Levotek - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose, maize starch, povidone K-30, magnesium stearate, purified talc, sodium carboxymethyl starch, colloidal silicon dioxide, croscarmellose sodium.

Composition of the film shell: hypromellose, titanium dioxide, macrogol 6000, talc purified.

Description:

250 mg tablets: white or almost white, biconcave, round, film-coated tablets, with a risk on one side.

Tablets 500 mg: white or almost white, biconvex, oval-shaped tablets, covered with a film membrane.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Fluoroquinolone, an antibacterial (bactericidal) agent. It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV,violates supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes morphological changes in the cytoplasm, cell wall and bacterial membranes.

Effective with respect to:

Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp. (incl. Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. Coagulase-negative and methicillin-sensitive (including moderately sensitive), including Staphylococcus aureus (methicillin-sensitive), Staphylococcus epidermidis (methicillin-sensitive), Streptococcus spp. (groups C and G), Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive, moderately sensitive, resistant), Streptococcus pyogenes, Streptococcus viridans (penicillin-sensitive, moderately sensitive, resistant);

Gram-negative microorganisms: Acinetobacter spp. (incl. Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (incl. Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive and resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (incl. Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-producing beta-lactamase), Morganella morganii, Neisseria gonorrhoeae (penicillin-sensitive, moderately sensitive, resistant), Neisseria meningitidis, Pasteurella spp. (at t.h. Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (at t.h. Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (at t.h. Pseudomonas aeruginosa), Salmonella spp., Serratia spp. (at t.h. Serratia marcescens);

anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veilonella spp .;

other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella spp. (at t.h. Legionella pneumophila), Mycobacterium spp. (at t.h. Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Pharmacokinetics:

Suction. After oral administration, it is quickly and almost completely absorbed from the gastrointestinal tract, the maximum concentration is determined in the plasma in 1-2 hours. The average value of the maximum concentration after taking 250 mg is 2.8 μg / ml, 500 mg - 5.2 μg / ml.

Distribution.

The connection with plasma proteins is 30-40%. It penetrates well into tissues and body fluids: lungs, bronchial mucosa, organs of the genitourinary system, bone tissue, sputum, cerebrospinal fluid; leukocytes, macrophages. The concentration of levofloxacin in the lung tissue is higher than in the blood plasma. Average volume the distribution of levofloxacin ranges from 89 to 112 liters after a single and repeated administration of 500 mg of the drug. 24-38 % the drug binds to blood plasma proteins. A slight cumulation is noted only when taking levofloxacin 500 mg twice a day.

Metabolism.

A small part is exposed to hepatic metabolism (oxidized and / or deacetylated).

Excretion.

The drug is partially metabolized. The half-life is 6-8 hours.

It is excreted mainly by the kidneys in unchanged form (about 87%) and 5% - in the form inactive metabolites for 48 hours. Less than 4% - intestine within 72 hours.

Special groups of patients.

Renal failure.

In patients with impaired renal function, the half-life of levofloxacin from plasma is increased, which requires dose adjustment to avoid cumulation. Levofloxacin It is not eliminated from the body by hemodialysis or prolonged outpatient peritoneal dialysis.

Liver failure.

The violation of liver function does not have a significant effect on the metabolism of levofloxacin.

Indications:

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

- ENT organs (including acute sinusitis);

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

- urinary tract and kidneys (including acute pyelonephritis);

- bacterial prostatitis;

- infections of the skin and soft tissues (festering atheromas, abscess, furunculosis);

- intra-abdominal infections;

- as part of complex therapy of drug-resistant forms of tuberculosis.

Contraindications:

Hypersensitivity to levofloxacin, other fluoroquinolones or other components of the drug, epilepsy, tendon damage with prior treatment with quinolones, pregnancy, lactation, children and adolescence (up to 18 years).

Carefully:The elderly, with a deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

Inside, before meals or at a break between meals, without chewing, squeezed enough liquid. The duration of treatment depends on the type and severity of the course of the disease, the course of treatment is 7-14 days. After reducing the symptoms of acute inflammation and normalizing the temperature, levofloxacin therapy continues for at least 48-72 hours.

Dosing of the drug in patients with normal renal function (creatinine clearance> 50 ml / min)

Acute antritis: 500 mg once a day, for 10-14 days.

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

Exacerbation of chronic bronchitis: 250-500 mg once a day, for 7-10 days. Uncomplicated urinary tract infections - 250 mg once a day, treatment course - 3 days.

Complicated urinary tract infections (incl.pyelonephritis) - 250 mg once a day (for a severe course of the disease, the dose should be increased), the course of treatment - 7-10 days. Bacterial prostatitis is 500 mg once a day, the course of treatment is 28 days.

Infections of the skin and soft tissues - 250-500 mg 2 times a day, treatment course^-7-14 days Intra-abdominal infection - 500 mg once a day, treatment course 7-14 days (in combination with antibacterial drugs acting on anaerobic flora). Complex therapy of drug-resistant forms of tuberculosis - 500 mg 1-2 times a day, treatment course - up to 3 months

Dosing of the drug in patients with impaired renal function (creatinine clearance <50 ml / min)

Clearance creatinine, ml / min	Dosing regimen
	Initial dose of 250 mg / 24 h		Initial dose of 500 mg / 24 h		Initial dose of 500 mg / 12 h

50-20		Further 125 mg / 24h		Then 250 mg / 24 h		Further 250 mg / 12 h
19-10		Further 125 mg / 48 h		Further 125 mg / 24 h		Further 125 mg / 12 h
<10 (incl. When hemodialysis and permanent outpatient peritoneal dialysis)		Further 125 mg / 48 h		Further 125 mg / 24 h		Further 125 mg / 24 h

After hemodialysis or permanent ambulatory peritoneal dialysis (CAPD), no additional doses are required.

Do not require dose adjustment in patients with impaired liver function.

Side effects:

From the digestive system: nausea, vomiting, diarrhea, decreased appetite, abdominal pain, pseudomembranous colitis, increased activity of "liver" transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.

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

From the side of metabolism: hypoglycemia (increased appetite, sweating, nervousness, trembling).

From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesia, anxiety, fear, hallucinations, confusion, depression, movement disorders, convulsions.

From the sense organs: impaired vision, hearing, smell, taste and tactile sensitivity.

From the side of the musculoskeletal system: arthralgia, myalgia, myasthenia gravis, rupture of tendons, rhabdomyolysis, tendonitis.

From the urinary system: hypercreatininaemia, interstitial nephritis.

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

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

Other - exacerbation of porphyria, photosensitivity, persistent fever, development of superinfection.

Overdose:

Symptoms: Gastrointestinal disorders (nausea), erosive lesions of the mucous membrane of the gastrointestinal tract, changes in QT interval, confusion, dizziness, seizures.

Treatment: symptomatic therapy, dialysis is not effective, a specific antidote is not known.

Interaction:

The drug increases the half-life of cyclosporine.

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

Cimetidine and drugs that block tubular secretion slow down excretion.

The effect is reduced by drugs that depress intestinal motility, sucralfate, magnesium or aluminum-containing antacids, iron salts andzinc (requires a break between reception for at least 2 hours).

Hypoglycemic drugs: Strict control over the level of glucose in the blood is necessary, since there is a possibility of hyper- and hypoglycemia while using them with levofloxacin.

Non-steroidal anti-inflammatory drugs and theophylline: when used with levofloxacin increase convulsive readiness.

Glucocorticosteroids: increase the risk of rupture of tendons.

Special instructions:

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

It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma) may develop seizures.

In patients receiving quinolone therapy, including levofloxacin, in rare cases, hypersensitivity reactions of immediate type were noted, up to anaphylaxis. When there are signs of immediate type hypersensitivity, the drug should be stopped.

If suspected pseudomembranous colitis should be immediately withdrawn levofloxacin and begin appropriate treatment. In such cases, drugs that depress intestinal motility should not be used.Rarely observed with the use of the drug tendonitis (primarily, inflammation of the Achilles tendon) can lead to rupture of tendons.

The elderly are more prone to tendinitis. Treatment with glucocorticosteroids increases the risk of rupture of tendons. If suspicion of tendonitis should immediately stop treatment with levofloxacin and begin appropriate treatment of the affected tendon, for example, providing him with a resting state.

Patients with insufficiency of glucose-6-phosphate dehydrogenase can react to fluoroquinolones by destruction of erythrocytes (hemolysis). In this regard, treatment of such patients with levofloxacin should be carried out with great care.

Effect on the ability to drive transp. cf. and fur:

Such side effects of levofloxacin as dizziness or stupor, drowsiness, and visual impairment may impair the ability to respond quickly and to concentration, which is a risk in situations where these abilities are of particular importance (for example, when driving, servicing machines and mechanisms, when performing work in an unstable situation).

Form release / dosage:

Tablets, film-coated, 250 mg, 500 mg.

Packaging:

10 tablets in contour PVC / aluminum package (blister). For 1 or 10 contour packs (blisters) together with instructions for use in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006396/10

Date of registration:06.07.2010 / 26.01.2018

Expiration Date:Unlimited

The owner of the registration certificate:Protek Biosystems Pvt. Ltd.Protek Biosystems Pvt. Ltd. India

Manufacturer: & nbsp

PROTECH BIOSYSTEMS, PVT. Ltd. India

Representation: & nbspProtekh Biosystems Pvt.LtdProtekh Biosystems Pvt.LtdRussia

Information update date: & nbsp07.03.2018

Illustrated instructions

Instructions

Levotek (Levotech)