Levofloxacin | Levolet P tablets coated.pl.ob. 500 mg 10 pcs.
Special Price
$20.37
Regular Price
$28.00
In stock
SKU
BID465054
Release form
Film-coated tablets
Film-coated tablets
Release form
Film-coated tablets
Packing
10 pcs.
Pharmacological action
Pharmacodynamics
Fluoroquinolone, a broad spectrum antimicrobial bactericidal agent. It blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall and membranes.
Levofloxacin is active against the following strains of microorganisms, both in vitro and in vivo.
Sensitive microorganisms
IPC Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagulase-negative methi-S (J) (methicillin-sensitive / moderately sensitive strains), Staphylococcus aureus methi-S (methicillin-sensitive strains), Staphylococcus epidermidis methi-S (methicillin-sensitive strains), (CNs - leukotoxin-containing. Streptococci groups C and G (including Streptococcus agalactiae, Streptococcus pneumoniae peni-S / UR (penicillin-sensitive / moderately sensitive / resistant strains)), Streptococcus pyogenes, Viridans streptococline R-peni -sensitive / resistant strains)
Aerobic gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans. Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S / R (ampicillin-sensitive / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis + / - (producing and non-producing P-lactamase strains), Morganella morganii, Neisseria gonorrhoeae non-PPNG / PPNG (producing and non-producing penicilli, penis) Pasteurella spp. (including, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp. (including Salmonella spp., Serratia marcescens).
Anaerobic microorganisms: Bacteroides jragilis, 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), Ricketsia spp., Ureaplasma urealyticum.
Moderately susceptible microorganisms (BMD> 4 mg / L):
Aerobic gram-positive microorganisms: Corynebacterium urealiticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methylic-resistant strains (methicillin-resistant resistant strains, methylicin-resistant strains) .
Aerobic gram-negative microorganisms: Burkholderia cepacia, Campilobacter jejuni, Campilobacter coli.
Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovaius, Prevotella spp., Porphyromonas spp.
Resistant microorganisms (BMD> 8 mg / L):
Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R (methicillin-resistant strains),
Staphylococcus coagulase-negative methi-onlative (coagulase
Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.
Other microorganisms: Mycobacterium avium.
Pharmacokinetics
When ingested, it is rapidly and almost completely absorbed (food intake has little effect on the speed and completeness of absorption). Bioavailability is 99%. The time to reach the maximum concentration (Tmax) is 1-2 hours when taking 250 and 500 mg, the average maximum concentration (Cmax) is 2.8 and 5.2 μg / ml, respectively. Communication with plasma proteins - 30-40%. It penetrates well into organs and tissues: lungs, mucous membrane of the bronchi, sputum, organs of the genitourinary system, polymorphic nuclear leukocytes, alveolar macrophages.
In the liver, a small portion is oxidized and / or deacetylated. It is excreted mainly by the kidneys by glomerular filtration and tubular secretion. The half-life (T ) Is 6-8 hours. Renal clearance is 70% of the total clearance. Less than 5% of levofloxacin is excreted as metabolites.
In urine, over a period of 24 hours, 70% is found unchanged, and over 48 hours - 87% of an oral dose. In feces, over a period of 72 hours, 4% of the oral dose is detected. In renal failure, a decrease in clearance of the drug and its excretion by the kidneys depends on the degree of decrease in creatinine clearance (CC).
Contraindications
Hypersensitivity to levofloxacin or other quinolones, as well as to any of the excipients of the drug LevoletВ® R.
- Epilepsy.
- Pseudoparalytic myasthenia gravis (myasthenia gravis) (see sections “Side effects”, “Special instructions”).
- A history of tendon injuries when taking fluoroquinolones.
- Creatinine clearance of 50 ml / min or less in patients with uncomplicated urinary tract infections (inability to select a dose for this form of release).
- Creatinine clearance of 19 ml / min and less (inability to select a dose for this form of release).
- Children and adolescents under 18 years of age (due to incomplete growth of the skeleton, since the risk of damage to the cartilaginous growth points cannot be completely excluded).
- Pregnancy (the risk of damage to the cartilage growth points of the fetus cannot be completely ruled out).
- The period of breastfeeding (the risk of damage to the cartilaginous bone growth points in the child cannot be completely excluded).
Precautions:
In patients predisposed to developing seizures [in patients with previous lesions of the central nervous system (CNS), in patients simultaneously receiving drugs that lower the threshold for convulsive readiness of the brain, such as fenbufen, theophylline] (see section “ Interaction with other medicines ”).
In patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions during treatment with quinolones).
In patients with impaired renal function (requires mandatory monitoring of renal function, as well as correction of the dosage regimen, see the section "Dosage and Administration").
In patients with known risk factors for QT interval prolongation: in elderly patients, female patients with patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia) with congenital prolongation of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) the simultaneous administration of drugs that can extend the QT interval (antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics) (see sections "Overdose", "Interaction with other drugs", "Special instructions").
In patients with diabetes receiving oral hypoglycemic drugs, for example, glibenclamide or insulin preparations (the risk of developing hypoglycemia increases).
In patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions with levofloxacin).
In patients with psychosis or in patients with a history of mental illness (see "Special Instructions").
Use during pregnancy and lactation
Levofloxacin is contraindicated in pregnant and lactating women.
Special instructions
Hospital infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) may require combination treatment. The prevalence of acquired resistance of seeded strains of microorganisms may vary depending on the geographical region and over time. In this regard, information on drug resistance in a particular country is required.
For the treatment of severe infections or in case of treatment failure, a microbiological diagnosis should be established with the isolation of the pathogen and determination of its sensitivity to levofloxacin.
Methicillin-resistant Staphylococcus aureus
It is highly likely that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, in case laboratory tests have not confirmed the sensitivity of this microorganism to levofloxacin.
Patients prone to seizures
Like other quinolones, levofloxacin should be used with great caution in patients with a tendency to seizures. Such patients include patients with previous lesions of the central nervous system, such as a stroke, severe traumatic brain injury, patients simultaneously receiving drugs that lower the threshold for cerebral seizure, such as fenbufen and other similar non-steroidal anti-inflammatory drugs or other drugs that lower the threshold convulsive readiness, such as theophylline (see section "Interaction with other drugs").
Pseudomembranous colitis
Developed during or after treatment with levofloxacin, diarrhea, especially severe, persistent and / or blood, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. In case of suspected development of pseudomembranous colitis, treatment with levofloxacin should be stopped immediately and specific antibiotic therapy should be started immediately (vancomycin, teicoplanin or metronidazole by mouth). Drugs that inhibit intestinal motility are contraindicated.
Tendonitis
Rarely observed tendinitis with quinolones, including levofloxacin, can lead to rupture of tendons, including the Achilles tendon. This side effect can develop within 48 hours after the start of treatment and can be bilateral. Elderly patients are more prone to the development of tendonitis. The risk of tendon rupture may increase while taking glucocorticosteroids. If you suspect a tendonitis, you should immediately discontinue treatment with LevoletВ® R and begin appropriate treatment of the affected tendon, for example, by providing it with sufficient immobilization (see sections "Contraindications" and "Side effects").
Hypersensitivity Reactions
Levofloxacin can cause serious, potentially fatal, hypersensitivity reactions (angioedema, anaphylactic shock), even with initial doses (see section “Side effects”). Patients should immediately stop taking the drug and consult a doctor.
Severe bullous reactions
When taking levofloxacin, cases of severe bullous skin reactions were observed, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section “Side effects”). In case of development of any reactions from the skin or mucous membranes, the patient should immediately consult a doctor and not continue treatment until his consultation.
Hepatic and biliary tract disorders
Cases of hepatic necrosis have been reported, including the development of fatal liver failure with levofloxacin, mainly in patients with severe underlying diseases, such as sepsis (see section “Side effects”). Patients should be warned about the need to discontinue treatment and urgently need to see a doctor in case of signs and symptoms of liver damage, such as anorexia, jaundice, dark urine, itching and abdominal pain.
Patients with renal failure
Since levofloxacin is excreted mainly through the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as correction of the dosage regimen (see section "Dosage and Administration"). When treating elderly patients, it should be borne in mind that patients of this group often have impaired renal function (see section "Dosage and Administration").
Prevention of photosensitization reactions
Although photosensitization with levofloxacin is very rare, patients are not recommended to undergo levofloxacin during the treatment and for 48 hours after treatment with strong solar or artificial ultraviolet radiation (for example, visit the solarium).
Superinfection
As with other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased reproduction of insensitive microorganisms (bacteria and fungi), which can cause changes in microflora, which is normally present in humans. As a result, superinfection may develop. Therefore, during the course of treatment, it is imperative to re-evaluate the patient's condition, and, if superinfection develops during treatment, appropriate measures should be taken.
QT prolongation
Very rare cases of QT prolongation have been reported in patients taking fluoroquinolones, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for lengthening the QT interval: in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia) with congenital lengthening of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can lengthen the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia) with congenital lengthening of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia) with congenital lengthening of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction hypomagnesemia) with congenital prolongation of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction hypomagnesemia) with congenital prolongation of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction such as antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction such as antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interactionvie with other medicines ”).
Patients with glucose-6-phosphate dehydrogenase deficiency
Patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase have a predisposition to hemolytic reactions when treated with quinolones, which should be taken into account when treating levofloxacin.
Hypo- and hyperglycemia (dysglycemia)
As with other quinolones, when levofloxacin was used, cases of hyperglycemia and hypoglycemia were observed, usually in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycemic drugs (for example, glibenclamide) or insulin preparations. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, monitoring of blood glucose concentration is required (see the section "Side effects").
Peripheral neuropathy
Patients taking fluoroquinolones, including levofloxacin, have sensory and sensory-motor peripheral neuropathy, the onset of which can be quick. If the patient develops symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.
Exacerbation of pseudoparalytic myasthenia gravis
Fluoroquinolones, including levofloxacin, are characterized by neuromuscular blocking activity and may increase muscle weakness in patients with pseudoparalytic myasthenia. In the post-marketing period, adverse reactions were observed, including pulmonary insufficiency, requiring mechanical ventilation, and death, which have been associated with the use of fluoroquinolones in patients with pseudoparalytic myasthenia gravis. The use of levofloxacin in patients with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended (see section "Side effects").
Use in an airborne droplet infection with anthrax
The use of levofloxacin in humans according to this indication is based on data on sensitivity to it of Bacillus anthracis obtained in in vitro and experimental studies in animals, as well as on limited data on the use of levofloxacin in person. The attending physician should refer to national and / or international documents that reflect the common point of view on the treatment of anthrax.
Psychotic reactions
When using quinolones, including levofloxacin, the development of psychotic reactions was reported, which in very rare cases progressed to the development of suicidal thoughts and behavioral disorders causing self-harm (sometimes after taking a single dose of levofloxacin (see section “Side effects”)). With the development of such reactions, treatment with levofloxacin should be discontinued and appropriate therapy should be prescribed. It should be used with caution in patients with psychoses or in patients with a history of mental illness.
Visual impairment
If any visual impairment develops, an immediate consultation with an ophthalmologist is necessary (see section “Side effects”).
Effect on laboratory tests
In patients taking levofloxacin, the determination of opiates in the urine can lead to false-positive results, which should be confirmed by more specific methods. Levofloxacin can inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false negative results of a bacteriological diagnosis of tuberculosis. Side effects of Levolet® P, such as dizziness or vertigo, drowsiness, and visual disturbances (see section “Side effects”), can reduce psychomotor reactions and ability to concentration. This may pose a certain risk in situations where these abilities are of particular importance (for example, when driving, servicing machines and mechanisms, and performing work in an unstable position).
Composition of
Each film-coated tablet 500 mg contains:
Active ingredient:
levofloxacin hemihydrate 512,466 mg, equivalent to 500 mg of levofloxacin.
Excipients:
microcrystalline cellulose (Avicel PH 101) 50.667 mg,
corn starch 50.2 mg,
silicon dioxide colloid 10 mg,
crospovidone 42.667 mg,
hypromellose (15 cps microcrystalline cellulose) 102) 60 mg,
magnesium stearate 10 mg.
Shell:
Opadry white OY 58900 (hypromellose (5 cP) 62.5%,
titanium dioxide (E171) 31.25%,
macrogol 400 6.25%) 22.5 mg.
Dosage and Administration
Inside, before meals or in between meals, without chewing, drinking plenty of fluids.
Sinusitis: 500 mg once daily. The course of treatment is 10-14 days.
Exacerbation of chronic bronchitis: 250-500 mg once a day. The course of treatment is 10-14 days.
Infections of the skin and soft tissues: 250 mg 1-2 times a day or 500 mg once a day. The course of treatment is 7-14 days.
Side effects
The following side effects are presented in accordance with the following gradations of their frequency of occurrence: very often (? 1/10) often (? 1/100, <1/10) infrequently (? 1/1000, <1/100 ) rarely (? 1/10000, < 1/1000) very rarely (<1/10000) (including individual messages)
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 use of the drug
Disorders of the heart
Rarely: sinus tachycardia, palpitations.
Frequency unknown (post-marketing data): QT interval lengthening, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the “pirouette” type, which can lead to cardiac arrest (see sections “Overdose”, “Special instructions”).
Disorders of the blood and lymphatic system
Infrequently: leukopenia (a decrease in the number of white blood cells in the peripheral blood), eosinophilia (an increase in the number of eosinophils in the peripheral blood).
Rarely: neutropenia (a decrease in the number of neutrophils in the peripheral blood), thrombocytopenia (a decrease in the number of platelets in the peripheral blood).
Frequency unknown (post-marketing data): pancytopenia (decrease in the number of all shaped elements in peripheral blood), agranulocytosis (absence or sharp decrease in the number of granulocytes in peripheral blood), hemolytic anemia.
Disorders of the nervous system
Often: headache, dizziness.
Infrequently: drowsiness, tremor, dysgeusia (perversion of taste).
Rarely: paresthesia, convulsions (see section "Special instructions").
Frequency unknown (post-marketing data): peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see "Special Instructions"), dyskinesia, extrapyramidal disorders, ageusia (loss of taste), parosmia (disorder of sensation of smell, especially subjective sensation of smell, objectively absent), including loss of smell, fainting, benign intracranial hypertension.
Visual impairment
Rarely: visual impairment, such as blurry images.
Frequency unknown (post-marketing data): transient loss of vision, uveitis.
Hearing impairment and labyrinthine disorders
Infrequently: vertigo (feeling of rejection or spinning or of one's own body or surrounding objects).
Rarely: tinnitus.
Frequency unknown (post-marketing data): hearing loss, hearing loss.
Disorders of the respiratory system, chest and mediastinal organs
Uncommon: shortness of breath.
Frequency unknown (post-marketing data): bronchospasm, allergic pneumonitis.
Disorders of the gastrointestinal tract
Often: diarrhea, vomiting, nausea.
Infrequently: abdominal pain, dyspepsia, flatulence, constipation.
Frequency unknown (post-marketing data): hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis (see section "Special instructions"), pancreatitis.
Disorders of the night and urinary tract
Infrequently: increased serum creatinine concentration.
Rarely: acute renal failure (for example, due to the development of interstitial nephritis).
Disorders of the skin and subcutaneous tissue
Infrequently: rash, itching, urticaria, hyperhidrosis.
Frequency unknown (post-marketing data): toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitization reactions (hypersensitivity to solar and ultraviolet radiation) (see section "Special Instructions"), leukocytoclastic vasculitis, stomatitis.
Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug.
Disorders of the musculoskeletal system and connective tissue
Infrequently: arthralgia, myalgia.
Rarely: tendon damage, including tendonitis (eg, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudoparalytic myasthenia gravis (see myasthenia gravis).
Frequency unknown (post-marketing data): rhabdomyolysis, tendon rupture (e.g., Achilles tendon). This side effect can be observed within 48 hours after the start of treatment and can be bilateral in nature (see also the section “Special Instructions”), rupture of ligaments, rupture of muscles, arthritis.
Metabolism and nutritional disorders
Infrequently: anorexia.
Rarely: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: “wolf” appetite, nervousness, perspiration, trembling).
Frequency unknown: hyperglycemia, hypoglycemic coma (see section "Special instructions").
Infectious and parasitic diseases
Infrequently: fungal infections, development of resistance of pathogenic microorganisms.
Vascular disorders
Rarely: lowering blood pressure.
Common disorders
Infrequently: asthenia.
Rarely: pyrexia (fever).
Frequency unknown: pain (including back, chest, and limb pain).
Immune system disorders
Rarely: angioedema.
Frequency unknown (post-marketing data): anaphylactic shock, anaphylactoid shock.
Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.
Disorders from the liver and biliary tract
Often: increased activity of “liver” enzymes in the blood (for example, alanine aminotransferase (ALT), aspartate aminotransferase (ACT), increased activity of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT).
Infrequently: increased concentration of bilirubin in the blood.
Frequency unknown (post-marketing data): severe liver failure, including cases of acute liver failure, sometimes fatal, especially in patients with a serious underlying disease (for example, in patients with sepsis) (see the section "Special Instructions") hepatitis, jaundice.
Mental disorders
Often: insomnia.
Infrequently: a feeling of anxiety, anxiety, confusion.
Rarely: mental disorders (eg, hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares.
Frequency unknown (post-marketing data): mental disorders with behavioral disorders causing self-harm, including suicidal thoughts and suicidal attempts.
Other possible adverse effects that apply to all fluoroquinolones
Very rare: attacks of porphyria (a very rare metabolic disease) in patients with porphyria.
Storage conditions
At a temperature not exceeding 25 РC.
Keep out of the reach of children!
The Expiration of
is 3 years.
Deystvuyuschee substances
Levofloxacin
Dosage form
tablet
Appointment
Adult prescription, Prescription children
Indications
From otitis media, sinusitis, From urinary tract infections, From boils, From pneumonia, From skin infections, From infectious diseases, From respiratory infections, Bronchitis
Possible product names
LEVOLET P 0.5 N10 TABLE P / O
LEVOLET P 0.5 N10 TABLE P / FILM / SHELL
Levolet P 500 mg Tab. cover captivity. about. X10 (R)
LION VEHICLE R 500MG. No. 10 TAB. P / O
Levolet R tab po 500mg x 10
Film-coated tablets
Packing
10 pcs.
Pharmacological action
Pharmacodynamics
Fluoroquinolone, a broad spectrum antimicrobial bactericidal agent. It blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall and membranes.
Levofloxacin is active against the following strains of microorganisms, both in vitro and in vivo.
Sensitive microorganisms
IPC Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagulase-negative methi-S (J) (methicillin-sensitive / moderately sensitive strains), Staphylococcus aureus methi-S (methicillin-sensitive strains), Staphylococcus epidermidis methi-S (methicillin-sensitive strains), (CNs - leukotoxin-containing. Streptococci groups C and G (including Streptococcus agalactiae, Streptococcus pneumoniae peni-S / UR (penicillin-sensitive / moderately sensitive / resistant strains)), Streptococcus pyogenes, Viridans streptococline R-peni -sensitive / resistant strains)
Aerobic gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans. Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S / R (ampicillin-sensitive / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis + / - (producing and non-producing P-lactamase strains), Morganella morganii, Neisseria gonorrhoeae non-PPNG / PPNG (producing and non-producing penicilli, penis) Pasteurella spp. (including, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp. (including Salmonella spp., Serratia marcescens).
Anaerobic microorganisms: Bacteroides jragilis, 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), Ricketsia spp., Ureaplasma urealyticum.
Moderately susceptible microorganisms (BMD> 4 mg / L):
Aerobic gram-positive microorganisms: Corynebacterium urealiticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methylic-resistant strains (methicillin-resistant resistant strains, methylicin-resistant strains) .
Aerobic gram-negative microorganisms: Burkholderia cepacia, Campilobacter jejuni, Campilobacter coli.
Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovaius, Prevotella spp., Porphyromonas spp.
Resistant microorganisms (BMD> 8 mg / L):
Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R (methicillin-resistant strains),
Staphylococcus coagulase-negative methi-onlative (coagulase
Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.
Other microorganisms: Mycobacterium avium.
Pharmacokinetics
When ingested, it is rapidly and almost completely absorbed (food intake has little effect on the speed and completeness of absorption). Bioavailability is 99%. The time to reach the maximum concentration (Tmax) is 1-2 hours when taking 250 and 500 mg, the average maximum concentration (Cmax) is 2.8 and 5.2 μg / ml, respectively. Communication with plasma proteins - 30-40%. It penetrates well into organs and tissues: lungs, mucous membrane of the bronchi, sputum, organs of the genitourinary system, polymorphic nuclear leukocytes, alveolar macrophages.
In the liver, a small portion is oxidized and / or deacetylated. It is excreted mainly by the kidneys by glomerular filtration and tubular secretion. The half-life (T ) Is 6-8 hours. Renal clearance is 70% of the total clearance. Less than 5% of levofloxacin is excreted as metabolites.
In urine, over a period of 24 hours, 70% is found unchanged, and over 48 hours - 87% of an oral dose. In feces, over a period of 72 hours, 4% of the oral dose is detected. In renal failure, a decrease in clearance of the drug and its excretion by the kidneys depends on the degree of decrease in creatinine clearance (CC).
Contraindications
Hypersensitivity to levofloxacin or other quinolones, as well as to any of the excipients of the drug LevoletВ® R.
- Epilepsy.
- Pseudoparalytic myasthenia gravis (myasthenia gravis) (see sections “Side effects”, “Special instructions”).
- A history of tendon injuries when taking fluoroquinolones.
- Creatinine clearance of 50 ml / min or less in patients with uncomplicated urinary tract infections (inability to select a dose for this form of release).
- Creatinine clearance of 19 ml / min and less (inability to select a dose for this form of release).
- Children and adolescents under 18 years of age (due to incomplete growth of the skeleton, since the risk of damage to the cartilaginous growth points cannot be completely excluded).
- Pregnancy (the risk of damage to the cartilage growth points of the fetus cannot be completely ruled out).
- The period of breastfeeding (the risk of damage to the cartilaginous bone growth points in the child cannot be completely excluded).
Precautions:
In patients predisposed to developing seizures [in patients with previous lesions of the central nervous system (CNS), in patients simultaneously receiving drugs that lower the threshold for convulsive readiness of the brain, such as fenbufen, theophylline] (see section “ Interaction with other medicines ”).
In patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions during treatment with quinolones).
In patients with impaired renal function (requires mandatory monitoring of renal function, as well as correction of the dosage regimen, see the section "Dosage and Administration").
In patients with known risk factors for QT interval prolongation: in elderly patients, female patients with patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia) with congenital prolongation of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) the simultaneous administration of drugs that can extend the QT interval (antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics) (see sections "Overdose", "Interaction with other drugs", "Special instructions").
In patients with diabetes receiving oral hypoglycemic drugs, for example, glibenclamide or insulin preparations (the risk of developing hypoglycemia increases).
In patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions with levofloxacin).
In patients with psychosis or in patients with a history of mental illness (see "Special Instructions").
Use during pregnancy and lactation
Levofloxacin is contraindicated in pregnant and lactating women.
Special instructions
Hospital infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) may require combination treatment. The prevalence of acquired resistance of seeded strains of microorganisms may vary depending on the geographical region and over time. In this regard, information on drug resistance in a particular country is required.
For the treatment of severe infections or in case of treatment failure, a microbiological diagnosis should be established with the isolation of the pathogen and determination of its sensitivity to levofloxacin.
Methicillin-resistant Staphylococcus aureus
It is highly likely that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, in case laboratory tests have not confirmed the sensitivity of this microorganism to levofloxacin.
Patients prone to seizures
Like other quinolones, levofloxacin should be used with great caution in patients with a tendency to seizures. Such patients include patients with previous lesions of the central nervous system, such as a stroke, severe traumatic brain injury, patients simultaneously receiving drugs that lower the threshold for cerebral seizure, such as fenbufen and other similar non-steroidal anti-inflammatory drugs or other drugs that lower the threshold convulsive readiness, such as theophylline (see section "Interaction with other drugs").
Pseudomembranous colitis
Developed during or after treatment with levofloxacin, diarrhea, especially severe, persistent and / or blood, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. In case of suspected development of pseudomembranous colitis, treatment with levofloxacin should be stopped immediately and specific antibiotic therapy should be started immediately (vancomycin, teicoplanin or metronidazole by mouth). Drugs that inhibit intestinal motility are contraindicated.
Tendonitis
Rarely observed tendinitis with quinolones, including levofloxacin, can lead to rupture of tendons, including the Achilles tendon. This side effect can develop within 48 hours after the start of treatment and can be bilateral. Elderly patients are more prone to the development of tendonitis. The risk of tendon rupture may increase while taking glucocorticosteroids. If you suspect a tendonitis, you should immediately discontinue treatment with LevoletВ® R and begin appropriate treatment of the affected tendon, for example, by providing it with sufficient immobilization (see sections "Contraindications" and "Side effects").
Hypersensitivity Reactions
Levofloxacin can cause serious, potentially fatal, hypersensitivity reactions (angioedema, anaphylactic shock), even with initial doses (see section “Side effects”). Patients should immediately stop taking the drug and consult a doctor.
Severe bullous reactions
When taking levofloxacin, cases of severe bullous skin reactions were observed, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section “Side effects”). In case of development of any reactions from the skin or mucous membranes, the patient should immediately consult a doctor and not continue treatment until his consultation.
Hepatic and biliary tract disorders
Cases of hepatic necrosis have been reported, including the development of fatal liver failure with levofloxacin, mainly in patients with severe underlying diseases, such as sepsis (see section “Side effects”). Patients should be warned about the need to discontinue treatment and urgently need to see a doctor in case of signs and symptoms of liver damage, such as anorexia, jaundice, dark urine, itching and abdominal pain.
Patients with renal failure
Since levofloxacin is excreted mainly through the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as correction of the dosage regimen (see section "Dosage and Administration"). When treating elderly patients, it should be borne in mind that patients of this group often have impaired renal function (see section "Dosage and Administration").
Prevention of photosensitization reactions
Although photosensitization with levofloxacin is very rare, patients are not recommended to undergo levofloxacin during the treatment and for 48 hours after treatment with strong solar or artificial ultraviolet radiation (for example, visit the solarium).
Superinfection
As with other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased reproduction of insensitive microorganisms (bacteria and fungi), which can cause changes in microflora, which is normally present in humans. As a result, superinfection may develop. Therefore, during the course of treatment, it is imperative to re-evaluate the patient's condition, and, if superinfection develops during treatment, appropriate measures should be taken.
QT prolongation
Very rare cases of QT prolongation have been reported in patients taking fluoroquinolones, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for lengthening the QT interval: in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia) with congenital lengthening of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can lengthen the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia) with congenital lengthening of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia) with congenital lengthening of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction hypomagnesemia) with congenital prolongation of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction hypomagnesemia) with congenital prolongation of the QT interval with heart diseases (heart failure, myocardial infarction, bradycardia) while taking medications that can extend the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction such as antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interaction such as antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that extend the QT interval. Therefore, they should be used with caution fluoroquinolones, including levofloxacin (see sections "With caution", "Dosage and administration", "Side effects", "Overdose" and "Interactionvie with other medicines ”).
Patients with glucose-6-phosphate dehydrogenase deficiency
Patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase have a predisposition to hemolytic reactions when treated with quinolones, which should be taken into account when treating levofloxacin.
Hypo- and hyperglycemia (dysglycemia)
As with other quinolones, when levofloxacin was used, cases of hyperglycemia and hypoglycemia were observed, usually in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycemic drugs (for example, glibenclamide) or insulin preparations. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, monitoring of blood glucose concentration is required (see the section "Side effects").
Peripheral neuropathy
Patients taking fluoroquinolones, including levofloxacin, have sensory and sensory-motor peripheral neuropathy, the onset of which can be quick. If the patient develops symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.
Exacerbation of pseudoparalytic myasthenia gravis
Fluoroquinolones, including levofloxacin, are characterized by neuromuscular blocking activity and may increase muscle weakness in patients with pseudoparalytic myasthenia. In the post-marketing period, adverse reactions were observed, including pulmonary insufficiency, requiring mechanical ventilation, and death, which have been associated with the use of fluoroquinolones in patients with pseudoparalytic myasthenia gravis. The use of levofloxacin in patients with an established diagnosis of pseudoparalytic myasthenia gravis is not recommended (see section "Side effects").
Use in an airborne droplet infection with anthrax
The use of levofloxacin in humans according to this indication is based on data on sensitivity to it of Bacillus anthracis obtained in in vitro and experimental studies in animals, as well as on limited data on the use of levofloxacin in person. The attending physician should refer to national and / or international documents that reflect the common point of view on the treatment of anthrax.
Psychotic reactions
When using quinolones, including levofloxacin, the development of psychotic reactions was reported, which in very rare cases progressed to the development of suicidal thoughts and behavioral disorders causing self-harm (sometimes after taking a single dose of levofloxacin (see section “Side effects”)). With the development of such reactions, treatment with levofloxacin should be discontinued and appropriate therapy should be prescribed. It should be used with caution in patients with psychoses or in patients with a history of mental illness.
Visual impairment
If any visual impairment develops, an immediate consultation with an ophthalmologist is necessary (see section “Side effects”).
Effect on laboratory tests
In patients taking levofloxacin, the determination of opiates in the urine can lead to false-positive results, which should be confirmed by more specific methods. Levofloxacin can inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false negative results of a bacteriological diagnosis of tuberculosis. Side effects of Levolet® P, such as dizziness or vertigo, drowsiness, and visual disturbances (see section “Side effects”), can reduce psychomotor reactions and ability to concentration. This may pose a certain risk in situations where these abilities are of particular importance (for example, when driving, servicing machines and mechanisms, and performing work in an unstable position).
Composition of
Each film-coated tablet 500 mg contains:
Active ingredient:
levofloxacin hemihydrate 512,466 mg, equivalent to 500 mg of levofloxacin.
Excipients:
microcrystalline cellulose (Avicel PH 101) 50.667 mg,
corn starch 50.2 mg,
silicon dioxide colloid 10 mg,
crospovidone 42.667 mg,
hypromellose (15 cps microcrystalline cellulose) 102) 60 mg,
magnesium stearate 10 mg.
Shell:
Opadry white OY 58900 (hypromellose (5 cP) 62.5%,
titanium dioxide (E171) 31.25%,
macrogol 400 6.25%) 22.5 mg.
Dosage and Administration
Inside, before meals or in between meals, without chewing, drinking plenty of fluids.
Sinusitis: 500 mg once daily. The course of treatment is 10-14 days.
Exacerbation of chronic bronchitis: 250-500 mg once a day. The course of treatment is 10-14 days.
Infections of the skin and soft tissues: 250 mg 1-2 times a day or 500 mg once a day. The course of treatment is 7-14 days.
Side effects
The following side effects are presented in accordance with the following gradations of their frequency of occurrence: very often (? 1/10) often (? 1/100, <1/10) infrequently (? 1/1000, <1/100 ) rarely (? 1/10000, < 1/1000) very rarely (<1/10000) (including individual messages)
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 use of the drug
Disorders of the heart
Rarely: sinus tachycardia, palpitations.
Frequency unknown (post-marketing data): QT interval lengthening, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the “pirouette” type, which can lead to cardiac arrest (see sections “Overdose”, “Special instructions”).
Disorders of the blood and lymphatic system
Infrequently: leukopenia (a decrease in the number of white blood cells in the peripheral blood), eosinophilia (an increase in the number of eosinophils in the peripheral blood).
Rarely: neutropenia (a decrease in the number of neutrophils in the peripheral blood), thrombocytopenia (a decrease in the number of platelets in the peripheral blood).
Frequency unknown (post-marketing data): pancytopenia (decrease in the number of all shaped elements in peripheral blood), agranulocytosis (absence or sharp decrease in the number of granulocytes in peripheral blood), hemolytic anemia.
Disorders of the nervous system
Often: headache, dizziness.
Infrequently: drowsiness, tremor, dysgeusia (perversion of taste).
Rarely: paresthesia, convulsions (see section "Special instructions").
Frequency unknown (post-marketing data): peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see "Special Instructions"), dyskinesia, extrapyramidal disorders, ageusia (loss of taste), parosmia (disorder of sensation of smell, especially subjective sensation of smell, objectively absent), including loss of smell, fainting, benign intracranial hypertension.
Visual impairment
Rarely: visual impairment, such as blurry images.
Frequency unknown (post-marketing data): transient loss of vision, uveitis.
Hearing impairment and labyrinthine disorders
Infrequently: vertigo (feeling of rejection or spinning or of one's own body or surrounding objects).
Rarely: tinnitus.
Frequency unknown (post-marketing data): hearing loss, hearing loss.
Disorders of the respiratory system, chest and mediastinal organs
Uncommon: shortness of breath.
Frequency unknown (post-marketing data): bronchospasm, allergic pneumonitis.
Disorders of the gastrointestinal tract
Often: diarrhea, vomiting, nausea.
Infrequently: abdominal pain, dyspepsia, flatulence, constipation.
Frequency unknown (post-marketing data): hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis (see section "Special instructions"), pancreatitis.
Disorders of the night and urinary tract
Infrequently: increased serum creatinine concentration.
Rarely: acute renal failure (for example, due to the development of interstitial nephritis).
Disorders of the skin and subcutaneous tissue
Infrequently: rash, itching, urticaria, hyperhidrosis.
Frequency unknown (post-marketing data): toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitization reactions (hypersensitivity to solar and ultraviolet radiation) (see section "Special Instructions"), leukocytoclastic vasculitis, stomatitis.
Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug.
Disorders of the musculoskeletal system and connective tissue
Infrequently: arthralgia, myalgia.
Rarely: tendon damage, including tendonitis (eg, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudoparalytic myasthenia gravis (see myasthenia gravis).
Frequency unknown (post-marketing data): rhabdomyolysis, tendon rupture (e.g., Achilles tendon). This side effect can be observed within 48 hours after the start of treatment and can be bilateral in nature (see also the section “Special Instructions”), rupture of ligaments, rupture of muscles, arthritis.
Metabolism and nutritional disorders
Infrequently: anorexia.
Rarely: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: “wolf” appetite, nervousness, perspiration, trembling).
Frequency unknown: hyperglycemia, hypoglycemic coma (see section "Special instructions").
Infectious and parasitic diseases
Infrequently: fungal infections, development of resistance of pathogenic microorganisms.
Vascular disorders
Rarely: lowering blood pressure.
Common disorders
Infrequently: asthenia.
Rarely: pyrexia (fever).
Frequency unknown: pain (including back, chest, and limb pain).
Immune system disorders
Rarely: angioedema.
Frequency unknown (post-marketing data): anaphylactic shock, anaphylactoid shock.
Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.
Disorders from the liver and biliary tract
Often: increased activity of “liver” enzymes in the blood (for example, alanine aminotransferase (ALT), aspartate aminotransferase (ACT), increased activity of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT).
Infrequently: increased concentration of bilirubin in the blood.
Frequency unknown (post-marketing data): severe liver failure, including cases of acute liver failure, sometimes fatal, especially in patients with a serious underlying disease (for example, in patients with sepsis) (see the section "Special Instructions") hepatitis, jaundice.
Mental disorders
Often: insomnia.
Infrequently: a feeling of anxiety, anxiety, confusion.
Rarely: mental disorders (eg, hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares.
Frequency unknown (post-marketing data): mental disorders with behavioral disorders causing self-harm, including suicidal thoughts and suicidal attempts.
Other possible adverse effects that apply to all fluoroquinolones
Very rare: attacks of porphyria (a very rare metabolic disease) in patients with porphyria.
Storage conditions
At a temperature not exceeding 25 РC.
Keep out of the reach of children!
The Expiration of
is 3 years.
Deystvuyuschee substances
Levofloxacin
Dosage form
tablet
Appointment
Adult prescription, Prescription children
Indications
From otitis media, sinusitis, From urinary tract infections, From boils, From pneumonia, From skin infections, From infectious diseases, From respiratory infections, Bronchitis
Possible product names
LEVOLET P 0.5 N10 TABLE P / O
LEVOLET P 0.5 N10 TABLE P / FILM / SHELL
Levolet P 500 mg Tab. cover captivity. about. X10 (R)
LION VEHICLE R 500MG. No. 10 TAB. P / O
Levolet R tab po 500mg x 10
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