Expiration date: 05/2025
The composition and form of issue:
Pills, the port of plano shell. 1 tablet contains:
levofloxacin hemihydrate the 780, 26 mg
(corresponding to 750 mg of levofloxacin)
Note substances: starch for baking — 71, 96 mg of MCC — 60, 5 mg no-K30 — 7, 5 mg of methyl parahydroxybenzoate — 0, 9 mg of parahydroxybenzoate — 0, 18 mg of talc purified — 19, 5 mg Mag — Start- 9, 6 mg carboximetilkrahmal entry — 9, 6 mg
Bolt: hypromellose purified talc Macro 6000 titanium dioxide crystal "sun" yellow
in blister PVC/aluminum 5 or 10 PCs in a carton pace of 1 or 10 in blister package or PVC 100, 500 or 1000 pieces in the banks of the PA high plot 1 package (for the station).
Pills, the port of plano shell. 1 tablet contains:
levofloxacin hemihydrate the 520, 15 mg
(corresponding to 500 mg levofloxacin)
Note substances: starch for baking — 49, 33 mg of MCC — 40 mg-K30 — 5 mg methyl parahydroxybenzoate — 0, 6 mg of parahydroxybenzoate — 0, 12 mg of talc purified — 12 mg Mag Start — 6, 4 mg carboximetilkrahmal entry — 6, 4 mg
Bolt: hypromellose purified talc Macro 6000 titanium dioxide crystal "sun" yellow
in blister PVC/aluminum 5 or 10 PCs in a carton pace of 1 or 10 in blister package or PVC 100, 500 or 1000 pieces in the banks of the PA high plot 1 package (for the station).
Pills, the port of plano shell. 1 tablet contains:
the levofloxacin hemihydrate 260 mg
(corresponding to 250 mg levofloxacin)
Note substances: starch for baking — 18, 64 mg microcrystalline — 30 mg-K30 — 1, 1 mg methyl parahydroxybenzoate — 0, 3 mg of parahydroxybenzoate — 0, 06 mg talc purified, 10 mg Mag Start — 5 mg carboximetilkrahmal record — 1, 5 mg
Bolt: hypromellose purified talc Macro 6000 titanium dioxide crystal "sun" yellow
in blister packs of PVC/aluminium 3, 5 or 10 PCs in a carton pace of 1 or 10 blister, blister or 2 or 5 pieces in the package made of PVC 100, 500 or 1000 pieces in the banks of the PA high plot 1 package (for the station).
Description carson forms:
Tablets 750 mg: oval, biconvex, plano port shell, from light to oranges oranges in color, with risk on one side.
Tablets 500 mg: Oval biconvex, plano port shell, from light to oranges oranges in color, with risk on one side.
Tablets 250 mg: round biconvex, plano port shell, from light oranges to oranges colors.
The island draws from the white with yellow was down to color.
Pharmacist:
Absorption: after a personal intake levofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake has little effect on the absorption rate and the plot. Bioavailability of 99%. C max in plasma achieved through 1-2 h for the dose of levofloxacin 250, 500 and 750 mg is 2, 8 5, 2 and 8 µg/ml, respectively.
Distribution: after administration of a single or multiple dose amount of the drug absorbed is directly proportional to the dose of print. Ravens concentrate (CSS) in plasma is achieved after 48 h. mean volume of distribution (VD) of levofloxacin ranges from 74 to 112 L. Binding? the plasma protein — 30-40%. Good Well in cells, tissues, organs and secrets: lungs, mucous membranes, Branch, Macro, equalizer macrophages (tan concentrate in the lungs 2-5 times the concentration in plasma), the genitourinary system, Polymer-der of leukocytes.
Metabolism: levofloxacin undergoes limited metabolism in the liver (oxidation and/or dizziness).
Excretion: excreted mainly by filtration p club and the channels of secrecy. T1 / 2 of levofloxacin is 6-8?. Less than 5% of the dose is excreted in the form of print decal and N-oxide metabolites. Nine in the form of p excreted 70% of the print inside the dose within 24 h and 87% for 48 h 4% to print inside the check dose was excreted within 72 h
Description Pharmacological action:
Levofloxacin is a synthetic thin Shark spectra of action. But DNK-girazu (topoisomerase II) and topoisomerase IL and emerged specialization and cross-linking of DNA breaks, inhibits DNA sites, causing global morphological changes in the cytoplasm, the cell position and the membrane of sensitive microorganisms.
Levofloxacin is effective against most microorganisms the following stem:
Aero the role of microorganisms is Corynebacterium diphtheriae, Enterococcus SPP. (including Enterococcus fecal), Listeria monocytogenes, Staphylococcus SPP. (lactosylceramide and coagulasepositive metitillinciuvstiveny/Mean STL stem, including stem metitillinciuvstiveny aureus, epidermal Staphylococcus, Streptococcus SPP. (including stem bacteria Staphylococcus groups C and G, Streptococcus agalactiae, streptococci of pyrrolidinedione, penicillinsusceptible/men STL/stem resistant pneumococcus, penicillinsusceptible/stem resistant Streptococcus group green)
Aero microorganisms grammatical — acinetobacter excl. planed (including acinetobacter baumanii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter SPP. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter Roman Empire), E. coli, Gardnerella vaginalis, haemophilus excl. planed (including By Haemophilus influenzae, haemophilus parainfluenzae, ampicillinampicillin/stem resistant Haemophilus influenzae), Helicobacter pylori, Klebsiella SPP. (incl. Klebsiella oxytoca, Klebsiella pneumonia), Moraxela catarrhalis (and reproducirse producing beta-lactamases stem), Morganella morganii, Neisseria SPP. (including the Meningococcus producing and reproducirse penicillin stem Neisseria gonorroeae), Pasteurella SPP. (including cones Pasteurella, Pasteurella dagmatis, pasteurella multocida), Proteus SPP. (including Proteus is beautiful, just Proteus), Providencia SPP. (including providencia rettgeri, providencia stuartii), Pseudomonas SPP. (including Pseudomonas aeruginosa), Serratia spp. (including serratia marcescens), Salmonella.
anaerobic bacteria — Bacteroides fragile, Bifidobacteria SPP., Filters bacteria, Fusobacterium excl. planed, Peptostreptococcus SPP., Propionibacterum spp. Veilonella spp.and
other microorganisms Bartonella spp. Chlamydia spp. (including Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis), Legionella pneumophila, Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma spp. (including Mycoplasma hominis, Mycoplasma pneumoniae), Rickettsia spp. Ureaplasma urealyticum.
Resistant organisms:
aerobic gram — positive microorganisms Corynebacterium jeikeium, Staphylococcus spp. (coagulasepositive methicillin, including methicillin Staphylococcus aureus)
aerobic gram — negative microorganisms Alcaligenes xylosoxidans
other microorganisms Mycobacterium avium.
Indications:
- Infectious-inflammatory diseases of mild and moderate severity, caused by sensitive microorganisms:
- infections of the lower respiratory tract (pneumonia, exacerbation of chronic bronchitis)
- acute bacterial sinusitis
- urinary tract infection and the kidney (including acute pyelonephritis)
- infections of skin and soft tissues (festering atheroma, abscess, boils)
- chronic bacterial prostatitis
- intra-abdominal infections (in combination with antibacterial drugs acting on the anaerobic flora)
- tuberculosis (in the complex therapy of drug-resistant forms).
Contraindications:
- hypersensitivity to levofloxacin, other fluoroquinolones or other components of the drug in history
- epilepsy
- the defeat of the tendons associated with taking quinolones in history
- childhood and adolescence to 18 years
- pregnancy
- lactation.
With care — old age (high likelihood of having a concomitant loss of kidney function), the deficit glukozo-6-fosfatdegidrogenaza.
Side effects:
From the nervous system: headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, seizures.
From the sensory organs: visual impairment, hearing, olfactory, gustatory and tactile sensitivity.
By SSS: reducing AD, vascular collapse, tachycardia, prolonged QT interval, atrial fibrillation.
From the digestive system: nausea, vomiting, diarrhea (including blood), indigestion, loss of appetite, abdominal pain, pseudomembranous colitis, increase in liver transaminases, hyperbilirubinemia, hepatitis, goiter.
From the metabolic: hypoglycemia (increased appetite, increased sweating, tremor, nervousness).
From the side of musculoskeletal system: arthralgia, muscular weakness, myalgia, rhabdomyolysis, tendon rupture, tendonitis.
From the urinary system: gipercreatininemia, interstitial nephritis, acute renal failure.
The bodies of the blood: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhage.
Allergic reactions: itching and hyperemia of the skin, swelling of the skin and mucous membranes, hives, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, dyspnea, anaphylactic shock, allergic pneumonitis, vasculitis.
Other: photosensitivity, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.
Drug interactions:
Levofloxacin increases the half-life of cyclosporine.
Effect of levofloxacin reduces BOS, depressing motoriku bowel, sucralfate, aluminum - or magnesium antacid medicines and iron tablets.
NSAIDs and theophylline with concomitant use with levofloxacin increase the risk of seizures in predisposed patients, and corticosteroids increase the risk of tendon rupture.
The simultaneous administration of levofloxacin with hypoglycemic drugs possible changes in the level of blood glucose, including hyperglycemia and hypoglycemia.
Levofloxacin enhances the effect of warfarin.
Cimetidine and drugs that block tubular secretion, slow down the excretion of levofloxacin.
Method of application and dose:
Inside, before meals or in between meals, without chewing, drinking plenty of water.
Adult patients with normal renal function (creatinine Cl >50 ml/min) applied in accordance with those shown in table schemas:
| Infection | Dose, mg | The multiplicity of reception day | The duration of treatment, days |
| Hospital-acquired pneumonia | 750 | 1 | 7–14 |
| Community-acquired pneumonia | 500 | 1–2 | 7–14 |
| 750 | 1 | 5* | |
| Exacerbation of chronic bronchitis | 500 | 1 | 7 |
| Acute bacterial sinusitis | 500 | 1 | 10–14 |
| 750 | 1 | 5 | |
| Uncomplicated urinary tract infection | 250 | 1 | 3 |
| Complicated urinary tract infections, including acute pyelonephritis | 250 | 1 | 10** |
| 750 | 1 | 5*** | |
| Uncomplicated infections of skin and subcutaneous tissue | 500 | 1 | 7–10 |
| Complicated infections of skin and subcutaneous tissue | 750 | 1 | 7–14 |
| Chronic bacterial prostatitis | 500 | 1 | 28 |
| Intra-abdominal infections (in combination with antibacterial drugs acting on the anaerobic flora) | 500 | 1 | 7–14 |
| Tuberculosis (in the complex therapy of drug-resistant forms) | 750 | 1 | Up to 3 months |
* This mode is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae.
** This mode is indicated for the treatment of urinary tract infections caused by Enterococcus faecalis, Enterococcus cloacae, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and for acute pyelonephritis caused by Escherichia coli.
*** This mode is indicated for the treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and acute pyelonephritis caused by Escherichia coli, including cases with concomitant bacteremia.
Dose adjustment of levofloxacin in adult patients with impaired renal function (Cl creatinine <50 ml/min)
| Dose in normal renal function every 24 hours | Cl creatinine from 20 to 49 ml/min | Creatinine Cl from 10 to 19 ml/min | Cl creatinine less than 10 ml/min, including hemodialysis or chronic ambulatory peritoneal dialysis |
| 750 mg | 750 mg every 48 hours | Initial dose 750 mg, then 500 mg every 48 hours | Initial dose 750 mg, then 500 mg every 48 hours |
| 500 mg | Initial dose 500 mg, then 250 mg every 24 h | Initial dose 500 mg, then 250 mg every 48 hours | Initial dose 500 mg, then 250 mg every 48 hours |
| 250 mg | Dose adjustment is not required | 250 mg every 48 h in uncomplicated urinary tract infections dose adjustment is not required | Information about dose adjustment is missing |
When violation of the liver dose adjustment is not required because the amount of metabolism of levofloxacin in the liver is limited.
Overdose:
Symptoms: nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, prolonged QT interval, mental confusion, dizziness, seizures.
Treatment: gastric lavage, if necessary — symptomatic therapy. There is no specific antidote, dialysis is ineffective.
Special instructions:
After normalization of body temperature is recommended to continue the treatment for at least 48-72 h.
Take levofloxacin at least 2 hours before or 2 hours after taking antacids magnesium/aluminum or sucralfate or with other products containing calcium, iron or zinc.
Due to the potential for fotosencibilization during treatment and for 5 days after the end of treatment with levofloxacin must avoid sunlight and artificial UV exposure. With the development of phototoxicity, drug treatment should be discontinued.
When signs of tendinitis and pseudomembranous colitis levofloxacin immediately cancelled.
It should be borne in mind that patients with brain damage in medical history (stroke, severe injury) may develop convulsions.
In case of insufficient glukozo-6-fosfatdegidrogenaza potential risk of hemolytic reactions.
In patients with diabetes mellitus during treatment with levofloxacin should be carefully monitor the level of glucose in the blood.
While the use of levofloxacin and warfarin are shown monitoring PV, INR or other tests of anticoagulation and monitor for signs of bleeding.
While taking levofloxacin may disrupt the patient's ability to concentration of attention and quickness of psychomotor reactions. In this regard, care must be taken when driving vehicles and occupation of other potentially hazardous activities.
