LEVOPIR [levofloxacin CP] 500 mg IV solution
LEVOPIR
instructions for the medical use of the medicinal product
Trademark
Levopir, Levopir
International non-proprietary name or generic name
Levofloxacin, Levofloxacin
Composition
Each vial (100 ml solution) contains:
active substance: levofloxacin (in the form of levofloxacin lactate) SR 500 mg
excipients: sodium chloride, water for injection.
Dosage form
Solution for infusion.
Pharmacotherapeutic group
Antimicrobial agents - fluoroquinolones.
Pharmacological properties
Levopyr is a synthetic broad-spectrum antibacterial drug from the group of levorotatory isomers of ofloxacin. The active substance is levofloxacin.
Pharmacodynamics
Levofloxacin blocks DNA gyrase, disrupts superspiration and cross-linking of DNA breaks, inhibits DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall, and membranes.
Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.
Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S (I), Staphylococcus aureus methi-S, Stacococcus epidermidis methi-S, Staphylococcus spp. (CNS), Streptococcus Group C and G, Streptococcus Agalactiae, Streptococcus Pneumoniae Peni I/S/R, Streptococcus Pyogenes, Viridans Streptococci Peni-S/R.
Aerobic gram-negative organisms: Acinetobacter baumannil, Acinetobacter spp, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter spp, Escherichia coli, Gardnerella hapinomycetemcomitans, Haemophilus vaginal influenzae, Haemophilus influenzae, influenzae Parainfluenza Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp, Moraxela catarrhalis (3+/p-, Morganella morganii, Neisseria gonorrhoeae non PPNG/PPNG, Neisseria meningitidis, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus Mirabilis, Proteus Vulgaris, Providencia Rettgeri, Providencia Stuartii, Providencia spp, Pseudomonas Aeruginosa, Pseudomonas spp, Salmonella spp, Serratia Marcescens, Serratia spp.
Anaerobic microorganisms: Bacteroides Fragilis, Bifidobacterium spp, Clostridium Perfringens, Fusobacterium spp, Peptostreptococcus, PropioniBacterum spp, Veilonella 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, Ricketsia spp, Ureaplasma urealyticum.
Pharmacokinetics
The pharmacokinetics of levofloxacin with single and repeated administration of the drug is linear.
After an intravenous infusion of levofloxacin at a dose of 500 mg for 1 hour, the average Cmax in plasma was 6.2±1.0 μg/ml, Tmax - 1.0±0.1 h.
Plasma protein binding - 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, urinary organs, bone tissue, cerebrospinal fluid, prostate gland, polymorphic leukocytes, alveolar macrophages.
In the liver, a small portion is oxidized and/or deacetylated.
After intravenous administration at a dose of 500 mg, T1 / 2 is 6.4 ± 0.7 hours. It is excreted from the body mainly by the kidneys by glomerular filtration and tubular secretion. Renal clearance is 70% of the total clearance. Less than 5% of levofloxacin is excreted as metabolites. In the urine within 24 hours, 70% is found unchanged, and after 48 hours - 87% of the administered dose. In the stool within 72 hours, 4% of the administered intravenous drug per dose is detected.
Indications for use
Infectious and inflammatory diseases of mild and moderate severity caused by susceptible pathogens:
• community-acquired pneumonia;
• as part of complex therapy for drug-resistant forms of tuberculosis;
• complicated kidney and urinary tract infections, including pyelonephritis;
• uncomplicated urinary tract infections;
• prostatitis;
• septicemia/bacteremia associated with the above indications;
• intra-abdominal infections.
Contraindications
• hypersensitivity to levofloxacin or other quinolones;
• epilepsy;
• tendon lesions in previous treatment with quinolones;
• children's and adolescence up to 18 years;
• pregnancy, breastfeeding period.
Method of application and dosage
The drug is administered intravenously.
Therapy begins with intravenous drip (within 30-60 minutes) administration of the drug at a dose of 250-500 mg 1-2 times / day. The treatment regimen depends on the indications and the clinical situation.
With positive dynamics of the patient's clinical condition, after a few days of treatment, it is possible to switch from intravenous drip to oral administration of the drug in the same dose.
Patients with impaired renal function require correction of the dosing regimen, depending on the size of the CC.
The duration of treatment, depending on the course of the disease, is not more than 14 days (with the exception of bacterial prostatitis).
Treatment is recommended to continue for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen.
Special instructions and precautions
Caution should be used in patients with renal insufficiency, in elderly patients due to the high probability of a concomitant decrease in kidney function, as well as in glucose-6-phosphate dehydrogenase deficiency.
During treatment, it is necessary to avoid solar and artificial UV radiation in order to avoid damage to the skin (photosensitivity).
If signs of tendinitis appear, Levopir is immediately canceled. It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), seizures may develop, and with deficiency of gluco-6-phosphate, the risk of hemolysis.
Influence on the ability to drive vehicles and mechanisms
Use with caution in patients whose activities are associated with the need for increased concentration of attention and speed of psychomotor reactions.
Use during pregnancy or lactation
The use is contraindicated during pregnancy and during breastfeeding.
Interaction with other drugs
There are reports of a pronounced decrease in the threshold for convulsive readiness with the simultaneous use of quinolones and substances that can, in turn, reduce the cerebral threshold for convulsive readiness. This also applies to the simultaneous use of quinolones and theophylline.
The action of levofloxacin is significantly weakened when used simultaneously with sucralfate. The same thing happens with the simultaneous use of magnesium or aluminum-containing antacids, as well as iron salts. Levofloxacin should be taken at least 2 hours before or 2 hours after taking these drugs.
With the simultaneous use of vitamin K antagonists, control of the blood coagulation system is necessary.
Excretion (renal clearance) of levofloxacin slows down somewhat under the action of cimetidine and problecid. It should be noted that this interaction has practically no clinical significance. However, with the simultaneous use of drugs such as probenecid and cimetidine, which block a certain route of excretion (channel of secretion), treatment with levofloxacin should be carried out with caution. This applies primarily to patients with limited renal function.
Levofloxacin slightly increases T1 / 2 of cyclosporine.
Taking corticosteroids increases the risk of tendon rupture.
By-effect
From the digestive system: nausea, vomiting, diarrhea, anorexia, abdominal pain, pseudomembranous enterocolitis, increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.
From the side of the cardiovascular system: lowering blood pressure, vascular collapse, tachycardia.
From the side of metabolism: hypoglycemia (increased appetite, sweating, trembling).
From the side of the central nervous system and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesia, anxiety, fear, hallucinations, confusion, depression, movement disorders, convulsions.
From the senses: impaired vision, hearing, smell, taste and tactile sensitivity.
From the musculoskeletal system: arthralgia, malgia, tendon rupture, muscle weakness, tendinitis.
From the urinary system: hypercreaticinemia, interstitial nephritis.
On the part of the hematopoietic system: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.
Dermatological reactions: photosensitivity, itching, swelling of the skin and mucous membranes, Stevens-Johnson syndrome, Lyell's syndrome.
Allergic reactions: urticaria, bronchospasm, dyspnea, anaphylactic shock, allergic pneumonitis, vasculitis.
Overdose
Symptoms: dizziness, confusion, lethargy, anxiety, drowsiness, vomiting.
Treatment: gastric lavage, symptomatic therapy.
Storage conditions
Store in a cool and dry place at a temperature not exceeding 30°C.
Keep out of the reach of children.
Best before date
3 years. Do not use after the expiry date stated on the package.
Recreation conditions
Recipe recommended.
Release form
1 bottle 100 ml with instructions for use in a cardboard box.