Levofloxacin tablets coated. 500 mg 10 pcs. (Levofloxacin)

Release form

Film-coated tablets.

Pharmacological action of

antimicrobial, fluoroquinolone.

ATX code: [J01MA12].

Pharmacological properties

Pharmacodynamics

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones containing levofloxacin as the active substance of the levorotatory ofloxacin. Levofloxacin blocks DNA gyrase, disrupts the supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes deep morphological changes in the cytoplasm, cell wall and membranes.

Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.

Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S (I), Staphylococcus aureus methi-S, Staphylocococococcus epidermis, Staphylococococcus epidermis C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I / S / R, Streptococcus pyogenes, Viridans streptococci peni-S / R.

Aerobic gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacaepper, Enterobacter cloacaepper, Enterobacter cloacaepperobacter Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S / R, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Moraxela catarrhalis Neissa negerma nerida neri Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp, Pscudomonas aeruginosa, Pseudomonas spp, Salmonella spp, Serratiaces.

Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp, Clostridium perfringens, Fusobacterium spp, Peptostreptococcus, Propionibacterum spp, Veilonella spp.

Other microorganisms: Bartonella spp, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp, Mycobacterium spp, Mycobacterium leprae, Micobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae, Ricketsia spp, Ureaplasma urealyticum.

Pharmacokinetics

Levofloxacin is rapidly and almost completely absorbed after oral administration. Eating little effect on the speed and completeness of absorption. The bioavailability of 500 mg of levofloxacin after oral administration is almost 100%. After taking a single dose of 500 mg of levofloxacin, the maximum concentration is 5.2-6.9 μg / ml, the time to reach the maximum concentration is 1.3 hours, the half-life is 6-8 hours.

Communication with plasma proteins - 30-40% . It penetrates well into organs and tissues: lungs, mucous membrane of the bronchi, sputum, organs of the genitourinary system, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages.

In the liver, a small portion is oxidized and / or deacetylated. It is excreted mainly by the kidneys by glomerular filtration and tubular secretion. After oral administration, approximately 87% of the dose taken is excreted in the urine unchanged for 48 hours, less than 4% with feces for 72 hours.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms - acute sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia, complicated urinary tract infections (including pyelonephritis), uncomplicated infections of the urinary tract, prostate and soft tissue infections septicemia / bacteremia associated with the above indications, intra-abdominal infection.

Special instructions

Levofloxacin cannot be used to treat children and adolescents because of the likelihood of damage to articular cartilage.

In the treatment of elderly patients, it should be borne in mind that patients of this group often suffer from impaired renal function (see section Dosage and Administration).

In severe pneumonia caused by pneumococci, levofloxacin may not produce the optimal therapeutic effect. Hospital infections caused by certain pathogens (P. aeruginosa), may require combination treatment.

During treatment with Levofloxacin, seizures may develop in patients with previous brain damage due to, for example, a stroke or severe trauma.

Despite the fact that photosensitization is very rare with levofloxacin, in order to avoid it, patients are not recommended to be exposed to strong sunlight or artificial ultraviolet radiation without special need.

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.

Rarely observed with levofloxacin, tendonitis (primarily inflammation of the Achilles tendon) can lead to rupture of tendons. Elderly patients are more prone to tendonitis. Treatment with glucocorticosteroids in all likelihood increases the risk of tendon rupture. If you suspect a tendonitis, you should immediately stop treatment with Levofloxacin and begin appropriate treatment of the affected tendon.

Patients with glucose-6-phosphate dehydrogenase deficiency (a hereditary metabolic disorder) may respond to fluoroquinolones by destroying red blood cells (hemolysis). In this regard, the treatment of such patients with levofloxacin should be carried out with great care.

Side effects of Levofloxacin, such as dizziness or numbness, drowsiness, and visual disturbances (see also section Adverse effects), may impair reactivity and concentration. This can be a risk in situations when these abilities are of particular importance (for example, when driving a car, when servicing machines and mechanisms, when performing work in an unstable position).

Composition

Active ingredient:

levofloxacin - 500 mg (in terms of levofloxacin hemihydrate - 512.46 mg).

Excipients:

microcrystalline cellulose, hypromellose (hydroxypropyl methylcellulose), primellose (croscarmellose sodium), calcium stearate.

Shell composition:

hypromellose (hydroxypropyl methylcellulose), macrogol 4000 (polyethylene glycol, polyethylene oxide), talc, titanium dioxide, yellow iron dye.

Description:

Tablets, film-coated yellow, round, biconvex. Two layers are visible in the cross section.

Dosage and administration of

The drug is taken orally once or twice a day. Do not chew the tablets and drink plenty of fluids (from 0.5 to 1 cup), you can take before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the putative pathogen.

Patients with normal or moderately reduced renal function (creatinine clearance> 50 ml / min.) are recommended the following dosage regimen:

Sinusitis: 500 mg once daily - 10-14 days.

Exacerbation of chronic bronchitis: 250 mg or 500 mg once a day for 7-10 days.

Community-acquired pneumonia: 500 mg 1-2 times a day - 7-14 days.

Uncomplicated urinary tract infections: 250 mg once daily - 3 days.

Prostatitis: 500 mg - 1 time per day - 28 days.

Complicated urinary tract infections, including pyelonephritis: 250 mg 1 time per day - 7-10 days.

Infections of the skin and soft tissues: 250 mg once a day or 500 mg 1-2 times a day - 7-14 days.

Septicemia / bacteremia: 250 mg or 500 mg 1-2 times a day - 10-14 days.

Intraabdominal infection: 250 mg or 500 mg once a day for 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

After hemodialysis or continuous ambulatory peritoneal dialysis, additional doses are not required.

In case of impaired liver function, a special selection of doses is not required, since levofloxacin is metabolized in the liver only to a very small extent.

As with other antibiotics, treatment with Levofloxacin 250 mg and 500 mg tablets is recommended to continue for at least 48-78 hours after normalization of body temperature or after laboratory-confirmed recovery.

Side effects

Allergic reactions:

Sometimes: itching and redness of the skin.

Rarely: general hypersensitivity reactions (anaphylactic and anaphylactoid reactions) with symptoms such as urticaria, narrowing of the bronchi and possibly severe suffocation.

In very rare cases: swelling of the skin and mucous membranes (for example, in the face and pharynx), a sudden drop in blood pressure and shock, increased sensitivity to solar and ultraviolet radiation (see Special instructions), allergic pneumonitis vasculitis.

In some cases: severe skin rashes with blistering, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and exudative erythema multiforme. General hypersensitivity reactions can sometimes be preceded by milder skin reactions. The above reactions may develop after the first dose several minutes or hours after administration of the drug.

Digestive system:

Often: nausea, diarrhea, increased activity of liver enzymes (eg, alanine aminotransferase and aspartate aminotransferase).

Sometimes: loss of appetite, vomiting, abdominal pain, digestive disorders.

Rarely: diarrhea with an admixture of blood, which in very rare cases can be a sign of intestinal inflammation and even pseudomembranous colitis (see Special instructions).

Metabolism:

Very rare: a decrease in blood glucose concentration, which is of particular importance for patients with diabetes, possible signs of hypoglycemia: increased appetite, nervousness, perspiration, trembling. Experience with other quinolones suggests that they are capable of exacerbating porphyria in patients already suffering from this disease. A similar effect is not excluded with the use of the drug levofloxacin.

From the nervous system:

Sometimes: headache, dizziness and / or stupor, drowsiness, sleep disturbances.

Rarely: anxiety, paresthesia in the hands, trembling, psychotic reactions such as hallucinations and depressions, agitated state, convulsions and confusion.

Very rarely: impaired vision and hearing, impaired taste and smell, decreased tactile sensitivity.

From the cardiovascular system:

Rarely: increased heart rate, lowering blood pressure.

Very rare: (shock-like) vascular collapse.

In some cases: lengthening the QT interval.

From the musculoskeletal system:

Rarely: tendon lesions (including tendonitis), joint and muscle pain.

Very rare: tendon rupture (e.g., Achilles tendon) this side effect can occur within 48 hours after the start of treatment and may be bilateral (see Special instructions) muscle weakness, which is of particular importance for patients with bulbar syndrome.

In some cases: muscle damage (rhabdomyolysis).

Urinary system:

Rarely: elevated serum bilirubin and creatinine.

Very rare: impaired renal function up to acute renal failure, interstitial nephritis.

From the hemopoietic organs:

Sometimes: an increase in the number of eosinophils, a decrease in the number of leukocytes.

Rarely: thrombocytopenia neutropenia, which may be accompanied by increased bleeding.

Very rare: agranulocytosis and the development of severe infections (persistent or recurrent fever, impaired well-being).

In some cases: hemolytic anemia pancytopenia.

Other adverse effects:

Occasionally: general weakness.

Very rare: fever.

Any antibiotic therapy can cause changes in microflora, which is normally present in humans. For this reason, increased reproduction of bacteria and fungi that are resistant to the antibiotic used may occur, which in rare cases may require additional treatment.

Drug Interactions

There are reports of a marked decrease in the seizure threshold while using quinolones and substances that in turn can lower the cerebral seizure threshold. This applies equally to the simultaneous use of quinolones and theophylline.

The effect of the drug Levofloxacin is significantly attenuated with simultaneous use with sucralfate. The same thing happens with the simultaneous use of magnesium- or aluminum-containing antacids, as well as iron salts. Levofloxacin should be taken at least than 2 hours before or 2 hours after taking these funds. No interaction with calcium carbonate was detected.

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

Excretion (renal clearance) of levofloxacin slightly slows down under the action of cimetidine and probenicide. It should be noted that this interaction has practically no clinical significance. However, with the simultaneous use of drugs such as probenicide and cimetidine, which block a specific excretion route (tubular secretion), treatment with levofloxacin should be carried out with caution. This applies primarily to patients with limited renal function.

Levofloxacin slightly increases the half-life of cyclosporine.

Taking glucocorticosteroids increases the risk of tendon rupture.

Overdose

Symptoms of an overdose of the drug Levofloxacin are manifested at the level of the central nervous system (confusion, dizziness, impaired consciousness and seizures of the type of epipressure). In addition, gastrointestinal upsets (for example, nausea) and erosive lesions of the mucous membranes, prolongation of the QT interval can be noted.

Treatment should be symptomatic. Levofloxacin is not excreted by dialysis (hemodialysis, peritoneal dialysis and permanent peritoneal dialysis). There is no specific antidote.

Storage conditions

List B. In a dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Expiration

2 years.

Do not use after the expiry date.

Deystvuyuschee substances

Levofloxacin

Pharmacy vacation

Po

Form of Treatment

tablets

Prescription

Adult prescription, Prescription doctor

Indications

Bronchitis, From pneumonia, From boils, From prostatitis, From urinary tract infections, From respiratory infections, From female genital infections, From tuberculosis, From infectious diseases, About t skin infections, From sinusitis, From sinusitis

Possible product names

Levofloxacin tablets. 500 mg 10 pcs.

Pharmstandard-Tomsk, Russia



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