-lives) after last doseFor inhalation anthrax (post-exposure), during an incident resulting in exposure to anthrax, risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on this drug may be acceptableA: Generally acceptable.

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