Volequin

Indonesia • Dexa Medica

Indication

Levofloxacin hemihydrate is indicated for adult (≥18 years) in infections with susceptible microorganism, such as:

  • Acute maxillary sinusitis
  • Acute bacterial exacerbations of chronic bronchitis
  • Community-acquired pneumonia
  • Uncomplicated skin and skin structure infections
  • Complicated urinary tract infection
  • Acute pyelonephritis

Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistence.

Composition

Each film-coated tablet contains:
Levofloxacin hemihydrate equivalent to Levofloxacin 500 mg

Package

Box, 1 blister @ 10 film coated tablet

Dosage Forms

Tablet

ATC Classification

J01M

Warning

Alcohol
Caution
This item may not be safe for use with alcohol. Use with caution and after consultation with your doctor.
Machinery
Caution
This item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.
Pregnancy
Not Recommended
This item is not safe for use during pregnancy.
Lactation
Not Recommended
This item is not safe for use during lactation.
Precaution

Contraindications:

  • Patients with known hypersensitive to levofloxacin hemihydrate or other quinolones
  • Patients with epilepsy
  • Patients with history of tendon disorder related to fluoroquinolone administration
  • Children or growing adolescent
  • Pregnant women and nursing mothers

Warning:
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, patients taking corticosteroid drugs, and patients with renal, heart or lung transplants.

Dosage

Usual dose in patients with normal renal function (creatinine clearance >80 ml/minute) is 250-500 mg once daily. The dosage can be used usually for 7-14 days depending on the severity of the disease:

  • Acute bacterial exacerbation of chronic bronchitis: 500 mg once daily for 7 days
  • Community-acquired pneumonia: 500 mg once daily for 7-14 days
  • Acute Acute maxillary sinusitis: 500 mg once daily for 10-14 days
  • Uncomplicated skin and skin structure infection: 500 mg once daily for 7-10 days
  • Complicated UTI: 250 mg once daily for 10 days
  • Acute pyelonephritis: 250 mg once daily for 10 days

Patients with impaired renal function, with acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, acute maxillary sinusitis, uncomplicated skin structure and skin infection should be given as follows:

Creatinine clearance

  • 50-80 ml/minute: no dosage adjustment
  • 20-49 ml/minute: initial dose 500 mg once daily, with subsequent dose 250 mg once daily
  • 10-19 ml/minute: inital dose 500 mg once daily, with subsequent dose 250 mg per 48 hours
  • Hemodialysis: initial dose 500 mg once daily, with subsequent dose 250 mg per 48 hours
  • CAPD (Chronic Ambulatory Peritoneal Dialysis): initial dose 500 mg once daily, with subsequent dose 250 mg per 48 hours

Patients with impaired renal function, with complicated urinary tract infection, acute pyelonephritis, the dose should be given as follow:

Creatinine clearance

  • ≥20 ml/minute: no dosage adjustment
  • 10-19 ml/minute: intial dose 250 mg, subsequent dose 250 mg per 48 hours

Levofloxacin hemihydrate tablet can be taken with or without regard to meals. Patients should be advised to drink fluid liberally.

* For detailed product information, see package insert.
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