Lefos Infusion

Composition :

Each ml LEFOS® 500 mg/100 ml Infus contain Levofloxacin hemihydrate equivalent with Levofloxacin base 5 mg

Each ml LEFOS® 750 mg/150 ml Infus contain Levofloxacin hemihydrate equivalent with Levofloxacin base 5 mg

 

Pharmacology :

Levofloxacin is a pure form (S) -enantiomer from mix racemic ofloxacin. Levofloxacin has a broad spectrum of antibacterial properties against both gram-positive and gram-negative bacteria, included anaerobic bacteria also. Levofloxacin also exhibits anti-bacterial activity against Chlamydia pneumoniae and Mycoplasma pneumoniae. Levofloxacin is often bactericidal at levels equal to or slightly higher than minimal inhibitory levels. The main mechanism of action is by inhibition of bacterial DNA gyrase (DNA topoisomerase II), resulting in inhibition of replication and DNA transcription.

Indication :                                                                                          

Levofloxacin is indicated for infections caused by sensitive microorganisms under conditions such as:

  • Chronic bronchitis with acute bacterial exacerbations
  • Community aquired pneumonia (including Penicillin – resistant Streptococcus pneumoniae strains)
  • Acute maxillary sinusitis
  • Skin infections
  • Urinary tract infections with complications
  • Acute pyelonephritis

Levofloxacin i.v. only given to patients who can not use oral Levofloxacin.

Dosage :

The usual dose for 7 – 14 days, depending on the severity of the disease. The usual dose in patients with normal renal function: 250 mg – 750 mg once daily depending on the type and severity of infection and the sensitivity of pathogenic bacteria.

LEFOS® Infusion is given by a slow intravenous infusion. After LEFOS® infusion for several days can be replaced with oral administration, depending on the patient’s condition. Elderly patients and patients with impaired liver function (but normal renal function) should be given as normal adult doses.

Dosage in patients with impaired renal function (creatinine clearance ≤ 50 ml / minutes):

Creatinine Clearance Dose Regimen
> 50 ml / minutes 250 mg once / 24 hours

(no dose adjustment required)

 500 mg once / 4 hours

(no dose adjustment required)
50 – 20 ml / minutes Initial dose: 250 mg then 125 mg / 24 hours Initial dose: 500 mg then 250 mg / 24 hours
19 – 10 ml / minutes Initial dose: 250 mg then 125 mg / 48 hours Initial dose: 500 mg then 125 mg / 24 hours
< 10 ml / minutes (including hemodialysis and CAPD)1 Initial dose: 500 mg then 125 mg / 24 hours Initial dose: 500 mg then 125 mg / 24 hours

 

1 No additional doses are required after hemodialysis or Continous Ambulatory Peritoneal Dialysis (CAP).

LEFOS® Infusion is a ready-to-use infusion solution, and should be given slowly into the vein. LEFOS® Infusion is given no less than 60 minutes (1 hour).

After a few days of use, treatment may be replaced with LEFOS® film-coated tablets, according to the patient’s condition.

After the bottle infusion is opened, LEFOS® Infusion should be used immediately to prevent bacterial contamination.

Giving LEFOS® Infusion should not be mixed with heparin or alkaline solutions (eg sodium hydrogen carbonate).

LEFOS® Infusion may be given in conjunction with: 0.9% NaCl solution (USP), 5% dextrose solution (USP), 2.5% dextrose ringer solution, or nutrient solution (amino acids, carbohydrates and electrolytes)

Presentation and Registration Number :

LEFOS® 500 mg/100 ml Infusion Box, vial  @ 100 ml; DKL1208017649A1

LEFOS® 750 mg/150 ml Infusion Box, vial  @ 150 ml; DKL1208017649A1

ON MEDICAL PRESCRIPTION ONLY

 

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