Universal reference book for medicines
Product name: TAVANIC ® (TAVANIC ® )

Active substance: levofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: SANOFI-AVENTIS DEUTSCHLAND (Germany) manufactured by SANOFI WINTHROP INDUSTRIE (France)
Composition, form of production and packaging

The tablets covered with a film membrane of pale yellowish-pink color, oblong, biconcave, with a groove on both sides.

1 tab.

levofloxacin hemihydrate 256.23 mg,

which corresponds to the content of levofloxacin 250 mg

[PRING] hypromellose - 5.4 mg, crospovidone - 7 mg, microcrystalline cellulose - 33.87 mg, sodium stearyl fumarate - 5 mg.

The composition of the film membrane: hypromellose - 5.433 mg, macrogol 8000 - 0.288 mg, titanium dioxide (E171) - 1.358 mg, talc - 0.407 mg, iron oxide red (E172) 0.007 mg, iron oxide yellow (E172) 0.007 mg.

3 pcs.
- blisters (1) - packs of cardboard.
5 pieces.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
The tablets covered with a film membrane of pale yellowish-pink color, oblong, biconcave, with a groove on both sides.

1 tab.

levofloxacin hemihydrate 512.46 mg,

which corresponds to the content of levofloxacin 500 mg

[PRING] hypromellose - 10.8 mg, crospovidone - 14 mg, microcrystalline cellulose - 67.74 mg, sodium stearyl fumarate - 10 mg.

The composition of the film membrane: hypromellose - 10.866 mg, macrogol 8000 - 0.575 mg, titanium dioxide (E171) 2.716 mg, talc 0.815 mg, iron oxide red (E172) 0.014 mg, iron oxide yellow (E172) 0.014 mg.

5 pieces.
- blisters (1) - packs of cardboard.
7 pcs.
- 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 2017.

PHARMACHOLOGIC EFFECT

Synthetic antimicrobial drug from the group of fluoroquinolones, levorotatory isofloxacin isomer.
Has a wide spectrum of antimicrobial action.
Levofloxacin 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 membranes of microbial cells.

Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.

In vitro are sensitive (BMD? 2 mg / ml, inhibition zone? 17 mm), aerobic Gram-positive microorganisms: Bacillus anthratis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus spp.
(including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative, methicillin-sensitive / methicillin-moderately sensitive strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Staphylococcus spp. (coagulase-negative), Streptococcus spp. groups C and G (including Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans (penicillin-sensitive / resistant strains), aerobic gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp ., Actinobacillus actinimycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (Including Enterobacter cloacae, Enterobacter aerogenes), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin-sensitive / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (Including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (strains producing and non-producing? -lactamase), Morganella morganii, Neisseria gonnorrhoeae (strains producing and non-producing penicillinase), Neisseria meningitidis, Pasteurella spp. (including Pasteurella cens, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (Hospital infections caused by Pseudomonas aeruginosa may require combined treatment), Salmonella spp., Serratia spp. (Serratia marcescens);anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterum 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.
Levofloxacin is moderately active (MPC = 4 mg / L, inhibition zone 16-14 mm) for aerobic Gram-positive microorganisms: Corynebacterium urealiticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains) ;
aerobic gram-negative microorganisms: Campilobacter jejuni, Campilobacter coli; anaerobic microorganisms: Prevotella spp., Porphyromonas spp.
To levofoloxacin are stable (MIC, ≥8 mg / L, inhibition zone13 mm), aerobic Gram-positive microorganisms: Staphylococcus aureus (methicillin-resistant strains), Staphylococcus spp.
(coagulase-negative methicillin-resistant strains); aerobic gram-negative microorganisms: Alcaligenes xylosoxidans; anaerobic microorganisms:Bacteroides thetaiotaomicronron; other microorganisms: Mycobacterium avium.
Clinical efficacy

In clinical trials, the drug was effective in the treatment of infections caused by the following microorganisms.

Aerobic Gram-positive microorganisms : Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.

Aerobic Gram-negative microorganisms: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxela (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.

Others: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

Resistance

Resistance to levofloxacin develops as a result of a phased process of mutations of genes encoding both topoisomerases of type II: DNA-gyrase and topoisomerase IV.
Other resistance mechanisms, such as the mechanism of influence on the penetration barriers of the microbial cell (the mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active excretion of the antimicrobial from the microbial cell), can also reduce the sensitivity of microorganisms to levofloxacin.
Due to the peculiarities of the mechanism of action of levofloxacin, there is usually no cross-resistance between levofloxacin and other antimicrobial agents.

PHARMACOKINETICS

Suction

After ingestion, levofloxacin is rapidly and almost completely absorbed from the digestive tract.
Food intake has little effect on its absorption. Absolute bioavailability with oral administration is 99-100%.
After a single administration of levofloxacin in a dose of 500 mg C max in blood plasma is achieved within 1-2 hours and is 5.2 ± 1.2 μg / ml.

The pharmacokinetics of levofloxacin is linear in the dosage range of 50 to 1000 mg.

C ss of levofloxacin in plasma with the intake of 500 mg of levofloxacin 1 or 2 times / day is achieved within 48 hours.

On the 10th day of taking Tavanik ® at a dose of 500 mg 1 time / day, the C max of levofloxacin in plasma was 5.7 ± 1.4 μg / ml, and the C min of levofloxacin (concentration before taking the next dose) in the plasma was 0.5 ± 0.2 μg / ml.

On the 10th day of taking Tavanik ® in a dose of 500 mg 2 times / day, the C max of levofloxacin in plasma was 7.8 ± 1.1 μg / ml, and C min of levofloxacin (concentration before taking the next dose) in plasma was 3.0 + 0.9 μg / ml.

Distribution

Binding to plasma proteins is 30-40%.

After a single and repeated administration of levofloxacin at a dose of 500 mg V d of levofloxacin averages 100 l, indicating a good penetration of levofloxacin into the organs and tissues of the human body.

After a single dose of levofloxacin in a dose of 500 mg C max, levofloxacin in the bronchial mucosa and epithelial lining fluid was achieved within 1-4 hours and amounted to 8.3 μg / g and 10.8 μg / ml, respectively, with penetration coefficients in the bronchial mucosa and fluid of the epithelial lining as compared to the concentration in the plasma of 1.1-1.8 and 0.8-3.0, respectively.

After 5 days of taking levofloxacin inside at a dose of 500 mg, the average concentrations of levofloxacin 4 hours after the last drug intake in the epithelial lining fluid were 9.94 μg / ml and in alveolar macrophages 97.9 μg / ml.

Cmax in the pulmonary tissue after taking levofloxacin inside at a dose of 500 mg was approximately 11.3 μg / g and was achieved 4-6 hours after taking the drug with penetration factors of 2-5 compared to the concentration in the plasma.

After 3 days of taking levofloxacin 500 mg once or twice per day, the C max of levofloxacin in the alveolar fluid was achieved 2-4 hours after the administration of the drug and was 4.0 and 6.7 μg / ml, respectively, with a penetration factor compared to the plasma concentrations which is 1.

Levofloxacin well penetrates into the cortical and spongy bone tissue, both in the proximal and distal parts of the femur with a coefficient of penetration (bone tissue / plasma) 0.1-3.
The C max of levofloxacin in the spongy bone of the proximal femur after oral administration at a dose of 500 mg was approximately 15.1 μg / g (2 hours after taking the drug).
Levofloxacin poorly penetrates into the cerebrospinal fluid.

After oral administration of levofloxacin at a dose of 500 mg 1 time / day for 3 days, the average concentration of levofloxacin in the prostate tissue was 8.7 μg / g, the average ratio of prostatic / plasma concentrations was 1.84.

Average concentrations in the urine 8-12 hours after ingestion at a dose of 150, 300 and 600 mg of levofloxacin were 44 μg / ml, 91 μg / ml and 162 μg / ml, respectively.

Metabolism

Levofloxacin is metabolized to a small extent (5% of the dose taken).
Its metabolites are demethyllevofloxacin and N-oxide levofloxacin, which are excreted by the kidneys. Levofloxacin is stereochemically stable and does not undergo chiral transformations.
Excretion

After oral administration, levofloxacin is relatively slowly removed from the plasma (T 1/2 - 6-8 h).
It is excreted mainly with urine (more than 85% of the dose taken). The total clearance of levofloxacin after a single dose of 500 mg was 175 ± 29.2 ml / min.
There are no significant differences in the pharmacokinetics of levofloxacin with its intravenous administration and ingestion, which confirms that oral and / or intravenous administration are interchangeable.

Pharmacokinetics in specific patient groups

The pharmacokinetics of levofloxacin in men and women do not differ.

Pharmacokinetics in elderly patients does not differ from that in young patients, except for differences in pharmacokinetics associated with differences in QC.

With renal failure, the pharmacokinetics of levofloxacin varies.
As the kidney function decreases, excretion through the kidneys and kidney clearance decreases, and T1/2 increases.
Pharmacokinetics in renal failure after a single dose of Tavanik ® in a dose of 500 mg

KK (ml / min) <20 20-49 50-80

Kidney clearance (ml / min) 13 26 57

T 1/2 (h) 35 27 9



INDICATIONS

Bacterial infections caused by susceptible to levofloxacin microorganisms in adults:

- Acute sinusitis;

- exacerbation of chronic bronchitis;

- community-acquired pneumonia;

uncomplicated urinary tract infections;

- Complicated urinary tract infections (including pyelonephritis);

- chronic bacterial prostatitis;

- infections of the skin and soft tissues;

- for complex treatment of drug-resistant forms of tuberculosis;

- prevention and treatment of anthrax during airborne infection.

When using Tavanik ® , official national recommendations for the proper use of antibacterial drugs should be taken into account, as well as the sensitivity of microorganisms in a particular country.

DOSING MODE

The drug is taken orally 250 or 500 mg 1 or 2 times / day.
Tablets should be taken without chewing and drinking with a sufficient amount of liquid (0.5 to 1 cup). If necessary, the tablets can be broken on the separating groove.
The drug can be taken before meals or at any time between meals.
eating does not affect the absorption of the drug.
The drug should be taken at least 2 hours before or 2 hours after taking antacid preparations containing magnesium and / or aluminum, zinc, iron salts or the administration of sucralfate.

Given that the bioavailability of levofloxacin in the use of Tavanic ® in tablets is 99-100%, in the case of transfer of the patient from / to the introduction of the drug on the taking of tablets, the treatment should be continued at the same dose that was used for IV infusion.

Dosing regimen is determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility.
Duration of treatment varies depending on the course of the disease.
Patients with normal renal function (CK> 50 mL / min) are recommended the following dosing regimen and duration of treatment.

Acute sinusitis: 2 tab.
250 mg or 1 tab. 500 mg 1 time / day (respectively 500 mg of levofloxacin) - 10-14 days.
Exacerbation of chronic bronchitis: 2 tab.
250 mg or 1 tab. 500 mg 1 time / day (respectively 500 mg of levofloxacin) - 7-10 days.
Community-acquired pneumonia: 2 tab.
250 mg or 1 tab. 500 mg 1-2 times / day (respectively 500-1000 mg of levofloxacin) - 7-14 days.
Uncomplicated urinary tract infections: 1 tab.
250 mg 1 time / day (respectively 250 mg of levofloxacin) - 3 days.
Complicated urinary tract infections: 2 tab.
250 mg 1 time / day (respectively 250 mg of levofloxacin) or 1 tab. 500 mg 1 time / day (respectively, 500 mg of levofloxacin) - 7-14 days.
Pyelonephritis: 2 tab.
250 mg 1 time / day or 1 tab. 500 mg 1 time / day (respectively 500 mg of levofloxacin) - 7-10 days.
Chronic bacterial prostatitis: 2 tab.
250 mg or 1 tab. 500 mg once a day (correspondingly 500 mg of levofloxacin) - 28 days.
Infections of the skin and soft tissues: 2 tab.
250 mg or 1 tab. 500 mg 1-2 times / day (respectively 500-1000 mg of levofloxacin) - 7-14 days.
As a part of complex therapy of drug-resistant forms of tuberculosis: 1 tab.
500 mg 1-2 times / day (respectively 500-1000 mg of levofloxacin) - up to 3 months.
Prevention and treatment of anthrax during airborne infection: 2 tab.
250 mg or 1 tab. 500 mg (respectively 500 mg levofloxacin) 1 time / day - up to 8 weeks.
Patients with renal dysfunction (KK? 50 ml / min) require a correction of the dosing regimen, depending on the value of KK,
Levofloxacin is mainly excreted by the kidneys.
QC Recommended dose

> 50 ml / min 250 mg / 24 h 500 mg / 24 h 500 mg / 12 h

50-20 ml / min first dose 250 mg then 125 mg / 24 h first dose 500 mg then 250 mg / 24 h first dose 500 mg then 250 mg / 12 h

19-10 ml / min first dose 250 mg then 125 mg / 48 h first dose 500 mg then 125 mg / 24 h first dose 500 mg then 125 mg / 12 h

<10 ml / min (including hemodialysis and CAPD * ) first dose 250 mg then 125 mg / 48 h first dose 500 mg then 125 mg / 24 h first dose 500 mg then 125 mg / 24 h

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

If the liver function is not required, correction of the dosing regimen is not required, since levofloxacin is only slightly metabolized in the liver.

For elderly patients , correction of the dosing regimen is not required, except for cases when the CK is reduced to 50 ml / min and below.

Skipping the drug

If the drug is missed, it is necessary to take the tablet as soon as possible and continue taking Tavanic ® according to the recommended dosing regimen.

SIDE EFFECT

Determination of the frequency of side effects: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10 000, <1 / 1000), very rarely (<1/10 000, including individual reports), the frequency is unknown (according to available data, it is not possible to determine the frequency of occurrence).

Data obtained in clinical trials and in the post-marketing application of the drug

From the side of the vascular system: rarely - sinus tachycardia, palpitation, lowering blood pressure;
frequency unknown (postmarketing data) - prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular pirouette tachycardia, which can lead to cardiac arrest.
On the part of the hematopoiesis system: infrequently - leukopenia, eosinophilia;
rarely - neutropenia, thrombocytopenia; frequency is unknown (postmarketing data) - pancytopenia, agranulocytosis, hemolytic anemia.
From the nervous system: often - headache, dizziness;
infrequently - drowsiness, tremor, dysgeusia (perversion of taste); rarely - paresthesia, convulsions; frequency is unknown (postmarketing data) - peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorders, loss of taste sensations, parosmia (odor disorder, especially subjective sense of smell, objectively absent), including loss of smell, fainting, benign intracranial hypertension .
Mental disorders: often - insomnia;
infrequently - a feeling of anxiety, confusion; rarely - mental disorders (hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares; frequency unknown (postmarketing data) - mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicidal attempts.
From the side of the organ of vision: very rarely - visual impairments, such as the vagueness of the visible image;
frequency unknown (postmarketing data) - transient loss of vision, uveitis.
From the side of the organ of hearing and labyrinthine disturbances: infrequently - vertigo (feeling of deflection or twisting or own body or surrounding objects);rarely - ringing in the ears;
frequency unknown (postmarketing data) - hearing loss, hearing loss.
From the respiratory system: infrequently - shortness of breath;
frequency unknown (postmarketing data) - bronchospasm, allergic pneumonitis.
On the part of the digestive system: often - diarrhea, vomiting, nausea;
Infrequent - abdominal pain, dyspepsia, flatulence, constipation; frequency is unknown (post-marketing data) - hemorrhagic diarrhea, which in very rare cases, it may be a sign of enterocolitis, including pseudomembranous colitis, pancreatitis, stomatitis.
Of the liver and biliary tract: often - increased ALT, AST, alkaline phosphatase, GGT; Infrequent - increased bilirubin concentration in the blood; frequency is unknown (post-marketing data) - severe hepatic failure, including cases of acute liver failure (sometimes fatal), especially in patients with severe underlying disease patients (e.g., in sepsis); hepatitis, jaundice.
On the part of the urinary tract:Infrequent - increased creatinine concentration in blood serum; rarely - acute renal failure (e.g., due to the development of interstitial nephritis).
Skin and subcutaneous tissue disorders: rare - rash, itching, hives, rash; frequency is unknown (post-marketing data) - toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reactions (hypersensitivity to sunlight and UV radiation), leukocytoclastic vasculitis. The reactions of the skin and mucous membranes can sometimes develop even after the first dose.
Immune system:rarely - urticaria; rarely - angioedema; frequency is unknown (post-marketing data) - anaphylactic shock, anaphylactoid shock. Anaphylactic and anaphylactoid reactions can sometimes develop even after the first dose.
On the part of the musculoskeletal system: rarely - arthralgia, myalgia; rare - the defeat tendons, including tendinitis (eg Achilles tendon), muscular weakness, which can be especially dangerous in patients with gravis (myasthenia gravis); frequency is unknown (post-marketing data) - rhabdomyolysis, tendon rupture (for example, the Achilles tendon, this side effect can be observed within 48 hours after initiation of treatment and can be two-way), torn ligaments, muscles gap arthritis.
From a metabolism:rarely - anorexia; rarely - hypoglycemia, particularly in patients with diabetes (possible symptoms of hypoglycemia: "ravenous" appetite, anxiety, sweating, trembling); the frequency is unknown - hyperglycemia, hypoglycemic coma.
Infectious and parasitic diseases: rare - fungal infections, the development of resistance of pathogens.
General reactions: rarely - fatigue; rarely - pyrexia (fever); the frequency is unknown - pain (including back pain, chest, legs).
Other potential adverse effects related to all fluoroquinolones
Rarely - attacks of porphyria in patients already suffering from the disease.
CONTRAINDICATIONS

- epilepsy;
- gravis (myastenia gravis);
- the defeat tendons, associated with hosting quinolones in history;
- child and adolescence to 18 years (due to the incomplete skeletal growth, since it is impossible to completely eliminate the risk of cartilage growth points);
- pregnancy (it is impossible to completely eliminate the risk of cartilage growth points in the fetus);
- breastfeeding (it is impossible to completely eliminate the risk of cartilage points of bone growth in children);
- increased sensitivity to levofloxacin or other quinolones, as well as any of the excipients of the drug.
With caution:
- in patients predisposed to seizures (in patients with previous CNS lesions in patients concurrently treated with drugs that reduce the seizure threshold of the brain readiness, such as fenbufen, theophylline);
- in patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions in the treatment of quinolones);
- in patients with impaired renal function (requires mandatory monitoring of renal function as well as correction dosing regimen);
- in patients with known risk factors for prolongation of the QT interval: elderly patients; in female patients; patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); syndrome with congenital long QT interval; cardiac diseases (cardiac insufficiency, myocardial infarction, bradycardia); while taking drugs capable to lengthen the interval QT (antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics);
- in patients with diabetes treated with oral hypoglycemic agents, e.g., glyburide or insulin (increasing the risk of hypoglycemia);
- patients with severe adverse reactions to other fluoroquinolones such as severe neurological reaction (similar to an increased risk of adverse reactions when applying levofloxacin);
- in patients with psychosis, or in patients with a history of mental illness.
PREGNANCY AND LACTATION

The drug is contraindicated during pregnancy and in breast-feeding women.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function requires correction mode depending on the value of KK.
QC 250 mg / 24 h to 500 mg / 24 h to 500 mg / 12 h
first dose of 250 mg of the first dose of 500 mg of the first dose of 500 mg of
50-20 ml / min and then 125 mg / 24 hours followed by 250 mg / 24 hours followed by 250 mg / 12h
19-10 ml / min and then 125 mg / 48 h then 125 mg / 24 h then 125 mg / 12 h
<10 ml / min (including hemodialysis and DAPD * ) and then 125 mg / 48 h then 125 mg / 24 h then 125 mg / 24 h
* - long ambulatory peritoneal dialysis.
After dialysis, or DAPD not required administration of additional doses.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If abnormal liver function does not require special selection of doses, because Tavanik ® metabolized in the liver is extremely small extent.
APPLICATION FOR CHILDREN

Is contraindicated in children and adolescents up to 18 years (due to the incomplete skeletal growth, since it is impossible to completely eliminate the risk of cartilage growth points).
APPLICATION IN ELDERLY PATIENTS

For elderly patients do not require correction dosing regime except QC decrease to 50 ml / min and lower.
SPECIAL INSTRUCTIONS

Nosocomial infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa), may require a combined treatment.
The prevalence of acquired resistance sown microorganisms may vary depending on geographic region and over time. In this connection it is required for resistance to the drug in a specific country information. For treatment of severe infections or when treatment failure should be set microbiological diagnosis with the release of the pathogen and the determination of its sensitivity to levofloxacin.
There is a high probability that the methicillin-resistant strains of Staphylococcus aureus are resistant to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant strains of Staphylococcus aureus, if laboratory tests have not confirmed the sensitivity of the organism to levofloxacin.
As with other quinolones, levofloxacin should be used with caution in patients with a predisposition to seizures: patients with previous CNS injury, such as stroke, severe head injury; in patients concomitantly receiving drugs that reduce the seizure threshold of the brain readiness, such as fenbufen and other similar NSAIDs and other drugs that lower seizure threshold, such as theophylline.
Evolved during or after treatment with levofloxacin diarrhea, particularly severe, persistent and / or blood can be a symptom of pseudomembranous colitis caused by Clostridium difficile. In case of suspicion for the development of pseudomembranous colitis treatment with levofloxacin should be discontinued immediately, and immediately begin to specific antibiotics (vancomycin, teicoplanin or metronidazole inside). Drugs which inhibit peristalsis are contraindicated.
Tendonitis rarely observed in the application of quinolones, including levofloxacin, may lead to rupture of the tendon, including the Achilles tendon. This side effect may occur within 48 hours after the start of treatment and may be bilateral. Elderly patients are more likely to develop tendinitis. The risk of tendon rupture can be increased while the application of corticosteroids. For suspected tendinitis should immediately stop treatment with Tavanic ®and start the appropriate treatment of the affected tendon, for example, to provide him with adequate immobilization.
Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (angioneurotic edema, anaphylactic shock), even when using the drug in the initial doses. Patients should stop taking the drug and consult a doctor.
In the application of levofloxacin bullous observed cases of severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis. In the case of any reaction on the part of the skin or mucous membranes of the patient should consult a doctor immediately and do not continue treatment before consulting a specialist.
It reported cases of liver necrosis, including the development of fatal liver failure, when using levofloxacin, mainly in patients with serious underlying diseases (e.g., sepsis). Patients should be warned about the need to stop treatment and urgent referral to a physician in case of signs and symptoms of liver damage, such as anorexia, jaundice, dark urine, itching, pain in the abdomen.
Because
levofloxacin is excreted mainly by the kidneys, in patients with impaired renal function requires mandatory monitoring of renal function, as well as the correction of dosing regimen. In the treatment of elderly patients should be borne in mind that this group of patients often suffer from impaired renal function.
Although the photosensitivity when applied levofloxacin is very rare for preventing its development in patients is not recommended during treatment and for 48 hours after treatment with levofloxacin subjected unnecessarily to strong sunlight or to artificial ultraviolet light (e.g., the solarium).
As with other antibiotics, the use of levofloxacin, particularly during a long time may lead to an increased reproduction insensitive thereto microorganisms (bacteria and fungi), which may cause changes in the microflora, which is normally present in humans, causing may develop superinfection . Therefore, during treatment, be sure to conduct a re-evaluation of the patient and in the case of superinfection during treatment should take appropriate measures.
It reported very rarely QT prolongation in patients receiving fluoroquinolones, including levofloxacin. In applying fluoroquinolones, including levofloxacin, caution in patients with known risk factors for QT interval elongation: Patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); syndrome with congenital long QT interval with heart diseases (cardiac insufficiency, myocardial infarction, bradycardia), while taking drugs capable of lengthening QT interval, such as antiarrhythmics of Class IA and III, tricyclic antidepressants, macrolides, antipsychotics. Elderly patients and female patients may be more sensitive to the drug, prolongs the QT interval.It should therefore be used with caution in these fluoroquinolones, including levofloxacin.
Patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions with quinolones treatment that should be taken into account when treating with levofloxacin.
As with other quinolones, when using levofloxacin observed cases of hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with oral hypoglycemic agents (e.g. glibenclamide) or insulin. Reported cases of hypoglycemic coma. In patients with diabetes mellitus requires careful monitoring of blood glucose concentration.
In patients receiving fluoroquinolones, including levofloxacin, marked sensory and sensory-motor peripheral neuropathy, the beginning 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.
Fluoroquinolones, including levofloxacin, characterized by blocking neuromuscular an active and may exacerbate muscle weakness in patients with gravis. The post-marketing period observed adverse reactions, including pulmonary failure requiring mechanical ventilation, and death that was associated with the use of fluoroquinolones in patients with gravis. The use of levofloxacin in patients with an established diagnosis of gravis is not recommended.
Application of levofloxacin for the prevention and treatment of anthrax with airborne contamination paths based on sensitivity data thereto Bacillus anthracis, obtained in in vitro studies and experimental studies carried out on animals as well as on the application of levofloxacin limited data in humans. The attending physician should refer to the
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