Levofloxacin pills 500mg, 5pcs

Composition

Yellow film-coated tablets, round, biconvex; two layers are visible on the cross-section.

1 tab.

levofloxacin hemihydrate 512.46 mg, which corresponds to a levofloxacin content of 500 mg

Excipients: microcrystalline cellulose-61.66 mg, hypromellose-17.98 mg, croscarmellose sodium-18.6 mg, polysorbate 80-3.1 mg, calcium stearate-6.2 mg.

Shell composition: (polymer – 15 mg hyprolose (hydroxypropyl cellulose) – 5.82 mg, talc – 5.78 mg, titanium dioxide – 3.26 mg, iron oxide yellow (yellow oxide) – 0.14 mg) or (dry mix for film coating containing hypromellose 50%, hyprolose of (hydroxypropyl cellulose) of 19.4%, talc 19.26%, titanium dioxide 10.87%, iron oxide yellow (yellow oxide) 0.47%) – 30 mg.

Pharmacological action

The optically active levorotatory isomer of ofloxacin is L-ofloxacin (S-(-)-enantiomer). It has a wide spectrum of antimicrobial activity. Blocks bacterial topoisomerase IV and DNA gyrase (topoisomerase II). Disrupts supercoiling and crosslinking of DNA breaks, causes deep morphological changes in the cytoplasm and cell wall. In concentrations equivalent to or exceeding the minimum suppressive concentrations (MPC), it most often has a bactericidal effect. The main mechanism of resistance development is associated with a mutation of the gyr-A gene with the possible development of cross-resistance between levofloxacin and other fluoroquinolones. Cross-resistance between levofloxacin and other classes of antibacterial drugs usually does not occur.

Indications

Infectious and inflammatory diseases caused by sensitive microorganisms:

— acute sinusitis;

– exacerbation of chronic bronchitis

— – community-acquired pneumonia—

– complicated urinary tract infections (including pyelonephritis)—

– uncomplicated urinary tract infections

— – prostatitis;

– skin and soft tissue infections—

– septicemia/bacteremia associated with the above indications—

– intra-abdominal infection.

Contraindications

-hypersensitivity to levofloxacin or other quinolones—

– renal failure (with a creatinine clearance of less than 20 ml / min. – due to the impossibility of dosing this dosage form);

– epilepsy

— – tendon damage during previous treatment with quinolones;

– children and adolescents (up to 18 years)—

– pregnancy and lactation.

Caution should be used in the elderly due to the high probability of concomitant decline in renal function, as well as in cases of glucose-6-phosphate dehydrogenase deficiency.

Side effects

The frequency of a particular side effect is determined using the following table:

Frequency of occurrence of side effects often: in 1-10 patients out of 100, sometimes: less than 1 patient out of 100 rarely: less than 1 patient out of 1,000 is very rare: less than 1 patient out of 10,000 individual cases less than 0.01%

Allergic reactions:  sometimes itching and redness of the skin; rarely – a common hypersensitivity reactions (anaphylactic and anaphylactoid reactions) with symptoms such as urticaria, bronchial constriction and possibly severe dyspnea; rarely – swelling of the skin and mucous membranes (for example, in the area of the face and throat), sudden drop in blood pressure and shock, increased sensitivity to the sun and UV radiation (see “Special instructions”), allergic pneumonitis, vasculitis; in some cases, severe skin rash with blistering, e. g., Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and erythema multiforme exudative. General hypersensitivity reactions may sometimes be preceded by milder skin reactions. The above-mentioned reactions may develop after the first dose in a few minutes or hours after use of the drug.

From the digestive system:  often – nausea, diarrhea, increased activity of liver enzymes (e. g., alanine aminotransferase and aspartate aminotransferase); sometimes loss of appetite, vomiting, abdominal pain, digestive disorders; rarely – diarrhea mixed with blood, which in very rare cases, it may be a sign of intestinal inflammation and even pseudomembranous colitis (see “Special instructions”).

From the side of metabolism:  very rarely-a decrease in the concentration of glucose in the blood, which is of particular importance for patients suffering from diabetes mellitus (possible signs of hypoglycemia: increased appetite, nervousness, perspiration, trembling). Experience with other quinolones suggests that they can cause an exacerbation of porphyria in patients already suffering from this disease. A similar effect is not excluded when using levofloxacin.

Nervous system disorders:  sometimes-headache, dizziness and / or numbness, drowsiness, sleep disorders;rarely – anxiety, paresthesia in the hands, trembling, psychotic reactions such as hallucinations and depression, agitation, convulsions and confusion;very rarely – visual and hearing disorders, impaired taste and smell, decreased tactile sensitivity.

From the cardiovascular system:  rarely-increased heart rate, decreased blood pressure; very rarely-vascular (shock-like) collapse; in some cases-prolongation of the Q-T interval.

From the musculoskeletal system:  rarely, the lesions of tendons (including tendonitis), joint and muscle pain;rarely – tendon rupture (e. g. Achilles tendon); this side effect can be observed within 48 hours after the start of treatment and may be bilateral in nature (see “Special instructions”), muscle weakness, of particular importance for patients with bulbar syndrome; in some cases, muscle damage (rhabdomyolysis).

From the urinary system:  rarely-increased levels of bilirubin and creatinine in the blood serum; very rarely-deterioration of renal function up to acute renal failure, interstitial nephritis.

From the side of hematopoietic organs:  sometimes-an increase in the number of eosinophils, a decrease in the number of white blood cells; rarely – neutropenia, thrombocytopenia, which can be accompanied by increased bleeding; very rarely – agranulocytosis and the development of severe infections (persistent or recurrent fever, deterioration of health); in some cases – hemolytic anemia; pancytopenia.

Other services:  sometimes-general weakness; very rarely-fever.

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

Interaction

There are reports of a marked decrease in the seizure threshold when quinolones and substances that can, in turn, reduce the cerebral seizure threshold are used simultaneously. This also applies to the simultaneous use of quinolones and theophylline.

The effect of Levofloxacin is significantly weakened when used concomitantly 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 2 hours before or 2 hours after taking these drugs. No interaction was detected with calcium carbonate.

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

Levofloxacin excretion (renal clearance) is slightly slowed by cimetidine and probenicide. It should be noted that this interaction has almost no clinical significance. However, levofloxacin should be treated with caution when concomitant use of drugs such as probenicidum and cimetidine blocks a certain pathway of elimination (tubular secretion). 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.

How to take, course of use and dosage

The drug is taken orally 1 or 2 times a day. Tablets should not be chewed and washed down with a sufficient amount of liquid (from 0.5 to 1 cup), can be taken before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

Patients with normal or moderately impaired renal function (creatinine clearance > 50 ml / min)The following dosage regimen is recommended:  sinusitis: 500 mg once a day-10-14 days; exacerbation of chronic bronchitis: 250 mg or 500 mg once a day-7-10 days; community-acquired pneumonia: 500 mg 1-2 times a day for 7-14 days. uncomplicated urinary tract infections: 250 mg 1 time a day – 3 days; prostatitis: 500 mg once a day for 28 days; complicated urinary tract infections, including pyelonephritis: 250 mg once a day for 7-10 days; skin and soft tissue infections: 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 for 10-14 days;intra-abdominal infection:  250 mg or 500 mg 1 time a day – 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

Patients following hemodialysis or ongoing outpatient peritoneal dialysis do not require additional doses.

Patients with impaired liver function do not require special dose selection, since levofloxacin is only very slightly metabolized in the liver.

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

Overdose

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 epipripad). In addition, gastrointestinal disorders (for example, nausea) and erosive lesions of the mucous membranes, prolongation of the Q-T interval may occur.

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

Special instructions

Levofloxacin should not be used for the treatment of children and adolescents due to the likelihood of damage to articular cartilage.

When treating senile patients, it should be borne in mind that patients in this group often suffer from impaired renal function (see the section “Dosage and use”).

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

During treatment with Levofloxacin, it is possible to develop a seizure attack in patients with previous brain damage caused, for example, by a stroke or severe injury.

Despite the fact that photosensitization is very rare when using levofloxacin, in order to avoid it, patients are not recommended to be exposed unnecessarily to strong solar or artificial ultraviolet radiation.

If pseudomembranous colitis is suspected, levofloxacin should be discontinued immediately and appropriate treatment should be initiated. In such cases, you can not use drugs that inhibit intestinal motility.

Rarely observed with Levofloxacin, tendinitis (primarily inflammation of the Achilles tendon) can lead to tendon rupture. Elderly patients are more prone to tendinitis. Treatment with glucocorticosteroids is likely to increase the risk of tendon rupture. If tendinitis is suspected, treatment with Levofloxacin should be discontinued immediately and appropriate treatment of the affected tendon should be initiated.

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

Influence on the ability to drive motor vehicles and manage mechanisms

Side effects of Levofloxacin, such as dizziness or numbness, drowsiness, and visual disturbances (see also the section “Side effects”), may impair reactivity and the ability to concentrate. This can pose a certain risk in situations where these abilities are particularly important (for example, when driving a car, when servicing machines and mechanisms, when performing work in an unstable position).

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Inflammation of the lungs, Sinusitis, Prostatitis, Sinusitis, Respiratory tract infections, Inflammation of the female genital organs, Boils, Skin Infections, Urinary tract Infections, Infectious diseases, Bronchitis, Tuberculosis