LEFLOBAKT
Active material: Levofloxacin
When ATH: J01MA12
CCF: Fluoroquinolone antibacterial drug
ICD-10 codes (testimony): A15, A56.0, A56.1, H66, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, L01, L02, L03, L08.0, N10, N11, N30, N34, N41
When CSF: 06.17.02.01
Manufacturer: Synthesis of (Russia)
Pharmaceutical form, composition and packaging
Pills, Film-coated yellow color, round, lenticular.
| 1 tab. | |
| levofloxacin (in the form of hemihydrate) | 250 mg |
Excipients: calcium stearate, starch 1500, potato starch, krospovydon (kollidon CL-M), povidone (polyvinylpyrrolidone), lactose (milk sugar), talc, microcrystalline cellulose.
The composition of the shell: gipromelloza (hydroxypropylmethylcellulose), macrogol (polyethylene glycol 4000), Titanium dioxide, tropeolin 0.
5 PC. – packings Valium planimetric (1) – packs cardboard.
5 PC. – packings Valium planimetric (2) – packs cardboard.
7 PC. – packings Valium planimetric (1) – packs cardboard.
7 PC. – plastic jars (1) – packs cardboard.
10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – plastic jars (1) – packs cardboard.
Pills, Film-coated yellow color, Oval.
| 1 tab. | |
| levofloxacin (in the form of hemihydrate) | 500 mg |
Excipients: calcium stearate, starch 1500, potato starch, krospovydon (kollidon CL-M), povidone (polyvinylpyrrolidone), lactose (milk sugar), talc, microcrystalline cellulose.
The composition of the shell: gipromelloza (hydroxypropylmethylcellulose), macrogol (polyethylene glycol 4000), Titanium dioxide, tropeolin 0.
5 PC. – packings Valium planimetric (1) – packs cardboard.
5 PC. – packings Valium planimetric (2) – packs cardboard.
7 PC. – packings Valium planimetric (1) – packs cardboard.
7 PC. – plastic jars (1) – packs cardboard.
10 PC. – plastic jars (1) – packs cardboard.
Pharmacological action
Fluoroquinolone antibacterial drug, broad-spectrum antibacterial agent.
Levofloxacin – levovrashtayushtiy ofloxacin isomer. Levofloxacin blocks enzymes DNK-girazu (topoisomerase II) and topoisomerase IV, crosslinking violates supercoiling and DNA breaks, It causes profound morphological alterations in the cytoplasm, cell wall and membrane of bacteria.
Levofloxacin is active against most strains of microorganisms in conditions in vitro, as well as in vivo.
Levofloxacin active against aerobic grampolaugitionah microorganisms: Staphylococcus spp. (koagulazonegativnye, Methicillin-sensitive/moderate Methicillin-sensitive strains), Staphylococcus aureus(methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains); Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-sensitive/moderate penicillin-sensitive/penicillin-resistant strains), Streptococcus spp. (the group with the, G), Streptococcus viridans (penicillin-sensitive and penicillin-resistant strains), Enterococcus faecalis, Corynebacterium diphtheriae, Listeria monocytogenes; Aerobic gram-negative microorganisms: Acinetobacter spp., Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Citrobacter different, Eikenella corrodens, Enterobacter spp. (incl. Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter sakazakii), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive/ampicillin-resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp., Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae (incl. strains, penicillinase), Neisseria meningitidis, Pasteurella spp. (incl. Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus is wonderful, Proteus vulgaris, providencia spp. (incl. Rettgeri Providence, Providence stuartii), Pseudomonas spp. (incl. Pseudomonas aeruginosa, Pseudomonas fluorescens), Salmonella spp., Serratia spp., Serratia wilting; anaerobes: Bacteroides fragilis, Bifidobacterium spr., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veillonella spp.; other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella spp. (incl. Legionella pneumophila, Mycobacterium spp. (incl. Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.
Pharmacokinetics
Absorption
The ingestion drug is rapidly and almost completely absorbed from the digestive tract. Food intake has little effect on the speed and completeness of suction. Bioavailability – 99%. Tmax is 1-2 no. At reception 250 mg 500 mg Cmax is 2.8 and 5.2 ug / ml, respectively.
Distribution
Plasma protein binding is 30-40%. Well into the organs and tissues: lungs, bronchial mucosa, sputum, organs of the urogenital system (in t. no. in prostate), bone, cerebrospinal fluid, polymorphonuclear leukocytes with nuclear, alyveolyarnыe macrophages.
Metabolism
In the liver, a small portion is oxidized and / or deacetylated.
Deduction
Excreted unaltered mainly with urine (by clubockova filtering and kanalzeva secreta). Renal clearance is 70% total clearance. T1/2 is 6-8 no. Less 5% levofloxacin is displayed in the form of metabolites. After oral admission in an unmodified form with kidneys within 24 h output 70% and for 48 no – 87% of the dose; in Calais during the 72 h detected 4%.
Testimony
Infectious-inflammatory diseases, caused by susceptible to levofloksacinu microorganisms:
-lower respiratory tract infection (incl. chronic bronchitis, pneumonia);
-Lor-organov (incl. sinusitis, otitis media);
-urinary organs (incl. acute pyelonephritis, prostatitis, urogenital chlamydiosis);
-skin and soft tissues (incl. festering atheroma, abscess, boils);
In the treatment of drug-resistant forms of TB.
Dosage regimen
The drug should be taken inside before a meal or between meals, without chewing, drinking plenty of fluids (from 0.5 to 1 cup).
At exacerbation of chronic bronchitis appoint 250-500 mg 1 times / day for 7-10 days.
At community-acquired pneumonia appoint 500 mg 1-2 times / day for 7-14 days.
At Sinus appoint 500 mg 1 times / day for 10-14 days.
At uncomplicated urinary tract infections appoint 250 mg 1 times / day for 3 days.
At complicated infections of the urinary tract (including pyelonephritis) – by 250 mg 1 times / day for 7-10 days.
At prostatitis appoint 500 mg 1 times / day for 28 days.
At infections of skin and soft tissue appoint 250-500 mg 1-2 times / day for 7-14 days.
IN complex therapy of drug-resistant tuberculosis appoint 500 mg 1-2 times / day (500-1000 mg / day) to 3 Months.
Levofloxacin displayed mainly kidneys, Therefore, when treating patients with reduced renal function you want to reduce the dose of the drug.
| CC | Dose for oral administration | |
| 500 mg / 24 h | 500 mg / 12 h | |
| 50-20 ml / min | the first dose 500 mg then 250 mg / 24 h | the first dose 500 mg then 250 mg / 12 h |
The appointment Leflobakta® in pill form to continue treatment for patients, who was first appointed in/with the introduction of levofloxacin solution for the infusions and there was an improvement in their condition, to conduct further reception of levofloxacin inside.
Side effect
From the digestive system: nausea, vomiting, diarrhea (incl. with blood), indigestion, decreased appetite, abdominal pain, pseudomembranous enterocolitis, increase in liver transaminases, giperʙiliruʙinemija, hepatitis, dysbiosis.
Cardio-vascular system: decrease in blood pressure, vascular collapse, tachycardia, QT prolongation.
Metabolism: gipoglikemiâ (incl. increased appetite, increased perspiration, tremor).
From the central and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, seizures (in predisposed patients).
From the senses: visual impairment, hearing, olfactory, gustatory and tactile sensitivity.
On the part of the musculoskeletal system: arthralgia, muscular weakness, myalgia, tendon rupture, Tendinitis, raʙdomioliz.
From the urinary system: giperkreatininemiя, interstitial nephritis, acute renal failure.
From the hematopoietic system: eozinofilija, gemoliticheskaya anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, gemorragii.
Allergic reactions: itchiness and redness of the skin, swelling of the skin and mucous membranes, hives, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, suffocation, anaphylactic shock, hypersensitivity pneumonitis, vasculitis.
Other: asthenia, aggravation of porphyria, photosensitivity, persistent fever, development of superinfection.
Contraindications
- Epilepsy;
— the defeat tendons in previously held hinolonami treatment;
— violation of the kidney in QC<20 ml / min, If you need kidney dialysis;
- Pregnancy;
- Lactation;
- Childhood and adolescence up 18 years;
- Hypersensitivity to the drug.
FROM caution You should use the drug with a deficit glukozo-6-fosfatdegidrogenaza, in elderly patients (a high probability of having a concomitant decrease in renal function).
Pregnancy and lactation
Do not use this drug during pregnancy and breastfeeding.
Cautions
After the normalization of body temperature, it is recommended to continue the treatment for at least 48-72 no.
During treatment should be avoided and the solar and artificial UV radiation to avoid damaging the skin (photosensitivity).
When signs of tendinitis, psevdomembranoznogo colitis levofloxacin should immediately cancel.
In patients with brain damage in history (incl. stroke, severe injury) may develop seizures; in case of insufficiency glukozo-6-fosfatdegidrogenaza deficit increases the risk of hemolysis.
Effects on ability to drive vehicles and management mechanisms
During treatment, you should be careful when driving vehicles and other potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Overdose
Symptoms: nausea, Erosive lesions of the mucous membranes of the DIGESTIVE TRACT, QT prolongation, confusion, dizziness, convulsions.
Treatment: symptomatic, gastric lavage, dialysis nyeeffyektivyen. No specific antidote.
Drug Interactions
Together with the application Leflobaktom® increases T1/2 cyclosporine.
Drugs, suppress intestinal motility, sucralfate, aluminisodergaszczye and other magnesium-containing antacid medicines and iron salts if you are applying to reduce the effect Leflobakta® (needed a break between the reception of at least 2 no).
If you are applying to Leflobakta® with npvs of the ibuprofen group, Theophylline increases readiness to cramping.
If you are applying to Leflobakta® with MCS increases the risk of tendon rupture.
If you are applying to Leflobakta® with cimetidine and drugs, block tubular secretion, slows the excretion of levofloxacin.
With a combination of levofloxacin with vitamin k antagonists should monitor blood clotting.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
List B. The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life – 2 year.
