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

Active substance: levofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: NIZHFARM (Russia) manufactured by HETERO DRUGS Limited (India) packed with SKOPINSKY FARM PLANT (Russia)
Composition, form of production and packaging
Tablets covered with a coat of
white or almost white color, round.

1 tab.

levofloxacin (in the form of hemihydrate) 250 mg

Excipients: hydroxypropyl cellulose LF, microcrystalline cellulose 102, sodium starch glycolate, crospovidone, sodium croscarmellose, silicon dioxide colloid, magnesium stearate, hydroxypropylmethylcellulose 15 CPS, talc purified, titanium dioxide, triacetin.

5 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
Tablets covered with a coat of white or almost white, capsular, with a risk on one side.

1 tab.

levofloxacin (in the form of hemihydrate) 500 mg

Excipients: hydroxypropyl cellulose LF, microcrystalline cellulose 102, sodium starch glycolate, crospovidone, sodium croscarmellose, silicon dioxide colloid, magnesium stearate, hydroxypropylmethylcellulose 15 CPS, talc purified, titanium dioxide, triacetin.

5 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

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

PHARMACHOLOGIC EFFECT

Levofloxacin is a synthetic broad-spectrum antibacterial agent from the group of fluoroquinolones, containing as an active substance levofloxacin, a levorotatory isofloxacin isomer.
Levofloxacin blocks DNA-gyrase, disrupts supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes.
Levofloxacin is active against most strains of microorganisms both in vitro and in vivo .

Aerobic Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp.
(including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative, methicillin-sensitive, methicillinumeric-sensitive), including Staphylococcus aureus methicillin-sensitive, methicillinumerally sensitive, Staphylococcus epidermidis methicillin-sensitive, methicillinumerally sensitive, Streptococcus spp. group C and G, Streptococcus agalactiae, Streptococcus pneumoniae
penicillin-sensitive / moderately sensitive / resistant, Streptococcus pyogenes, Streptococcus spp.
viridans are penicillin-sensitive / resistant.
Aerobic Gram-negative microorganisms: Acinetobacter spp., (Including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter spp.
(including Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, ampicillin susceptible / resistant, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp., Klebsiella oxytoca, Klebsiella pneumoniae, Moxarella catarrhalis B-lactamase-producing and B-lactamase-mediated, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella spp., Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Salmonella spp., Serratia spp., incl. 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, Legionella spp., Mycobacterium spp.
(including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.
Moderately sensitive microorganisms.

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, Campilobacter jejuni, Campilobacter coli.

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

Stable microorganisms.

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

Levofloxacin is rapidly and almost completely absorbed after oral administration.
Food intake has little effect on the speed and completeness of absorption.Bioavailability of 500 mg of levofloxacin after oral administration is almost 100%. After taking a single dose of 500 mg of levofloxacin, the maximum concentration is 5.2 μg / ml, the time to reach the maximum concentration is 1.3 hours, the half-life is 6-8 hours.
The connection with plasma proteins is 30-40%.
It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages.
In the liver, a small portion is oxidized and / or deacetylated.
It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion.After oral administration, approximately 87% of the dose received is excreted by the kidneys unchanged for 48 hours, less than 4% through the intestine for 72 hours.
INDICATIONS

Infectious-inflammatory diseases caused by susceptible to levofloxacin microorganisms:

- Acute sinusitis;

- exacerbation of chronic bronchitis;

- community-acquired pneumonia;

- Complicated urinary tract infections (including pyelonephritis);

uncomplicated urinary tract infections;

- chronic bacterial prostatitis;

- infections of the skin and soft tissues;

- intra-abdominal infection;

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

DOSING MODE

Inside, 1 or 2 times a day (every 24 or 12 hours).

Tablets can not be chewed and washed down with a sufficient amount of liquid (from 0.5 to 1 cup), 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 sinusitis (inflammation of the paranasal sinuses): 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 mg once a day or 500 mg 1-2 times a day-7-14 days.

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

Tuberculosis (as part of complex therapy of drug-resistant forms): 500 mg 1-2 times a day for up to 3 months.

In patients with impaired renal function , the interval between doses should be increased and a lower dose should be used.
When creatinine clearance is 50-20 ml / min, the first dose is 500 mg in the first 24 hours, then 250 mg once or twice a day, depending on the pathogen, localization and severity of the infection.
After hemodialysis or permanent ambulatory peritoneal dialysis (CAPD), no additional doses are required.

If the liver function is not required, a special dose selection is required, since levofloxacin is metabolized in the liver to a small extent.

For elderly patients , there is no need to change the dosage regimen, except for cases of low creatinine clearance.

Treatment with levofloxacin is recommended to continue no less than 48-72 hours after the normalization of body temperature or after a significant eradication of the pathogen.
If you missed taking the drug, you should take the pill as soon as possible, without waiting for the next time. Further, to observe equal intervals of time between doses - 24 h (with the mode of reception 1 time per day) or 12 h (with the mode of reception 2 times a day).
SIDE EFFECT

The frequency of this or that side effect is determined by the following table:

Frequency Occurrence of side effects

often: 1-10 patients out of 100

infrequently: less than 1 patient out of 100

rarely: less than 1 patient out of 1,000

very rarely: less than 1 patient out of 10,000

individual cases less than 0.01%

Skin reactions and general hypersensitivity reactions

Infrequent: itching and redness of the skin.

Rarely: general hypersensitivity reactions (anaphylactic and anaphylactoid reactions) with symptoms such as hives, constriction of the bronchi and possibly severe choking.

In very rare cases: swelling of the skin and mucous membranes (for example, in the face and pharynx), sudden drop in blood pressure and shock;
increased sensitivity to solar and ultraviolet radiation (see Specific guidance); allergic pneumonitis; vasculitis.
In some cases: severe skin rashes with the formation of blisters, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme.
Common hypersensitivity reactions can sometimes be preceded by lighter skin reactions. The above reactions may develop after the first dose in a few minutes or hours after the administration of the drug.
Action on the gastrointestinal tract and metabolism

Often: nausea, diarrhea, dysbiosis.

Infrequent: loss of appetite, vomiting, abdominal pain, indigestion.

Rarely: hemorrhagic diarrhea (bloody diarrhea), which in very rare cases can be a sign of inflammation of the intestine and even pseudomembranous colitis (see Special instructions).

Very rarely: a drop in blood sugar (hypoglycemia), which is of particular importance for patients suffering from diabetes mellitus;
possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling. The experience with the use of other quinolones indicates that they are capable of exacerbating porphyria (a very rare metabolic disease) in patients already suffering from this disease. A similar effect is not excluded even when levofloxacin is used.
Action on the nervous system

Infrequent: headache, dizziness and / or numbness, vertigo (feeling deflected or twisted or your own body or surrounding objects), drowsiness, sleep disturbance, insomnia.

Rarely: depression, anxiety, psychotic reactions (for example, with hallucinations), paresthesia, tremor, psychomotor agitation, agitation (stimulation), confusion, convulsions, anxiety, fear.

Very rarely: dysgeusia (taste distortion), loss of taste, parosmia, a sense of smell, especially a subjective sense of smell, objectively absent), including loss of smell, visual and hearing impairment, hearing loss, ringing in the ears, lowering of tactile sensitivity.

The frequency is not known: peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, nightmares, extrapyramidal disorders, mental disorders with behavioral disorders with self-harm, including suicidal attempts.

Action on the cardiovascular system

Rarely: sensation of a palpitation, depression of arterial pressure.
Very rarely: (shock-like) vascular collapse. In some cases: prolongation of the QT interval.
Action on muscles, tendons and bones

Rarely: tendon lesions (including tendonitis), joint and muscle pain.

Very rarely: rupture of tendons (eg Achilles tendon);
this side effect can be observed within 48 hours after the start of treatment and can be bilateral (see Special instructions); muscle weakness, which is of particular importance for patients with pseudo-paralytic myasthenia gravis (myasthenia gravis).
In some cases: muscle damage (rhabdomyolysis).

Action on the liver and kidneys

Often: increased activity of liver enzymes (eg, alanine aminotransferase and aspartate aminotransferase).

Rarely: an increase in the level of bilirubin and creatinine in the blood serum (a sign of restriction of liver or kidney function).

Very rarely: liver reactions (eg, inflammation of the liver);
impairment of kidney function up to acute renal failure, for example, due to allergic reactions (interstitial nephritis).
The frequency is not known: severe hepatic insufficiency, including cases of acute liver failure, especially in patients with severe underlying disease (eg, sepsis).

Action on the blood

Infrequently: an increase in the number of eosinophils, a decrease in the number of leukocytes.

Rarely: neutropenia;
thrombocytopenia, which can be accompanied by increased bleeding, hemorrhage.
Very rarely: agranulocytosis and the development of severe infections (persistent or recurrent increase in body temperature, deterioration of well-being).

In some cases: hemolytic anemia;
pancytopenia.
Other side effects

Infrequent: general weakness (asthenia).

Very rarely: fever.

Any antibiotic therapy can cause changes in the microflora (bacteria and fungi), which is normally present in humans.
For this reason, increased reproduction of bacteria and fungi resistant to the antibiotic used (secondary infection and superinfection) can occur, which in rare cases may require additional treatment.
CONTRAINDICATIONS

- epilepsy;

- lesions of tendons during the previous treatment with quinolones;

- Children and adolescence (up to 18 years);

- pregnancy and lactation;

- hypersensitivity to levofloxacin, other quinolones, other components of the drug.

With caution

Predisposition to convulsive reactions (atherosclerosis of cerebral vessels, cerebral circulation disorders (including history), organic diseases of the central nervous system), renal failure, congenital QT interval prolongation syndrome, heart failure, myocardial infarction, bradycardia, electrolyte imbalance ( hypokalemia, hypomagnesemia), elderly age (over 65 years), diabetes mellitus, myasthenia gravis, psychosis and other mental disorders (including in anamnesis), hepatic porphyria, at the same time
(antiarrhythmic class I and III, tricyclic and tetracyclic antidepressants, neuroleptics, macrolides, antifungal, imidazole derivatives, some antihistamines, including astemizole, terfenadine, ebastin), simultaneous use of drugs that lower the threshold convulsive readiness (fenbufen, theophylline), cimetidine, probenecid, deficiency of glucose-6-phosphate dehydrogenase.
PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function, the interval between doses should be increased and a smaller dose should be used.
With KK 50-20 ml / min, the first dose is 500 mg in the first 24 hours, then 250 mg once or twice a day, depending on the pathogen, localization and severity of the infection.
After hemodialysis or permanent ambulatory peritoneal dialysis (CAPD), no additional doses are required.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If the liver function is not required, a special dose selection is required, since levofloxacin is metabolized in the liver to a small extent.

APPLICATION FOR CHILDREN

Contraindication: children and adolescence (up to 18 years).

APPLICATION IN ELDERLY PATIENTS

For elderly patients, there is no need to change the dosage regimen, except for cases of low creatinine clearance.

In the treatment of senile patients, it should be borne in mind that patients of this group often suffer from impaired renal function.

SPECIAL INSTRUCTIONS

Levofloxacin can not be used to treat children and adolescents because of the possibility of joint cartilage damage.

Since levofloxacin is excreted mainly by the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as correction of the dosing regimen.

In the treatment of senile patients, it should be borne in mind that patients of this group often suffer from impaired renal function.

Very rare cases of prolonged QT interval in patients receiving fluoroquinolones, including levofloxacin, have been reported.
When using fluoroquinolones, including levofloxacin, caution should be used in patients with known risk factors for prolonging the QT interval: elderly; violation of electrolyte balance (hypokalemia, hypomagnesemia); syndrome of congenital interval QT; myocardial infarction, heart failure, bradycardia; simultaneous administration of drugs that can extend the QT interval.
In patients with diabetes mellitus receiving oral hypoglycemic agents, for example glibenclamide, or insulin, the use of quinolones increases the risk of developing hypoglycemia.
Such patients need to monitor the concentration of glucose in the blood.
In patients receiving fluoroquinolones, including levofloxacin, sensory and sensory-motor neuropathy was noted, the onset of which can be rapid.
If the patient has symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.
Caution should be exercised in patients with pseudo-paralytic myasthenia gravis.

In severe pneumonia caused by Streptococcus pneumoniae, levofloxacin may not provide the optimal therapeutic effect.
Hospital infections caused by certain pathogens (Pseudomonas aeruginosa) may require combined treatment.
During treatment with the drug Levofloxacin-Stade, it is possible to develop an attack of seizures in patients with previous brain damage due, for example, to a stroke or severe trauma.
Convulsive readiness may also increase with simultaneous use of fenbufen, similar non-steroidal anti-inflammatory drugs or theophylline (see "Interaction").
Despite the fact that photosensitization is observed with levofloxacin very rarely, it is not recommended to undergo strong sunlight or artificial ultraviolet irradiation to avoid it.

If pseudomembranous colitis is suspected, levofloxacin should be immediately discontinued and appropriate treatment initiated.
In such cases, drugs that depress intestinal motility should not be used.
Rarely observed with the use of the drug levofloxacin tendinitis (primarily inflammation of the Achilles tendon) can lead to rupture of tendons.
The elderly are more prone to tendinitis. Glucocorticosteroids treatment ( "cortisone drugs") are likely to increase the risk of tendon rupture. If tendinitis is suspected, immediately discontinue treatment with levofloxacin and begin the appropriate treatment of the affected tendon, for example, providing him rest state (see. "Contraindications" and "Side effects").
Patients with a deficiency of glucose-6-phosphate dehydrogenase (an inherited metabolic disorder) can respond to fluoroquinolones destruction of erythrocytes (hemolysis). In this regard, the treatment of such patients with levofloxacin should be performed with caution.
Such side effects of the drug Levofloxacin-STADA as dizziness or stupor, drowsiness and visual disturbances (see. Also "Side effect) can slow psychomotor reactions and the ability to focus. This may be a risk in situations where these capabilities are of particular importance (eg while driving, maintenance of machines and mechanisms, when working in unstable position). during treatment with levofloxacin is not recommended alcohol intake.
OVERDOSE

Symptoms: nausea, erosive lesions of the mucous membrane of the gastrointestinal tract, the lengthening of the interval QT, confusion, dizziness, seizures.
Treatment: symptomatic, gastric lavage, antacids; Dialysis is ineffective.
The specific antidote is not known.
DRUG INTERACTION

There are reports of marked decrease in the seizure threshold, while the use of quinolones and substances that can, in turn, lower the cerebral seizure threshold. Equally, it also relates to the simultaneous application of quinolones and theophylline, fenbufen or similar to them nonsteroidal anti-inflammatory drugs (for the treatment of rheumatic diseases).
Action levofloxacin formulation significantly attenuated while the use of sucralfate (the means to protect the gastric mucosa) drug depressing bowel motility. The same thing happens while applying magnesium- or aluminum-containing antacids (drugs to treat heartburn and gastralgia) and iron salts (for the treatment of anemia). Levofloxacin should take no less than 2 hours before or 2 hours after administration thereof. With calcium carbonate interactions not revealed.
While the use of indirect anticoagulants, coumarin derivatives, vitamin K antagonists required control MHO (international normalized ratio).
When simultaneous administration of drugs prolonging the interval QT (IAi III antiarrhythmic classes, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, imidazole derivatives, some antihistamines, including astemizole, terfenadine, ebastine) may lengthening QT.
Excretion (renal clearance) of levofloxacin slightly slowed down by the action of cimetidine and probenecid. It should be noted that this interaction is practically has no clinical significance. However, while the use of drugs and cimetidine probenecid type blocking certain path clearance (tubular secretion) treatment with levofloxacin should be performed with care. This applies especially to patients with reduced renal function.
Levofloxacin slightly increases the half-life of cyclosporin.
The use of glucocorticosteroids increases the risk of rupture of tendons.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

In a dry, dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children. Period of validity of 3 years.
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