Composition, form of production and packaging
Tablets covered with a film coat of white or almost white color, capsular, biconvex; On the cross-section, two layers are visible, the inner layer from light yellow to yellow, white inclusions are allowed.
1 tab.
levofloxacin (in the form of hemihydrate) 250 mg
Excipients: lactulose - 300 mg, crospovidone - 32.5 mg, povidone K17 - 10 mg, sodium stearyl fumarate - 9.75 mg, talc - 6.5 mg, microcrystalline cellulose up to 650 mg.
The composition of the shell: (hypromellose - 9.52 mg, titanium dioxide - 5.22 mg, macroline 4000 - 4.16 mg, talc - 1.1 mg) - up to 670 mg.
5 pieces. - packings of cellular contour (1) - packs cardboard.
5 pieces. - packings cellular planimetric (2) - packs cardboard.
7 pcs. - packings of cellular contour (1) - packs cardboard.
7 pcs. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - polymer cans (1) - packs of cardboard.
10 pieces. - plastic bottles (1) - packs of cardboard.
Tablets covered with a film coat of white or almost white color, capsular, biconvex; On the cross-section, two layers are visible, the inner layer from light yellow to yellow, white inclusions are allowed.
1 tab.
levofloxacin (in the form of hemihydrate) 500 mg
Excipients: lactulose - 600 mg, crospovidone - 65 mg, povidone K17 - 20 mg, sodium stearyl fumarate - 19.5 mg, talc - 13 mg, microcrystalline cellulose - up to 1300 mg.
The composition of the shell: (hypromellose - 19.04 mg, titanium dioxide - 10.44 mg, macroline 4000 - 8.32 mg, talc - 2.2 mg) - up to 1340 mg.
5 pieces. - packings of cellular contour (1) - packs cardboard.
5 pieces. - packings cellular planimetric (2) - packs cardboard.
7 pcs. - packings of cellular contour (1) - packs cardboard.
7 pcs. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - polymer cans (1) - packs of cardboard.
10 pieces. - plastic bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
A synthetic broad spectrum antibacterial agent from the group of fluoroquinolones, containing as an active substance the 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 acts bactericidal, is active against a large number of pathogens of bacterial infections both in vitro and in vivo.
Sensitive microorganisms (minimal suppressive concentration (MIC of? 2 mg / l)
Aerobic Gram-positive microorganisms: Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase negative,
methicillin-sensitive / leukotoxin-containing / moderately sensitive strains), incl. Staphylococcus aureus (Staphylococcus epidermidis), 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., Incl. Acinetobacter baumannii, Acinetobacillus actinomycetecomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp., Incl. Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (ampicillin susceptible / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp., Incl. Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis (producing and non-producing ОІ-lactamase strains), Morganella morganii, Neisseria gonorrhoeae (producing and non-producing penicillinase strains), Neisseria meningitidis, Pasteurella spp., Incl. Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia spp., Incl. Providencia rettgeri, Providencia stuartii, Pseudomonas spp., Incl. Pseudomonas aeruginosa (hospital
infections caused by Pseudomonas aeruginosa may require combined treatment), Serratia spp., incl. Serratia marcescens, Salmonella spp.
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. , incl. Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma
hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.
Moderately sensitive microorganisms (IPC = 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: Campylobacter jejuni, Campylobacter coli.
Anaerobic microorganisms: Prevotella spp., Porphyromonas spp.
Resistant microorganisms (MIC of more than 8 mg / l)
Aerobic Gram-positive microorganisms: Staphylococcus aureus (methicillin-resistant strains), others
Staphylococcus spp. (coagulase-negative methicillin-resistant strains).
Aerobic Gram-negative microorganisms: Alcaligenes xylosoxidans.
Anaerobic microorganisms: Bacteroides thetaiotaomicron.
Other microorganisms: Mycobacterium avium.
Clinical efficacy (efficacy in clinical studies for infections caused by
microorganisms listed below)
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, Moraxella catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.
Other microorganisms: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.
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 oral administration, levofloxacin is rapidly and almost completely absorbed from the small intestine. Food intake has little effect on the speed and completeness of absorption. Bioavailability of levofloxacin in a dose of 500 mg after oral administration is almost 100%. After taking a single dose of 500 mg C max levofloxacin is 5.2 В± 1.2 Ојg / ml,
Time to reach C max - 1.3 h.
Distribution
Binding to plasma proteins - 30-40%. Well penetrates into organs and tissues: lungs, bronchial mucosa, organs
genitourinary system, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes and alveolar macrophages.
Metabolism and excretion
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. T 1/2 - 6-8 hours. After oral administration, approximately 87% of the dose is excreted for 48 hours by the kidneys in unchanged form, less than 4% within 72 hours through the intestine.
Pharmacokinetics in specific patient groups
In renal failure, the decrease in clearance of levofloxacin and its excretion by the kidneys depends on the degree of decrease in the clearance of creatinine (CC). With KK 50-80 ml / min T 1/2 is 9 hours, the renal clearance is 57 ml / min; with KK 20-49 ml / min T 1/2 is 27 hours, the renal clearance is 26 ml / min; when the SC is less than 20 ml / min T 1/2 is 35 hours, the renal clearance is 13 ml / min.
INDICATIONS
Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:
- lower respiratory tract (exacerbation of chronic bronchitis, community-acquired pneumonia);
- ENT organs (including acute sinusitis);
- urinary tract and kidneys (including acute pyelonephritis);
- skin and soft tissues (abscesses, furunculosis);
- chronic bacterial prostatitis;
- intra-abdominal infections;
- drug-resistant forms of tuberculosis - as part of complex therapy.
When using the drug should take into account the official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country.
DOSING MODE
The drug is taken orally, before meals or in a break between meals, without chewing, squeezed with enough liquid.
Acute sinusitis: 500 mg 1 time / day for 10-14 days.
Community-acquired pneumonia: 500 mg 1-2 times / day, 7-14 days.
Exacerbation of chronic bronchitis: 250-500 mg 1 time / day for 7-10 days.
Uncomplicated urinary tract infections: 250 mg 1 time / day for 3 days.
Complicated urinary tract infections: 500 mg 1 time / day for 7-14 days.
Pyelonephritis: 500 mg 1 time / day for 7-10 days.
Chronic bacterial prostatitis: 500 mg 1 time / day, treatment course - 28 days.
Infections of the skin and soft tissues: 500 mg 1-2 times / day for 7-14 days;
Complex therapy of drug-resistant forms of tuberculosis: 500 mg 1-2 times / day, treatment course - up to 3 months.
The duration of treatment depends on the type and severity of the disease. If necessary, it is possible to switch from one dosage form of levofloxacin to another .
After relief of symptoms of acute inflammation and normalization of temperature, it is recommended to continue therapy with levofloxacin for 48-72 hours.
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.
Dosage of the drug in patients with impaired renal function (CC less than 50 ml / min):
Creatinine clearance, ml / min Dosing regimen
Initial dose 500 mg / 24 h Initial dose 500 mg / 12 h
50-20 Further 250 mg / 24 hours Further 250 mg / 12 h
19-10 See section "Contraindications" See section "Contraindications"
In patients with impaired liver function, dose adjustment is not required.
SIDE EFFECT
The incidence of adverse reactions is classified according to WHO recommendations: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely (from? 1/10 000 to <1/1000), very rarely (from <1/10 000, including individual cases), the frequency is unknown (according to available data, it was not possible to establish the frequency of occurrence).
From the cardiovascular system: rarely - sinus tachycardia, a feeling of heartbeat, a decrease in blood pressure; frequency unknown - prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular pirouette tachycardia, which can lead to cardiac arrest.
From the hemopoietic system: infrequently - leukopenia (decrease in the number of leukocytes in the peripheral blood), eosinophilia (an increase in the number of eosinophils in peripheral blood); rarely - neutropenia (a decrease in the number of neutrophils in peripheral blood), thrombocytopenia (a decrease in the number of platelets in the peripheral blood); frequency unknown - pancytopenia (decrease in the number of all formed elements in the peripheral blood), agranulocytosis (absence and / or a sharp decrease in the number of granulocytes in the peripheral blood), hemolytic anemia.
From the nervous system: often - headache, dizziness; infrequently - drowsiness, tremor, dysgeusia (perversion of taste); rarely - paresthesia, convulsions; frequency is unknown - peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorders, agevia (loss of taste sensations), parosmia (odor disorder, especially subjective sense of smell, objectively absent), including loss of smell; fainting, benign intracranial hypertension.
From the side of the psyche: often - insomnia; infrequently - a feeling of anxiety, anxiety, confusion; rarely - mental disorders (eg, hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares; frequency is unknown - 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 - uveitis, transient loss of vision.
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 - hearing loss, hearing loss.
On the part of the respiratory system: infrequently: dyspnea; frequency unknown - bronchospasm, allergic pneumonitis.
From the digestive tract: often - diarrhea, nausea, vomiting; infrequently - abdominal pain, flatulence, constipation, indigestion; the frequency is unknown - stomatitis, hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis, pancreatitis.
On the part of the liver and bile ducts: often - increased activity of liver enzymes in the blood (for example, ALT, AST, increased activity of alkaline phosphatase and GGT, infrequent increase in bilirubin concentration in the blood, frequency unknown - severe hepatic insufficiency, including cases of acute liver failure, sometimes with a fatal outcome, especially in patients with severe underlying disease (eg, in patients with sepsis), hepatitis, jaundice.
From the side of the urinary system: infrequently - giperkreatininemiya (increased concentration of creatinine in the blood serum); rarely acute renal failure (eg, due to the development of interstitial nephritis).
From the skin and subcutaneous tissues: infrequently - rash, itching, hives, hyperhidrosis; frequency unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis, exudative erythema multiforme, photosensitivity reactions (hypersensitivity to solar and ultraviolet radiation), leukocytoclastic vasculitis. Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug.
From the musculoskeletal system: infrequently - arthralgia, myalgia; rarely - tendon lesions, including tendonitis (eg Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudo-paralytic myasthenia gravis; frequency is unknown - rhabdomyolysis, tendon rupture (eg Achilles tendon This side effect can be observed within 48 hours after the beginning of treatment and can be bilateral), ligament rupture, muscle rupture, arthritis.
From the side of metabolism and nutrition: infrequently - anorexia; rarely - hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling); frequency unknown - hyperglycemia, hypoglycemic coma.
Infectious and parasitic diseases: infrequently - fungal infections, development of resistance of pathogenic microorganisms.
General disorders: infrequent - asthenia; rarely pyrexia (fever); frequency unknown - pain (including pain in the back, chest and extremities).
From the immune system: rarely - angioedema; frequency unknown - anaphylactic shock, anaphylactoid shock. Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.
Other possible undesirable effects related to all fluoroquinolones
Very rarely: attacks of porphyria (a very rare metabolic disease) in patients with porphyria.
CONTRAINDICATIONS
- hypersensitivity to levofloxacin, other fluoroquinolones or components of the drug;
- epilepsy;
- damage to the tendons during the previous treatment with quinolones;
- Pregnancy;
- lactation period;
- children and adolescence under 18;
- lactose intolerance or lactase deficiency, as well as glucose-galactose malabsorption.
In the absence of the possibility of dividing the tablets into two, the use of the drug in patients with impaired renal function is contraindicated:
- in patients with SC less than 50 ml / min it is not possible to use the dosage regimen with an initial dose of 250 mg / 24 h;
- in patients with CK less than 20 ml / min it is not possible to use the dosage regimen with an initial dose of 500 mg / 24 h and 500 mg / 12 h;
- with QC less than 10 ml / min (including with hemodialysis and permanent ambulatory peritoneal dialysis) it is not possible to apply for all dosage regimens.
Carefully:
- with deficiency of glucose-6-phosphate dehydrogenase;
- in patients with psychoses or in patients who have a history of mental illness;
- in patients who are predisposed to developing seizures (in patients with previous CNS lesions and patients receiving concomitant drugs that reduce the threshold of convulsive brain readiness, such as fenbufen, theophylline);
- in patients with renal dysfunction with KK 50-20 ml / min;
- in patients with known risk factors for prolonging the QT interval on the ECG: in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia), with the syndrome of congenital prolongation of the QT interval, with heart disease (heart failure, myocardial infarction, bradycardia), while taking medications means capable of
prolong the QT interval, such as antiarrhythmic agents of IA and III class, tricyclic antidepressants, macrolides, neuroleptics, in elderly patients and women;
- in patients with diabetes mellitus receiving oral hypoglycemic agents, for example, glibenclamide, or insulin;
- in patients with severe adverse reactions to other fluoroquinolones, such as severe neurologic reactions.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be used in patients with impaired renal function with KK 50-20 ml / min.
In the absence of the possibility of dividing the tablets into two, the use of the drug in patients with impaired renal function is contraindicated:
- in patients with SC less than 50 ml / min it is not possible to use the dosage regimen with an initial dose of 250 mg / 24 h;
- in patients with CK less than 20 ml / min it is not possible to use the dosage regimen with an initial dose of 500 mg / 24 h and 500 mg / 12 h;
- with QC less than 10 ml / min (including with hemodialysis and permanent ambulatory peritoneal dialysis) it is not possible to apply for all dosage regimens.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Do not require dose adjustment in patients with impaired liver function.
APPLICATION FOR CHILDREN
Contraindication: children and adolescence under 18 years.
APPLICATION IN ELDERLY PATIENTS
Carefully: to the elderly. In the treatment of elderly patients, it should be borne in mind that they often suffer from impaired renal function.
SPECIAL INSTRUCTIONS
The prevalence of acquired resistance of microorganisms can vary depending on the geographical region and over time, and therefore it is necessary to determine the sensitivity of the pathogen to levofloxacin.
There is a high probability that Staphylococcus aureus (methicillin-resistant strains) will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for treatment of established
or suspected of infections caused by Staphylococcus aureus (methicillin-resistant strains) if the laboratory tests did not confirm the sensitivity of the microorganism to levofloxacin.
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. Risk of tendon can be increased while taking corticosteroids. If tendinitis is suspected, immediately discontinue drug treatment and start appropriate therapy 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 after the first dose. In the case of development, patients should stop taking the drug and seek emergency medical attention.
When receiving 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 seek medical advice immediately and not continue to treat his advice.
It reported cases of liver necrosis, including the development of fatal liver failure when using levofloxacin, mainly in patients with serious underlying diseases, such as 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, and abdominal pain.
Because Levofloxacin is excreted primarily through 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 aware that patients in this group are often marked renal dysfunction.
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. As a result, may develop superinfection. Therefore, in the course of treatment required to reassess the patient's condition 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); congenital long QT interval syndrome; heart disease (heart
failure, 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.
Despite the fact that the photosensitivity during treatment with levofloxacin observed infrequently, it is recommended to patients not exposed to strong sunlight or artificial UV radiation during treatment and for 48 hours after treatment.
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. If you suspect a pseudomembranous
colitis should be lifted immediately levofloxacin and begin appropriate treatment (vancomycin, teicoplanin or
metronidazole inside). Contraindicated the use of drugs that suppress peristalsis.
As with other quinolones, levofloxacin should be used with caution in patients with a predisposition to the development of seizures: patients with previous CNS lesions (stroke, severe head injury), patients concurrently treated with drugs that reduce the seizure threshold of the brain activity, such as fenbufen and other NSAIDs or other drugs, such as theophylline. In the event of seizures of the drug should be discontinued.
Patients with a deficiency of glucose-6-phosphate dehydrogenase (an inherited metabolic disorder) can respond to fluoroquinolones destruction of erythrocytes (hemolysis). In connection with this, treatment with levofloxacin should be performed with caution.
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 preparations. Reported cases of hypoglycemic coma. In patients with diabetes require blood glucose concentration monitoring.
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.
In the application of quinolones, including levofloxacin, it reported on the development of psychotic reactions, which in rare cases progressed to the development of suicidal thoughts and behavior disorders with self-harm (sometimes after a single dose of levofloxacin). With the development of these reactions should discontinue treatment levofloxacin and prescribe appropriate therapy. Caution should be prescribed to patients with psychosis or patients with a history of psychiatric illness.
With the development of any impairment need immediate consultation of the ophthalmologist.
With simultaneous use of anticoagulants and levofloxacin requires regular monitoring of blood coagulation parameters.
In patients treated with levofloxacin, determination of opiates in urine may lead to false-positive results, which should be confirmed by a more specific methods.
Levofloxacin can inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false negative results bacteriological diagnosis of tuberculosis.
Fluoroquinolones, including levofloxacin, characterized by blocking neuromuscular activity holding and may enhance muscle weakness in patients with gravis.Observed adverse reactions, including pulmonary failure, requesting a ventilator, 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.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment should refrain from driving and classes of potentially hazardous activities that require high concentration and psychomotor speed reactions.
OVERDOSE
Symptoms of an overdose of the drug levofloxacin are shown on the central nervous system level (confusion, dizziness, impairment of consciousness, and seizures). In addition, it can be marked gastrointestinal symptoms (eg, nausea, vomiting) and erosive lesions of the mucous membranes of the gastrointestinal tract. In studies using ultrahigh doses of levofloxacin were shown lengthening the interval QT.
Treatment: gastric lavage and symptomatic therapy. Levofloxacin is output by hemodialysis or peritoneal dialysis. There is no specific antidote.
DRUG INTERACTION
There are reports of marked decrease in the seizure threshold, while the use of quinolones and substances that reduce the cerebral seizure threshold. This also applies to the simultaneous reception of quinolones and theophylline, as well as NSAIDs - propionic acid derivatives.
Pharmacokinetic interactions of levofloxacin with theophylline is not revealed.
Oral administration together with preparations containing divalent and trivalent cations such as zinc or iron salts (drugs for the treatment of anemia) of magnesium and / or aluminum-containing preparations (such as antacids), didanosine (only formulations containing as buffer aluminum or magnesium), resulting in decreased absorption and levofloxacin weakening effect, so it should be given 2 hours before or 2 hours after administration of the above drugs.
Calcium salts have a minimal effect on the absorption of levofloxacin when taken orally.
Action levofloxacin significantly attenuated while the use of sucralfate (the means to protect the gastric mucosa). Patients receiving levofloxacin and sucralfate, sucralfate advised to take 2 hours after receiving levofloxacin.
Levofloxacin concentration while taking fenbufen increased by only 13%.
With simultaneous use of vitamin K antagonists requires monitoring of blood coagulation parameters.
Patients treated with levofloxacin in combination with indirect anticoagulants (eg, warfarin), there was an increase in prothrombin time / INR and / or the development of bleeding, including heavy.
Therefore, while the use of anticoagulants and levofloxacin requires regular monitoring of blood coagulation parameters.
With simultaneous use of drugs that violate renal tubular secretion, such as probenecid and cimetidine, and levofloxacin, caution, especially in patients with renal insufficiency. Excretion (renal clearance) of levofloxacin slows down under the action of cimetidine on probenecid and 24% - 34%. It is unlikely that this could be of clinical importance in the normal renal function.
Levofloxacin while the use of antiarrhythmic drugs IA and Class III, tricyclic antidepressants, macrolides, antipsychotics may cause lengthening of the interval QT. Levofloxacin increases T 1/2 33% of cyclosporin. Because this increase is clinically insignificant, cyclosporin dose correction at its simultaneous application of levofloxacin is required.
GCS increases the risk of tendon rupture.
Levofloxacin pharmacokinetics while the use of digoxin, glibenclamide, ranitidine, warfarin does not change sufficiently that it had clinical significance.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be protected from moisture and light, reach of children at a temperature not higher than 25 В° C. Shelf life - 2 years. Do not use after the expiration date.
