Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Acute bacterial sinusitis 500 mg once daily for 10-14 days. Acute bacterial exacerbation of chronic bronchitis; Pyelonephritis 500 mg once daily for 7-10 days. Uncomplicated cystitis 250 mg once daily for 3 days. Community-acquired pneumonia; Complicated skin and soft tissue infections 500 mg once daily or bid for 7-14 days. Complicated urinary tract infections 500 mg once daily for 7-14 days. Chronic bacterial prostatitis 500 mg once daily for 28 days. Treatment and postexposure prophylaxis of inhalation anthrax 500 mg once daily for 8 weeks. IV Community-acquired pneumonia; Complicated skin and soft tissues infections 500 mg once daily or bid for 7-14 days. Complicated urinary tract infections 500 mg once daily for 7-14 days. Pyelonephritis 500 mg once daily for 7-10 days. Chronic bacterial prostatitis 500 mg once daily for 28 days. Treatment and postexposure prophylaxis of inhalation anthrax 500 mg once daily for 8 weeks. All doses are given via infusion over 60 minutes. Ophthalmic Bacterial conjunctivitis As 0.5% solution: Instill 1-2 drops into the affected eye(s) 2 hourly up to 8 times/day during waking hours for days 1-2, then 4 times/day on days 3-5. Treatment duration depends on the severity and type of infection. Usual duration: 5 days. Bacterial corneal ulcer As 1.5% solution: Instill 1-2 drops into affected eye(s) every 30 minutes to every 2 hours during waking hours and approx 4 and 6 hours after retiring on days 1-3, then every 1-4 hours while awake thereafter. Inhalation Pseudomonal lung infections in cystic fibrosis 240 mg bid (12 hours apart) via nebuliser for 28 days followed by 28 days treatment-free. Cycle may be repeated according to patient response.
Oral soln: Should be taken on an empty stomach. Take on an empty stomach 1 hr before or 2 hr after meals. Ensure adequate fluid intake.
Tab: May be taken with or without food. Ensure adequate fluid intake.
Hypersensitivity to levofloxacin or other quinolones. Epilepsy, history of tendon disorders related to previous fluoroquinolone use.
Special Precautions
Patient with history of prolonged QT interval, uncorrected electrolyte disorders (e.g. hypokalaemia), risk factors that predispose to seizures or lower the seizure threshold, pre-existing aortic aneurysm and/or dissection, latent or actual defects in G6PD, diabetes mellitus, history or risk factors of psychiatric disorders, history of or risk factors for tendon disorder, severe underlying diseases (e.g. sepsis), haemoptysis (inhalation). Renal impairment. Children and elderly. Pregnancy and lactation. Not recommended as treatment option for known or suspected MRSA and E. coli infection due to increased risk of resistance in some countries. Patient Counselling This drug may cause dizziness, drowsiness, visual disturbances (ophthalmic) if affected, do not drive or operate machinery. Avoid exposure to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium) during treatment and for 48 hours following discontinuation. Ophthalmic: Remove contact lenses prior to instillation of ophthalmic drops and wait at least 15 minutes before reinserting. Monitoring Parameters Monitor LFT, renal and haematopoietic function, WBC count, blood glucose level in diabetic patients, signs of infection, altered mental status, signs and symptoms of tendonitis or tendon rupture, altered glucose regulation, crystalluria, bronchospasm or haemoptysis. Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks.
Adverse Reactions
Significant: CNS effects including seizures, increased intracranial pressure, lightheadedness, dizziness, tremor; psychotic reactions (e.g. hallucinations, nervousness, delirium), sensory or sensorimotor peripheral neuropathy, prolonged QT interval, blood glucose disturbances (hypo-/hyperglycaemia), phototoxicity, superinfection (prolonged use), bronchospasm, cough or productive cough, haemoptysis, fluoroquinolone-resistant P. aeruginosa (inhalation), exacerbation of myasthenia gravis, interstitial nephritis, acute renal insufficiency or failure, hypotension (rapid or bolus IV infusion). Rarely, tendinitis, tendon rupture, suicidal thoughts, self-endangering behaviour, crystalluria, cylindruria, torsades de pointes, Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis. Blood and lymphatic system disorders: Rarely, pancytopenia, agranulocytosis, haemolytic or aplastic anaemia, leukopenia, eosinophilia. Cardiac disorders: Dyspnoea, chest pain, arrhythmia. Eye disorders: Ocular burning, decreased vision and mucous strand, blurred vision, eye pain, eye irritation, eyelid oedema, eye pruritus, chemosis, photophobia, conjunctivitis, dry eye syndrome. Gastrointestinal disorders: Diarrhoea, vomiting, nausea, dyspepsia, constipation, abdominal pain. General disorders and administration site conditions: Fatigue, fever, asthenia, hyperhidrosis. Hepatobiliary disorders: Rarely, hepatitis, jaundice. Injury, poisoning and procedural complications: Infusion site reaction (e.g. pain, reddening), phlebitis. Investigations: Increased hepatic enzymes (ALT/AST, alkaline phosphatase, GGT), decreased forced expiratory volume. Metabolism and nutrition disorders: Anorexia, oedema. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Headache, vertigo, dysgeusia. Psychiatric disorders: Insomnia. Reproductive system and breast disorders: Vaginitis. Respiratory, thoracic and mediastinal disorders: Increased bronchial secretions, rarely, allergic pneumonitis. Skin and subcutaneous tissue disorders: Rash, pruritus. Vascular disorders: Rarely, vasculitis.
Potentially Fatal: Hypersensitivity reactions (e.g. angioedema, anaphylactic shock), Clostridium difficile-associated disease (e.g. pseudomembranous colitis), hypoglycaemic coma, severe hepatotoxicity.
Drug Interactions
Decreased absorption with Fe salts, Zn-containing multivitamins, Mg- or Al-containing antacids, didanosine. Decreased bioavailability with sucralfate. Increased risk of CNS stimulation and seizures with drugs which may affect seizure threshold (e.g. theophylline, NSAIDs). Decreased renal clearance with cimetidine and probenecid due to blockage of renal tubular secretion of levofloxacin. May increase the half-life of ciclosporin. Increased INR and/or bleeding with vitamin K antagonists (e.g. warfarin). Increased risk of severe tendon disorders with corticosteroids. Increased risk for QT interval prolongation with class IA and III antiarrhythmics, TCA, macrolides and antipsychotic agents. May result to altered blood glucose levels with antidiabetic agents (e.g. insulin, glibenclamide).
ATC Classification
S01AE05 - levofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Disclaimer: This information is independently developed by CIMS based on levofloxacin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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