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Antibiotics

Levofloxacin STADA® 500 mg

 

Pack size:  

Box of 2 blisters x 7 film-coated tablets.

 

Composition:

Each film coated tablet contains levofloxacin 500 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

In adults with infections of mild or moderate severity, levofloxacin is orally administerred for the treatment of the following infections when due to levofloxacin-susceptible microorganisms:

  • Community-acquired pneumonia.
    500 mg once or twice daily, 7 - 14 days.
  • Complicated urinary tract infections including pyelonephritis.
    500 mg once daily, 7 - 14 days.
  • Pyelonephritis:
    500 mg once daily, 7 - 10 days.
  • Chronic bacterial prostatitis.
    500 mg once daily, 28 days.
  • Skin and soft tissue infections.
    500 mg once or twice daily, 7 - 14 days.
  • Uncomplicated urinary tract infections: 250 mg once daily, 3 days.
    Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see Precautions) and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.
  • Acute bacterial exacerbations of chronic bronchitis (ABECB): 500 mg once daily, 7 - 10 days.
    Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see Precautions) and for some patients ABECB is self-limiting, reserve levofloxacin for treatment of ABECB in patients who have no alternative treatment options.
  • Acute bacterial sinusitis (ABS): 500 mg once daily, 10 - 14 days.
    Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see Precautions) and for some patients ABS is self-limiting, reserve levofloxacin for treatment of ABS in patients who have no alternative treatment options.
  • Impaired renal function:


Or as prescribed by physicians.

 

  • Hypersensitivity to levofloxacin or other quinolones or to any ingredient of the drug.
  • Patients with epilepsy.
  • Patients with known G6PD deficiency.
  • Patients with history of tendon disorders related to fluoroquinolone administration.
  • Children under 18 years of age.
     

Common

  • Nausea, diarrhea.
  • Increased liver enzymes.
  • Insomnia, headache.

Uncommon

  • Dizziness, nervous, agitation, anxiety.
  • Abdominal pain, flatulence, dyspepsia, vomiting, constipation.
  • Increased blood bilirubin.
  • Vaginitis, vaginal Candida infection.
  • Pruritus, eruption.

Rare

  • Hypertension or hypotension, arrhythmia.
  • Pseudomembranous colitis, dry mouth, gastritis, tongue edema.
  • Arthralgia, muscle weakness, myalgia, osteomyelitis, Achilles tendinitis.
  • Convulsions, abnormal dreams, depression, psychosis.
  • Quincke's edema, anaphylactic shock, Stevens-Johnson syndrome and Lyell's syndrome.

     

  • Tendinitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. The risk of tendinitis and tendon rupture is increased in the elderly, in patients using corticosteroids and in patients receiving daily dose of 1000 mg. If tendinitis is suspected, treatment with levofloxacin must be halted immediately.
  • Clostridium difficile-associated disease: Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin, may be symptomatic of associated disease, the most severe form of Clostridium difficile which is pseudomembranous colitis. If pseudomembranous colitis is suspected, levofloxacin must be stopped immediately.
  • Patients with renal impairment: Since levofloxacin is excreted mainly by the kidneys, the dose of levofloxacin should be adjusted in patients with renal impairment.
  • Patients with glucose-6-phosphate dehydrogenase deficiency: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents, and so levofloxacin should be used with caution.
  • Levofloxacin should be used with extreme caution in patients predisposed to seizures, such as patients with pre-existing central nervous system lesions.
  • Disglycaemia: As with all quinolones, hypoglycemia and hyperglycemia has been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glibenclamide) or with insulin. In these diabetic patients, careful monitoring of blood glucose is recommended.
  • Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval: Congenital long QT syndrome, concomitant use of drugs that are known to prolong the QT interval (e.g. class IA and III antiarrhythmic, tricyclic antidepressants, macrolides), uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesaemia), elderly, cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
  • Caution should be exercised in patients with myasthenia because the symptoms may be more severe.
  • There are announcements of adverse reaction, such as mental disorder, increased intracranial pressure, CNS stimulation, which may lead to convulsions, tremor, restlessness, headache, insomnia, depression, confusion, hallucinations, nightmares, and, rarely, suicidal thoughts or acts, have been reported with quinolones, may occur following the first dose of the drug. If nervous system effects occur, discontinue levofloxacin and institute appropriate measures. Use with caution in patients with known or suspected CNS disorders e.g. seizures, cerebral arteriosclerosis… because it may increase the risk of convulsions.
  • Hypersensitivity reactions with many different clinical manifestations, even anaphylactic shock when using quinolones, including levofloxacin have been reported. Levofloxacin should be discontinued immediately after there are the first signs of hypersensitivity reactions and initiate appropriate measures.
  • Photosensitivity from moderate to severe levels have been reported with many fluoroquinolone antibiotics including levofloxacin (although to date, the incidence of this adverse reaction when using levofloxacin is very low < 0.1%). Patients should avoid direct exposure to sunlight during treatment and 48 hours following treatment.
  • Disabling and potentially irreversible serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects.
  • Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting fluoroquinolones. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue this medicine immediately at the first signs or symptoms of any serious adverse reactions. In addition, avoid the use of fluoroquinolones, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
  • Pregnancy: Reproductive studies in animals did not raise specific concern. However in the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in pregnant women.
  • Lactation: Levofloxacin must not be used in breast-feeding women.
  • Effects to ability to drive and use machines: Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving or operating machinery).

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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