Korfetsin-solofarm drops Ch. 0.5% 5ml vial 1 piece

$2.72

Korfetsin-solofarm drops Ch. 0.5% 5ml vial 1 piece

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Description

Composition
Active substance:
1 ml solution contains:
Levofloxacin hemihydrate levofloxacin based on 5.0 mg.
Excipients:
Benzalkonium chloride 0.05 mg Sodium chloride 9.0 mg, 1 M hydrochloric acid solution or 1 M sodium hydroxide solution to a pH of 6.0 -7.0, Water for injection to 1.0 ml.
Description:
The clear solution is yellow or yellowish-green color.
Product form:
0.5% eye drops.
5 ml in a vial with a dropper of low density polyethylene and the lid from the first control opening of the vial or dropper, high density polyethylene together with the lid and screwed plug-dropper. 1 bottle together with instructions for use in a stack of cardboard.
Contraindications
Hypersensitivity to levofloxacin or any of the components of the drug as well as other quinolones.
Carefully
Childhood.
Dosage
5 mg / ml
Indications
Surface treatment of bacterial eye infections caused by susceptible microorganisms, in adults and children older than 1 year.
Prevention of complications after surgical and laser eye surgery.
Interaction with other drugs
Special studies on the interaction of the drug is not performed. Because the maximum concentration in plasma levofloxacin after topical application in the eye at least 1000 times lower than after ingestion of standard doses inwardly, interaction with other drugs for systemic use characteristic likely clinically insignificant.
Overdose
Total levofloxacin contained in one bottle of eye drops, is too small to cause toxic reactions even after accidental ingestion. After topical administration of an excess dose eye drug should be rinsed with clean (tap) water at room temperature.
pharmachologic effect
Pharmacological group:
The antimicrobial agent – fluoroquinolone.
Pharmacodynamics:
Levofloxacin – a L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin relates mainly to the L-isomer. As an antibacterial drug class of fluoroquinolones, levofloxacin blocking DNA gyrase (topoisomerase II) and topoisomerase IV, and crosslinking gives supercoiling of DNA breaks (deoxyribonucleic acid) inhibits the synthesis of DNA, causes profound morphological change in the cytoplasm, the cell wall and membranes. The mechanism of development of resistance to levofloxacin resistance may develop, primarily, by two basic mechanisms, namely the decrease in intracellular concentration of the drug or a change in the target of the drug. Changing the targets – two bacterial enzyme DNA gyrase and topoisomerase IV are the result of mutations in chromosomal genes encoding DNA gyrase (gyrA and gyrB) and topoisomerase IV (rarS and parE; grlA and grlB in Staphylococcus aureus). The stability of the drug due to the low intracellular concentrations develops as a result of changes in the outer cell membrane porin channel system, leading to a decrease in fluoroquinolone Incoming negative bacteria, or by efflux pumps. Efflux-mediated resistance is described in relation to pneumococci (PmrA), staphylococci (NorA), anaerobic and gram-negative bacteria. Plasmid mediated resistance to quinolones (determined on the basis qnr gene) was detected in respect of Klebsiella pneumoniae and Escherichia coli. Perhaps the development of cross-resistance between fluoroquinolones. Single mutations may not result in clinical stability, but multiple mutations cause clinical resistance to all drugs within the fluoroquinolone class. Subject to changes in outer membrane porins and efflux systems may have a broad substrate specificity, affecting several classes of antibacterial agents and leading to multiple resistance. Established in vitro and in clinical studies confirmed the effectiveness against gram-positive aerobes – Enterococcus faecalis. Staphylococcus aureus (methicillin-susceptible strains), Staphylococcus epidermidis (methicillin-susceptible strains), Staphylococcus saprophyticus, Streptococcus pneumoniae (incl multidrug strains -MDRSP..), Streptococcus pyogenes; Gram-negative aerobes – Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus paraintluenzae, Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, and other microorganisms – Chlamydia pneumoniae, Mycoplasma pneumoniae. For most (> 90%) strains of the following in vitro microbial set minimum inhibitory concentration of levofloxacin (2 ug / ml and less), but the efficacy and safety of clinical application of levofloxacin in the treatment of infections caused by these agents has not been established in adequate and well-controlled studies : gram-positive aerobes – Staphylococcus haemolyticus, Streptococcus (group C / F), Streptococcus (group G), Streptococcus agalactiae, Streptococcus milleri. Streptococcus viridans; Gram-negative aerobes – Acinetobacter lwoffii, Acinetobacter baumannii, Bordetella pertussis, Citrobacter (diversus) koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella morganii, Pantoea (Enterobacter) agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens ; Gram-positive anaerobic bacteria – Clostridium perfringens. Sensitive microorganisms: Aerobic gram-positive microorganisms – Corynebacterium diphtheriae, Enterococcus spp, including Enterococcus faecalis, Listeria monocytogenes, Staphylococcus spp.. (Coagulase metitsillinchuvstvitelnye / leykotoksinsoderzhaschie / moderately sensitive strains), including Staphylococcus aureus (metitsillinchuvstvitelnye strains), Staphylococcus epidermidis (metitsillinchuvstvitelnye strains), Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penitsillinchuvstvitelnye / moderately sensitive / resistant strains), Streptococcus pyogenes, Streptococcus spp. group viridans (penicillin sensitive / resistant strains); aerobic gram-negative organisms -. Acinetobacter spp, including Acinetobacter baumannii, Acinetobacillus actinomycetecomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp, including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae. (ampicillin-sensitive / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp., including Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis (producing and producing no beta-lactamase producing strains), Morganella morganii, Neisseria gonorrhoeae (producing and producing no penicillinase strains), Neisseria meningitidis, Pasteurella spp., including Pasteurella can is, Pasteurella dagmatis, Pasteurella multocida, Proteus vulgaris, Providencia spp., including Providencia rettgeri, Providencia stuartii, Pseudomonas spp., including Pseudomonas aeruginosa, Serratia spp., including Serratia marcescens, Salmonella spp .; anaerobic microorganisms – Bacteroides fragilis, Bifidobacterium spp, Clostridium perfringens, Fusobacterium spp, Peptostreptococcus spp, Propionibacterium spp, Veilonella spp .;…. other microorganisms – Bartonella spp, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp, Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae… Rickettsia spp., Ureaplasma urealyticum. Moderately sensitive microorganisms (MIC more than 4 mg / l): aerobic microorganisms grampolozhitelnye – Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium. Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains); gramotritsatelnye aerobic microorganisms – Burkhoideria cepacia, Campylobacter jejuni, Campylobacter coli; anaerobic organisms – Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp, Porphyromonas spp.. Resistant microorganisms (MIC more than 8 mg / ml) were: Aerobic Gram-positive microorganisms – Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp. (Coagulase methicillin-resistant strains); aerobic Gram-negative organisms – Alcaligenes xylosoxidane; other microorganisms – Mycobacterium avium. In vitro activity of levofloxacin is approximately 2 times higher than for ofloxacin against representatives of Enterobacteriaceae, Pseudomonas aeruginosa and gram-positive microorganisms. In the case of levofloxacin in the treatment of chlamydial eye diseases that require concomitant therapy. The degree of susceptibility of microorganisms to levofloxacin can have significant geographical differences. The maximum concentration of levofloxacin achieved by using eye drops of 0.5%, greater than 100 times the value of the minimum inhibitory concentration (MIC) of levofloxacin sensitive microorganisms.
Pharmacokinetics:
After instillation into the eye levofloxacin is well maintained in the tear film.
Levofloxacin concentration in tear fluid after a single dose (1 drop) rapidly reaches high values ​​and is held at a level for at least 6 hours above the minimum inhibitory concentration for the most sensitive ocular pathogens (less than or equal to 2 mcg / ml). In studies in healthy volunteers have shown that the mean levofloxacin concentration in the tear film, as measured at 4 and 6 hours after topical application amounted to 17.0 .mu.g / ml and 6.6 ug / ml, respectively. Five of the six volunteers levofloxacin concentrations were 2 mg / ml or higher after 4 hours after instillation. Four of the six volunteers, this concentration has remained at 6 hours after instillation. Average concentrations of levofloxacin in plasma 1 hour after the application – from 0.86 ng / ml in 1-th day to 2.05 ng / ml. Maximum concentration in plasma levofloxacin, equal to 2.25 ng / ml detected on day 4 after two days of the drug every 8 hours prior to 2 times per day. The maximum concentrations of levofloxacin, achieved on the 15 th day, more than 1000 times lower than the concentrations that have been observed after oral administration of standard doses of levofloxacin.
Pregnancy and breast-feeding
Pregnancy
There is insufficient data on the use of levofloxacin in pregnant women.
The results of the preclinical studies do not indicate direct or indirect adverse effects with respect to toxic effects on reproduction and fetal development. The potential risk for humans is unknown drug. Levofloxacin eye drops can be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Levofloxacin enters the breast milk. However, when used in therapeutic doses of levofloxacin, effects on the infant are not expected. Levofloxacin eye drops can be used during breast-feeding if the potential benefit to the mother outweighs any possible risk to the infant.
fertility
After topical levofloxacin not cause deterioration of fertility in rats when exposed to significantly exceeding the maximum human dose.
Conditions of supply of pharmacies
Prescription.
side effects
The frequency of adverse reactions during therapy levofloxacin was about 10%. In most cases, the severity of adverse reactions ranged from mild to moderate; adverse reactions were observed mainly on the part of the organ of vision. Information about adverse events were obtained in clinical trials and on post-application.
Violations by the immune system:
Rare: systemic allergic reactions, including skin rash.
Very rare: anaphylactic shock.
Disorders of the nervous system:
Uncommon: headache.
Violations by the organ of vision:
Common: burning sensation in the eye, reduced vision, filamentous mucous discharge in the conjunctival cavity.
Uncommon: chemosis, conjunctival injection, papillary conjunctivitis, eyelid edema, erythema of eyelid, discomfort in the eye, itching of the eye, eye pain, syndrome of “dry” eyes, photophobia.
Violations by the respiratory, thoracic and mediastinal disorders:
Uncommon: Rhinitis.
Very rare: swelling of the larynx.
The profile of adverse events when using the drug in the pediatric population is comparable to the adult population.
special instructions
The drug should not be administered subconjunctivally in the anterior chamber of the eye. The drug should not be used while wearing hydrophilic (soft) contact lenses due to the presence of the preservative benzalkonium chloride, which may be absorbed by contact lenses and have an adverse effect on the eye tissue, and may cause discoloration of contact lenses. To avoid contamination of the dropper tip and solution, with instillation should not touch the eyelids and tissues around the eyes. Long-term treatment with levofloxacin (as well as other antibiotics) is possible overgrowth of non-susceptible organisms, including fungal flora. In case of deterioration of the disease or lack of improvement in the application of levofloxacin to cancel therapy levofloxacin and go to therapy antibacterial agents other groups, carrying the extended ophthalmologic examination including biomicroscopy and fluorescein test. Information about the efficacy and safety of levofloxacin in the treatment of corneal ulcers are absent. During clinical studies have indicated formation of precipitates of the cornea.
Effects on ability to drive vehicles and mechanisms:
The drug has no significant effect on the ability to drive vehicles, machinery. Immediately after instillation may temporarily blurred vision. It is not recommended to drive and engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions to restore the clarity of visual perception.
Storage conditions
Store at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
Locally, in the affected eye. Duration of treatment is determined by the severity of the condition, its clinical and bacteriological characteristics. The average duration of a course of therapy is 5 days. 1-2 drops in the affected eye (s) every two hours up to 8 times per day during wakefulness during the first 2 days, then 4 times a day from the 3rd to 5th days. When applying multiple drugs instillation interval between them should be at least 15 minutes.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Grotex Ltd.

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