Composition, form of production and packaging
The tablets covered with a film shell of white color, capsular form, with a risk from both sides.
1 tab.
levofloxacin (in the form of hemihydrate) 500 mg
[PRING] crospovidone - 22 mg, microcrystalline cellulose - 65 mg, hypromellose - 8 mg, silicon colloidal dioxide - 5 mg, talc - 3 mg, magnesium stearate - 7 mg.
The composition of the membrane: hypromellose - 10.3 mg, macrogol - 1.2 mg, titanium dioxide (E171) - 6 mg, talc - 1.2 mg, methyl parahydroxybenzoate - 0.12 mg, propyl parahydroxybenzoate - 0.06 mg.
5 pieces. - blisters (10) - packs of cardboard.
5 pieces. - blisters (100) - packs of cardboard.
5 pieces. - blisters (50) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Levofloxacin is a synthetic broad-spectrum antibacterial agent from the group of fluoroquinolones, containing as an active substance levofloxacin, a levorotatory isofloxacin isomer. It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes.
Effective against most strains of microorganisms both in vitro and in vivo: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii , Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Clostridium perfringens, Mycobact erium tuberculosis.
PHARMACOKINETICS
When ingested quickly and almost completely absorbed (eating little influence on speed and completeness of absorption). Bioavailability is 99%. The concentration of the drug in the plasma reaches its peak 1-2 hours after its administration (T Cmax ). When taking 500 mg C max drug in plasma - 5.2 mcg / ml. The connection with plasma proteins is 24-38%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, bone tissue, cerebrospinal fluid, prostate gland, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion of the drug is oxidized and / or deacetylated. Kidney clearance is 70% of the total clearance. T 1/2 - 6-8 hours. Excreted mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% of the kidneys are excreted within 24 hours, 87% within 48 hours; During the 72 hours, 4% of the dose taken internally is excreted through the intestine.
INDICATIONS
Bacterial infections of mild and moderate severity caused by microorganisms sensitive to levofloxacin:
- infections of the lower respiratory tract (exacerbation of chronic bronchitis, community-acquired pneumonia, including penicillin-resistant form of Streptococcus pneumonia), ENT organs (acute sinusitis, otitis media), complicated and uncomplicated urinary tract infections (including acute pyelonephritis), skin and soft tissues (festering atheromas, abscess, boils), bacterial prostatitis;
- intra-abdominal infections, tuberculosis (complex therapy of drug-resistant forms).
DOSING MODE
Inside, before meals or in the interval between meals, without chewing, squeezed with enough liquid (0.5 to 1 cup). The dose is determined by the nature and severity of the infection, as well as by the suspected pathogen susceptibility.
Patients with normal or moderately reduced renal function (creatinine clearance> 50 mL / min) are recommended the following dosing regimen:
Sinusitis: 500 mg once a day - 10-14 days.
Exacerbation of chronic bronchitis: 250 mg or 500 mg 1 time / day - 7-10 days.
Community-acquired pneumonia: 500 mg 1-2 times / day - 7-14 days.
Uncomplicated urinary tract infections: 250 mg 1 time / day - 3 days.
Complicated urinary tract infections, including pyelonephritis: 250 mg 1 time / day - 7-10 days.
Bacterial prostatitis: 500 mg - 1 time / day - 28 days.
Infections of the skin and soft tissues: 250 mg 1 time / day or 500 mg 1-2 times / day - 7-14 days.
Intra-abdominal infections: 250 mg or 500 mg 1 time / day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).
Tuberculosis: inside, 500 mg 1-2 times / day to 3 months.
Dosing regimen with impaired renal function:
250 mg / 24 h 500 mg / 24 h 500 mg / 12 h
Creatinine clearance First dose: 250 mg First dose: 500 mg First dose: 500 mg
50-20 ml / min Then: 125 mg / 24 hours Then: 250 mg / 24 hours Then: 250 mg / 12 h
19-10 ml / min Then: 125 mg / 48 h Then: 125 mg / 24 h Then: 125 mg / 12 h
<10 ml / min (including hemodialysis and DAPD 1 ) Then: 125 mg / 48 h Then: 125 mg / 24 h Then: 125 mg / 24 h
1 - no additional doses are required after hemodialysis or DAPD.
If the liver function is not required, special dose selection is required, since levofloxacin is metabolized in the liver in small amounts.
If you missed taking the drug, you need to take the pill as soon as possible until the time of the next appointment is approaching. Then continue to take Tanflomed according to the scheme.
SIDE EFFECT
The frequency of this or that side effect is determined by the following table:
Frequency Occurrence of side effects
Often: 1-10 patients out of 100
Sometimes: Less than 1 patient out of 100
Rarely: Less than 1 patient out of 1000
Very rare: Less than 1 patient out of 10,000
In some cases: Less than 0.01%
Allergic reactions.
Sometimes: itching and redness of the skin.
Rarely: hypersensitivity reactions with such symptoms as hives, bronchospasm, severe suffocation.
Very rarely: swelling of the skin and mucous membranes, sudden drop in blood pressure and anaphylactic shock; photosensitivity (see "Special instructions"); allergic pneumonitis; vasculitis.
In some cases: malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exudative erythema multiforme. Common hypersensitivity reactions can sometimes be preceded by lighter skin reactions. The above reactions may develop after the first dose in a few minutes or hours after the administration of the drug.
From the gastrointestinal tract and metabolism
Often: nausea, diarrhea.
Sometimes: loss of appetite, vomiting, abdominal pain.
Rarely: stool with an admixture of blood, which in very rare cases can be a sign of inflammation of the intestine and even pseudomembranous colitis (see "Special instructions"), dysbacteriosis.
Very rarely: hypoglycemia (possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling).
The experience with the use of other quinolones indicates that they are capable of causing an exacerbation of porphyria in patients already suffering from this disease.A similar effect is not excluded when using the drug Tanflomed.
From the nervous system
Sometimes: headache, weakness, dizziness and / or numbness, drowsiness, sleep disturbance (including insomnia).
Rarely: depression, anxiety, hallucinations, paresthesia, tremor, psychomotor agitation, confusion, fear, epileptic seizure attacks, anxiety.
Very rarely: visual and hearing impairments, violations of taste sensitivity and smell, a decrease in tactile sensitivity.
From the side of the cardiovascular system
Rarely: increased heart rate, increased heart rate, lower blood pressure.
Very rarely: vascular collapse.
In some cases: prolongation of the QT interval.
From the side of the musculoskeletal system
Rarely: tendon lesions (including tendonitis), arthralgia, myalgia.
Very rarely: rupture of tendons (eg, Achilles tendon); this side effect can be observed within 48 hours after the start of treatment and can be bilateral (see "Special instructions"); muscle weakness, which is of particular importance for patients suffering from myasthenia gravis.
In some cases: muscle damage (rhabdomyolysis).
From the liver and kidneys
Often: increased activity of liver enzymes (alanine aminotransferase and aspartate aminotransferase).
Rarely: hyperbilirubinemia, hypercreatininaemia.
Very rarely: hepatitis; acute renal failure, interstitial nephritis.
From the blood and organs of hematopoiesis
Sometimes: an increase in the number of eosinophils, a decrease in the number of leukocytes.
Rarely: neutropenia; thrombocytopenia, which can be accompanied by hemorrhages and increased bleeding.
Very rarely: agranulocytosis and the development of severe infections.
In some cases: hemolytic anemia; pancytopenia.
Other
Sometimes: general weakness (asthenia).
Very rarely: fever, development of superinfection.
CONTRAINDICATIONS
- pregnancy, lactation;
- Children and adolescence (up to 18 years);
- hypersensitivity to levofloxacin or other components of the drug;
- hypersensitivity to other quinolones, epilepsy, tendon damage with prior treatment with quinolones;
With caution: the elderly (due to the high likelihood of concomitant decline in kidney function); deficiency of glucose-6-phosphate dehydrogenase; complex therapy with drugs that slow kidney clearance.
PREGNANCY AND LACTATION
Due to the inadequacy of clinical studies and the possible harmful effects of quinolones on articular cartilage in the growth period, Tanflomed should not be used during pregnancy and lactation.
SPECIAL INSTRUCTIONS
As with the use of other antibiotics, treatment with Tanflomed is recommended to continue for at least 48-72 hours after the normalization of body temperature.
Tanflomed can not be used to treat children and adolescents because of the possibility of joint cartilage damage.
When treating patients of senile age, it should be borne in mind that patients of this group often suffer from impaired renal function (see section "Method of administration and dose").
In severe pneumonia caused by pneumococci, Tanflomed may not provide the optimal therapeutic effect. Hospital infections caused by certain pathogens(Pseudomonas aeruginosa) may require combined treatment.
During treatment with the drug Tanflomed, it is possible to develop an attack of seizures in patients with previous brain damage due, for example, to a stroke or severe trauma.
Despite the fact that photosensitization is observed with levofloxacin very rarely, it is not recommended to undergo severe sunlight or artificial ultraviolet irradiation (for example, sun exposure in the highlands or visiting the solarium) without special need to avoid it.
If suspicion of pseudomembranous colitis should immediately cancel Tanflomed and begin appropriate treatment. In such cases, drugs that depress intestinal motility should not be used.
Rarely observed with the use of the drug Tanflomed tendonitis (primarily inflammation of Achilles tendon) can lead to rupture of tendons. The elderly are more likely to develop tendonitis. Treatment with glucocorticosteroids increases the risk of rupture of tendons. If suspicion of tendonitis should immediately stop treatment with Tanflomed and begin appropriate treatment of the affected tendon, providing the patient with a resting state (see "Contraindications" and "Side effect").
Patients with insufficiency of glucose-6-phosphate dehydrogenase (hereditary metabolic disorder) may respond to the administration of fluoroquinolones by the development of hemolysis (see "Contraindications / with caution").
Influence on the ability to drive and the speed of psychomotor reactions
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms of overdose with the drug Tanflomed are manifested at the level of the central nervous system (confusion, dizziness, impaired consciousness and seizures as epi-seizures). In addition, gastrointestinal disorders (eg, nausea) and erosive lesions of the mucous membranes may occur.
Treatment is symptomatic. Levofloxacin is not excreted by dialysis. There is no specific antidote.
DRUG INTERACTION
There are reports of a marked decrease in the level of convulsive readiness with simultaneous use of quinolones and substances, which in turn can reduce the cerebral threshold of convulsive readiness. Equally, this also applies to the simultaneous use of quinolones, theophylline and non-steroidal anti-inflammatory drugs.
The effect of levofloxacin is significantly weakened by simultaneous application of sucralfate. The same thing happens with the simultaneous use of magnesium- oraluminum-containing antacid agents, as well as preparations of iron salts. Levofloxacin should be taken at least 2 hours before or 2 hours after taking these drugs.
The use of glucocorticosteroids increases the risk of rupture of tendons.
With the simultaneous use of vitamin K antagonists , monitoring of blood coagulation indexes is necessary.
Removal (renal clearance) of levofloxacin slightly slows down under the action of cimetidine and probenecid, which block tubular secretion.
Levofloxacin slightly increases T 1/2 cyclosporine.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a dry place, protected from light, out of reach of children, at a temperature of no higher than 25 В° C. Shelf life - 3 years. Do not use after expiry date.
