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

Fluoroquinolone, an antibacterial (bactericidal) agent. It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts 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. (at t.h. Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (at t.h. Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive and resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (at t.h. Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-reducing 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.

The peak plasma concentration for intravenous administration of 500 mg of the drug is 6.2 μg / ml. The pharmacokinetics of levofloxacin is linear. Concentration in the blood plasma for ingestion and intravenous administration of equivalent doses of levofloxacin is identical. With a single administration of 500 mg of levofloxacin intravenously drip for 60 minutes. time to reach the maximum concentration (T_max) 1.0 ± 0.1 h, half life (T_1/2) 6.4 ± 0.7 h.

Distribution.

Good penetrates 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. The average volume of distribution of levofloxacin ranges from 89 to 112 l after a single and multiple intravenous administration of 500 mg of the drug. 24-38% of the drug binds to blood plasma proteins. A slight cumulation is noted only when 500 mg of levofloxacin is administered twice a day.

Allocation.

The drug is partially metabolized. It is mainly excreted by the kidneys in the unchanged form (about 87%) and 5% - in the form of inactive metabolites within 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);

- genital organs;

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

- septicemia / bacteremia;

- 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 deficit glucose-6-phosphate dehydrogenase.

Dosing and Administration:

Intravenous, drip slowly, at least 60 minutes 500 mg (100 ml infusion solution) 1 -2 times a day.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 diminishing the simpvolumes of acute inflammation and temperature normalization, levofloxacin therapy continues for at least 48-72 hours. Depending on the patient's condition after a few days of treatment, it is possible to switch to taking the drug inside at the same dose, considering the equivalence of both routes of administration.

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

Indications	Daily dose
Community-acquired pneumonia	500 mg 1-2 times a day, 7-14 days
Complicated urinary tract infections (including pyelonephritis)	250 mg once a day (with a heavy disease, the dose should be increased), 7-10 days
Infectious diseases of skin and soft tissues	500 mg twice a day, 7-14 days
Cepoultry / bacteremia	500 mg 1-2 times a day, 10-14 days
Yingtrabdominal infection	500 mg once a day, 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

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

Clearance creatinine ml / min	Dosages for intravenous administration
	250 mg / 24 h	500 mg / 24 h	500mg / 12h
	Initial dose of 250 mg	Initial dose of 500 mg	Initial dose of 500 mg
50-20	Further 125 mg / 24h	Then 250 mg / 24 h	Further 250 mg / 12 h
1.9-10	Further 125 mg / 48 h	Further 125 mg / 24 h	Further 125 mg / 12 h
<10 (incl. at hemodialysis and permanent ambulatory 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), bronchospasm, anaphylactic shock, allergic pneumonitis, vasculitis.

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

Local Reactions: pain, redness at the injection site, phlebitis.

Overdose:

Symptoms - gastrointestinal disorders (nausea), erosive lesions of the gastrointestinal mucosa, alteration of the QT interval, confusion, dizziness, convulsions.

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

Interaction:

The drug increases the half-life of cyclosporine.

Compatible with 0.9% sodium chloride solution, 5% dextrose solution, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition.

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 drug solution can not be mixed with heparin or solutions that impose an alkaline reaction (for example, sodium bicarbonate solution).

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.

DLucocorticosteroids: increase the risk of rupture of tendons.

Special instructions:

During treatment, sun and artificial 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. If after the levofloxacin appears pruritus or other signs of immediate type hypersensitivity, the drug should be discontinued.

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 corticosteroids 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:Solution for infusions 5 mg / ml.

Packaging:

100 ml into a bottle of polyethylene. 1 bottle in a polypropylene bag, then in a cardboard box along with instructions for medical use.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

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-007035/09

Date of registration:04.09.2009 / 21.12.2017

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

Information update date: & nbsp07.03.2018

Illustrated instructions

Instructions

Levotek (Levotech)