Volexin 500

Volexin 500

201912-0118 • 18533 Views • Box of 2 blisters x 10 film coated tablets.

COMPOSITION

Each VOLEXIN 500 film coated long tablet contains:

Active ingredient:

Levofloxacine 500 mg

 

Levofloxacin is indicated in the treatment of the following infections due to susceptible micro-organisms:

  • Nosocomial and community acquired pneumonia
  • Acute pyelonephritis
  • Complicated or uncomplicated skin and skin structure infections:
  • Bacterial prostatitis
  • Post-exposure prophylaxis and radical treatment of anthrax.
  • Complicated urinary tract infections.
  • Because fluoroquinolone antibiotics, including levofloxacin, have been associated with serious adverse reactions (see Precautions) and infections in some patients may resolve spontaneously such as: uncomplicated urinary tract infections; acute infectious exacerbation of chronic bronchitis; acute bacterial sinusitis; Levofloxacin should be used in these patients only when there are no alternative treatment options.

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration: 

VOLEXIN film-coated tablets are taken orally, with or without food. Drink with plenty of water.

Posology

Skin and skin structure infections:

  • Complicated: 750 mg, once daily for 7 – 14 days
  • Uncomplicated: 250 – 500 mg, once daily for 7 – 10 days

Chronic bacterial prostatitis: 500 mg, once daily for 28 days

Anthrax: 

  • Prophylactic treatment after exposure to anthrax bacilli: 500 mg, once daily for 8 weeks.
  • Treatment of anthrax: Intravenous infusion, then oral medication when the patient's condition allows, 500 mg, once a day for 8 weeks

Complicated urinary tract infections: 250 mg, once daily for 10 days.

Acute pyelonephritis: 250 mg, once daily for 10 days.

Community-acquired pneumonia: 500 mg, once daily for 7 – 14 days.

 Nosocomial acquired pneumonia: 750 mg, once daily for 7 – 14 days.

Acute sinusitis: 500 mg, once daily for 10 – 14 days.

Acute exacerbation of chronic bronchitis: 500 mg, once daily for 10 – 14 days.

Uncomplicated urinary tract infections: 250 mg, once daily for 3 days.

Dosage in patients with impaired renal function:

Creatinine clearance CLcr

(ml/min)

First dose

Remained dose

Complicated urinary tract infections, acute pyelonephritis

≥ 20

No dose adjustment required

10 – 19

250 mg

125 mg every 24 giờ

Other indications

50 – 80

No dose adjustment required

20 – 49

500 mg

250 mg every 24 giờ

10 – 19

500 mg

125 mg every 24 giờ

Hemodialysis

500 mg

125 mg every 24 giờ

Continuous peritoneal dialysis

500 mg

125 mg every 24 giờ

CONTRAINDICATIONS

Hypersensitive to levofloxacin or other quinolones or to any of the excipients

Patients with epilepsy, G6PD enzyme deficiency, patients with a history of tendon disorders related to fluoroquinolone administration

Children under 18 years

Pregnancy and breast-feeding women.

WARNINGS AND PRECAUTIONS

Serious, potentially irreversible, and disabling adverse reactions, including tendinitis, tendon rupture, peripheral neuropathy, and CNS adverse effects.

Fluoroquinolone antibiotics have been associated with potentially fatal and irreversible adverse reactions in various body systems. These reactions may occur simultaneously in the same patient. Commonly reported adverse reactions to include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system adverse effects (hallucinations, anxiety, depression). , insomnia, severe headache, and confusion). These reactions can occur within a few hours to several weeks of taking the drug. Patients of any age or without pre-existing risk factors may experience these adverse reactions.

Discontinue use at the first sign or symptom of any serious adverse reaction. In addition, avoid the use of fluoroquinolone antibiotics in patients who have experienced serious fluoroquinolone-related reactions

In a patient with a history of convulsions.

Diarrhea, especially severe, persistent, and/or bloody diarrhea, during and after levofloxacin therapy, may be a symptom of Clostridium difficile pseudomembranous colitis. If pseudomembranous colitis is suspected, levofloxacin should be discontinued.

Tendinitis, rarely seen with quinolones, can sometimes lead to tendon rupture, especially in the Achilles tendon. This undesirable effect occurs within 48 hours of starting treatment and can be bilateral. The risk of tendinitis may be increased with corticosteroids.

In patients with renal impairment, the dose must be adjusted because levofloxacin is poorly excreted by the kidneys

Patients with latent or actual glucose-6-phosphate dehydrogenase deficiency are susceptible to hemolytic reactions during treatment with levofloxacin.

Shelf-life

36 months from the manufacturing date. Do not use it after the expiry date.

 

Box of 2 blisters x 10 film-coated tablets.

Box of 3 blisters x 10 film-coated tablets.

Box of 5 blisters x 10 film-coated tablets.

 

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