Indication
It is a fluoroquinolone antibiotic medicine used in adults, age 18 years or older to treat certain infections caused by certain bacteria.
It is indicated for the treatment of mild to moderate bacterial infections in adults caused by levofloxacin sensitive bacteria: Acute sinusitis (inflammation of one or more paranasal sinuses), inflammation of the lower airways (acute exacerbation of chronic bronchitis, community acquired pneumonia),...
Adult:
Acute sinusitis: 500 mg once daily for 7 to 14 days
Acute exacerbation of chronic bronchitis: 500 mg once daily for 7 to 10 days Community acquired pneumonia: 500 mg once or twice daily for 7 to 14 days
Urinary Tract infection: 500 mg once daily for 7 to 14 days
Urinary Tract infection (uncomplicated infection): 250 mg once daily for 3 days
Chronic prostatis: 500 mg once daily for 28 days
Complicated skin and soft tissue infections: 500 mg once or twice daily for 7 to 14 days
Inhalation of anthrax (treatment and post-exposure prophylaxis):500 mg once daily for 8 weeks.
Each film-coated caplet contains:
Levofloxacin Hemihydrate USP equivalent to Levofloxacin... 250 mg / 500 mg.
Levofloxacin is a synthetic broad spectrum antimicrobial agent and optically active levo isomer of ofloxacin. Chemically, Levofloxacin, a chiral fluorinated carboxy quinolone, is the pure (-)-(S)-9-fluoro-2, 3-dihydro-3- methyl-10-( 4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine...
Mechanism of Action
The main mechanism of action of Levofloxacin is the inhibition of DNA gyrase. It is two fold stronger than that of ofloxacin. There is not much difference between the minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC). The activity of Levofloxacin is bactericidal. In...
Pharmacological Action
Levofloxacin is active against Gram-positive and Gram negative organisms. It is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. It has greater activity against Pneumococci than Ciprofloxacin. Levofloxacin is licensed for community acquired pneumonia...
Absorption: Rapidly and almost completely absorbed. Food prolongs time to peak plasma concentration and decreases peak concentrations.
Bioavailability: Approximately 99%.
Time to peak plasma concentration: Within 1-2 hr. Distribution: The mean volume of distribution of levofloxacin generally ranges from 74-112 L after single and multiple 500- and 750-mg doses, indicating widespread distribution into body tissue.
Metabolism: Levofloxacin is stereo-chemically stable in plasma and urine and does not invert metabolically to its enantiomer, D-ofloxacin. It undergoes limited metabolism in humans and is primarily excreted as unchanged drug in the urine.
Excretion: Levofloxacin is excreted largely as unchanged drug in the urine. Following oral and intravenous administration of levofloxacin, it is eliminated relatively slowly from the plasma (t1/2 : 6 - 8 hr). Excretion is primarily by the renal route (> 85 % of the administered dose).
Hypersensitivity to levofloxacin, any component of the formulation or other quinolones. Patients who suffer from epilepsy, with a history of tendon disorders related to the treatment with an antibiotic of the fluoroquinolone class. It is also contraindicated in children under 18 years of age, pregna...
Use caution in patients with bradycardia, hypokalaemia, hypomagnesemia, or in those receiving concurrent therapy with Class Ia or Class III Antiarrhythmias. If an allergic reactions (itching, urticaria, dyspnea or facial edema, loss of consciousness, tingling, cardiovascular collapse) occurs with qu...
Prolonged use may result in superinfection, pseudo membranous colitis may occur and should be considered in all patients who present with diarrhea.
Tendon inflammation and/or rupture has been reported; discontinue at first sign of tendon inflammation or pain.
Tendon effects, hypersensitivity reactions, other serious and sometimes fatal reactions, hepatotoxicity, CNS effect, Clostrium difficle associated diarrhoea, peripheral neuropathy, prolongation of QT interval, musculoskeletal disorders in pediatric patients, blood glucose disturbances, photosensitiv...
Levofloxacin exhibits a low potential for acute toxicity. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.
Levofloxacin should not be co-administered with any solution containing multivalent cations, e.g. magnesium, through the same IV line.
The elimination of levofloxacin was slightly reduced by cimetidine and probenecid. However, these interactions are unlikely to be of clinical relevance. Levofloxacin should be given carefully when it is co-administered with drugs that affect a certain mode elimination (tubular secretion) e.g. proben...
The half-life of cyclosporin was increased by 33% when co-administered with levofloxacin.
No pharmacokinetic interactions of levofloxacin were found with warfarin in a clinical study. However, levofloxacin is reported to enhance the effects of warfarin. Elevation of the prothrombin time and bleeding episodes have been reported with concurrent warfarin and levofloxacin. Disturbance of blo...
Levofloxacin may cause increase levels of azlocillin, cyclosporin and caffeine. Azlocillin, cimetidine, loop diuretics (furosemide, torsemide) and probenecid increase quinolone levels (decreased renal secretion).
Concomitant administration of NSAID with a quinolone including levofloxacin may increase risk of CNS stimulation and convulsive seizures.
Theophylline levels should be closely monitored and appropriate dosage adjustments made when levofloxacin is co-administered. Adverse reactions including seizures, may occur with or without an elevation in serum theophylline level.
Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.
10 x 10's Blisters.