Instructions for Fleksid (levofloxacin)
Composition:
1 film-coated tablet contains:
active substance: levofloxacin
(in the form of hemihydrate) 500 (512.46) mg, respectively; excipients: lactose monohydrate 26.54 mg, povidone 35.00 mg, sodium carboxymethyl starch 24.00 mg, talc 18.00 mg, silicon dioxide colloidal anhydrous 13.00 mg, croscarmellose sodium 9.0 mg, glyceryl dibehenate 12.00 mg; film sheath: hypromellose 9.924 mg, hyprolose 2.476 mg, macrogol 6000 2.00 mg, iron oxide yellow 0.138 mg, iron oxide red 0.138 mg, titanium dioxide 4.324 mg, talc 1.00 mg.
general description:
Fluoroquinolone group antibacterial drug
Fleksid Special conditions:
Hospital infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) may require combination treatment.
Risk of development of resistance The prevalence of acquired resistance of seeded strains of microorganisms can 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 selection of the pathogen and determination of its sensitivity to levofloxacin. Methicillin-resistant Staphylococcus aureus There is a high probability that Methicillin-resistant Staphylococcus aureus is resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for
treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, if laboratory tests have not confirmed the sensitivity of this microorganism to levofloxacin. Disability (disability) and potential irreversible serious adverse reactions due to fluoroquinolones
The use of fluoroquinolones, including levofloxacin, was associated with disability and the development of irreversible serious adverse reactions from various body systems that can develop simultaneously in the same patient. Adverse reactions caused by fluoroquinolones include tendonitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, as well as side effects from the nervous system (hallucinations, anxiety, depression, insomnia, headaches and confusion). These reactions can develop from a few hours to several weeks after starting levofloxacin therapy. The development of these adverse reactions was observed in patients of any age or without the presence of previous risk factors. If the first signs or symptoms of any serious adverse reactions occur, immediately stop using levofloxacin. The use of fluoroquinolones, including levofloxacin, should be avoided in patients who have had any of these serious adverse reactions.
Patients prone to seizures
Like other quinolones, levofloxacin should be used with great caution in patients with a predisposition to seizures. Such patients include patients with previous lesions of the central nervous system, such as stroke, severe craniocerebral trauma; patients who are simultaneously receiving drugs that lower the threshold for convulsive activity of the brain, such as fenbufen and other similar hysteroid anti-inflammatory drugs or other drugs that lower the threshold for convulsive activity, such as theophylline (see section “Interaction with other drugs”).
Elderly patients are more prone to the development of tendonitis; in patients
taking fluoroquinolones, the risk of tendon rupture may increase with the simultaneous use of glucocorticosteroids. In addition, patients after transplantation have an increased risk of developing tendonitis, therefore caution is advised when prescribing fluoroquinolones in this category of patients. In patients with impaired renal function, the daily dose should be adjusted based on creatinine clearance.
Patients should be advised to remain at rest when the first signs of tendonitis or tendon rupture appear, and consult your doctor. If you suspect the development of tendonitis, you should immediately discontinue treatment with Flexid * and begin appropriate treatment of the affected tendon, for example, 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 stop taking the preparation immediately.
When using levofloxacin in such patients, the risk of developing hypoglycemia increases, up to hypoglycemic coma.
It is necessary to inform patients about the symptoms of hypoglycemia (confusion, dizziness, wolfish appetite, headache, nervousness, palpitations or increased heart rate, pallor of the skin, perspiration, trembling, weakness). If the patient develops hypoglycemia, it is necessary to immediately stop treatment with levofloxacin and begin appropriate therapy. In these cases, it is recommended to switch to therapy with another other than fluoroquinolones, if possible. When conducting levofloxacin treatment in elderly patients, in patients with diabetes mellitus, careful monitoring of blood glucose concentration is recommended.
Peripheral neuropathy
Psychotic reactions Psychotic reactions, including suicidal thoughts / attempts, have been reported in patients taking fluoroquinolones, including levofloxacin, sometimes after taking a single dose. In case of development of any side effects from the central nervous system, including mental disorders, treatment with levofloxacin should be stopped immediately and appropriate therapy should be prescribed. In these cases, it is recommended to switch to therapy with another other than fluoroquinolones, if possible. It should be used with caution in patients with psychoses or in patients with a history of mental illness.
Drug Interactions Fleksid:
Interactions requiring caution With preparations containing magnesium, aluminum, iron and zinc, didanosine.
Preparations containing divalent or trivalent cations, such as zinc or iron salts (drugs for the treatment of anemia),
magnesium and / or aluminum-containing preparations (such as antacids), didanosine (only dosage forms containing aluminum or magnesium as a buffer) are recommended to be taken at least 2 hours before or 2 hours after taking Flexid® tablets.
Calcium salts have a minimal effect on the absorption of levofloxacin when taken orally.
With sucralfate.
The effect of the drug Flexid * is significantly weakened with the simultaneous use of sucralfate (a means to protect the gastric mucosa).
The concentration of levofloxacin while taking fenbufen increases only by 13%.
With indirect anticoagulants (vitamin K antagonists).
In patients treated with levofloxacin in combination with indirect anticoagulants (e.g. warfarin), there was an increase in PV / INR and / or the development of bleeding, including and heavy. Therefore, with the simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood coagulation indicators with probenecid and cimetidine is necessary.
increased the half-life of cyclosporine by 33%. Since this increase is clinically insignificant, dose adjustment of cyclosporine with its simultaneous use with levofloxacin is not required.
With glucocorticosteroids.
Simultaneous administration of GCS increases the risk of tendon rupture.
With drugs lengthening the interests of QT. Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that extend the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics).
Other.
Clinical and pharmacological studies to study the possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide, ranitidine and warfarin showed that the pharmacokinetics of levofloxacin with simultaneous use with these drugs does not change sufficiently to make it clinically significant.
Pharmacodynamics Fleksid:
Flexide is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones containing levofloxacin as the active substance of the levorotatory ofloxacin isomer. Levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts the supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall and microbial cell membranes.
Levofloxacin is active against most strains of microorganisms, both in vitro and in vivo.
In vitro
Sensitive microorganisms (BMD <2 mg / L, inhibition zone> 17 mm)
Aerobic Gram-Positive Microorganisms: Bacillus anthracis,
Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagu / ase-negative methi-S (I) (coagulase-negative methicillin-sensitive / -moderately sensitiveci-sensitive (Stius sensitive), Stomatus Staphylococcus epidermidis methi-S (methicillin-sensitive), Streptococci groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni-I / S / R (penicillin-moderately sensitive / -sensitive / -resistant), Streptococcus pyogenes-sirid, / R (penicillin-sensitive / -resistant).
Aerobic gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens,
Enterobacter aerogenes, Enterobacter cloacae, Enterobacterspp., Escherichia coli lefelius giuli lefeli Gardius -resistant)
Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Moraxella catarrhalis J3 + // 3- (producing and non-producing beta-lactamases), Morganella morganii, non-generating plants, non-producing , Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp., Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp., Pseudomonas aeruginosa (hospital infections caused by Pseudomonas sperppom, combined pseudomonas aeruginosa. Salmonella spp., Serratia marcescens, Serratia spp.
Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus, Propionibacterium spp., Veillonella spp.
Levofloxacin-resistant microorganisms (BMD> 8 mg / L; inhibition zone <13 mm)
Aerobic gram-positive microorganisms: Staphylococcus aureus methi-R (methicillin-resistant), Staphylococcus coagulase-negative methi-R (coagulase-negative methicillin-resistant).
Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans. Anaerobic microorganisms: Bacteroides thetaiotaomicron.
Other microorganisms: Mycobacterium avium.
Resistance:
Levofloxacin resistance develops as a result of a stepwise process of mutating genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV (modification of the target of action). Other resistance mechanisms, such as the mechanism of influence on the penetration barriers of a microbial cell (the mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of an antimicrobial agent from a microbial cell), can also reduce the sensitivity of microorganisms to levofloxacin.
Due to the nature of the mechanism of action of levofloxacin, there is usually no cross-resistance between levofloxacin and other antimicrobial agents.
Clinical efficacy (effectiveness in clinical trials in the treatment of infections caused by the following microorganisms)
Aerobic gram-positive microorganisms: Enterococcus faecal is, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes. Aerobic gram-negative microorganisms: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Morganella morganii, Proteus mirabonis aerosens, Proteus mirabonis aerosens, Pomeus mirabonis aerosens,
Other microorganisms: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.
Pharmokinetics Fleksid:
Suction
Levofloxacin is rapidly and almost completely absorbed after oral administration, food intake has little effect on absorption. Absolute bioavailability when administered is 99-100%. After a single dose of 500 mg of levofloxacin, the maximum plasma concentration (Stax) is achieved within 1-2 hours and is 5.2 ± 1.2 μg / ml. The pharmacokinetics of levofloxacin is linear in the dose range from 50 to 1000 mg. The equilibrium state of the concentration of levofloxacin in blood plasma when taking 500 mg of levofloxacin 1 or 2 times a day is reached within 48 hours.
On the 10th day of oral administration, the drug Flexid ^ 500 mg 1 time per day Stach of levofloxacin is 5.7 ± 1.4 μg / ml, and the minimum concentration of levofloxacin (concentration before taking the next dose) (Cmin) in blood plasma is 0.5 ± 0.2 mcg / ml
On the 10th day of oral administration of the drug Flexidc 500 mg 2 times a day
was 7.8 ± 1.1 μg / ml, and Cmin - 3.0 ± 0.9 μg / ml
Distribution
Communication with blood plasma proteins is 30-40%. After a single dose of 500 mg of levofloxacin, the volume of distribution of levofloxacin is, on average, 100 l, which indicates good penetration of levofloxacin into the organs and tissues of the human body.
Penetration into the mucous membrane of the bronchi, fluids of the epithelial lining, alveolar macrophages
After a single oral administration of 500 mg of levofloxacin: the maximum concentrations of levofloxacin in the mucous membrane of the bronchi and epithelial lining fluid were achieved within 1 h or 4 h and amounted to 8.3 μg / g and 10.8 μg / ml, respectively; with penetration coefficients in the bronchial mucosa and epithelial lining fluid, compared with a plasma concentration of 1.1-1, and 0.8-3, respectively.
After 5 days of ingestion of 500 mg of levofloxacin, the average concentration of levofloxacin 4 hours after the last administration of the drug in the epithelial lining fluid was 9.94 μg / ml and in the alveolar macrophages, 97.9 μg / ml.
Penetration into the lung tissue
The maximum concentration in the lung tissue after ingestion of 500 mg of levofloxacin was
approximately 11.3 μg / g and were achieved 4-6 hours after taking the drug with penetration coefficients of 2-5, compared with the concentration in the blood plasma.
Penetration into the alveolar fluid
After 3 days of taking 500 mg of levofloxacin 1 or 2 times a day, the maximum concentrations of levofloxacin in the alveolar fluid were reached 2-4 hours after taking the drug and were 4.0 and 6.7 μg / ml, respectively, with a penetration coefficient of 1, in comparison with plasma concentrations.
Indications Fleksid:
Levofloxacin-sensitive bacterial infections 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;
• complex treatment of drug-resistant forms of tuberculosis;
• Prevention and treatment of anthrax with airborne infection.
When using Flexidk, official national recommendations for the appropriate use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country, should be taken into account (see "Special instructions"
Contraindications Fleksid:
• hypersensitivity to levofloxacin or to other quinolones, as well as to any of the excipients of Flexid®;
epilepsy;
• pseudoparalytic myasthenia gravis (myasthenia gravis) (see sections "Side effects", "Special instructions");
• tendon lesions when taking fluoroquinolones in history;
• children and adolescents under 18 years of age (due to incomplete skeleton growth, since the risk of damage to the cartilaginous growth zones cannot be completely ruled out);
• pregnancy (the risk of damage to the cartilaginous growth points of the fetus cannot be completely excluded);
• the period of breastfeeding (the risk of damage to the cartilaginous areas of bone growth in a child cannot be completely excluded).
Carefully
• In patients predisposed to the development of seizures (in patients with previous lesions of the central nervous system (CNS), in patients taking drugs that lower the threshold for convulsive activity of the brain, such as fenbufen, theophylline) (see section “Interaction with other drugs means ").
• 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; in female patients, in patients with uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); with congenital lengthening of the QT interval; with heart disease (cardiac
insufficiency, myocardial infarction, bradycardia); while taking medications that can extend the QT interval (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics) (see sections "Overdose", "Interaction with other drugs", "Special instructions").
• In patients with diabetes receiving oral hypoglycemic drugs (eg, 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”).
In elderly patients, in patients after transplantation, as well as with the concomitant use of glucocorticosteroids (increased risk of tendonitis and tendon rupture) (see section "Special Instructions").
Use during pregnancy and during breastfeeding
Levofloxacin is contraindicated in pregnant and lactating women.
Overdose Fleksid:
Symptoms: Based on toxicological data
studies in animals, the most important expected symptoms of an acute overdose of levofloxacin are symptoms from the central nervous system (impaired consciousness, including confusion, dizziness and convulsions).
In post-marketing use of the drug in case of an overdose, effects from the central nervous system, including confusion, convulsions, hallucinations and tremors, were observed.
Perhaps the development of nausea and the occurrence of erosion of the gastrointestinal mucosa.
In clinical and pharmacological studies conducted with doses of levofloxacin in excess of therapeutic, prolongation of the QT interval was shown.
Treatment: in case of overdose, careful monitoring of the patient is required, including ECG monitoring. The treatment is symptomatic. In case of acute overdose of Flexid * tablets, gastric lavage and antacid administration are indicated to protect the gastric mucosa. Levofloxacin is not excreted through dialysis (hemodialysis, peritoneal dialysis, and permanent ambulatory peritoneal dialysis). There is no specific antidote.
Side effects Fleksid:
The following side effects are presented in accordance with the following gradations of their frequency
occurrence: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000,
<1/1000) and very rarely (<1/10000) (including individual messages); frequency unknown (available
data to establish the frequency of occurrence was not possible).
Data obtained in clinical trials and with post-registration use of the drug
Infectious and parasitic diseases
infrequently: fungal infections, the development of resistance of pathogenic microorganisms.
Disorders from 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 (decrease in platelet count in peripheral blood);
frequency unknown: (post-registration data): pancytopenia (decrease in the number of all uniform
elements in the peripheral blood), agranulocytosis (absence or sharp decrease in the number of granulocytes
in peripheral blood), hemolytic anemia.
Immune system disorders:
rarely: angioedema;
unknown frequency
(post-registration data):
anaphylactic shock, anaphylactoid shock.
Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.
Metabolic and nutritional disorders:
infrequently: anorexia;
rarely: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: “wolf” appetite, nervousness, perspiration, trembling);
the frequency is unknown: hyperglycemia, severe hypoglycemia, up to the development of hypoglycemic coma, especially in elderly patients, patients with diabetes mellitus, taking oral hypoglycemic drugs or insulin (see the section "Special Instructions").
Mental disorders are often: insomnia; infrequently: anxiety, anxiety, confusion; rarely: mental disorders (eg, hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares;
frequency unknown (post-registration data): mental disorders with behavioral disorders causing self-harm, including suicidal thoughts and suicidal attempts, impaired attention, disorientation, nervousness, memory impairment, delirium.
Disorders from the nervous system:
often: headache, dizziness;
infrequently: drowsiness, tremor, dysgeusia (perversion of taste); seldom: paresthesia, convulsions (see the section "Special Instructions"); the frequency is unknown (post-registration data): peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see "Special Instructions" section), dyskinesia, extrapyramidal disorders, agovesia (loss of taste), parosmia (disorder of sensation of smell, especially subjective smell, objectively absent), including loss of smell, fainting, increased intracranial pressure (benign intracranial hypertension, pseudotumor of the brain).
Disorders from the side of organazrenie:
rarely: visual impairment, such as blurry image;
unknown frequency
(post-registration data): transient loss of vision, uveitis.
Hearing disorders and labyrinth disorders:
infrequently: vertigo (feeling of rejection or spinning, or one's own body or surrounding objects);
rarely: tinnitus;
frequency unknown (post-registration data):
hearing loss, hearing loss.
Heart Disorders:
seldom'. sinus tachycardia,
palpitations
frequency unknown (post-registration data):
lengthening of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the pirouette type, which can lead to cardiac arrest (see sections "Overdose", "Special
instructions ”).
Violations of the vessels:
rarely: lowering blood pressure.
Disorders of the respiratory system, chest and mediastinal organs
infrequently: shortness of breath;
frequency unknown (post-registration data):
bronchospasm, allergic pneumonitis.
Violations of the gastrointestinal tract:
often: diarrhea, vomiting, nausea;
infrequently: abdominal pain, dyspepsia, flatulence, constipation;
unknown frequency
(post-registration data): hemorrhagic diarrhea, which in very rare cases can be
a sign of enterocolitis, including pseudomembranous colitis (see section "Special instructions"),
pancreatitis.
Violations of the liver and biliary tract: often: increased activity of “liver” enzymes in the blood (for example, alanine aminotransferase (ALT), aspartamenotransferase (ACT), increased activity of alkaline phosphatase (ALP) and gamma-glutamyl transferase GTT); infrequently: increased concentration of bilirubin in the blood; the frequency is unknown (post-registration data): severe liver failure, including cases of acute liver failure, sometimes fatal, especially in patients with a serious underlying disease (for example, patients with sepsis) (see section “Special instructions”), hepatitis, jaundice. Disorders from the skin and subcutaneous tissues: infrequently: rash, itching, urticaria, hyperhidrosis;
the frequency is unknown (post-registration 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.
Violations of the musculoskeletal system and connective tissue: infrequently: arthralgia, myalgia; rarely: tendon damage,
including tendonitis (for example, the Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudoparalytic myasthenia gravis (myasthenia gravis) (see "Special Instructions");
unknown frequency
(post-registration data): rhabdomyolysis, tendon rupture (for example, Achilles tendon. This
a side effect may occur within 48 hours after the start of treatment and may be bilateral
character (see also the section "Special Instructions")), rupture of ligaments, rupture of muscles, arthritis.
Violations of the kidneys and urinary tract:
infrequently: increased serum creatinine concentration;
rarely: acute renal failure (e.g., due to development
interstitial nephritis).
General disorders
infrequently, asthenia; rarely: pyrexia (fever); frequency unknown: pain (including back, chest, and limb pain).
Other possible unwanted effects related to all fluoroquinolones:
very rare: attacks of porphyria
(a very rare metabolic disease) in patients with porphyria.
Ways of application:
Flexid tablets 250 mg or 500 mg are taken orally once or twice a day. Tablets should be swallowed without chewing and drinking plenty of fluids (from 0.5 to 1 cup). If necessary, tablets can be broken along the dividing groove. The drug can be taken before meals or at any time between meals, since eating does not affect the absorption of the drug (see section "Pharmacokinetics").
The drug should be taken at least 2 hours before or 2 hours after taking preparations containing magnesium and / or aluminum, iron, zinc or sucralfate (see section "Interaction with other drugs").
Considering that the bioavailability of levofloxacin when taking Flexid® in tablets is 99-100%, in the case of transferring a patient from intravenous infusion of Flexidk to tablets, treatment should continue with the same dose that was used for intravenous infusion (see section “Pharmacokinetics” ").
Skipping one or more doses of the drug
If you accidentally missed the drug, you need to take the next dose as soon as possible and then continue to take the drug Flexid "according to the recommended dosage regimen.
Doses and duration of treatment
The dosage regimen is determined by the nature and severity of the infection, as well as the sensitivity of the alleged pathogen. The duration of treatment varies depending on the course of the disease.
Recommended dosing regimen and duration of treatment in patients with normal or moderately reduced renal function (CC> 50 ml / min.):
Acute sinusitis - 2 tablets. Flexid® 250 mg or 1 tablet. Flexid "500 mg once a day (respectively, 500 mg of levofloxacin) - 10-14 days. Exacerbation of chronic bronchitis - 2 tablets. Flexid" 250 mg or 1 table. Flexid "500 mg once a day (respectively, 500 mg of levofloxacin) - 7-10 days.
Community-acquired pneumonia - 2 tablets. Flexid® 250 mg or 1 tablet. Flexid * 500 mg 1-2 times a day (respectively, 500-1000 mg of levofloxacin) - 7-14 days.
Uncomplicated urinary tract infections - 1 tab. Flexid * '250 mg 1 time per day (respectively 250 mg of levofloxacin) - 3 days. Complicated urinary tract infections - 2 tablets. Flexid * 250 mg 1 time per day or 1 tablet. Flexid * 500 mg once a day (respectively, 500 mg of levofloxacin) - 7-14 days.
Pyelonephritis - 2 tablets. Flexid * 250 mg 1 time per day or 1 tablet Flexid * 500 mg 1 time per day (respectively 500 mg of levofloxacin) - 7-10 days.
Chronic bacterial prostatitis - 2 tablets. Flexid * 250 mg or 1 tablet. Flexid * 500 mg once a day (respectively 500 mg of levofloxacin) - 28 days.
Infections of the skin and soft tissues - 2 tablets. Flexid * 250 mg or 1 tablet. Flexid * 500 mg 1-2 times a day (respectively, 500-1000 mg of levofloxacin) - 7-14 days.
Comprehensive treatment of drug-resistant forms of tuberculosis - 1 tab. Flexide * 500 mg 1-2 times a day (respectively, 500-1000 mg of levofloxacin) - up to 3 months.
Prevention and treatment of anthrax with airborne infection, 2 tablets. Flexid * 250 mg or 1 tablet. Flexid * 500 mg (respectively, 500 mg of levofloxacin) 1 time per day for up to 8 weeks. Dosage regimen in patients with impaired renal function (CC <50 ml / min)
Levofloxacin is excreted mainly by the kidneys, therefore, in the treatment of patients with impaired renal function, a dose reduction is required (see table below).
KK Dosing regimen of Flexidk tablets
Recommended dose for KK> 50ml / min 250 mg / 24 h Recommended dose for KK> 50ml / min: 500 mg / 24 h Recommended dose for KK> 50 ml / min: 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 continuous ambulatory peritoneal dialysis (CAPD), additional doses are not required.
Dosage regimen in patients with impaired liver function In case of impaired liver function, no dosage regimen correction is required, since levofloxacin is slightly metabolized in the liver.
Dosage regimen in elderly patients
For elderly patients, correction of the dosage regimen is not required, with the exception of cases of QC reduction to 50 ml / min and below.
