Novell Pharma


Averroes Pharma
Concise Prescribing Info
Mild, moderate & severe infections caused by levofloxacin-susceptible microorganisms in adults ≥18 yr.
Dosage/Direction for Use
Adult Administer by slow IV infusion over 60-90 min every 24 hr. Acute bacterial exacerbation of chronic bronchitis 500 mg every 24 hr for 7 days. Community-acquired pneumonia 500 mg every 24 hr for 7-14 days. Acute maxillary sinusitis 500 mg every 24 hr for 10-14 days. Uncomplicated skin & skin structure infections 500 mg every 24 hr for 7-10 days. Complicated UTI & acute pyelonephritis 250 mg every 24 hr for 10 days. Renal impairment CrCl 20-40 mL/min Initially 500 mg, then 250 mg every 24 hr, CrCl 10-19 mL/min, hemodialysis & CAPD Initially 500 mg, then 250 mg every 48 hr.
Hypersensitivity to levofloxacin or other quinolones. Patients w/ epilepsy, history of tendon disorders related to fluoroquinolone administration. Pregnancy & lactation. Childn or adolescents.
Special Precautions
Not recommended for known or suspected MRSA infections. Inhalational anthrax. Discontinue use if conspicuous drop in BP, convulsive seizures, hypersensitivity reactions, psychotic reactions occur. Patients on controlled Na diet. Clostridium difficile-associated diarrhea; pseudomembraneous colitis; superinfection. Patients predisposed to seizures; G6PD deficiency, severe bullous skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), dysglycaemia, psychotic patients, history of psychiatric disease, peripheral neuropathy, myasthenia gravis, vision disorders. Congenital long QT syndrome, uncorrected electrolyte imbalance (eg, hypokalemia, hypomagnesemia), cardiac disease (eg, heart failure, MI, bradycardia). Photosensitisation. Avoid exposure to strong sunlight or artificial UV rays. High doses. Concomitant use w/ corticosteroids, theophylline, vit K antagonist eg, warfarin, class IA & III antiarrhythmics, TCAs, macrolides, antipsychotics. False -ve results in TB diagnosis. Hepatic necrosis, fatal hepatic failure. Renal impairment. Women. Elderly >60 yr.
Adverse Reactions
Insomnia; headache, dizziness; phlebitis; diarrhoea, vomiting, nausea; increased hepatic enzyme; infusion site reaction eg, pain & reddening.
Drug Interactions
Reduced absorption w/ Fe salts, Mg- or Al-containing antacids or didanosine. Reduced bioavailability w/ sucralfate. Lowered cerebral seizure threshold w/ theophylline & NSAIDs. Higher conc w/ fenbufen. Reduced renal clearance by cimetidine & probenecid. Increased t½ of ciclosporin. Increased coagulation &/or bleeding w/ vit K antagonist eg, warfarin. Prolonged QT interval w/ class IA & III antiarrhythmics, TCAs, macrolides & antipsychotics.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Levores soln for infusion 5 mg/mL
100 mL x 1's
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