Levofloxacin-Vertex, 500 mg 5 pcs

Pharmacotherapeutic group: Antimicrobial, fluoroquinolone

Pharmacological action

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin:

– lower respiratory tract infections (exacerbations of chronic bronchitis, community-acquired pneumonia);

– acute maxillary sinusitis;

– uncomplicated urinary tract infections;

– complicated urinary tract infections (including acute pyelonephritis);

– skin and soft tissue infections (suppurated atheromas, abscesses, furuncles);

– chronic bacterial prostatitis;

– intra-abdominal infection;

– complex therapy of drug-resistant forms of tuberculosis.

Active ingredient

Composition

1 film-coated tablet contains

Active ingredient:

levofloxacin hemihydrate in terms of levofloxacin – 500.00 mg

Excipients (core):

microcrystalline cellulose – 60.00 mg,

sodium carboxymethyl starch – 35.00 mg,

povidone (polyvinylpyrrolidone) – 30.00 mg,

magnesium stearate – 10.00 mg,

croscarmellose sodium – 16.54 mg,

colloidal silicon dioxide – 6.00 mg.

Auxiliary substances (coating):

Opadray White – 30.00 mg, including polyvinyl alcohol – 14.070 mg, macrogol 3350 – 7.080 mg, talc – 5.220 mg, titanium dioxide – 3.630 mg.

How to take, the dosage

The drug should be used orally with meals or between meals, without chewing, with plenty of fluid.

The dosage is determined by the nature and severity of the infection and the sensitivity of the suspected pathogen.

The recommended dose for adults with normal renal function (creatinine clearance (KK)>50 ml/min):

In acute bacterial sinusitis, 500 mg once daily for 10-14 days;

In exacerbations of chronic bronchitis, 250-500 mg once daily for 7-10 days;

In community-acquired pneumonia, 500 mg once or twice daily for 7-14 days;

In uncomplicated urinary tract and kidney infections, 250 mg once daily for 3 days;

In complicated urinary tract infections, 250 mg once daily for 7-10 days;

In chronic bacterial prostatitis – 500 mg once daily for 28 days;

Infections of the skin and soft tissue – 250-500 mg 1-2 times daily for 7-14 days;

Intra-abdominal infections – 500 mg 1 time per day for 7-14 days (in combination with antibacterials acting on anaerobic flora);

Tuberculosis (complex therapy of drug-resistant forms) – 500 mg 1-2 times per day, treatment course up to 3 months.

Interaction

Quinolones may enhance the ability of drugs, including theophylline, nonsteroidal anti-inflammatory drugs to lower the seizure threshold. Higher concentrations of levofloxacin have been observed when concomitantly administered with fenbufen than with motor therapy.

The effects of levofloxacin are reduced by drugs that inhibit intestinal motility, sucralfate, magnesium- or aluminum-containing antacids, iron and zinc salts.

The use of glucocorticosteroids increases the risk of tendon rupture.

Levofloxacin increases the anticoagulant activity of warfarin.

Elevation (renal clearance) of levofloxacin is slightly delayed by cimetidine and probenecid due to possible blockage of tubular secretion of levofloxacin in kidneys. It should be noted that this interaction is of clinical importance especially for patients with impaired renal function.

Levofloxacin increases the half-life of cyclosporine.

The concomitant use of levofloxacin and hypoglycemic agents leads to changes in plasma glucose concentration (hypoglycemia and hyperglycemia).

When used concomitantly with agents prolonging the Q-T interval (antiarrhythmic drugs of classes IA and III, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungals, imidazole derivatives, some antihistamines, including astemizole, terfenadine, ebastine) the Q-T interval may be prolonged.

Special Instructions

The drug should be used at least 2 hours before or 2 hours after taking preparations of iron salts, zinc, antacids and sucralfate.

At the time of treatment with the drug, sunlight and artificial UV radiation should be avoided to avoid damage to the skin (photosensitization).

In case of signs of tendinitis, pseudomembranous colitis, allergic reactions the drug should be discontinued immediately.

People with a history of brain damage (stroke, severe trauma) may have seizures, with insufficiency of glucose-6-phosphate dehydrogenase – risk of hemolysis.

In concomitant use of levofloxacin and warfarin, careful monitoring of prothrombin time and other coagulation parameters is necessary.

A close monitoring of plasma glucose concentrations is recommended during concomitant use of the drug with hypoglycemic agents.

As levofloxacin is excreted mainly by the kidneys, in patients with impaired renal function it is necessary to monitor renal function and adjust the dosing regimen. Cases of Q-T interval prolongation have been reported in patients receiving fluoroquinolones, including levofloxacin. When using fluoroquinolones including levofloxacin, caution should be observed in patients with known risk factors for Q-T interval prolongation: elderly age; electrolyte imbalance (hypokalemia, hypomagnesemia); congenital Q-T interval prolongation syndrome; heart disease (heart failure, myocardial infarction, bradycardia); concurrent use of drugs that can prolong Q-T interval.

In patients receiving fluoroquinolones, including levofloxacin, sensory and sensory-motor peripheral neuropathy, the onset of which may be rapid, have been reported. If the patient develops symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the possible risk of developing irreversible changes.

Contraindications

Hypersensitivity to levofloxacin and other fluoroquinolones, epilepsy, tendon involvement with previous treatment with quinolones, pregnancy, breastfeeding, childhood and adolescence (under 18 years).

With caution

Elderly age (high likelihood of concomitant decreased renal function), glucose-6-phosphate dehydrogenase deficiency.

Side effects

Digestive system disorders: nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis, increased activity of “hepatic” transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.

Cardiovascular system disorders: decreased arterial pressure, vascular collapse, tachycardia, increased Q-T interval in cardiogram, atrial fibrillation.

Metabolic disorders: hypoglycemia (increased appetite, increased sweating, shivering, nervousness), hyperglycemia (dry mouth, thirst, increased urination, fatigue, blurred vision, dry or itchy skin, arrhythmia).

Nervous system disorders: Headache, dizziness, weakness, drowsiness, insomnia, restlessness, paresthesias in the hands, fear, hallucinations, confusion, depression, movement disorders, seizures, peripheral sensory neuropathy, Peripheral sensory-motor neuropathy, mental disorders with self-harm behavioral disorders including suicidal ideation and suicide attempts, extrapyramidal disorders, agitation (agitation), nightmares.

Sensory organs: disorders of vision, hearing, smell, taste and tactile sensitivity, tinnitus.

Musculoskeletal disorders: arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.

Urinary system disorders: hypercreatininemia, interstitial nephritis, acute renal failure.

Hematopoietic system disorders: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

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

Others: asthenia, exacerbation of porphyria, photosensitization, persistent fever, leukocytoclastic vasculitis, development of superinfection.

Overdose

Symptoms:

Confusion, dizziness, impaired consciousness, seizures, nausea, vomiting, and erosive lesions of mucous membranes are possible. Studies have shown that when levofloxacin is used in doses greater than the average therapeutic dose, prolongation of the Q-T interval may occur.

Treatment:

If necessary, symptomatic therapy is carried out. Levofloxacin is not excreted by hemodialysis, peritoneal dialysis and continuous peritoneal dialysis. There is no specific antidote.

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