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LVZ 250/500

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Each film coated tablet contains:

Levofloxacin hemihydrate

Eq. to Levofloxacin                          250mg/500mg



Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral and intravenous adminstration.

Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antibacterial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of action of levoflxacin and other quinolone antibacterials involves inhibition of bacterial topoisomerase II (DNA gyrase) and topoisomerase IV. Topoisomerases are essential in controlling the topological state of DNA, and are vital for DNA replication, transcription, repair and recombination.

Fluoroquinolones, including levofloxacin, different in chemical structure and mode of action from other classes of antimicrobial agents, such as b-lactam, aminoglycosides, and macrolides. Therefore, microorganisms resistant to these later classes of antimicrobial agents may be susceptible to fluroquinolones. For example, b-lactam production and alterations in penicillin-binding proteins have no effect no levofloxacin activity. Conversely, microorganisms resistant to fluoroquinolones may be susceptible to other classes of antimicrobial agents.



Levofloxacin Tablets are indicated for the treatment of adults with bacterial infection caused by susceptible of the designated microorganisms in the infection listed below.



Levofloxacin tablets are contraindicated in persons with a history of hypersensitivity to levofloxavin, quinolone antimicrobial agents, or any other components of this product.

Levofloxacin is also contraindicated in persons with a history of tendonitis or tendon rupture associated with the use of any member of the quinolone group of antimicrobial agents.



The Safety and Efficacy of Levofloxacin Tablets in Children, Adolescents (Under the age of 18 years), Pregnant Woman and Nursing Mothers have not been established


Dosage & Administration

No Indication Dosage Duration
1 Acute Excerbations of Chronic Bronchitis  250-500mg OD 7-10 days
2 Acute bacterial sinusitis  500mg OD or 750mg OD 10-14 days5days
3 Community Acquired Pneumonia  500mg OD or 750mg OD 7-14 days5days
4 Nosocomial pneumonia  750mg OD 7-14 days
5 Complicated UTI  250mg OD 10 days
6 Uncomplicated UTI  250mg OD 3days
7 Chronic bacterial prostatitis  500mg OD 28 days
8 Acute pyelonephritis  250mg OD 10 days
9 Uncomplicated skin and skin structrue infections  500mg OD 7-10 days
10 Complicated skin and skin structure infections  750mg OD 7-14 days
11 Treatment and postexposure prophylaxis of inhalation anthrax  500mg OD 60 days
12 For patients with CrCI of 20-49 mL/min Initial dose 500mg followed by 250mg OD
13 If CrCl is 10-19mL/min, the initial dose of 500mg is adminstered followed by 250 mg every 48 hours


Drug Interactions

Antacids, Sucralfate, Metal Cations, Multivatamins

While the clelation by divalent cations is less marked than with other quinolones, concurrent administeration of Levofloxacin Tablets with antacids containing magnesium, or aluminium,

as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after levofloxacin administration.



No apparent effect of theophylline on levofloxacin absorption and disposition was observed. However, concomitant administration of other quinolones with thephylline has resulted in prolonged elimination half-life,

elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions in the patient population. Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when levoflaxacin is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.



No apparent effect of warfarin on levofloxacin absorption and disposition was observedThere have been reports during the post-marketing experience in patients that levoflaxacin enhances the effects of wafarin. .

Elevations of the prothrombin time in the setting of concurrent warfarin and levofloxacin use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if levofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.



No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study invloving healthy volunteers.

However, elevated serum levels of cyclosporine have been reported in the patient population when co-administered with some other quinolones. Levofloxacin Cmax and ke were slightly lower while Tmax and t1/2 were slightly longer in the presence of cyclosporine than those observed in other studies without concomitant medication. The differences, however, are not considered to be clinically significant. Therefore, no dosage adjustment is required for levofloxacin or cyclosporine when administered concomitantly.



No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers.

Levofloxacin absorption and disposition kinetics were similar in the presence or absence of diaoxin. Therefore, no dosage adjustment for levofloxacin or digoxin is required when administered concomitantly.


Prohenecid and Cimetidine:

No significant effect of probenecid or cimetidine on the rate and extent of levofloxacin absorption was observed in a clinical study invloving healthy volunteers.

The AUC and t1/2of levofloxacin were 27-38% and 30% higher, respectively, while CL/F and CLR were 21-35% lower during concomitant treatment with probenecid or cimetidine compared to levofloxacin alone. Although these differences were statistically significant, the changes were not high enough to warrant dosage adjustment for levofloxacin when probenecid or cimetidine is co-administered.


Non-steroidal anti-inflammatory drugs:

The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including levofloxacin, may increase the risk of CNS stimulation and convulsive siezures.


Antidiabetic agents:

Disturbances of bood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent.

Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.


Interactions with Laboratory or Diagnostic Testing:

Some quinolones, including levofloxacin, may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.



Overdosage, SymptonsAnd Treatment

Levofloxacin exhibits a low potential for acute toxicity. In the event of an acute over dosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.



LVZ (Levofloxacin) is available in 250 & 500mg strengths.

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