Universal reference book for medicines
Product name: LEVOSTAR (LEVOSTAR)

Active substance: levofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: ACTAVIS GROUP hf.
(Iceland) manufactured by ACTAVIS hf. (Iceland)
Composition, form of production and packaging
The tablets covered with a film cover of
pink color, oval, biconcave, with risk on one side and engraving "L" - on another.

1 tab.

levofloxacin hemihydrate 256.23 mg,

which corresponds to the content of levofloxacin 250 mg

Excipients: sodium stearyl fumarate 6.4 mg, crospovidone (polyplasdon XL) 12.8 mg, silicon dioxide colloidal anhydrous (aerosil 200) 1.6 mg, copovidone (plastidone S-630) 16 mg, microcrystalline cellulose 26.97 mg.

Composition of the film shell: opadrai II pink 31K34554 (lactose monohydrate 3.84 mg, HPMC 2910 / hypromellose 15cP 2.688 mg, titanium dioxide 2.2886 mg, triacetin 0.768 mg, iron oxide red oxide 0.0096 mg, iron oxide yellow oxide 0.0058 mg ).

10 pieces.
- blisters (1) - packs of cardboard.
The tablets covered with a film cover of pink color, oval, biconcave, with risk on one side and engraving "L" - on another.

1 tab.

levofloxacin hemihydrate 512.46 mg,

which corresponds to the content of levofloxacin 500 mg

Excipients: sodium stearyl fumarate 12.8 mg, crospovidone (polyplasdon XL) 25.6 mg, silicon dioxide colloidal anhydrous (aerosil 200) 3.2 mg, copovidone (plastidone S-630) 32 mg, microcrystalline cellulose 53.94 mg.

The composition of the film shell: opadrai II pink 31K34554 (lactose monohydrate 7.68 mg, HPMC 2910 / hypromellose 15cR 5.376 mg, titanium dioxide 4.5772 mg, triacetin 1.536 mg, iron oxide red oxide 0.0192 mg, iron oxide yellow oxide 0.0116 mg ).

10 pieces.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Levofloxacin is a broad-spectrum antibiotic from the group of fluoroquinolones, containing as an active substance the levorotatory isofloxacin isomer.
It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, 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.
Gram-positive microorganisms are sensitive to the action of the drug - Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci; Gram-negative organisms - 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.
PHARMACOKINETICS

When ingested quickly and almost completely absorbed (eating little influence on speed and completeness of absorption).
Absolute bioavailability of the order of 100%. Time to reach the maximum concentration in the plasma (Tc max) - 1 h.
The connection with plasma proteins is about 30-40%.
After a long dose of 500 mg once a day, a slight cumulation is observed. Moderate cumulation of levofloxacin is observed already on the third day of taking the drug at a dose of 500 mg 2 times a day. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, polymorphonuclear leukocytes, alveolar macrophages. The maximum concentration of levofloxacin (C max ) in bronchial mucosa and epithelial lining fluid after oral administration of 500 mg of the drug is 8.3 μg / g and 10.8 μg / ml, respectively; C max levofloxacin in the blister fluid is 4.0-6.7 μg / ml, Tc max in this case is 2-4 hours. C max in the lung tissues after oral administration of 500 mg of the drug is 11/3 μg / g and Tc max is 4- 6 hours Levofloxacin penetrates into the cerebrospinal fluid in small amounts. At oral intake of 500 mg / day of levofloxacin on the third day of treatment of Cmax in the tissues of the prostate at 2, 6 and 24 hours after taking the drug - 8/7 μg / g, 8/2 μg / g and 2/0 μg / g, respectively . The ratio of prostatic / plasma concentrations averaged 1.84. The average C max value in the urine after taking 500 mg of the drug after 8-12 hours is 200 mg / l.
In the liver, a small part of the preparation is oxidized and / or deacetylated.
The half-life (T 1/2 ) is 6-8 hours. It is excreted mainly by the kidneys (about 85% of the dose) by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites.
With violations of kidney function and a decrease in renal clearance, T 1/2 increases.

During clinical trials, there was no difference in the pharmacokinetics of the drug in men and women.

INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- Infections of the lower respiratory tract (exacerbation of chronic bronchitis, community-acquired pneumonia);

- infection of the ENT organs (acute sinusitis);

- Urinary tract infection and kidney infection (including acute pyelonephritis);

- infections of the genitals (including bacterial prostatitis);

- skin and soft tissue infections (festering atheromas, abscess, boils);

- intra-abdominal infections;

- tuberculosis (complex therapy of drug-resistant forms).

DOSING MODE

Inside, during a meal or during a break between meals, without chewing, squeezed with enough liquid.

Doses are determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility,

The recommended dose of the drug for adults with normal renal function (CK> 50 ml / min):

In acute sinusitis - 500 mg once a day for 10-14 days;

With exacerbation of chronic bronchitis - from 250 to 500 mg once a day for 7-10 days;

With community-acquired pneumonia , 500 mg 1 or 2 times a day for 7-14 days;

In uncomplicated infections of the urinary tract and kidneys - 250 mg 1 time per day for 3 days;

With complicated infections of the urinary tract and kidneys - 250 mg once a day for 7-10 days;

With bacterial prostatitis - 500 mg once a day for 28 days;

For infections of the skin and soft tissues - 250 mg - 500 mg 1 or 2 times a day for 7-14 days;

Intra-abdominal infections - 250 mg twice a day or 500 mg once a day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

Tuberculosis - inside by 500 mg 1-2 times a day to 3 months.

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

Creatinine clearance, ml / min Dosing regimen

250 mg / 24 h, the first dose: 250 mg 500 mg / 24 h, the first dose: 500 mg 500 mg / 12 h, the first dose: 500 mg

50-20 then: 125 mg / 24 hours then: 250 mg / 24 hours then: 250 mg / 12 h

19-10 then: 125 mg / 48 hours then: 125 mg / 24 hours then: 125 mg / 12 h

<10 (including hemodialysis and DAPD) * then: 125 mg / 48 h then: 125 mg / 24 hours then: 125 mg / 24 h

* No additional doses are required after hemodialysis or long-term outpatient peritoneal dialysis (DAPD).

If the liver function is not required, a special dose selection is required, since levofloxacin is only slightly metabolized in the liver and excreted mainly by the kidneys.

If you missed taking the drug should, as soon as possible, take a pill, until the time of the next admission is near.
Then continue taking levofloxacin according to the scheme.
The duration of therapy depends on the type of disease (see above).
In all cases, treatment should continue from 48 to 72 hours after the disappearance of the symptoms of the disease.
SIDE EFFECT

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

From the cardiovascular system: lowering blood pressure, vascular collapse, tachycardia, lengthening the QT interval, extremely rarely - atrial fibrillation.

From the side of 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: visual, hearing, smell, taste and tactile sensitivity.

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

From the side of the urinary system: hypercreatininaemia, interstitial nephritis, acute renal failure.

On the part of the organs of hematopoiesis: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

Allergic reactions: skin itching and hyperemia, 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: photosensitization, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.

CONTRAINDICATIONS

- epilepsy;

- damage to the tendons during the previous treatment with quinolones;

- Pregnancy;

- lactation period;

- Children 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.

With caution: the elderly (due to the high likelihood of concomitant decline in kidney function), deficiency of glucose-6-phosphate dehydrogenase.

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

For patients with impaired renal function (CK <50 ml / min), dosage regimen correction is required.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If the liver function is not required, a special dose selection is required, since levofloxacin is only slightly metabolized in the liver and excreted mainly by the kidneys.

APPLICATION FOR CHILDREN

Contraindication: children and adolescence (up to 18 years);

APPLICATION IN ELDERLY PATIENTS

With caution: the elderly (due to the high likelihood of concomitant decline in kidney function).

SPECIAL INSTRUCTIONS

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

During treatment, sun and artificial UV irradiation should be avoided to avoid damage to the skin (photosensitivity).

When there are signs of tendinitis, pseudomembranous colitis, allergic reactions, levofloxacin is immediately withdrawn.

It should be borne in mind that the development of seizures is possible in patients with a history of brain damage (stroke, severe trauma), and the risk of hemolysis is a deficiency in glucose-6-phosphate dehydrogenase.

Impact on the ability to drive vehicles and manage mechanisms

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.

OVERDOSE

Expected symptoms of an overdose of Levofloxacin are manifested at the level of the central nervous system (confusion, dizziness, impaired consciousness and seizures of the type of epiprip).
In addition, gastrointestinal disorders (eg, nausea) and erosive lesions of the mucous membranes may occur. From the side of the cardiovascular system, an extension of the QT interval can be observed.
Treatment is symptomatic.
ECG monitoring is required to monitor the QT interval. You can use antacids. Levofloxacin is not excreted by dialysis. There is no specific antidote.
DRUG INTERACTION

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

With the simultaneous use of vitamin K antagonists, control over the blood coagulation system is necessary.

Elimination (renal clearance) of levofloxacin slightly slows down under the action of cimetidine and probenecid in view of the possible blocking of tubular secretion of levofloxacin in the kidneys.
It should be noted that this interaction is of clinical importance, primarily for patients with impaired renal function. Levofloxacin increases the half-life of cyclosporine.
TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

At a temperature of no higher than 25 ° C.
Keep out of the reach of children! Shelf life - 2 years. Do not use after the expiration date printed on the package.
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