Levofloxacin


Concise Prescribing Info
Indications/Uses
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.
Dosage Details
Inhalation/Respiratory
Pseudomonal lung infections in cystic fibrosis
Adult: 240 mg bid (12 hourly) via nebuliser for 28 days followed by 28 days treatment-free. Cycle may be repeated according to patient response.

Intravenous
Complicated urinary tract infections
Adult: 500 mg once daily for 7-14 days, infused over 60 minutes.

Intravenous
Chronic bacterial prostatitis
Adult: 500 mg once daily for 28 days, infused over 60 minutes

Intravenous
Community-acquired pneumonia, Complicated skin and soft tissue infections
Adult: 500 mg once daily or bid for 7-14 days, infused over 60 minutes.

Intravenous
Pyelonephritis
Adult: 500 mg once daily for 7-10 days, infused over 60 minutes.

Intravenous
Treatment and postexposure prophylaxis of inhalation anthrax
Adult: 500 mg once daily for 8 weeks, infused over 60 minutes.
Child: ≥6 months weighing <50 kg: 8 mg/kg up to max 250 mg 12 hourly; ≥50 kg: 500 mg 24 hourly. All doses to be given for 60 days.

Ophthalmic
Bacterial corneal ulcer
Adult: 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.

Ophthalmic
Bacterial conjunctivitis
Adult: As 0.5% solution: Instill 1-2 drops into the affected eye(s) 2 hourly up to 8 times daily during waking hours for days 1-2, then 4 times daily on days 3-5. Treatment duration depends on the severity and type of infection. Usual duration: 5 days.
Child: ≥1 year Same as adult dose.

Oral
Acute bacterial sinusitis
Adult: 500 mg once daily for 10-14 days.

Oral
Community-acquired pneumonia, Complicated skin and soft tissue infections
Adult: 500 mg once daily or bid for 7-14 days.

Oral
Chronic bacterial prostatitis
Adult: 500 mg once daily for 28 days.

Oral
Acute bacterial exacerbation of chronic bronchitis, Pyelonephritis
Adult: 500 mg once daily for 7-10 days.

Oral
Treatment and postexposure prophylaxis of inhalation anthrax
Adult: 500 mg once daily for 8 weeks.
Child: ≥6 months weighing <50 kg: 8 mg/kg up to max 250 mg 12 hourly; ≥50 kg: 500 mg 24 hourly. All doses to be given for 60 days.

Oral
Uncomplicated cystitis
Adult: 250 mg once daily for 3 days.

Oral
Complicated urinary tract infections
Adult: 500 mg once daily for 7-14 days.
Renal Impairment
Oral
Acute bacterial sinusitis; Acute bacterial exacerbation of chronic bronchitis; Pyelonephritis; Community-acquired pneumonia; Complicated skin and soft tissue infections; Complicated urinary tract infections; Uncomplicated cystitis; Chronic bacterial prostatitis; Treatment and postexposure prophylaxis of inhalation anthrax
 
 CrCl (mL/min) Dosage 
 <10, on haemodialysis and CAPD For dosing of 250 mg 24 hourly: Initially, 250 mg followed by 125 mg 48 hourly. For dosing of 500 mg 24 hourly: Initially, 500 mg followed by 125 mg 24 hourly. For dosing of 500 mg 12 hourly: Initially, 500 mg followed by 125 mg 24 hourly.
 10-19 For dosing of 250 mg 24 hourly: Initially, 250 mg followed by 125 mg 48 hourly. For dosing of 500 mg 24 hourly: Initially, 500 mg followed by 125 mg 24 hourly. For dosing of 500 mg 12 hourly: Initially, 500 mg followed by 125 mg 12 hourly.
 20-50 For dosing of 250 mg 24 hourly: Initially, 250 mg followed by 125 mg 24 hourly. For dosing of 500 mg 24 hourly: Initially, 500 mg followed by 250 mg 24 hourly. For dosing of 500 mg 12 hourly: Initially, 500 mg followed by 250 mg 12 hourly.

Intravenous
Community-acquired pneumonia; Complicated skin and soft tissue infections; Pyelonephritis; Complicated urinary tract infections; Chronic bacterial prostatitis; Treatment and postexposure prophylaxis of inhalation anthrax
CrCl (mL/min) Dosage 
 <10, on haemodialysis and CAPD For dosing of 250 mg 24 hourly: Initially, 250 mg followed by 125 mg 48 hourly. For dosing of 500 mg 24 hourly: Initially, 500 mg followed by 125 mg 24 hourly. For dosing of 500 mg 12 hourly: Initially, 500 mg followed by 125 mg 24 hourly.
 10-19 For dosing of 250 mg 24 hourly: Initially, 250 mg followed by 125 mg 48 hourly. For dosing of 500 mg 24 hourly: Initially, 500 mg followed by 125 mg 24 hourly. For dosing of 500 mg 12 hourly: Initially, 500 mg followed by 125 mg 12 hourly.
 20-50 For dosing of 250 mg 24 hourly: Initially, 250 mg followed by 125 mg 24 hourly. For dosing of 500 mg 24 hourly: Initially, 500 mg followed by 250 mg 24 hourly. For dosing of 500 mg 12 hourly: Initially, 500 mg followed by 250 mg 12 hourly.

Inhalation
Pseudomonal lung infections in cystic fibrosis

 CrCl (mL/min) Dosage 
 Severe (<20)  Not recommended.
Administration
Tab: May be taken with or without food. Ensure adequate fluid intake.
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.
Reconstitution
IV infusion: Dilute with 5% dextrose solution or 0.9% NaCl to a final concentration of 5 mg/mL.
Incompatibility
Solutions containing multivalent cations (e.g. Mg, Ca), heparin, or alkaline solutions.
Contraindications
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.
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 admin 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.
Ophth/Parenteral/PO: C
Patient Counseling Information
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.
MonitoringParameters
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.
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).
Lab Interference
May give false-positive results for determination of opiates in urine using immunoassay.
Action
Description: Levofloxacin is the S(-)enantiomer of racemic ofloxacin. It inhibits bacterial topoisomerase IV and DNA-gyrase, the enzymes required for DNA replication, transcription, repair, recombination and transposition, thereby inhibiting the relaxation of supercoiled DNA and promoting breakage of bacterial DNA strands.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the gastrointestinal tract (oral). Absolute bioavailability: Approx 99% (oral). Time to peak plasma concentration: Within 1-2 hours (oral).
Distribution: Widely distributed into body tissues including bronchial mucosa and lungs, enters breastmilk. Volume of distribution: 1.27 L/kg. Plasma protein binding: Approx 24-38%, mainly to albumin.
Metabolism: Minimally metabolised in the liver.
Excretion: Mainly via urine (approx 87% as unchanged drug, <5% as metabolites); faeces (<4%). Elimination half-life: 6-8 hours; 0.5-1 hour (inhalation).
Chemical Structure

Chemical Structure Image
Levofloxacin

Source: National Center for Biotechnology Information. PubChem Database. Levofloxacin, CID=149096, https://pubchem.ncbi.nlm.nih.gov/compound/Levofloxacin (accessed on Jan. 22, 2020)

Storage
Tab/oral solution/ophthalmic solution: Store between 20-25°C. IV solution: Store below 25°C. Protect from light. Infusion bag: Store below 30°C. Protect from light.
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
S01AE05 - levofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
References
Anon. Levofloxacin (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/07/2019.

Anon. Levofloxacin (Oral Inhalation). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/07/2019.

Anon. Levofloxacin (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/07/2019.

Buckingham R (ed). Levofloxacin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/07/2019.

Iquix Levofloxacin Solution (Vistakon Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 24/09/2014.

Joint Formulary Committee. Levofloxacin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/09/2014.

Levaquin Tablet, Film-Coated; Solution; Injection, Solution (Janssen Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 24/09/2014.

Levaquin Tablets, Oral Solution and Injection. U.S. FDA. https://www.fda.gov/. Accessed 24/09/2014.

Levofloxacin Injection (Akorn, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2019.

Levofloxacin Oral Solution (Hi-Tech Pharmacal Co., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2019.

Levofloxacin Solution for Injection (Hi-Tech Pharmacal Co., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2019.

Levofloxacin Solution/Drops (Micro Labs Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2019.

Levofloxacin Tablet (Jubilant Cadista Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2019.

McEvoy GK, Snow EK, Miller J et al (eds). Levofloxacin (EENT). AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 05/07/2019.

McEvoy GK, Snow EK, Miller J et al (eds). Levofloxacin. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/07/2019.

Quinsair Nebuliser Solution (Adare Pharmaceuticals). European Medicines Agency [online]. Accessed 02/07/2019.

Quinsair Nebuliser Solution (Adare Pharmaceuticals). MHRA. https://products.mhra.gov.uk/. Accessed 02/07/2019.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 MIMS. All rights reserved. Powered by MIMS.com
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