Expiration date: 02/2025
Pharmacological action
An antimicrobial agent of broad-spectrum, fluoroquinolone. Has a bactericidal effect. Levofloxacin does DNK-girazu (topoisomerase II) and topoisomerase IV, violates supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, cell walls and membranes of bacterial cells.
Active against Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Clostridium perfringens, Chlamydia pneumonia, Enterococcus faecalis, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Streptococcus spp. the viridians group.
Pharmacokinetics
After instillation into the eyes of levofloxacin is well maintained in the tear film. In studies in healthy volunteers have shown that the average concentration of levofloxacin in the tear film, measured after 4 and 6 h after topical application were 17 mcg/ml and 6.6 µg/ml, respectively. Five of the six volunteers the concentration of levofloxacin was 2 µg/ml and above after 4 h after instillation. In four of six volunteers this concentration remained after 6 h after instillation. The average concentration of levofloxacin in the application of eye drops in watery moisture is statistically significantly higher mean concentration of ofloxacin (p=0.0008). In fact it is approximately twice higher than average concentration of ofloxacin (1139.9±717.1 ng/ml, 621.7±368.7 ng/ml, respectively).
The average levofloxacin concentration in plasma 1 hour after application - 0.86 ng/ml at day 1 to 2.05 ng/ml Cmax of levofloxacin in plasma, equal to 2.25 ng/ml detected on day 4 after two days of the drug every 2 hours up to 8 times/day. Cmax of levofloxacin achieved on the 15th day, more than 1000 times lower than those concentrations which are observed after ingestion of standard doses of levofloxacin.
Testimony
Treatment of infections of the anterior eye caused by sensitive to levofloxacin microorganisms.
Contraindications
- children up to age 1 year,
- hypersensitivity to the drug component
- hypersensitivity to levofloxacin and other hinolonam.
- Caution: childhood and adolescence to 18 years.
Application of pregnancy and breastfeeding
Animal studies have not shown any particular risk. But due to the lack of data clinical studies and because of the risk of fluoroquinolone exposure on the formation of cartilage the purpose of the drug is possible only in cases when the expected benefit of therapy for the mother outweighs the potential risk to the fetus.
If necessary, the appointment of the drug during lactation breastfeeding should be discontinued.
Special instructions
To avoid contamination of the solution should not touch dropper tip to eyelids and tissues around the eyes.
L-OPTIC ROMPHARM, eye drops, 5% cannot be entered subkonyunktivalno, you should avoid direct instillation in the anterior chamber of the eye.
In the treatment of fluoroquinolones for systemic use was observed hypersensitivity reactions, even after one dose. If you experience allergic reactions during treatment with levofloxacin, discontinue use.
As with treatment with other antibiotics, prolonged use of levofloxacin may lead to excessive growth of resistant organisms and fungi.
During treatment, if deterioration or improvement noted in 3-5 days, treatment should be discontinued and appoint an alternative therapy.
Drops should not be used while wearing soft contact lenses when availability drops preservative benzalkonium chloride which can be absorbed by contact lenses and have adverse action on eye tissues and cause discoloration of contact lenses.
Should not wear contact lenses of any type if you have symptoms of bacterial conjunctivitis.
When simultaneous use of several ophthalmic drugs for topical application it is necessary to observe a 15 minute interval between instillation.
Effects on ability to drive vehicles and management mechanisms
In the case of transient reduction in visual acuity after using the drops L-OPTIC ROMPHARM is not recommended to drive vehicles or operate potentially dangerous machinery until it is restored.
Composition
Eye drops in the form of a clear solution of pale yellow to light yellow with a greenish tint.
Active substance: levofloxacin (hemihydrate) 5 mg.
Auxiliary substances: sodium chloride - 8.75 mg, benzalkonium chloride 0.05 mg, hydrochloric acid 10% solution or sodium hydroxide 1M solution to pH 6.5±0.05, purified water to 1 ml.
Method of application and doses
Applied locally in the affected eye.
Adults and children over 1 year instill 1-2 drops in affected eye(s) every 2 hours up to 8 times/day during wakefulness within the first 2 days, then 4 times/day from the 3rd to 7th day. The duration of the drug is 5-7 days.
Side effects
Side of body: often (1-10%) - intermittent burning sensation in eye, eye redness, decreased visual acuity, infrequently (0.1-1%) appearance of mucus in the form of strands in the tear film, rare (0.01-0.1%) - blepharitis, chemosis, papillary growths and the appearance of follicles on the conjunctiva, dry eye, erythema of the eyelids, itching and eye pain, photophobia.
Other: rare (0.01-0.1%) allergic reaction, headache, rhinitis.
Since the product contains benzalkonium chloride, may develop contact dermatitis and eye irritation
Drug interactions
After topical application of levofloxacin Cmax in plasma is 1,000 times less than when taken orally, so the effects of interactions with other drugs is unlikely.
Overdose
The total number of levofloxacin contained in one bottle of eye drops (25 mg) is too small to cause toxic reactions even after casual intake. After local application of excessive doses of eye drops L-OPTIC ROMPHARM eyes should be rinsed with clean (tap) water at room temperature.
Symptoms: when a deliberate or accidental ingestion nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, prolonged QT interval, mental confusion, dizziness, seizures.
Treatment: symptomatic therapy, dialysis ineffective.
Storage conditions
The drug should be stored out of reach of children at temperature not exceeding 25°C
Shelf life
3 years. After opening bottle drops should be used within 4 weeks.
