Universal reference book for medicines
Product name: LEVOFLOXACIN (LEVOFLOXACIN)

Active substance: levofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: DALHIMFARM (Russia)
Composition, form of production and packaging
The tablets covered with a film cover of
yellow color, round, biconcave, on a break of light yellow color;
mass of the tablet 330 mg.
1 tab.

levofloxacin (in the form of hemihydrate) 250 mg

Excipients: sodium croscarmellose (impellose) 7 mg, magnesium stearate 3.2 mg, polyvinylpyrrolidone medium molecular weight 14 mg, microcrystalline cellulose 21.6 mg, silicon dioxide colloid (aerosil) 5 mg, talc 6.4 mg, pregelatinized starch (Starch-1500) 12.8 mg.

The composition of the shell: Opadrai II (polyvinyl alcohol partially hydrolyzed) 4 mg, macrogol (polyethylene glycol 3350) 2.02 mg, talc 1.48 mg, titanium dioxide 1.459 mg, aluminum lacquer based on yellow quinoline (E104) 0.84 mg, iron oxide dye (II) ( E172) 0.198 mg, aluminum lacquer based on indigocarmine (E132) 0.003 mg.

5 pieces.
- polymer cans (1) - packs of cardboard.
5 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- polymer cans (1) - packs of cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
The tablets covered with a film cover of yellow color, round, biconcave, on a break of light yellow color;
tablet weight 660 mg.
1 tab.

levofloxacin (in the form of hemihydrate) 500 mg

Excipients: sodium croscarmellose (impellosis) 14 mg, magnesium stearate 6.4 mg, polyvinylpyrrolidone medium molecular weight 28 mg, cellulose microcrystalline 43.2 mg, silicon dioxide colloid (aerosil) 10 mg, talc 12.8 mg, pregelatinized starch (Starch-1500) 25.6 mg.

Sheath composition: Opadrai II (polyvinyl alcohol partially hydrolysed) 8 mg, macrogol (polyethylene glycol 3350) 4.04 mg, talc 2.96 mg, titanium dioxide 2.918 mg, aluminum lacquer based on yellow quinoline (E104) 1.68 mg, iron oxide dye (II) ( E172) 0.396 mg, aluminum lacquer based on indigo carmine (E132) 0.006 mg.

5 pieces.
- polymer cans (1) - packs of cardboard.
5 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- polymer cans (1) - packs of cardboard.
10 pieces.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Levofloxacin is a broad-spectrum antimicrobial bactericide from the group of fluoroquinolones.
It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes.
To the preparation in vitro sensitive (minimal inhibitory concentration less than 2 mg / l):

Aerobic Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp.
(including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (leukotoxin-containing, coagulase-negative methicillin-sensitive / moderately sensitive strains), including Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-susceptible strains), Streptococcus spp. Groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin susceptible / moderately sensitive / resistant strains), Streptococcus pyogenes, Streptococcus spp. groups of viridans (penicillin-sensitive / resistant strains).
Aerobic Gram-negative microorganisms: Acinetobacter spp.
(including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (Ampicillin susceptible / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-producing beta-lactamase strains), Morganella morganii, Neisseria gonorrhoeae (including penicillinase producing and non-producing penicillinase strains), Neisseria meningitidis, Pasteurella spp. (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (t. h. Providencia rettgeri, Providencia stuartii), Pseudomonas spp.(including Pseudomonas aeruginosa), Salmonella spp., Serratia spp. (including 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 pneumophila, Mycobacterium spp.
(including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Ricketsia spp., Ureaplasma urealyticum.
Moderately sensitive microorganisms (minimum inhibitory concentration more than 4 mg / l):

Aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains).

Aerobic Gram-negative microorganisms: Burkholderia cepacia, Campylobacter jejuni, Campylobacter coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp., Porphyromonas spp.

Stable microorganisms (minimum inhibitory concentration more than 8 mg / l):

Aerobic Gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp.
(coagulase-negative methicillin-resistant strains).
Aerobic Gram-negative microorganisms: Alcaligenes xylosoxidans.

Other microorganisms: Mycobacterium avium.

PHARMACOKINETICS

When ingestion, levofloxacin is rapidly and almost completely absorbed (food intake has little effect on the speed and completeness of absorption).
Bioavailability is 99%. Time to reach C max in blood plasma - 1-2 h; with the intake of 250 and 500 mg C max in blood plasma is about 2.8 and 5.2 μg / ml, respectively. The connection with plasma proteins is 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, polymorphonuclear leukocytes, alveolar macrophages.
In the liver, a small portion is oxidized and / or deacetylated.
Kidney clearance is 70% of the total clearance. T 1/2 - 8 hours. It is excreted mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% are excreted by the kidneys within 24 hours, and 87% in 48 hours; intestine for 72 hours deduced 4% of the internal dose of levofloxacin.
INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to levofloxacin, including:

acute bacterial sinusitis;

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

- infections of the urinary tract and kidneys (including acute pyelonephritis);

- chronic bacterial prostatitis;

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

- intra-abdominal infections in combination with drugs acting on anaerobic microflora;

- tuberculosis (complex therapy of drug-resistant forms).

DOSING MODE

The drug is taken orally once or twice a day.
Tablets can 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 suspected pathogen susceptibility.
Patients with normal or moderately reduced renal function (creatinine clearance> 50 mL / min) are recommended the following dosing regimen:

Acute bacterial sinusitis: 500 mg once a day - 10-14 days.

Exacerbation of chronic bronchitis: 250 mg or 500 mg once a day - 7-10 days.

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

Uncomplicated urinary tract infections: 250 mg once a day - 3 days.

Chronic bacterial prostatitis: 500 mg once a day - 28 days.

Complicated urinary tract infections, including pyelonephritis: 250 mg once a day - 7-10 days.

Infections of the skin and soft tissues: 250-500 mg 1-2 times a day - 7-14 days.

Intraabdominal infection: 500 mg once a day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

With tuberculosis (as part of complex therapy) - 500 mg 1-2 times per day, the course of treatment - up to 3 months.

Correction of the dose of levofloxacin in adult patients with impaired renal function (creatinine clearance less than 50 ml / min)

Dose with normal kidney function every 24 hours Creatinine clearance from 20 to 49 ml / min Creatinine clearance from 10 to 19 ml / min Creatinine clearance less than 10 ml / min, incl.
with hemodialysis or chronic outpatient peritoneal dialysis
1000 mg Initial dose 500 mg every 12 hours, then 250 mg every 12 hours Initial dose 500 mg every 12 hours, then 125 mg every 12 hours Initial dose 500 mg every 12 hours, then 125 mg every 24 hours

500 mg Initial dose 500 mg, then 250 mg every 24 hours Initial dose 500 mg, then 250 mg every 48 hours Initial dose 500 mg, then 250 mg every 48 hours

250 mg Dose correction is not required 250 mg every 48 hours. In uncomplicated urinary tract infections, dose adjustment is not required No dose correction information is available

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

If the liver function is not required, special dose selection is required, since levofloxacin is metabolized in the liver only to a very small extent.
For elderly patients, there is no need to change the dosage regimen, except for cases of low creatinine clearance
As with the use of other antimicrobial drugs, treatment with levofloxacin is recommended to continue at least 48-72 hours after the normalization of body temperature or after a reliable eradication of the pathogen.

If you missed taking the drug, you should take the pill as soon as possible until the time of the next appointment is near.
Then continue taking the drug according to the scheme.
SIDE EFFECT

On the part of the digestive system: nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis;increased activity of "hepatic" transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.

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

On the part of metabolism: hypoglycemia (increased appetite, increased sweating, trembling, nervousness), hyperglycemia.

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

From the senses: visual, hearing, smell, taste and tactile sensitivity.

From the musculoskeletal system: arthralgia, muscle weakness, myalgia, tendon rupture, tendonitis, rhabdomyolysis.

From the side of the urinary system: hypercreatininaemia, interstitial nephritis, acute renal failure.

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

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

Other: photosensitization, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.

CONTRAINDICATIONS

Hypersensitivity to levofloxacin and other fluoroquinolones, epilepsy, tendon damage with quinolones previously treated, pregnancy, breastfeeding, children and adolescence (up to 18 years).

Carefully

Elderly age (high probability of concomitant decrease in kidney function), deficiency of glucose-6-phosphate dehydrogenase.

PREGNANCY AND LACTATION

Contraindicated in pregnancy and during breastfeeding.

APPLICATION FOR CHILDREN

Contraindicated in childhood and adolescence (under 18 years).

APPLICATION IN ELDERLY PATIENTS

With caution: elderly age (high probability of concomitant decrease in kidney function).

SPECIAL INSTRUCTIONS

Levofloxacin is taken at least 2 hours before or 2 hours after ingestion of aluminum-or magnesium-containing antacids, or sucralfate, or other preparations containing calcium, iron or zinc salts.

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

When there are signs of tendinitis, pseudomembranous colitis, allergic reactions, levofloxacin is immediately withdrawn.

It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), convulsions may develop, with insufficiency of glucose-6-phosphate dehydrogenase - the risk of hemolysis increases.

Patients with diabetes mellitus during treatment with levofloxacin should carefully monitor the concentration of glucose in the blood.

With the simultaneous use of levofloxacin and warfarin, monitoring of prothrombin time, international normalized ratio or other anticoagulation tests, as well as monitoring of bleeding symptoms, is shown.
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE

Symptoms : nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, prolongation of the QT interval, confusion, dizziness, convulsions.

Treatment : gastric lavage, symptomatic therapy, dialysis is not effective.

DRUG INTERACTION

Increases T 1/2 cyclosporine.

The effect of the drug reduces drugs that depress intestinal motility, sucralfate, aluminum and magnesium-containing antacid drugs and iron salts (a break between intake of at least 2 hours is necessary).

Non-steroidal anti-inflammatory drugs, theophylline increase the risk of seizures, glucocorticosteroids increase the risk of rupture of tendons.

Cimetidine and drugs that block tubular secretion slow down excretion.

Hypoglycemic drugs: strict control over the concentration of glucose in the blood is necessary, since there is a possibility of hyper- and hypoglycemia with simultaneous use with levofloxacin.

Levofloxacin increases the anticoagulant effectiveness of warfarin.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The preparation should be stored in a dry, protected from light place, at a temperature not exceeding 25 ° С.
Keep out of the reach of children.
Shelf life - 2 years.
Do not use after expiry date.
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