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Levofloxacin IMP 750 mg/150ml

Manufacturer

Branch of Imexpharm Corporation - Binh Duong Hi-Tech Plant

Applicant company

Imexpharm Pharmaceutical Joint Stock Company

Active ingredient

Levofloxacin (as Levofloxacin hemihydrat)

Content

750 mg/150 ml

Shelf life

24 months

Dosage Form

Solution for intravenous infusion

Package

Box of 10 bags x 1 bottles x 150ml

Visa Number

893115055523

Issuing Date

24/03/2023

Therapeutic area

Antibiotics

Indication

Levofloxacin is a fluoroquinolone antibacterial agent indicated in adults (>=18 years) for the treatment of infections caused by susceptible bacteria:
- Pneumonia: hospitals and Community acquired pneumonia
- Skin and soft tissue infections: Complicated and uncomplicated
- Chronic bacterial prostatitis.
- Acute pyelonephritis and complicated urinary tract infections
- Pyelonephritis
- Uncomplicated urinary tract infections.
- Acute exacerbation of chronic bronchitis.
- Inhalation anthrax
To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are caused or suspected to be caused by susceptible bacteria.

Dosage

Dosage in patients with normal renal function (creatinine clearance > 50 mL/min)
Pneumonia hospitals: 750 mg in 24 hours. Total duration of treatment (according to severity) 7 – 14 days.
Community-acquired pneumonia (1): 500 mg in 24 hours. Total duration of treatment (according to severity) 7 – 14 days.
Community-acquired pneumonia (2): 750 mg in 24 hours. Total duration of treatment (according to severity) 7 – 14 days.
Complicated skin and soft tissue infections: 750 mg in 24 hours. Total duration of treatment (according to severity) 7 – 14 days.
Uncomplicated skin and soft tissue infections: 500 mg in 24 hours. Total duration of treatment (according to severity) 7 – 10 days.
Chronic bacterial prostatitis: 500 mg in 24 hours. Total duration of treatment (according to severity) 28 days.
Acute pyelonephritis and complicated urinary tract infections or Chronic bacterial prostatitis (3): 750 mg in 24 hours. Total duration of treatment (according to severity) 5 days.
Acute pyelonephritis and complicated urinary tract infections or Chronic bacterial prostatitis (4): 750 mg in 24 hours. Total duration of treatment (according to severity) 10 days.
Uncomplicated urinary tract infections: 250 mg in 24 hours. Total duration of treatment (according to severity) 3 days.
Acute exacerbation of chronic bronchitis: 500 mg in 24 hours. Total duration of treatment (according to severity) 7 days.
Inhalation anthrax: 750 mg in 24 hours. Total duration of treatment (according to severity) 5 days. 500 mg in 24 hours. Total duration of treatment (according to severity) 10-14 days.
(1) Community-acquired pneumonia by Staphylococcus aureus nhạy cảm methicilin, Streptococcus pneumoniae (bao gồm các chủng đa kháng thuốc), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila hoặc Mycoplasma pneumoniae.
(2) Community-acquired pneumonia by Streptococcus pneumoniae (ngoại trừ các chủng đa kháng thuốc), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae hoặc Chlamydophila pneumoniae.
(3) Acute pyelonephritis and complicated urinary tract infections by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis và viêm thận - bể thận cấp tính do E. coli, kể cả trường hợp bị nhiễm khuẩn huyết đồng thời.
(4) Acute pyelonephritis and complicated urinary tract infections by Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa và viêm thận - bể thận cấp tính do E. coli.
Impaired renal function (creatinine clearance ≤50 mL/min)
- Levofloxacin excretion is reduced in patients with impaired renal function. Therefore, use with caution and monitor the patient's clinical condition before and after use.
- Patients with creatinine clearance ≥ 50 mL/min: no dose adjustment is required.
- Patients with impaired renal function (creatinine clearance <50 mL/min): dose adjustment is required to avoid accumulation of levofloxacin in the body.
Impaired liver function
No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
Elderly population
No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function.

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