Levofloxacin-Vertex pills 250mg, 10pcs

Composition

Active ingredient:

levofloxacin hemihydrate 256.23 mg, which corresponds to the content of levofloxacin 250 mg

Auxiliary substances:

microcrystalline cellulose,

hypromellose (hydroxypropylmethylcellulose),

primellose (croscarmellose sodium),

calcium stearate.

Shell composition:

hypromellose,

macrogol 4000,

talc,

titanium dioxide,

iron oxide yellow dye.

Pharmacological action

Levofloxacin is an antibiotic with a bactericidal type of action. The drug blocks the work of enzymes that are necessary for the synthesis of DNA of microorganisms, without which they are not capable of reproduction.

As a result of blocking DNA synthesis in the bacterial cell wall, changes occur that are incompatible with the normal life and functioning of microbe cells.

This mechanism of action on bacteria is bactericidal, since microorganisms die, and not only lose their ability to multiply.

Levofloxacin destroys pathogenic bacteria that cause inflammation in certain organs. As a result, the cause of inflammation is eliminated, and recovery occurs due to the use of an antibiotic.

Levofloxacin can cure inflammation in any organ caused by microorganisms that are sensitive to it. That is, if cystitis, pyelonephritis or bronchitis is caused by bacteria that Levofloxacin has a detrimental effect on, then all these inflammations in different organs can be cured with an antibiotic.

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 insufficiency (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:

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; very rarely – swelling of the skin and mucous membranes (for example, in the face and throat), sudden drop in blood pressure and shock, hypersensitivity to sunlight and ultraviolet radiation (see “Special Instructions”), allergic pneumonitis, vasculitis; in some cases – severe Blistering skin rashes, such as Stevens – Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), and exudative erythema multiforme.

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 (for example, alanine aminotransferase and aspartate aminotransferase); sometimes – loss of appetite, vomiting, abdominal pain, digestive disorders; rarely – diarrhea with blood admixture, which in very rare cases can 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 – tendon damage (including tendinitis), joint and muscle pain; very rarely-tendon rupture (for example, Achilles tendon); this side effect may 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).

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

The combined use of Levofloxacin with Fenbufen, nonsteroidal anti-inflammatory drugs (for example, Aspirin, Paracetamol, Ibuprofen, Nimesulide, etc. ) and theophylline increases the readiness of the central nervous system for seizures.

The effectiveness of Levofloxacin decreases when used simultaneously with Sucralfate, antacids (for example, Almagel, Rhenium, Phosphalugel, etc. ) and iron salts. To neutralize the effect of these drugs on Levofloxacin, you should spread their intake for 2 hours.

The combined use of Levofloxacin and glucocorticoids (for example, hydrocortisone, prednisone, Methylprednisone, dexamethasone, betamethasone, etc. ) leads to an increased risk of tendon rupture.

Taking alcoholic beverages together with Levofloxacin leads to increased side effects that develop from the central nervous system (dizziness, drowsiness, visual impairment, loss of concentration and weak reaction).

How to take it, 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 1 time a day-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 for 7-14 days.

 uncomplicated urinary tract infections:  250 mg 1 time a day – 3 days; prostatitis:  500 mg-1 time a day-28 days; complicated urinary tract infections, including pyelonephritis:  250 mg once a day for 7-10 days; skin and soft tissue infections: 250 mg 1 time 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).

Storage conditions

In a dark place, at a temperature not exceeding 25 °C.

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Indications

Bronchitis, Sinusitis, Prostatitis, Skin Infections, Urinary Tract Infections, Pneumonia, Pyelonephritis