Tavanic 5mg ml solution for infusion 100ml

Levofloxacin

Solution

1 ml contains: Levofloxacin hemihydrate 5.1246 mg, which corresponds to the content of levofloxacin 5 mg. Additional substances: sodium chloride - 9 mg, hydrochloric acid - 1.2-1.6 mg, sodium hydroxide - 0-0.3 mg, water d / and - up to 1 ml.

Antimicrobial agent for broad-spectrum fluoroquinolone. Bactericidal effect. It blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes. It is active against Enterococcus faecalis, Staphylococcus aureus, Staphylococrosus-tempus. 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, Acinetob acter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providcncia stuartii, Serratia marcescens, Clostridium retrosi, Cloidtigeri, Serratia marcescens, Clostridium rettgeri

When ingestion is absorbed from the gastrointestinal tract quickly and almost completely. Food intake has little effect on the speed and completeness of absorption. Bioavailability is 99%. Cmax is achieved in 1-2 hours and when taken 250 mg and 500 mg is 2.8 and 5.2 mcg / ml, respectively. Binding to plasma proteins - 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the urogenital system, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and / or deacetylated. Renal clearance is 70% of total clearance. T1 / 2 - 6-8 hours. Excreted mainly by the kidneys by glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% is excreted in the urine within 24 hours and 87% in 48 hours; in the feces for 72 hours, 4% of the ingested dose is detected. After i / v infusion of 500 mg for 60 min. Cmax - 6.2 mcg / ml. For intravenous and repeated injections, the apparent Vd after administration of the same dose is 89-112 l, Cmax - 6.2 mcg / ml, T1 / 2 - 6.4 h.

Infectious and inflammatory diseases in adults caused by susceptible microorganisms: - community-acquired pneumonia; - complicated urinary tract infections (including pyelonephritis); - uncomplicated urinary tract infections; - chronic bacterial prostatitis; - septicemia / bacteremia associated with the above indications ; - infections of the abdominal cavity; - for complex treatment of drug-resistant forms of tuberculosis.

- epilepsy; - tendon lesions when using fluoroquinolones in history; - children and adolescents under 18 years old (due to incomplete growth of the skeleton, because the risk of damage to the cartilage growth points cannot be completely excluded); - pregnancy (the risk of damage cartilage growth points in the fetus); - lactation period (it is impossible to completely eliminate the risk of damage to the cartilage growth points of the bones in an infant); - hypersensitivity to levofloxacin or to other quinolones. With caution: - in patients prone to development of seizures (in patients with previous CNS lesions, in patients simultaneously receiving medications that reduce the threshold of convulsive readiness of the brain, such as fenbufen, theophylline); in patients with latent or manifested glucose-6-phosphate dehydrogenase deficiency treatment with quinolones); - in patients with impaired renal function (mandatory monitoring of renal function is required, as well as correction of the dosage regimen); - in patients with known risk factors for lengthening the interval la QT: in elderly patients; in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesiemia); with congenital long QT syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); while taking drugs that can prolong the QT interval; - in patients with diabetes mellitus who are receiving oral hypoglycemic agents, such as glibenclamide or insulin (the risk of hypoglycemia increases); reactions (increased risk of similar undesirable reactions when using levofloxacin); - in patients with pseudoparalytic myasthenia (myasthenia gravis).

It is recommended to continue taking the drug Tavanic for at least 48–78 hours after normalization of body temperature or after reliable destruction of the pathogen. In order to avoid photosensitivity, patients should not be exposed to strong solar or artificial ultraviolet radiation.Careful monitoring of blood glucose levels in diabetic patients receiving oral hypoglycemic agents or insulin is recommended. If pseudomembranous colitis is suspected, the drug should be discontinued immediately and appropriate treatment should be started without using drugs that suppress intestinal motility. If you suspect tendonitis, you should immediately cancel the drug Tavanic and begin appropriate treatment. During the period of treatment, it is necessary to refrain from driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor speed.

Contraindicated for use in pregnancy and lactation (breastfeeding).

The drug is taken orally or injected intravenously 250-500 mg 1-2 times / day. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. For patients with normal or moderately impaired renal function (CC> 50 ml / min) drug It is recommended to appoint in the following doses. Community-acquired pneumonia: 500 mg 1-2 times / day (daily dose - 500-1000 mg of levofloxacin). The course of treatment is 7-14 days. Uncomplicated urinary tract infections: 250 mg 1 time / day (daily dose - 250 mg of levofloxacin). The course of treatment is 3 days. Complicated urinary tract infections (including pyelonephritis): 250 mg 1 time / day. In severe infections, an increase in dose is possible. The course of treatment is 7-10 days. Chronic bacterial prostatitis: 500 mg 1 time / day (daily dose - 500 mg of levofloxacin). The course of treatment is 28 days. Septicemia / bacteremia: 500 mg 1-2 times / day (daily dose - 500-1000 mg of levofloxacin). The course of treatment is 10-14 days. Infection of the abdominal cavity: 500 mg 1 time / day. The course of treatment is 7-14 days in combination with antibacterial drugs acting on the anaerobic flora. Infections of the skin and soft tissues: orally on 1 tab. 250 mg (250 mg of levofloxacin) 1 time / day, or 2 tab. 250 mg or 1 tab. 500 mg (500 mg of levofloxacin) 1-2 times / day (respectively, 500-1000 mg of levofloxacin per day). The course of treatment is 7-14 days. As part of the complex therapy of drug-resistant forms of tuberculosis, Tavanic is prescribed 500 mg 1-2 times / day (500-1000 mg of levofloxacin / day) for up to 3 months. Patients with impaired renal function need to be adjusted for dosing depending on the value of QC.

From the side of the cardiovascular system: often - phlebitis; rarely - sinus tachycardia, decreased blood pressure; Unknown frequency (post-marketing data) - prolongation of the QT interval. On the side of the hemopoietic system: infrequently - leukopenia, eosinophilia; rarely - neutropenia, thrombocytopenia; unknown frequency (post-marketing data) - pancytopenia, agranulocytosis, hemolytic anemia. On the nervous system: often - headache, dizziness; infrequently - drowsiness, tremor, dysgeusia (taste perversion); rarely - paresthesia, convulsions; unknown frequency (post-marketing data) - peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorders, loss of taste, parosmia (odor sensation disorder, especially the subjective smell sensation that is objectively missing), including loss of smell. Psychology: often - insomnia; infrequently - anxiety, confusion; rarely, mental disorders (for example, with hallucinations), depression, agitation (agitation), sleep disorders, nightmares; unknown frequency (post-marketing data) - mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicidal attempts. On the part of the organ of vision: very rarely - on vision, such as blurring of the visible image. On the part of the organ of hearing and labyrinth disorders: infrequently - vertigo (feeling of deviation or whirling or own body or surrounding objects); rarely tinnitus; unknown frequency (post-marketing data) - hearing loss. On the part of the respiratory system: infrequently - shortness of breath; unknown frequency (post-marketing data) - bronchospasm, allergic pneumonitis. From the digestive system: often - diarrhea, vomiting, nausea; infrequently - abdominal pain, dyspepsia; unknown frequency (post-marketing data) - hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis. From the side of the liver and biliary tract: often - increased activity of ALT, AST; infrequently - an increase in the concentration of bilirubin in the blood; unknown frequency (post-marketing data) - severe liver failure, including cases of acute liver failure,especially in patients with severe underlying disease (eg, sepsis); hepatitis. From the urinary tract: infrequently - an increase in serum creatinine concentration; seldom - acute renal failure (for example, due to the development of interstitial nephritis). Dermatological reactions: rarely - rash, itching, urticaria; unknown frequency (post-marketing data) - toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reactions (increased sensitivity to solar and ultraviolet radiation), leukocytoclastic vasculitis. Reactions from the skin and mucous membranes can sometimes develop even after the first dose of the drug is given. Allergic reactions: infrequently - urticaria; rarely, angioedema; unknown frequency (post-marketing data) - anaphylactic shock, anaphylactoid shock. Anaphylactic and anaphylactoid reactions can sometimes develop even after administration of the first dose of the drug. On the part of the musculoskeletal system: infrequently - arthralgia, myalgia; rarely - affection of tendons, including tendonitis (for example, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudoparalytic myasthenia (myasthenia gravis); unknown frequency (post-marketing data) - rhabdomyolysis, tendon rupture (for example, Achilles tendon). This side effect can be observed within 48 hours after the start of treatment and can be bilateral. On the side of metabolism: infrequently - anorexia; rarely - hypoglycemia, especially in patients with diabetes mellitus (possible symptoms of hypoglycemia: wolf appetite, nervousness, perspiration, tremors). Infectious and parasitic diseases: infrequently - fungal infections, development of resistance of pathogenic microorganisms. General reactions: infrequently - asthenia; rarely - pyrexia (increased body temperature). Local reactions: often - a reaction at the injection site (soreness, flushing of the skin). Other possible undesirable effects related to all fluoroquinolones. Very rare: attacks of porphyria (a very rare metabolic disease) in patients already suffering. this disease.

Symptoms: based on the data obtained in toxicological studies conducted in animals, the most important expected symptoms of an acute overdose of the drug Tavanic are symptoms of the central nervous system (impaired consciousness, including confusion, dizziness and convulsions).With post-marketing use of the drug in overdose, effects from the central nervous system, including confusion, convulsions, hallucinations and tremors, have been observed. Perhaps the development of nausea and the occurrence of erosions of the gastrointestinal mucosa. In clinical and pharmacological studies conducted with levofloxacin doses higher than therapeutic, prolongation of the QT interval was shown. Treatment: in case of overdose, careful monitoring of the patient, including ECG monitoring, is required. Symptomatic treatment. In the case of an acute overdose of Tavanic pills, gastric lavage and the introduction of antacids to protect the gastric mucosa are indicated. Levofloxacin is not excreted by dialysis (hemodialysis, peritoneal dialysis, and permanent outpatient peritoneal dialysis). There is no specific antidote.

Increases T1 / 2 of cyclosporine. The effect of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, magnesium and aluminum-containing antacids and iron salts (a break between taking at least 2 hours is required). With simultaneous use of NSAIDs, theophylline increases seizure readiness, GCS - increase risk of tendon rupture. Tsimetidin and drugs that block tubular secretion, slow down the excretion of levofloxacin. The solution of levofloxacin for IV administration is compatible with 0.9% sodium chloride solution, 5% dex solution throses, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). Levofloxacin solution for intravenous administration cannot be mixed with heparin and solutions having an alkaline reaction.

Patients of advanced age are used with caution (high probability of concomitant reduction in kidney function). After normalization of temperature, it is recommended to continue treatment for at least 48-78 hours. Duration of intravenous infusion of 500 mg (100 ml of infusion solution) should be at least 60 minutes. During treatment, it is necessary to avoid solar and artificial UV irradiation in order to avoid damage to the skin (photosensitization). When signs of tendinitis appear, levofloxacin is immediately discontinued.It should be borne in mind that patients with a history of brain damage (stroke, severe injury) may develop seizures, if glucose-6-phosphate dehydrogenase is insufficient, there is a risk of hemolysis. Impact on ability to drive motor vehicles and control mechanisms. occupations by potentially dangerous types of activity requiring increased concentration of attention and quickness of psychomotor reactions.