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);
— infections of the ENT organs (acute sinusitis);
– urinary tract and kidney infections (including acute pyelonephritis);
— genital infections (including bacterial prostatitis);
– infections of the skin and soft tissues (festering atheromas, abscess, boils);
— intra-abdominal infections;
— tuberculosis (complex therapy of drug-resistant forms).

Pharmacological effect

Levofloxacin is a broad-spectrum antibiotic from the group of fluoroquinolones, containing the levorotatory isomer of ofloxacin as an active substance. Blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes.

Effective against most strains of microorganisms both in vitro and in vivo. Sensitive to the action of the drug:

– 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;

Also sensitive are anaerobic microorganisms (Clostridium perfringens, Bacteroides fragilis) and other groups of microorganisms – Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycobacterium tuberculosis.

Special instructions

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

During treatment, it is necessary to avoid solar and artificial UV irradiation to avoid damage to the skin (photosensitization).

If signs of tendinitis, pseudomembranous colitis, or allergic reactions appear, levofloxacin is immediately discontinued.
It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), seizures may develop; with glucose-6-phosphate dehydrogenase deficiency, there is a risk of hemolysis.

The effect of Levostarf on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Levofloxacin

Composition

1 tab.:
– levofloxacin hemihydrate 256.23 mg, which is resp. content of levofloxacin 250 mg

– levofloxacin hemihydrate 512.46 mg, which is resp. content of levofloxacin 500 mg

Excipients:

sodium stearyl fumarate,

crospovidone (polyplasdon XL),

colloidal silicon dioxide anhydrous (Aerosil 200),

copovidon (plasdon S-630),

microcrystalline cellulose.

Film shell composition:

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

Contraindications

— epilepsy;
– tendon damage due to previous treatment with quinolones;
— pregnancy;
– lactation period;
– childhood and adolescence (up to 18 years);
– lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
– hypersensitivity to levofloxacin or other fluoroquinolones, as well as to the excipients of the drug Levostar.
With caution: older age (due to the high likelihood of a concomitant decrease in renal function), glucose-6-phosphate dehydrogenase deficiency

Side Effects

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

From the cardiovascular system: decreased blood pressure, vascular collapse, tachycardia, prolongation of the QT interval, extremely rarely – atrial fibrillation.

Metabolism: hypoglycemia (increased appetite, increased sweating, trembling).

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

From the senses: disturbances of vision, hearing, smell, taste and tactile sensitivity.

From the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.

From the urinary system: hypercreatininemia, interstitial nephritis, acute renal failure.

From the hematopoietic organs: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

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

Other: photosensitivity, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.

Interaction

There are reports of a marked decrease in the level of convulsive readiness with the simultaneous use of quinolones and substances that can, in turn, reduce the threshold of convulsive readiness. This also applies equally to the simultaneous use of quinolones, theophylline and NSAIDs. The effect is reduced by drugs that inhibit intestinal motility, sucralfate, magnesium- or aluminum-containing antacids, iron and zinc salts (a break of at least 2 hours between doses is required).
Taking glucocorticosteroids increases the risk of tendon rupture.

When using vitamin K antagonists simultaneously, monitoring of the blood coagulation system is necessary.
The elimination (renal clearance) of levofloxacin is slightly slowed down by cimetidine and probenecid due to the possible blocking of tubular secretion of levofloxacin in the kidneys. It should be noted that this interaction is of clinical significance, primarily for patients with impaired renal function. Levofloxacin increases the half-life of cyclosporine.

Overdose

The expected symptoms of an overdose of Levofloxacin appear at the level of the central nervous system (confusion, dizziness, impaired consciousness and seizures of the epileptic type). In addition, gastrointestinal disorders (for example, nausea) and erosive lesions of the mucous membranes may occur. From the cardiovascular system, a prolongation of the QT interval may be observed.

Treatment is symptomatic. ECG monitoring is required to monitor the QT interval. You can use antacid medications. Levofloxacin is not eliminated by dialysis. There is no specific antidote.

Manufacturer

Actavis Ltd, Malta