Expiration date: 09/2025

Release form 

Tablets, film-coated

Composition

1 tablet contains levofloxacin (levofloxacin hemihydrate a) 500, 00 (512, 46) mg.

Packaging

10 PCs 

Pharmacological action

Optically active levorotatory isomer of ofloxacin, L - ofloxacin (S-(-)-enantiomer). Has a broad spectrum of antimicrobial activity. Inhibit bacterial topoisomerase IV and DNA-girazu (topoisomerase II). Disrupts supercoiling and cross-linking of DNA breaks, causes profound morphological changes in cytoplasm, cell wall. At concentrations equivalent to or exceeding the minimum inhibitory concentrations (IPC) are often bactericidal activity. The main mechanism of development of resistance is associated with mutation of the gene gyr-A possible development of cross-resistance between levofloxacin and other fluoroquinolones. Cross-resistance between levofloxacin and other antibacterial drugs classes usually does not occur. 

Testimony

Infectionamoxicillin diseases caused by sensitive to levofloxacin by microorganisms:

• acute bacterial sinusitis,
  
• exacerbation of chronic bronchitis,
  
• community-acquired pneumonia,
  
• complicated infectious diseases of the urinary tract, including pyelonephritis,
  
• chronic bacterial prostatitis,
  
• infections of skin and soft tissues.
  

Contraindications

Hypersensitivity to levofloxacin, to other hinolonam or other components of the drug, epilepsy, including a history of lesions of the tendons associated with the use of fluoroquinolones in anamnesis, childhood and adolescence to 18 years, pregnancy, breastfeeding.

Method of application and doses

Levofloxacin is taken orally 1-2 times per day. Dose and duration of treatment are determined by the nature and severity of the infection, and the alleged sensitivity of the pathogen. Tablets should be taken without chewing and with sufficient amount of liquid (½to 1 Cup). Selection of dose pills you can break in a dividing groove in equal parts. The drug can be taken before a meal or anytime between meals. 

Treatment with Levofloxacin-Teva is recommended to continue for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen. 

Acute bacterial sinusitis: 1 tablet (500 mg) 1 times a day for 10-14 days. 

Acute bronchitis and exacerbation of chronic bronchitis: ½ -1 tablet (250-500 mg), 1 times a day for 7-10 days. 

Community acquired pneumonia: 1 tablet (500 mg) 1-2 times daily for 7-14 days. 

Complicated infectious diseases of the urinary tract, including pyelonephritis: ½ tablet (250 mg) 1 times a day for 7-10 days. 

Chronic bacterial prostatitis: 1 tablet (500 mg) 1 times a day for 28 days. 

Infections of skin and soft tissue: 1 tablet (500 mg) 1-2 times daily for 7-14 days. 

Patients with hepatic impairment correction dosing regimen is not required. 

Patients with impaired renal function (KK less 50 ml/min) requires a correction mode depending on the magnitude of KK.

Special instructions

With the use of levofloxacin have been cases of tendinitis, which mainly affects the Achilles tendon and can cause it to rupture. In elderly patients and with concomitant use of corticosteroids, the likelihood of developing tendinitis and tendon rupture with the use of levofloxacin increases. If you suspect tendonitis, you should immediately cancel levofloxacin and start appropriate treatment, providing a state of peace in the affected area. 

If you suspect pseudomembranous colitis (diarrhoea, particularly severe and/or bloody) should be promptly discontinued levofloxacin and start appropriate treatment. 

During treatment with levofloxacin may develop an attack of convulsions in patients with previous brain damage (including stroke or severe brain injury). 

With the use of quinolones in patients with deficiency of glucose-6-phosphate dehydrogenase possible hemolysis of red blood cells. 

If necessary, use of levofloxacin in patients with diabetes need to control glucose concentration in the blood. 

Sometimes after the first dose of levofloxacin may develop pronounced, potentially fatal hypersensitivity reactions (angioedema, anaphylactic shock). 

Despite the fact that photosensitivity has been reported during the use of levofloxacin is very rare, to prevent its development, patients should avoid sun exposure or UV exposure. 

While the use of levofloxacin and anticoagulants is necessary to monitor the status of the blood coagulation system. 

When taking fluoroquinolones, including levofloxacin, may develop psychotic reactions, which is very rare with the progression can lead to suicidal thoughts and potentially dangerous behavior. With the development of such phenomena the drug should be discontinued. 

In the application of levofloxacin in patients that have predisposing factors for QT prolongation, it is necessary to study electrocardiogram before and during the treatment with levofloxacin. 

When taking fluoroquinolones was observed cases of sensory or sensorimotor peripheral neuropathy. To prevent the development of irreversible effects in the development of symptoms of peripheral neuropathy levofloxacin should be discontinued immediately. 

While taking levofloxacin the patients might have false-positive test results for the presence of opiates in urine. To confirm a positive test result you should use more specific methods. 

There are reports of rare cases of liver failure on the background of treatment with levofloxacin, primarily in patients with severe diseases such as sepsis. When symptoms of liver dysfunction such as loss of appetite, jaundice, dark urine, itching or sensitivity of the abdominal wall during palpation, levofloxacin should be discontinued. 

In appointing the drug in elderly patients should be borne in mind that patients in this group often have renal dysfunction.

Drug interactions

Absorption of levofloxacin is significantly reduced when the simultaneous administration with sucralfate, magnesium or aluminum-containing antacids and iron salts (the interval between administration of levofloxacin and these drugs should be at least 2 hours). With calcium carbonate interactions have been identified. 

Chinolone can enhance the ability of drugs (including theophylline) lowering the threshold of convulsive readiness. At simultaneous reception with fenbufen observed higher concentrations of levofloxacin (13%) than monotherapies. 

Levofloxacin excretion is slowed by the action of cimetidine (24%) and probenecid (34%). 

Levofloxacin is a slight increase in T1/2 cyclosporine. 

Concurrent administration with glucocorticosteroids (GCS) have an increased risk of tendon rupture. 

Concurrent administration of levofloxacin with oral anticoagulants increases the coagulation time and/or bleeding. 

Levofloxacin while the use of antiarrhythmic drugs of IA and III class, tricyclic antidepressants, macrolides can cause prolongation of the QT interval.

Overdose

Symptoms: nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, dizziness, confusion and convulsions, according to the type of epileptic seizures. 

Treatment: symptomatic therapy, ECG monitoring. There is no specific antidote. Hemodialysis is not effective. Symptoms: nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, dizziness, confusion and convulsions, according to the type of epileptic seizures. 

Treatment: symptomatic therapy, ECG monitoring. There is no specific antidote. Hemodialysis is not effective.

Storage conditions

At a temperature not exceeding 25°C protected from light. Keep out of reach of children.