In adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients Tablets cannot be administered to patients who weigh less than 30 kg because of the limitations of the available strength. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced in these patients. 500 mg PO/IV once daily for 10-14 days or 750 mg PO/IV once daily for 5 days Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis Indicated 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 500 mg PO/IV once daily for 10-14 days Nausea (7%) Headache (6%) Diarrhea (5%) Insomnia (4%) Constipation (3%) Dizziness (3%) Dyspepsia (2%) Rash (2%) Vomiting (2%) Chest pain (1%) Dyspnea (1%) Edema (1%) Fatigue (1%) Injection-site reaction (1%) Moniliasis (1%) Pain (1%) Pruritus (1%) Vaginitis (1%) Cardiac: Cardiac arrest, palpitation, ventricular tachycardia, arrhythmia Nervous system: Tremor, convulsions, paresthesia, vertigo, hypertonia, hyperkinesias, abnormal gait, somnolence, syncope Metabolic: Hypoglycemia, hyperglycemia, hyperkalemia Blood/lymphatic system: Anemia, thrombocytopenia, granulocytopenia Musculoskeletal/connective tissue: Arthralgia, tendonitis, myalgia, skeletal pain Gastrointestinal (GI): Gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous/C difficile colitis Hepatobiliary: Abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatase Psychiatric: Anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disorder, anorexia, abnormal dreaming Other: Immune hypersensitivity reaction, acute renal failure, urticaria, phlebitis, epistaxis Cardiac: Prolonged QT interval, torsades de pointes, tachycardia Musculoskeletal/connective tissue: Tendon rupture, muscle injury, rhabdomyolysis Skin/subcutaneous tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity/phototoxicity, leukocytoclastic vasculitis Renal and urinary disorders: Interstitial nephritis Vascular disorders: Vasodilation Blood/lymphatic system: Pancytopenia, aplastic anemia, leukopenia, hemolytic anemia, eosinophilia Hepatobiliary: Hepatic failure, hepatitis, jaundice Psychiatric: Psychosis, paranoia, suicidal ideation, isolated reports of suicide attempts Nervous system: Exacerbation of myasthenia gravis, anosmia, ageusia, parosmia, dysgeusia, peripheral neuropathy, abnormal electroencephalogram (EEG), dysphonia, isolated reports of encephalopathy, pseudotumor cerebri Central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion) Respiratory, thoracic and mediastinal disorders: Isolated reports of allergic pneumonitis Immune system disorders: Hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions, anaphylactic shock, angioneurotic edema, serum sickness Eye disorders: Uveitis, vision disturbance (including diplopia), visual acuity reduced, vision blurred, scotoma Otologic: Hypoacusis, tinnitus General disorders and administration site conditions: Multiorgan failure, pyrexia May exacerbate muscle weakness in patients with myasthenia gravis; fluoroquinolones should be avoided in patients with known history of myasthenia gravis Because 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 options For 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 option Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose Use caution in hematologic and renal toxicities Hepatotoxicity reported with therapy Peripheral 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 permanent Commonly 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 fluoroquinolones Risk 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 phototoxicity Fatal hypoglycemia reported in elderly patients with or without diabetes; prompt treatment when symptoms are present is essential May cause C difficile-associated colitis Prolonged use may result in fungal or bacterial superinfection Prolongation 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 drugs May produce false-positive urine opiate screens In 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 therapy Pediatric 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):2184-2190 Clostridium 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 indicated Prescribing 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 bacteria L-stereoisomer of parent compound ofloxacin; D-isomer form is inactive Inhibits DNA gyrase activity, which in turn promotes breakage of DNA strands Good monotherapy with extended coverage against Pseudomonas spp, as well as excellent activity against pneumococcus Additive: Linezolid Y-site: Amikacin, aminophylline, ampicillin, bivalirudin, caffeine, cefotaxime, cimetidine, clindamycin, dexamethasone, dexmedetomidine, dobutamine, dopamine, epinephrine, fenoldopam, fentanyl, gentamicin, lactated hetastarch, insulin (at 1 U/m L 5 mg/m L levofloxacin), isoproterenol, lidocaine, linezolid, lorazepam, metoclopramide, oxacillin, pancuronium, penicillin G sodium, phenobarbital, phenylephrine, sodium bicarbonate, vancomycin Premixed: No further preparation needed Single-use vials: Dilute in 50-100 m L D5W or NS or D5/NS solution for injection to 5 mg/m L; alternative solutions include sodium lactate, Plasma-Lyte, D5/lactated Ringer, D5/NS and potassium chloride Reconstituted solution should be clear, slightly yellow, and free of particulate matter Reconstituted drug is stable for 72 hours at room temperature, 14 days when refrigerated in plastic containers, and 6 months when frozen Thaw at room temperature or in refrigerator only Give by IV infusion only, not bolus; rapid or bolus administration has been associated with hypotension and must be avoided Infuse 250-500 mg over 60 minutes or 750 mg over 90 minutes Avoid using IV line with solution containing multivalent cations (ie, magnesium, calcium) Compatible with potassium additives The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
The NICE British National Formulary (BNF) and British National Formulary for Children (BNFc) sites are only available to users in the UK, Crown Dependencies and British Overseas Territories. If you believe you are seeing this page in error please contact us. Growing resistance in some bacteria that commonly cause community-acquired pneumonia (CAP) in children has increased the need for alternative antibiotics. Food and Drug Administration for use in children, but historical data on fluoroquinolones in children suggest an adverse event rate similar to that found in adults. Because levofloxacin has a broad spectrum of activity against bacterial and atypical pathogens and because it has an acceptable safety profile in adults, Bradley and colleagues studied the safety and effectiveness of levofloxacin to treat CAP in children. This randomized, multicenter, open-label study evaluated children six months to 16 years of age in seven countries, including the United States. Children were eligible to participate if they had a clinical diagnosis of CAP based on positive radiographic findings and the presence of two or more clinical findings of pneumonia (e.g., fever, dyspnea, cough, chest pain, abnormal white blood cell count, physical signs on examination). Children in outpatient and inpatient settings were included. Children were excluded if they received systemic antibiotics for more than 24 hours immediately before enrollment, if they required antibiotics other than the study drugs, or if they had an infection suspected to be resistant to the study drugs.
The efficacy and safety of 750-mg, 5-day levofloxacin was recently shown to be comparable to 500-mg, 10-day levofloxacin in a randomized, double-blind, multicentre clinical trial for mild-to-severe community-acquired pneumonia (CAP). This subgroup analysis attempted to compare the safety and efficacy of a short-course levofloxacin regimen with traditional levofloxacin dosing for PSI Class III/IV patients. This retrospective, subgroup analysis focused on Pneumonia Severity Index Class III and IV patients enrolled in the study. Measurements included clinical and microbiological success rates, adverse events, and symptom resolution by day 3 of therapy. Of the 528 patients in the ITT population, 219 (41.5%) were categorized as PSI Class III/IV and included in this analysis. Among the clinically evaluable patients, 90.8% (69/76) of patients treated with the 750-mg regimen achieved clinical success, compared with 85.5% (71/83) treated with 500-mg levofloxacin (95% CI,−15.9 to 5.4). Eradication rates in the microbiologically evaluable population were comparable for the 750- and 500-mg regimens (88.9% vs 87.5%, respectively; 95% CI,−18.3 to 15.6). Acute bacterial sinusitis is a common, usually self-limited condition often associated with allergies and environmental irritants, as well as co-infection with viruses and fungi. Acute bacterial sinusitis is 200 times less common than viral rhinosinusitis. Symptoms and signs suggesting bacterial, as opposed to viral sinusitis include purulent nasal discharge in combination with facial pain and maxillary toothache, facial swelling and tenderness. Most diagnoses are based on history and physical examination as opposed to laboratory cultures and sinus xrays, which are considered unreliable. Category: Levofloxacin is a fluoroquinolone class, broad-spectrum antibacterial agent. Mechanism of Action: Levofloxacin exerts its action by inhibiting the bacterial topoisomerases II (DNA gyrase) and topoisomerases IV, which interferes with DNA replication, transcription, repair, and recombination. Indications: indicated for the treatment of adults with upper and lower respiratory tract, urinary tract infections, and infections of skin/skin structure. Dose & Duration: The recommended dose for levofloxacin is 500mg i.v./oral once daily for 10-14 days (normal course of therapy) or 750mg i.v./oral once daily for 5 days (short-course therapy).
For the recommended LEVAQUIN® tablet dosage in pediatric patients with inhalational anthrax or plague, see Dosage and Administration 2.2. LEVAQUIN®. Levofloxacin oral liquid should be taken 1 hour before or 2 hours after eating. This medicine works best when there is a constant amount in the blood. To help.