Lefos

Composition :

Each film coated tablet LEFOS® 500 contain Levofloxacin Hemihydrate equivalent with Levofloxacin 500 mg

Each film coated caplet LEFOS® 750 contains Levofloxacin Hemihydrate equivalent with Levofloxacin 750 mg

Pharmacology :

Levofloxacin is an optical isomer of S – (-) of ofloxacin. Has a broad spectrum antibacterial effect. Levofloxacin is active against gram-positive bacteria and gram-negative bacteria including anaerobic bacteria. Furthermore, Levofloxacin showed antibacterial activity against Chlamydia pneumoniae and Mycoplasma pneumoniae. Levofloxacin is often bactericidal at levels equal to or slightly greater than its inhibitory concentration.

The main mechanism of action of levofloxacin is through inhibition of DNA gyrase, type II topoisomerase. This results in inhibition of bacterial DNA replication and transcription processes.

Indication:

Levofloxacin is indicated for treatment in adults (> 18 years old) with mild, moderate, to severe infections caused by sensitive bacteria.

  • Acute bacterial sinusitis caused by Streptococcus pneumonia, Haemophillus influenza, or Moraxella catarrhalis.
  • Acute exacerbations of chronic bronchitis caused by Streptococcus sureus, Streptococcus pneumoniae, Haemophilus influenza, Haemophilus parainfluenza or Moraxella catarrhalis.
  • Nosocomial pneumonia caused by Staphylococcus aureus resiten to methicillin, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Additional therapy should be used when there is clinical indication. Where Pseudomonas aeruginosa is suspected to be a pathogenic bacteria, combination therapy with anti-pseudomonas β-lactam group is recommended.
  • Community acquired pneumonia caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenza, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophilla, or Mycoplasma pneumoniae.
  • Multi Drug Resistant (MDR) pneumoniae which isolated from strain of bacteria that is resistant to two or more of the following antibiotics: penicillin, second-generation cephalosporins such as cefuroxime, macrolides, tetracyclines, and trimethoprim / sulfamethoxazole.
  • Chronic bacterial prostatitis caused by Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis.
  • Complications of the skin and skin infections.
  • Complications of urinary tract infections.
  • Avute pyelonefritis.

Dosage :

The usual dose of Levofloxacin tablets is 250 mg or 500 mg orally administered every 24 hours, which is indicated for infection and that is due to the following dosage table. Levofloxacin may be administered before food. Oral doses should be given at least two hours before or two hours after administration of antacids containing magnesium, aluminum, sulralfate, metal cations such as iron, and multivitamins with zinc or didanosine.

Infection Dosage Interval Duration Daily Dose
Community acquired pneumonia 500 mg

 

750 mg

24 hours

 

24 hours

7-14 days

 

5 days

500 mg

 

750 mg

Nosocomial Pneumonia 750 mg 24 hours 7 – 14 days 750 mg
Acute sinusitis maxilaris 500 mg

 

750 mg

24 hours

 

24 hours

7 – 14 days

 

5 days

500 mg

 

750 mg

Acute Exacerbation Chronic bronchitis 500 mg

 

750 mg

24 hours

 

24 hours

7 days

 

3-5 days

500 mg

 

750 mg

Chrinic prostatitis bakteria 500 mg 24 hours 28 days 500 mg
Complications of skin and skin infections, urinary tract infections complications, acute pyelonephritis: 250 mg – 750 mg once daily depending on the type and severity of the suspected pathogenic bacteria, usually for 7-14 days depending on the infection suffered

 

Patients with renal impairment (creatinine clirens ≤ 50 mL / min)

Creatinine clirens Dosage Regimen
> 60 mL/min 1 x 250 mg/24 hours 1×500 mg/24 hours
50 – 20 mL/min Initial: 250 mg.

Next 125 mg/24 hours.

Initial: 500 mg.

Next 250 mg/24 hours.

19 – 10 mL/menit Initial: 250 mg.

Next 125 mg/48 hours

Initial: 500 mg.

Next 250 mg/24 hours.

< 10 mL/menit (dengan hemodialisa dan CAPD) Awal: 250 mg.

Selanjutnya 125 mg/48 jam

Initial: 500 mg.

Next 250 mg/24 hours.

 

CAPD: Continous Ambulatory Peritoneal Dialysis

Presentation and Registration Number :

LEFOS® 500 Box 1 strip @ 10 film coated tablets; DKL0408013517A1

LEFOS® 750 Box 1 strip @ 10 film coated caplets; DKL1708024909A1

ON MEDICAL PRESCRIPTION ONLY

 

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