Levofloxacin Kabi

Levofloxacin Kabi

levofloxacin

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Concise Prescribing Info
Contents
Levofloxacin
Indications/Uses
Treatment of community-acquired pneumonia; complicated skin & soft tissue infections; pyelonephritis & complicated UTI; chronic bacterial prostatitis. Post-exposure prophylaxis & curative treatment of inhalation anthrax.
Dosage/Direction for Use
Administer as slow IV infusion once daily or bd. Infusion time must be at least 30 min for 250 mg, or 60 min for 500 mg Levofloxacin Kabi. Initial IV treatment may be completed w/ oral presentation as considered appropriate for the individual patient. Treatment duration includes IV + oral treatment. Time to switch from IV to oral treatment depends on clinical situation but is normally 2-4 days. Patient w/ normal renal function (CrCl >50 mL/min) Community-acquired pneumonia; complicated skin & soft tissue infections 500 mg once daily or bd for 7-14 days. Pyelonephritis 500 mg once daily for 7-10 days. Complicated UTI 500 mg once daily for 7-14 days. Chronic bacterial prostatitis 500 mg once daily for 28 days. Inhalation anthrax 500 mg once daily for 8 wk. Patient w/ impaired renal function CrCl 20-50 mL/min 250 mg/24 hr dose regimen: 250 mg 1st dose, then 125 mg/24 hr. 500 mg/24 hr dose regimen: 500 mg 1st dose, then 250 mg/24 hr. 500 mg/12 hr dose regimen: 500 mg 1st dose, then 250 mg/12 hr, CrCl 10-19 mL/min 250 mg/24 hr dose regimen: 250 mg 1st dose, then 125 mg/48 hr. 500 mg/24 hr dose regimen: 500 mg 1st dose, then 125 mg/24 hr. 500 mg/12 hr dose regimen: 500 mg 1st dose, then 125 mg/12 hr, CrCl <10 mL/min (including haemodialysis & continuous peritoneal dialysis) 250 mg/24 hr dose regimen: 250 mg 1st dose, then 125 mg/48 hr. 500 mg/24 hr dose regimen: 500 mg 1st dose, then 125 mg/24 hr. 500 mg/12 hr dose regimen: 500 mg 1st dose, then 125 mg/24 hr.
Contraindications
Hypersensitivity to levofloxacin or any other quinolone. Patients w/ epilepsy; history of tendon disorders related to fluoroquinolone administration. Pregnancy & lactation. Childn or growing adolescents.
Special Precautions
Not recommended for the treatment of known or suspected MRSA infections unless there is confirmed susceptibility of the organism to levofloxacin. Risk of E. coli resistance. Associated w/ disabling & potentially irreversible serious adverse reactions including tendinitis & tendon rupture, peripheral neuropathy, & CNS effects. Immediately discontinue at the 1st signs or symptoms of any serious adverse reactions. Immediately stop infusion in case of a conspicuous drop in BP during infusion. Immediately stop treatment & initiate appropriate treatment if Clostridium difficile-associated disease is suspected or confirmed. Quinolones may lower seizure threshold & may trigger seizures. Patients w/ latent or actual defects in G6PD activity may be prone to haemolytic reactions when treated w/ quinolone antibacterial agents. Can cause serious, potentially fatal hypersensitivity reactions. Reports of severe cutaneous adverse reactions including TEN, SJS, DRESS; disturbances in blood glucose, usually in DM patients receiving concomitant oral hypoglycaemic agent or insulin; photosensitisation; psychotic reactions; QT interval prolongation; peripheral neuropathy; hepatobiliary disorders; aortic aneurysm & dissection, particularly in elderly patients; aortic & mitral valve regurgitation after intake of fluoroquinolones. May exacerbate muscle weakness in patients w/ myasthenia gravis. Advise patient to immediately consult an eye specialist in case of vision disorders. May result in overgrowth of non-susceptible organisms, especially in prolonged use. Avoid concomitant use of corticosteroids. Monitor coagulation tests (PT/INR) when given concomitantly w/ a vit K antagonist (eg, warfarin). Determination of opiates in urine may give false +ve results. May inhibit the growth of Mycobacterium tuberculosis, giving false -ve results in bacteriological diagnosis of TB. May affect ability to drive or operate machinery. Patients on a controlled Na diet. Patients w/ renal impairment. Elderly.
Adverse Reactions
Insomnia; headache, dizziness; phlebitis; diarrhoea, vomiting, nausea; increased hepatic enzymes (ALT/AST, alkaline phosphatase, GGT); infusion site reaction (pain, reddening).
Drug Interactions
Pronounced lowering of the cerebral seizure threshold may occur when quinolones are concurrently given w/ theophylline, NSAIDs, or other agents which lower the seizure threshold. Increased conc w/ fenbufen. Reduced renal clearance w/ drugs that affect the tubular renal secretion eg, probenecid, cimetidine. Increased t½ of ciclosporin. Increased coagulation tests (PT/INR) &/or bleeding w/ vit K antagonists (eg, warfarin). Potential additive effect on QT interval w/ drugs known to prolong the QT interval (eg, class IA & III antiarrhythmics, TCAs, macrolides, antipsychotics).
MIMS Class
Quinolones
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Levofloxacin Kabi soln for infusion 500 mg/100 mL
Packing/Price
1's
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