Description
Release form
Film-coated tablets
Packaging
5 tablets per blister strip pack of PVC film and varnished aluminum printed foil.
Pharmacological action
It has a protective effect on the normal intestinal microflora, thereby it has increased gastrointestinal safety. Along with the powerful antibacterial effect of a wide spectrum, it has an immunomodulatory effect, which can be especially important in the treatment of chronic or recurrent diseases of infectious etiology.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
of the lower respiratory tract (exacerbation of chronic bronchitis, community-acquired pneumonia)
ENT organs (including acute sinusitis)
urinary tract and kidneys (including acute pyelonephritis)
skin and soft tissues (abscesses, furunculosis)
chronic bacterial prostatitis
intra-abdominal infections
drug-resistant forms of tuberculosis – as part of a complex of tuberculosis.
Contraindications
Hypersensitivity to levofloxacin, other fluoroquinolones or drug components, epilepsy, tendon damage with previous treatment with quinolones, pregnancy, lactation, childhood and adolescence (up to 18 years).
Lactose intolerance or lactase deficiency, as well as glucose-galactose malabsorption.
Precautions for the elderly, with a deficiency of glucose-6-phosphate dehydrogenase.
Special instructions
In the treatment of elderly patients, it should be borne in mind that they often suffer from impaired renal function.
Despite the fact that photosensitivity during treatment with levofloxacin is quite rare, patients are not recommended to undergo strong sunlight or artificial ultraviolet radiation.
If pseudomembranous colitis is suspected, levofloxacin should be withdrawn immediately and appropriate treatment should be initiated. In such cases, drugs that inhibit intestinal motility should not be used.
Patients with glucose-6-phosphate dehydrogenase deficiency (a hereditary metabolic disorder) may respond to fluoroquinolones by destroying red blood cells (hemolysis). In this regard, treatment with levofloxacin should be carried out with caution.
Side effects of levofloxacin, such as dizziness or drowsiness, as well as visual impairment (see the section “Side effects”), can impair reactivity and make it difficult to drive a car or operate machinery.
Composition
One tablet contains:
Active ingredient: levofloxacin hemihydrate (in terms of levofloxacin) 500 mg
Excipients: lactulose, lactose monohydrate, low molecular weight povidone, croscarmellose sodium, sodium lauryl sulfate, talc, magnesium stearate, cellulose microcrystalline dichromol, tromol .
Dosage and administration
Inside, before meals or between meals, without chewing, with plenty of fluids.
Acute sinusitis: 500 mg once a day for 10-14 days
Community-acquired pneumonia: 500 mg 1-2 times a day, 7-14 days
Exacerbation of chronic bronchitis: 250-500 mg 1 time per day for 7-10 days
Uncomplicated urinary tract infections- 250 mg 1 time per day for 3 days
Complicated urinary tract infections (including pyelonephritis): 250 mg 1 time per day (in case of severe disease, the dose should be increased) within 7-10 days
Chronic bacterial prostatitis – 500 mg once a day, treatment – 28 days
Infections of the skin and soft tissues: 250-500 mg 1-2 times a day for 7-14 days
Intraabdominal infection – 500 mg 1 time per day, the course of treatment is 7-14 days (in combination with antibacterial drugs acting on anaerobic microflora)
Complex treatment of drug-resistant forms of tuberculosis: 500 mg 1-2 times a day, course of treatment – up to 3 months
The duration of treatment depends on the type and severity of the disease.
After stopping the symptoms of acute inflammation and normalizing the temperature, it is recommended to continue therapy with levofloxacin for 48-72 hours.
Dosage of the drug in patients with impaired renal function (creatinine clearance less than 50 ml / min):
50-20 ml / min:
Initial dose 250 mg / 24 h: further 125 mg / 24 h
Initial dose 500 mg / 24 h : further 250 mg / 24 h
Initial dose 500 mg / 12 h: further 250 mg / 12 h
19-10 ml / min:
Initial dose 250 mg / 24 h: further 125 mg / 48 h
Initial dose 500 mg / 24 h: further 125 mg / 24 h
Initial dose 500 mg / 12 h: further 125 mg / 12 h
? 10 * ml / min:
Initial dose 250 mg / 24 h: further 125 mg / 48 h
Initial dose 500 mg / 24 h: further 125 mg / 24 h
Initial d 500 mg / 12 h: further 125 mg / 24 h
* incl. with hemodialysis and continuous ambulatory peritoneal dialysis
After hemodialysis or continuous ambulatory peritoneal dialysis, additional doses are not required.
Dose adjustment is not required in patients with impaired liver function.
Side effects of the
From the digestive system: nausea, vomiting, diarrhea (including blood), indigestion, decreased appetite, abdominal pain, pseudomembranous colitis increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis, dysbiosis.
From the cardiovascular system: lowering blood pressure, vascular collapse, tachycardia, lengthening of the QT interval, atrial fibrillation.
From the side of the nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, cramps.
On the part of the sensory organs: impaired vision, hearing, smell, taste and tactile sensitivity.
From the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendonitis, rhabdomyolysis.
From the urinary system: hypercreatininemia, interstitial nephritis, acute renal failure.
From the hemopoietic organs: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhage.
From the side of metabolism: hypoglycemia (increased appetite, increased sweating, trembling).
Allergic reactions: itching and hyperemia of the skin, swelling of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospasm, suffocation, anaphylactic shock, allergic pneumonitis.
Other: asthenia, exacerbation of porphyria, photosensitivity, persistent fever, development of superinfection.
Drug interaction
There are reports of a marked decrease in the seizure threshold while using quinolones and substances that lower the cerebral seizure threshold. This also applies to the simultaneous administration of quinolones and theophylline, as well as non-steroidal anti-inflammatory drugs – derivatives of propionic acid.
The effect of the drug is weakened when used simultaneously with sucralfate, antacids containing magnesium or aluminum, and iron salts. Levofloxacin should be taken at least 2 hours before taking these medicines.
With the simultaneous use of vitamin K antagonists, monitoring of the blood coagulation system is necessary.
Renal clearance of levofloxacin slightly slows cimetidine and probenecid. Levofloxacin slightly increases the half-life of cyclosporine.
Taking glucocorticosteroids increases the risk of tendon rupture.
Overdose
Symptoms of an overdose of levofloxacin appear at the level of the central nervous system (confusion, dizziness, impaired consciousness and convulsions). Moreover, gastrointestinal upsets (e.g., nausea, vomiting) and erosive lesions of the mucous membranes of the gastrointestinal tract may occur. In studies using ultra-high doses of levofloxacin, an extension of the QT interval has been shown.
Levofloxacin is not excreted by hemodialysis or peritoneal dialysis. There is no specific antidote (counteracting substance).
Treatment – gastric lavage and symptomatic therapy.
Storage Conditions
In a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Expiration
Expiration 2 years. Do not use after the expiry date.
active substance
Levofloxacin
conditions granted through pharmacies
In retseptu
The dosage form of
tablet
Appointment
Adults doctor’s prescription
