Levostar, 500 mg 10 pcs.

Levofloxacin is a broad-spectrum antibiotic from the group of fluoroquinolones, containing the left-handed isomer ofloxacin as the active substance. It blocks DNA-enzyme (topoisomerase II) and topoisomerase IV, breaks supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes deep morphological changes in cytoplasm, cell wall and membranes.

It is effective against most strains of microorganisms both in vitro and in vivo conditions. To the action of the drug are sensitive:

– Gram-positive microorganisms – Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci;

– Gram-negative microorganisms – Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichiacoli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens;

Anaerobic microorganisms (Clostridiumperfringens, Bacteroides fragilis) and other groups of microorganisms – Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium tuberculosis are also sensitive.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
– lower respiratory tract infections (exacerbation of chronic bronchitis, community-acquired pneumonia);
– ENT organ infections (acute sinusitis);
– urinary tract and kidney infections (including.Infections of the urinary tract and kidneys (including acute pyelonephritis);
– Infections of genitals (including bacterial prostatitis);
– Skin and soft tissue infections (suppurated atheromas, abscesses, furuncles);
– Intra-abdominal infections;
– Tuberculosis (complex therapy of drug-resistant forms).

Active ingredient

Composition

1 tablet:
– levofloxacin hemihydrate 256.23 mg, which corresponds to the content of levofloxacin 250 mg

– levofloxacin hemihydrate 512.46 mg, which corresponds to the content of levofloxacin. 500 mg of levofloxacin

Excipients:

Sodium stearyl fumarate,

Crospovidone (polyplasdon XL),

colloidal anhydrous silica (aerosil 200),

copovidone (plasdon S-630),

microcrystalline cellulose.

Composition of the film coating:

Opadray II pink 31K34554 (lactose monohydrate, HPMC 2910/hypromellose 15cP, titanium dioxide, triacetin, iron oxide red dye, iron oxide yellow dye).

How to take, the dosage

Orally, with meals or between meals, without chewing, drinking plenty of fluids.

Doses are determined by the nature and severity of the infection and the sensitivity of the suspected pathogen,
The recommended dose of Levostar for adults with normal renal function (CKR >50 ml/min):

In acute sinusitis, 500 mg once daily for 10-14 days;

In exacerbations of chronic bronchitis, 250 to 500 mg once daily for 7-10 days;

In community-acquired pneumonia – 500 mg Levostar 1 or 2 times a day for 7-14 days;

In uncomplicated urinary tract and kidney infections – 250 mg once a day for 3 days;

In complicated urinary tract and kidney infections, 250 mg once daily for 7-10 days;

In bacterial prostatitis, 500 mg once daily for 28 days;

In skin and soft tissue infections, 250 mg to 500 mg once or twice daily for 7-14 days;

In intra-abdominal infections – 250 mg of Levostar 2 times a day or 500 mg once a day for 7-14 days (in combination with antibacterials acting on anaerobic flora).

Tuberculosis – orally 500 mg 1-2 times a day for up to 3 months.

For patients with impaired renal function (CK < 50 ml/min):

Interaction

There are reports of a marked decrease in the level of seizure activity when using quinolones and substances that can, in turn, lower the threshold of seizure activity. This applies equally to the simultaneous use of quinolones, theophylline and NSAIDs. The effect is decreased by drugs that suppress intestinal motility, sucralfate, magnesium- or aluminum-containing antacids, iron and zinc salts (a break of at least 2 hours between doses is necessary).
Administration of glucocorticosteroids increases the risk of tendon rupture.

When using vitamin K antagonists at the same time it is necessary to monitor the clotting system.
Excretion (renal clearance) of levofloxacin is slightly delayed under the influence of cimetidine and probenecid due to possible blockage of tubular secretion of levofloxacin in kidneys. It should be noted that this interaction is of clinical importance, especially for patients with impaired renal function. Levofloxacin increases the half-life of cyclosporine.

Special Instructions

Levofloxacin should be used at least 2 hours before or 2 hours after taking preparations of iron salts, zinc, antacids and sucralfate.

At the time of treatment, sunlight and artificial UV exposure must be avoided to avoid skin damage (photosensitization).

In case of signs of tendinitis, pseudomembranous colitis and allergic reactions levofloxacin should be immediately discontinued.
It should be noted that patients with a history of brain damage (stroke, severe trauma) may develop seizures, with insufficiency of glucose-6-phosphate dehydrogenase – risk of hemolysis.

The effect of Levostarf on driving and operating machinery

At the time of treatment, caution should be exercised when driving motor vehicles and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

– epilepsy;
– tendon affection in previous treatment with quinolones;
– pregnancy;
– lactation;
– childhood and adolescence (under 18 years);
– Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
– Hypersensitivity to levofloxacin or other fluoroquinolones, as well as to Levostar excipients.
With caution: elderly age (due to high probability of concomitant reduction of renal function), glucose-6-phosphate dehydrogenase deficiency.

Side effects

Digestive system disorders: nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis; increased activity of “hepatic” transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.

Cardiovascular system disorders: decreased arterial pressure, vascular collapse, tachycardia, prolongation of QT interval, very rarely – atrial fibrillation.

Metabolic disorders: hypoglycemia (increased appetite, increased sweating, trembling).

Nervous system disorders: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, motor disorders, epileptic seizures (in predisposed patients).

Sensory organs: disorders of vision, hearing, smell, taste and tactile sensitivity.

Musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.

Urinary system disorders: hypercreatininemia, interstitial nephritis, acute renal failure.

Hematopoietic disorders: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

Allergic reactions: itching and hyperemia of the skin, swelling of the skin and mucous membranes, urticaria, erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospasm, choking, anaphylactic shock, allergic pneumonitis, vasculitis.

Others: photosensitization, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.

Overdose

The expected symptoms of Levofloxacin overdose are manifested at the CNS level (confusion, dizziness, impaired consciousness and seizure-like epileptic seizures). In addition, gastrointestinal disorders (e.g., nausea) and erosive lesions of mucous membranes may be noted. From the cardiovascular system, prolongation of the QT interval may be observed.

The treatment is symptomatic. ECG monitoring to monitor the QT interval is necessary. Antacid medications may be used. Levofloxacin is not excreted by dialysis. There is no specific antidote.

Similarities