L-Optik Rompharm, 1 piece, 5 ml, 0.5%, eye drops

The drug L-Optic is an antimicrobial drug used in ophthalmology. As an antibacterial drug of the fluoroquinolone class, levofloxacin selectively inhibits bacterial topoisomerase II-DNA gyrase and topoisomerase IV. The preferred targets of levofloxacin in gram-negative bacteria are DNA gyrase, and in gram-positive bacteria topoisomerase IV. Effective against the following microorganisms: Category I: Usually susceptible species Aerobic gram-positive: Staphylococcus aureus (MSSA - methicillin-sensitive strains), Staphylococcus pneumoniae, Staphylococcus pyogenes, Viridans group streptococci. Aerobic gram-negative: Escherichia coli, Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Pseudomonas aeraginosa (local cultures) Other microorganisms: Chlamydia trachomatis (treatment of patients with chlamydial conjunctivitis requires concomitant systemic antimicrobial therapy) Category II: Species for which acquired resistance may be a problem Aerobic gram-positive microorganisms: Staphylococcus aureus (MRSA methicillin-resistant strains); Staphylococcus epidermidis.

Mode of application

For all categories of patients: for the first two days, instill 1-2 drops of L-Optic solution into the affected eye(s) every 2 hours, but no more than 8 times a day during the first two days, and then no more than 4 times per day for the next 3-5 days of treatment. The duration of treatment depends on the severity of the disease and the clinical course of the disease. Usually the duration of treatment is 5 days. Safety and effectiveness in the treatment of corneal ulcers and neonatal blenorrhea have not been studied. Children and adolescents Children aged one year and older are given the same doses as adults. The safety and effectiveness of use in children under one year of age have not been determined. Elderly Patients No dosage adjustment is necessary for elderly patients. Directions for use: For local ophthalmic use. To prevent contamination of the drug, do not touch the tip of the dropper to any surface (eyelids, area around the eyes, eyelashes, etc.).

After use, the bottle must be tightly closed. If possible, have someone put the medicine in your eyes. You must first read these instructions. Instructions for using eye drops: Wash your hands. Open the bottle. Do not touch the tip of the dropper to any surface (eyelids, eye area, eyelashes, or other surfaces). If you wear contact lenses, you should remove them before using the drops and reinsert them no earlier than 15 minutes after use. Unscrew the cap. Tilt your head back and look at the ceiling. Pull your lower eyelid down slightly. Hold the bottle upside down over your eye and gently squeeze the bottle to squeeze a drop into your eye. Keep your eye closed by pressing your finger on the inner corner of your eye for 1 minute. Blot your eye to remove excess eye drops. Close the bottle after each use of eye drops.

Side effects

Side effects are usually mild to moderate, transient, and usually limited to ocular symptoms. The frequency of adverse reactions is described as follows: very often (≥1/10); often (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000); frequency unknown (cannot be determined from available data). From the organs of vision. Often: burning of the eyes, decreased visual acuity and the appearance of mucus in the form of strands. Rare: blepharitis, chemosis, conjunctival papillary reaction, eyelid edema, discomfort, itching and pain in the eyes, conjunctival hyperemia, conjunctival follicles, dry eyes, eyelid erythema and photophobia. No precipitates on the cornea were observed during clinical studies. From the immune system. Rare: extraocular allergic reactions, including skin rash. Very rare (including isolated reports): anaphylaxis. From the nervous system. Rarely: headache. From the mediastinal organs and respiratory phenomena. Rarely: rhinitis. Very rare (including isolated reports): laryngeal edema.

L-Optic Rompharm

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones. The active substance contains levofloxacin, a levorotatory isomer of ofloxacin.

Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes of microbial cells.

Levofloxacin is active against most strains of microorganisms in vitro

and
in vivo.
The following are sensitive to the action of the drug:

sensitive in vitro (minimum inhibitory concentration (MIC) ≤2 mg/ml, zone of inhibition >17 mm)

:

— aerobic gram-positive microorganisms: Bacillus anthracis, Corynebacterium diphtheriae, Corynebacteriurn jeikeium, Enterococcus spp.

(including Enterococcus faecalis),
Listeria monocytogenes, Staphylococcus spp
.
(coagulase-negative methicillin-sensitive/moderately sensitive strains), Staphylococcus aureus
(methicillin-sensitive strains),
Staphylococcus epidermidis
(methicillin-sensitive strains),
Staphylococcus spp.
(leukotoxin-containing);
Streptococcus spp.
groups C and G,
Streptococcus agalactiae, Streptococcus pneumonia
(penicillin-sensitive/moderately sensitive/resistant strains),
Streptococcus pyogenes, Streptococcus spp.

viridians
groups (penicillin-sensitive/resistant strains);

— aerobic gram-negative microorganisms: Acinetobacter spp

.
(including Acinetobacter baumannii
),
Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (Enterobacter aerogenes, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenza
(ampicillin-sensitive/resistant strains),
Haemophilus paraintluenzae, Helicobacter pylori, Klebsiella spp.
(including
Klebsiella oxytoca, Klebsiella pneumoniae
),
Moraxella catarrhalis
(beta-lactamase producing and non-producing strains),
Morganella morganii, Neisseria gonorrhoeae
(penicillinase producing and non-producing strains),
Neisseria meningitidis, Pasteurella spp.
(including
Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida
),
Proteus mirabilis, Proteus vulgaris, Providencia spp.
(including
Providencia rettgeri, Providencia stuartii
),
Pseudomonas spp.
(hospital infections caused by
Pseudomonas aeruginosa
may require combination treatment),
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 spp.

(including
Legionella pneumophila
),
Mycobacterium spp
.
(including Mycobacterium leprae, Mycobacterium tuberculosis
),
Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.
Moderately sensitive microorganisms (MIC = 4 mg/l; inhibition zone 16-14 mm)

:

— aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis

(methicillin-resistant strains),
Staphylococcus haemolyticus
(methicillin-resistant strains);

— aerobic gram-negative microorganisms: Campylobacter jejuni, Campylobacter coli;

— anaerobic microorganisms: Prevotella spp., Porphyromonas spp.

Resistant microorganisms (MIC ≥8 mg/l; inhibition zone <13 mm)

:

— aerobic gram-positive microorganisms: Staphylococcus aureus

(methicillin-resistant strains), other
Staphylococcus spp.
(coagulase-negative methicillin-resistant strains);

— aerobic gram-negative microorganisms: Alcaligenes xylosoxidans;

— anaerobic microorganisms: Bacteroides thetaiotaomicron;

— other microorganisms: Mycobacterium avium.

Resistance

to levofloxacin develops as a result of a step-by-step process of mutations in the genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV.
Other mechanisms of resistance, such as the mechanism of influencing the penetration barriers of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa
) and the mechanism of efflux (active removal of the 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, cross-resistance between levofloxacin and other antimicrobial agents is not usually observed.

Pregnancy

There are no data on the use of levofloxacin in pregnant women. The use of L-Optic in pregnant women is possible only in cases where the potential benefit to the mother outweighs the potential risk to the fetus. Levofloxacin is excreted into breast milk. However, if therapeutic doses are used, no adverse reactions are expected in the child. However, the drug should not be used during lactation, unless the potential benefit to the mother outweighs the potential risk to the baby.

Additionally

The drug L-Optic cannot be administered subconjunctivally or directly into the anterior chamber of the eye. Fluoroquinolones for systemic use can cause allergic reactions even after a single use. If an allergic reaction to levofloxacin occurs, you should stop using the drug. As with other antimicrobial agents, long-term use of the drug can lead to the growth of resistant strains of microorganisms, including fungi. If the clinical picture worsens or after a certain period of clinical improvement is not observed, it is necessary to stop using the drug and prescribe alternative therapy. When using other ophthalmic agents simultaneously, the interval between instillations should be at least 15 minutes. Patients who have symptoms of a superficial bacterial eye infection should not wear contact lenses. The medicine contains benzalkonium chloride and may cause eye irritation. Impact on the ability to drive vehicles and operate machinery Temporary blurred vision can affect the ability to drive a vehicle and operate machinery and equipment. If blurred vision occurs after instillation, the patient should wait until vision is restored before driving or operating any equipment.

L-Optik Rompharm, 1 piece, 5 ml, 0.5%, eye drops

Levofloxacin is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones. The active substance contains levofloxacin, a levorotatory isomer of ofloxacin.

Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes of microbial cells.

Levofloxacin is active against most strains of microorganisms in vitro and in vivo.

The following are sensitive to the action of the drug:

in vitro sensitive (minimum inhibitory concentration (MIC) ≤2 mg/ml, inhibition zone >17 mm):

— aerobic gram-positive microorganisms: Bacillus anthracis, Corynebacterium diphtheria, Corynebacterium jeikeium, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (coagulase-negative methicillin-sensitive/moderately sensitive strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis (methicillin-sensitive strains), Staphylococcus spp. (leukotoxin-containing); Streptococcus spp. groups C and G, Streptococcus agalactiae, Streptococcus pneumonia (penicillin-sensitive/moderately sensitive/resistant strains), Streptococcus pyogenes, Streptococcus spp. viridians groups (penicillin-sensitive/resistant strains);

— aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (Enterobacter aerogenes, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenza (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (beta-lactamase producing and non-producing strains), Morganella morganii, Neisseria gonorrhoeae (penicillinase producing and non-producing strains), Neisseria meningitidis, Pasteurella spp. (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (nosocomial infections caused by Pseudomonas aeruginosa may require combination treatment), 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 spp. (including Legionella pneumophila), Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Moderately sensitive microorganisms (MIC = 4 mg/l; inhibition zone 16–14 mm):

— aerobic gram-positive microorganisms: Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus hemolyticus (methicillin-resistant strains);

— aerobic gram-negative microorganisms: Campylobacter jejuni, Campylobacter coli;

— anaerobic microorganisms: Prevotella spp., Porphyromonas spp. Resistant microorganisms (MIC ≥8 mg/l; inhibition zone <13 mm):

— aerobic gram-positive microorganisms: Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp. (coagulase-negative methicillin-resistant strains);

— aerobic gram-negative microorganisms: Alcaligenes xylosoxidans;

— anaerobic microorganisms: Bacteroides thetaiotaomicron;

— other microorganisms: Mycobacterium avium.

Resistance to levofloxacin develops as a result of a stepwise process of mutations in the genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV. Other resistance mechanisms, such as the mechanism of influencing the penetration barriers of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of the 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, cross-resistance between levofloxacin and other antimicrobial agents is not usually observed.

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