Trade name of the drug: Tavamed Active substance (INN): levofloxacin Dosage form: infusion solution Composition: 100 ml of the solution contains: active substance: levofloxacin hemihydrate -500 mg; excipients: sodium chloride - 900 mg, water for injection up to 100 ml. Description: transparent solution from pale yellow to greenish yellow. Pharmacotherapeutic group: Antibacterial synthetic agent (group of fluoroquinolones). ATX Code: J01MA12
Pharmacological properties Pharmacodynamics Tavamed is a synthetic broad–spectrum antibacterial drug from the group of fluoroquinolones containing ofloxacin as an active agent. Levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts superspiralization and crosslinking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes of microbial cells. Levofloxacin is active against most strains of microorganisms, both in vitro and in vivo. In vitro: Sensitive microorganisms (MPC ≤2 mg/l; inhibition zone ≥17 mm) – Aerobic gram-positive microorganisms: Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I) [coagulase-negative, methicillin-sensitive/-moderately sensitive)], Staphylococcus aureus methi-S (methicillin-sensitive), Staphylococcus epidermidis methi-S (methicillin-sensitive), Staphylococcus spp. CNS (coagulase negative), Streptococci groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I/S/R (penicillin-moderately sensitive/-sensitive/-resistant), Streptococcus pyogenes, Viridans streptococci peni-S/R (penicillin-sensitive/-resistant). – Aerobic gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter cloacae, Enterobacter spp., Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi -S/R (ampicillin-sensitive/-resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Moraxella catarrhalis β+/β- (producing and non-producing beta-lactamases), Morganella morganii, Neisseria gonorrhoeae non PPNG/PPNG (non-producing and producing penicillinase), Neisseria meningitidis, Pasteurella spp., Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp., Pseudomonas aeruginosa (hospital infections caused by Pseudomonas aeruginosa may require combined treatment), Pseudomonas spp., Salmonella spp., Serratia marcescens, Serratia spp. –Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus, Propionibacterium spp., Veillonella spp. – Other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp., Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp ., Ureaplasma urealyticum. Moderately sensitive microorganisms (MPC = 4 mg/l; inhibition zone 16-14 mm) – Aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant), Staphylococcus haemolyticus methi-R (methicillin-resistant). – Aerobic gram-negative microorganisms: Campylobacter jejuni/coli. – Anaerobic microorganisms: Prevotella spp., Porphyromonas spp. Levofloxacin-resistant microorganisms (MPC ≥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 gradual process of mutations of genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV. Other resistance mechanisms, such as the mechanism of influence on the penetration barriers of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of antimicrobial agent from the microbial cell), may also reduce the sensitivity of microorganisms to levofloxacin. Due to the peculiarities of the mechanism of action of levofloxacin, there is usually no cross-resistance between levofloxacin and other antimicrobial agents. Clinical efficacy (efficacy in clinical trials in the treatment of infections caused by the microorganisms listed below) – Aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes. – Aerobic gram-negative microorganisms: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens. – Others: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae. Pharmacokinetics After an intravenous 60-minute infusion of levofloxacin at a dose of 500 mg to healthy volunteers, the maximum plasma concentration (Cmax) averaged 6.2 micrograms/ml. The pharmacokinetics of levofloxacin is linear in the dose range from 50 to 1000 mg. The equilibrium state of levofloxacin concentration in blood plasma with the administration of 500 mg of levofloxacin 1 or 2 times a day is reached within 48 hours. On day 10 of intravenous administration of Tavamed 500 mg 1 time per day, the Cmax of levofloxacin was 6.4+0.8 mcg / ml, and the minimum concentration of levofloxacin (concentration before the next dose) in blood plasma (Cmin) was 0.6+ 0.2 mcg / ml. TavanikR 500 mg 2 times a day, the Cmax of levofloxacin was 7.9+1.1 mcg/ml, and the Cmin was 2.3+0.5 mcg/ml. Distribution The association with serum proteins is 30-40%. The volume of levofloxacin distribution averages 100 liters after a single and multiple intravenous injection of 500 mg, which indicates good penetration of levofloxacin into organs and tissues of the human body. Penetration into the bronchial mucosa, epithelial lining fluid, alveolar macrophages Levofloxacin penetrates well into the bronchial mucosa, epithelial lining fluid, alveolar macrophages with penetration coefficients into the bronchial mucosa and epithelial lining fluid, compared with plasma concentrations of 1.1–1.8 and 0.8–3, respectively. Levofloxacin penetrates well into the lung tissue with penetration coefficients of 2-5, compared with the concentration in blood plasma. Penetration into the alveolar fluidLevofloxacin penetrates well into the alveolar fluid with a penetration coefficient of 1, compared with plasma concentrations. When levofloxacin was administered 500 mg 1 or 2 times a day for 3 days, the maximum concentrations of levofloxacin in the alveolar fluid were reached 2-4 hours after administration and amounted to 4.0 and 6.7 mcg / ml, respectively. Penetration into bone tissue Levofloxacin penetrates well into cortical and spongy bone tissue, both in the proximal and distal parts of the femur with a penetration coefficient (bone tissue / blood plasma) of 0.1-3. Penetration into the cerebrospinal fluid Levofloxacin does not penetrate the cerebrospinal fluid well. Penetration into the prostate tissue Levofloxacin penetrates well into the prostate tissue (the average ratio of prostate/blood plasma concentrations was 1.84). Concentrations in urine High concentrations of levofloxacin are created in the urine, several times higher than the concentrations of levofloxacin in blood plasma. Metabolism Levofloxacin is metabolized to a small extent (5% of the dose taken). Its metabolites are demethylevofloxacin and levofloxacin N-oxide, which are excreted by the kidneys. Levofloxacin is stereochemically stable and does not undergo chiral transformations. Withdrawal After intravenous administration, levofloxacin is relatively slowly excreted from the blood plasma (the half-life [T1/ 2] is 6-8 hours). Excretion is mainly through the kidneys (more than 85% of the dose taken). The total clearance of levofloxacin after a single administration of 500 mg was 175+29.2 ml / min. There are no significant differences in the pharmacokinetics of levofloxacin during its intravenous administration and oral administration, which confirms that oral administration and intravenous route of administration are interchangeable. Pharmacokinetics in individual groups of patients The pharmacokinetics of levofloxacin in men and women do not differ. Pharmacokinetics in elderly patients does not differ from that in young patients, except for differences in pharmacokinetics associated with differences in creatinine clearance (CC). In renal insufficiency, the pharmacokinetics of levofloxacin changes. As renal function worsens, renal excretion and renal clearance (CIR) decrease, and T1/2 increases.
Indications for use Bacterial infections sensitive to levofloxacin in adults: – community-acquired pneumonia; – complicated urinary tract infections (including pyelonephritis); – chronic bacterial prostatitis; – infections of the skin and soft tissues; – for the complex treatment of drug-resistant forms of tuberculosis; – prevention and treatment of anthrax in the airborne pathway of infection. When using Tavamed, official national recommendations for the proper use of antibacterial drugs should be taken into account, as well as the sensitivity of pathogenic microorganisms in a particular country (see section "Special instructions").
Method of administration and dosage The dosage regimen is determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. The duration of treatment varies depending on the course of the disease. As with the use of other antibiotics, treatment with TavanikR is recommended to continue for at least 48-78 hours of reliable eradication of the pathogen. Treatment with the drug should not be interrupted or terminated prematurely without the doctor's instructions. Depending on the patient's condition, after a few days of treatment, it is possible to switch from intravenous infusion to taking the same dose of the drug in tablets (due to the fact that the bioavailability of levofloxacin when taking tablets of the drug Tavamed is 99-100%) (see the section "Pharmacokinetics"). If the administration of the drug is accidentally missed, then it is necessary, as soon as possible, to introduce the missed dose and continue to administer Tavamed in accordance with the recommended dosage regimen. Recommended dosage regimen and duration of treatment in patients with normal renal function (CC ≥ 50 ml/min) – Community-acquired pneumonia: 500 mg of levofloxacin 1-2 times a day (respectively, a daily dose of 500-1000 mg of levofloxacin) - 7-14 days. – Complicated urinary tract infections: 500 mg of levofloxacin once a day (respectively, a daily dose of 500 mg of levofloxacin) - 7-14 days. – Pyelonephritis: 500 mg of levofloxacin once a day (respectively, a daily dose of 500 mg of levofloxacin) - 7-10 days. – Uncomplicated urinary tract infections: 250 mg of levofloxacin 1 time per day (respectively, a daily dose of 250 mg of levofloxacin) - 3 days. – Chronic bacterial prostatitis: 500 mg of levofloxacin 1 time per day (respectively, the daily dose of 500 mg of levofloxacin) - 28 days; – Infections of the skin and soft tissues: 500 mg of levofloxacin 1-2 times a day (respectively, a daily dose of 500-1000 mg of levofloxacin) - 7-14 days. – Complex treatment of drug-resistant forms of tuberculosis: 500 mg of levofloxacin 1-2 times a day (respectively, a daily dose of 500-1000 mg of levofloxacin) - up to 3 months. – Prevention and treatment of anthrax in the airborne pathway of infection: 500 mg of levofloxacin 1 time per day (respectively, a daily dose of 500 mg of levofloxacin) - for up to 8 weeks. Dosage regimen in patients with impaired renal function (CC < 50 ml / min) Levofloxacin is excreted mainly through the kidneys, therefore, in the treatment of patients with impaired renal function, it is necessary to reduce the dose of the drug (see the table below).
Dosage regimen Creatinine clearance (CC) Dosage regimen of the drug Tavamed Recommended dose for CC 50 ml/min: 250 mg/ 24 h Recommended dose for CC 50 ml/min: 500 mg/ 24 h Recommended dose for CC 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 zhatem By 125/12 h < 10 ml/min. (including hemodialysis and PAPD1 first dose: 250 mg then 125 mg / 48 h. the first dose: 500 mg then 125 mg / 24 h first dose: 500 mg then By 125/24 h
1 = no additional doses are required after hemodialysis or permanent outpatient peritoneal dialysis (PAPD). Dosage regimen in patients with impaired liver function In case of impaired liver function, no correction of the dosage regimen is required, since levofloxacin is only slightly metabolized in the liver. Dosage regimen in elderly patients For elderly patients, no correction of the dosage regimen is required, except in cases of a decrease in CC to 50 ml / min and below. Method of application The infusion solution of the drug Tavamed is administered once or twice a day. The infusion solution of the drug Tavamed 500 mg is administered SLOWLY intravenously drip. The duration of infusion of 1 vial of Tavamed 500 mg solution (100 ml with 500 mg of levofloxacin) should be at least 60 minutes, in the case of administration of half a vial (50 ml with 250 mg of levofloxacin), the duration of infusion should be at least 30 minutes (see section "Special instructions"). Tavamed, infusion solution, 500 mg is compatible with the following infusion solutions: 0.9% sodium chloride solution, 5% dextrose solution, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). The solution of the drug Tavamed 500 mg should not be mixed with heparin or solutions having an alkaline reaction (for example, with a solution of sodium bicarbonate). After removing the vial from the cardboard pack, the infusion solution can be stored in room light without light protection for no more than 3 days!
Side effect The following side effects are presented in accordance with the following gradations of their frequency: very frequent (≥1/10); frequent (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000) (including individual reports); unknown frequency (according to available data, it is not possible to determine the frequency of occurrence). Data obtained in clinical trials and post-marketing use of the drug Disorders of the heart Rare: sinus tachycardia, palpitation sensation. Unknown frequency (post-marketing data): prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the "pirouette" type, which can lead to cardiac arrest (see sectionsOverdose≫, ≪Special instructions≫). Disorders of the blood and lymphatic system Infrequent: leukopenia (decrease in the number of leukocytes in peripheral blood), eosinophilia (increase in the number of eosinophils in peripheral blood). Rare: neutropenia (decrease in the number of neutrophils in peripheral blood), thrombocytopenia (decrease in the number of platelets in peripheral blood). Unknown frequency (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 Frequent: headache, dizziness. Infrequent: drowsiness, tremor, dysgeusia (perversion of taste). Rare: paresthesia, convulsions (see section "Special instructions"). Unknown frequency (post-marketing data): peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see section "Special instructions"), dyskinesia, extrapyramidal disorders, loss of taste sensations, parosmia (disorder of the sense of smell, especially subjective sense of smell, objectively absent), including loss of sense of smell, syncope, benign intracranial hypertension. Visual organ disordersVery rare: visual disturbances, such as blurring of the visible image. Unknown frequency: transient vision loss.
Hearing disorders and labyrinthine disorders Infrequent: vertigo (feeling of deflection or circling of one's own body or surrounding objects). Rare: tinnitus. Unknown frequency (post-marketing data): hearing loss, hearing loss. Disorders of the respiratory system, chest and mediastinal organs Infrequent: shortness of breath. Unknown frequency (post-marketing data): bronchospasm, allergic pneumonitis. Disorders of the gastrointestinal tract Frequent: diarrhea, vomiting, nausea. Infrequent: abdominal pain, dyspepsia, flatulence, constipation. Unknown frequency (post-marketing data): hemorrhagic diarrhea, which in very rare cases may be a sign of enterocolitis, including pseudomembranous colitis (see section "Special instructions"); pancreatitis. Disorders of the kidneys and urinary tract Infrequent: increased serum creatinine concentration. Rare: acute renal failure (for example, due to the development of interstitial nephritis). Disorders of the skin and subcutaneous tissues Infrequent: rash, itching, urticaria, hyperhidrosis. Unknown frequency (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 the first dose of the drug is administered. Disorders of the musculoskeletal system and connective tissue Infrequent: arthralgia, myalgia Rare: tendon damage, including tendinitis (for example, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudoparalytic myasthenia gravis (see the section "Special instructions"). Unknown frequency (post-marketing data): rhabdomyolysis, tendon rupture (for example, Achilles tendon. This side effect may occur within 48 hours after the start of treatment and may be bilateral in nature (see also section "Special instructions")), ligament rupture, muscle rupture, arthritis. Metabolic and nutritional disorders Infrequent: anorexia. Rare: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling). Unknown frequency: hyperglycemia, hypoglycemic coma (see section "Special instructions"). Infectious and parasitic diseases Infrequent: fungal infections, development of resistance of pathogenic microorganisms. Vascular disorders Frequent: phlebitis. Rare: decreased blood pressure. General disorders and disorders at the injection site Frequent: reaction at the injection site (soreness, hyperemia of the skin). Infrequent: asthenia. Rare: pyrexia (increase in body temperature). Unknown frequency: pain (including pain in the back, chest, limbs). Disorders of the immune system Rare: angioedema. Unknown frequency (post-marketing data): anaphylactic shock, anaphylactoid shock. Anaphylactic and anaphylactoid reactions can sometimes develop even after the first dose of the drug is administered. Disorders of the liver and biliary tract Frequent: increased activity of liver enzymes in the blood (for example, alanine aminotransferase (AlAT), aspartate aminotransferase (AsAT)), increased activity of alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT). Infrequent: increased concentration of bilirubin in the blood. Unknown frequency (post-marketing data): severe hepatic insufficiency, including cases of acute hepatic insufficiency, sometimes with fatal outcome, especially in patients with severe underlying disease (for example, in patients with sepsis); hepatitis, jaundice. Mental disorders Frequent: insomnia. Infrequent: feeling of anxiety, anxiety, confusion. Rare: mental disorders (e.g. hallucinations, paranoia), depression, agitation (arousal), sleep disturbances, nightmares. Unknown frequency (post-marketing data): mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicidal attempts. Other possible undesirable effects related to all fluoroquinolones Very rare: attacks of porphyria (a very rare metabolic disease) in patients with porphyria.
Contraindications – hypersensitivity to levofloxacin or to other quinolones, as well as to any of the excipients of the drug Tavamed; – epilepsy; – tendon lesions with the use of fluoroquinolones in the anamnesis; – pseudoparalytic myasthenia gravis (see sections "Side effect", "Special instructions"); – children and adolescents under 18 years of age (due to the incompleteness of skeletal growth, since the risk of damage to cartilaginous growth points cannot be completely excluded); – pregnancy (the risk of damage to cartilaginous growth points in the fetus cannot be completely excluded); – the period of breastfeeding (it is impossible to completely exclude the risk of damage to the cartilaginous points of bone growth in a child);
With caution – In patients predisposed to the development of seizures [in patients with previous lesions of the central nervous system (CNS), in patients simultaneously taking drugs that lower the threshold of convulsive readiness of the brain, such as fenbufen, theophylline] (see the section "Interaction with other drugs"). – 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 (mandatory monitoring of renal function is required, as well as correction of the dosage regimen, see the section "Method of administration and doses"). – In patients with known risk factors for prolongation of the QT interval: in elderly patients; in female patients, in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia); with congenital prolongation of the QT interval syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); while taking medications, capable of prolonging the QT interval (antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, neuroleptics) (see sections ≪Overdose≫, ≪Interaction with other drugs≫, ≪Special instructions≫).–In patients with diabetes mellitus receiving treatment with oral hypoglycemic drugs, for example, glibenclamide or insulin preparations (the risk of hypoglycemia increases). – In patients with diabetes mellitus receiving treatment with oral hypoglycemic drugs, for example, glibenclamide or insulin preparations (the risk of hypoglycemia increases). – In patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions when using levofloxacin). – In patients with psychosis or in patients with a history of mental illness (see the section "Special instructions").
Drug interactions Interactions requiring caution With theophylline, fenbufen or similar drugs from the group of nonsteroidal anti-inflammatory drugs that reduce the threshold of convulsive readiness of the brain The pharmacokinetic interaction of levofloxacin with theophylline has not been revealed. However, with the simultaneous use of quinolones and theophylline, nonsteroidal anti-inflammatory drugs and other drugs that reduce the threshold of convulsive readiness of the brain, a marked decrease in the threshold of convulsive readiness of the brain is possible. The concentration of levofloxacin with simultaneous administration of fenbufen increases only by 13%. With indirect anticoagulants (vitamin K antagonists) In patients taking levofloxacin in combination with indirect anticoagulants (for example, warfarin), there was an increase in prothrombin time / international normalized ratio and/or the development of bleeding, including severe. Therefore, with the simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood clotting indicators is necessary. With probenecid and cimetidine With the simultaneous use of drugs that violate renal tubular secretion, such as probenecid and cimetidine, and levofloxacin, caution should be exercised, especially in patients with renal insufficiency. The excretion (renal clearance) of levofloxacin slows down under the action of cimetidine by 24% and probenecid by 34%. It is unlikely that this may have clinical significance in normal renal function. With cyclosporine Levofloxacin 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 glucocorticosteroids increases the risk of tendon rupture. With medications that lengthen the QT interval Levofloxacin, like other fluoroquinolones, should be used with caution in patients taking drugs that prolong the QT interval (for example, antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, neuroleptics). Other Clinical and pharmacological studies conducted to study possible pharmacokinetic interactions of levofloxacin with calcium carbonate, digoxin, glibenclamide, ranitidine and warfarin have shown that the pharmacokinetics of levofloxacin when used concomitantly with these drugs does not change sufficiently for it to have clinical significance.
Special instructions Hospital infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) may require combined treatment. The prevalence of acquired resistance of the germinated 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 if treatment is ineffective, a microbiological diagnosis should be established with the isolation of the pathogen and determination of its sensitivity to levofloxacin. Methicillin-resistant Streptococcus aureus There is a high probability 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, if laboratory tests have not confirmed the sensitivity of this microorganism to levofloxacin Duration of infusions It is necessary to strictly adhere to the recommended duration of administration, which should be at least 60 minutes (for 100 ml of infusion solution) or 30 minutes (for 50 ml of solution). The experience of using levofloxacin shows that during the infusion, there may be an increased heartbeat and a transient decrease in blood pressure. In rare cases, there may be vascular collapse. If there is a marked decrease in blood pressure during the infusion of levofloxacin, the infusion is stopped immediately.
Patients predisposed to the development of 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 traumatic brain injury; patients simultaneously taking drugs that lower the threshold of convulsive readiness of the brain, such as fenbufen and other similar nonsteroidal anti-inflammatory drugs or other drugs that lower the threshold of convulsive readiness, such as theophylline (see section ≪Interaction with other medicines≫). Pseudomembranous colitis Diarrhea developed during or after treatment with levofloxacin, especially severe, persistent and/or with blood, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. If pseudomembranous colitis is suspected, treatment with levofloxacin should be stopped immediately and specific antibiotic therapy (vancomycin, teicoplanin or metronidazole inside) should be started immediately. Drugs that inhibit intestinal peristalsis are contraindicated. Tendinitis Rarely observed tendinitis with the use of quinolones, including levofloxacin, can lead to rupture of tendons, including the Achilles tendon. This side effect may develop within 48 hours after the start of treatment and may be bilateral. Elderly patients are more predisposed to the development of tendinitis. The risk of tendon rupture may increase with simultaneous administration of glucocorticosteroids. If tendinitis is suspected, treatment with Tavamedi should be stopped immediately and appropriate treatment of the affected tendon should be initiated, for example, by ensuring sufficient immobilization (see sections ≪Contraindications≫ and ≪Side effect≫). Hypersensitivity reactions Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (angioedema, anaphylactic shock) (see the section "Side effect"). Patients should immediately stop the administration of the drug and consult a doctor. Severe bullous reactions When taking levofloxacin, there have been cases of severe bullous skin reactions, such as Stevens-Johnson syndrome or toxicundeclared (CM. (see below). In the case of the developed cakih-libo reaction with storon, the skin or the mucisticle of the obolochek patient do not slowly revert to the Vratsa and do not extend the treatments to the ego consultations. Transgressions co storon. baked and jellied. waterfucking putey I have reported cases of advanced pecan necrosis, including the development of fatal pecan necrosis with levofloxacin changes, the main picture of the patient with tjaeldel'maelm'saelm, e.g. with sepsis (CM). (see below). Patient. below.
Patient aposematic How to treat levofloxacin, how to treat a patient with a function disorder, how to treat a function disorder, how to treat a function disorder, how to control a function disorder, how to treat a dosage regimen (CM. tab (mode of changes and dosage). In the treatment of a patient with an increased risk, the name of the patient should be noted in this group. tab (mode of changes and dosage). Pre-treatment developed reaction photosensitization Hot photosensitization in levofloxacin changes the eye rarely, if the developed patient does not change the time of treatment and in the course of 48 hours after the final treatment levofloxacin is subject to treatment without special needs, strong solnechnomatous or severe ultracephalitis (e.g., visit solnaria). Superinfection How and when replacing other antibiotics, levofloxacin, especially over a very long time, you can lead to increased reproduction of the insensitive microorganism (bacterium and Gribov), which you can in aposematicvat changed microflora. In the result you can develop superinfection. During the course of the treatments, the patient is evaluated again and, in the case of the developed over-time treatments, the superinfections follow the appropriate measurement. Woodline interval In the case of a patient, I have seen a few cases of the same period. ftorquinolone, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for prolongation of the QT interval: in elderly patients; in patients with uncorrected electrolyte disorders (with hypokalemia, hypomagnesemia); with congenital prolongation of the QT interval syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); with simultaneous take medications that can prolong the QT interval, such as antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, neuroleptics. Elderly and female patients may be more sensitive to drugs that lengthen the QT interval. Further follow-up with precision in NIH ftorhinolone, including levofloxacin (CM. sections ≪caution≫, ≪Method of application and dose≫, ≪Side effects≫, ≪Overdose≫ and ≪Interaction with other drugs≫). Patient with glucose-6-phosphatdegydrogenase deficiency. In a patient with latent or demonstrable fluconazole glucose-6-phosphatdegydrogenase fluconazole deficiency, the name has been shown to preclude gemolytic reactions to quinolones and to be followed with caution to levofloxacinoma. Hypo and hyperglycaemia (dysglycaemia) In addition to other quinolone, in addition to levofloxacin, cases of giperglycaemias and gipoglycaemias have been observed, especially in patients with diabetes mellitus with diabetes mellitus receiving timely treatment with oral gipoglycaemic agents (e.g. glibenclamidoma) or insulin preparations. I reported the case to the developed gipoglycemic comma. In a patient with diabetes mellitus, glucose concentrations were monitored in the blood (CM). (see below).
Peripheric neiopathy In patients using ftorhinolone, including levofloxacin, check the sensornaya and sensoromotor peripherial neiopathy, home kotoroi can be B. As a result, the patient appears symptomateddevelopmental neyropathies, levofloxacin substitution is lower than normal. Empirically, it is possible to minimize the risk of development irreversibly. Exacerbation of pseudoparalytic myasthenia (Apostille) Ftorquinolone Apostille, including levofloxacin, characterized by blocking neuro-manguage conduct activity, and may increase the extemporaneous weakness in patients with pseudoparalytic myasthenia. In the postmarketing period, there have been observed adverse events, including Lego deficiency, the need for proper ventilation of legkih, and a smerteleinergy ischod, Kotor evaluative association with ftorhinolone replacement in patients with pseudoparalytic myasthenia. Replacement of levofloxacin in the patient with a well-established transgendered diagnosis of pseudoparalytic myasthenia did not change (CM. (see below). Prophylaxis and treatment of Siberian ulcer. The use of levofloxacin in humans for this indication is based on data on the sensitivity of Bacillus anthracis to it, obtained in in vitro studies and in experimental studies conducted on animals, as well as on limited data on the use of levofloxacin in humans. Attending physicians should refer to national and/or international documents that reflect the point of view developed by joint efforts on the treatment of anthrax. Psychotic reactions In the case of quinolone replacement, including levofloxacin, general development of psychotic reactions, Kotor, in rare cases, I progressed to the development of suicidal behaviour. In the development of such a reaction treatment levofloxacinoma, then discontinue and appoint appropriate treatment. Follow with precision appoint a drug patient with psychoses or a patient named in Anamnesis mental illness. Visual disturbances In the development of lovemandh visual disturbance necessary non-medial consultation ophthalmologist (CM. (see below). Influence of labrange test. In patients using levofloxacin, the definition of opiate in Moche can be applied to the results of the conference will be published in the following pages: Levofloxacin can ingibirovate Rostaexpress and bring it to the end of the day in the negative of the transgenic result of the bacteriological diagnosis of tuberculosis. Change in bremenization and lactation period Tavamed contra-indicated for the changes in beremenn Urgh and steering tuberous womanstin. Influence of the ability to drive a car and complex paragliding mechanisms Takye pobochna wawrabefefect, the preparation of Tavamed, how the goal or vertigo, sleepiness and racial adjustment of the vision (CM. (see section), can reduce psychomotor excitability and ability to concentrate attention. You can pose a certain amount of risk in situations where the paragliding abilities are of particular importance (e.g., in driving a car, in servicing a machine and a mechanism, in in the Apostille and working in unstable situations).
Peredosis Symptomservices Based on the data obtained in toxicological studies on animals, the most important expected symptoms of acute overdose of Tavamed are symptoms from the central nervous system (disorders of consciousness, including confusion, dizziness and convulsions). In post-marketing adjustments, the preparation in peredozirovka observed empirfect, co-storon, central nervous system, including conjugation, sudorogi, gallucination and tremor. Possible development of thosnot aposematic and aposematic. In clinical-pharmacological and post-mortem studies, I have conducted on the fluconazole dosages of levofloxacin, translating the therapeutic, B Apostille, indicated by the line of the Apostille interval. Treatment of peredoses In the case of referrals, the patient shall be monitored closely, including EXTRAVEX monitoring. Treatment symptomatic. Levofloxacin is not excreted by dialysis (gemodialysis, peritoneal dialysis and permanent outpatient peritoneal dialysis). The specific antidote didn't work.
Shape in aposematic In polymerna urgane vial around P. P. low tops of 100 ml. 1 vial with instructions on medical procedure in cardboard patchou.
Feeding conditions Eat in dry and protected from the world, at a temperature of up to 25. Eat in an uncomplicated place.
Shelf life 2 years. Do not follow the date of expiration.
Terms of leave from pharmacy Recipe.
Manufacturer JEDUX PARENTERAL PVT. LTD., India
Owner registration certificates HARASHA PHARMA PVT. LTD., India
Name and address organizations making claims (proposals) for quality medicinal products of territories Republic of Uzbekistan «FUTURE-WORLD GROUP» Republic of Uzbekistan, Tashkent, Chilanzarsky r-n, str. Sanyat 13A. Tel.:+99891 134 94 14 E-mail: info.fwg@yandex.com
