L-Optic Rompharm eye drops 0.5%, 5ml

Composition

1 ml-levofloxacin (in the form of hemihydrate) 5 mg.

Auxiliary substances:

sodium chloride-8.75 mg,

benzalkonium chloride-0.05 mg,

hydrochloric acid 10% solution or sodium hydroxide 1M solution-up to pH 6.5±0.05,

purified water – up to 1 ml

Pharmacological action

 Broad-spectrum antimicrobial drug L-optik-fluoroquinolone. It has bactericidal properties. Levofloxacin is able to block DNA gyrase (topoisomerase II) and topoisomerase II of bacterial microflora, disrupting supercoiling and elimination of DNA breaks. It suppresses DNA synthesis, causing deep morphological disorders of the cytoplasm, cell wall and membranes of bacterial cells.

After instillation, levofloxacin remains in the tear film for a long time.

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. groups viridians.

 Pharmacokinetics

 After instillation into the eye, levofloxacin is well preserved in the tear film. In studies on healthy volunteers, it was shown that the average concentrations of levofloxacin in the tear film, measured 4 and 6 hours after topical application, were 17 mcg/ml and 6.6 mcg/ml, respectively.

In five of the six volunteers, levofloxacin concentrations were 2 micrograms / ml or higher 4 hours after instillation. In four of the six volunteers, this concentration was preserved 6 hours after instillation. The average concentration of levofloxacin in aqueous humor was statistically significantly higher than the average concentration of ofloxacin (p=0.0008). In fact, it is approximately twice as high as the average concentration of ofloxacin (1139.9±717.1 ng / ml and 621.7±368.7 ng / ml, respectively).

The average concentration of levofloxacin in blood plasma 1 h after use-from 0.86 ng / ml on day 1 to 2.05 ng / ml. Cmax of levofloxacin in plasma, equal to 2.25 ng / ml, was detected on day 4 after two days of using the drug every 2 hours up to 8 times/day. Cmax of levofloxacin, reached on day 15, is more than 1000 times lower than those concentrations that are observed after oral use of standard doses of levofloxacin.

Indications

Infections of the anterior eye caused by microorganisms sensitive to levofloxacin.

Use during pregnancy and lactation

 Ongoing animal studies have not shown any specific risk. However, since there are no data from clinical studies and because of the risk of exposure to fluoroquinolones on cartilage formation, the drug can only be prescribed in cases where the expected benefit of therapy for the mother exceeds the possible risk for the fetus.

If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

 Use in children

 Contraindicated in children under 1 year of age.

With caution: children under 18 years of age.

Contraindications

• Children under one year old;
• Hypersensitivity to the components;
• Quinolone intolerance;
• Breast-feeding.

The use of the drug in children, adolescents under 18 years of age and pregnant women should be carried out with extreme caution.

Side effects

• Passing burning sensation in the eye, hyperemia of the eye, decreased visual acuity; manifestation of mucus (strands in the tear film); blepharitis, chemosis, appearance of follicles and papillary growths on the conjunctiva, erythema of the eyelids, dry eye syndrome, itching and pain in the eye, photophobia.
• Allergic reactions, headaches, and rhinitis.
• Development of contact dermatitis, eye irritation.

Interaction

After topical use, the Cmax of levofloxacin in plasma is 1000 times less than with oral use, so the effects of interaction with other drugs are unlikely.

How to take, course of use and dosage

 Assign topically to the affected eye.

Children older than one year and adult patients are instilled 1 or 2 drops conjunctivally into the affected eye up to 8 times a day (or every 2 hours) during wakefulness. This continues for the first two days, then (3-7 days) switch to the dosage regimen 4 times a day. The duration of use of L-optik is up to 7 days.

Overdose

The volume of levofloxacin, which contains one bottle of L-optik drops, is too small to cause significant toxic reactions, even if unintentionally ingested. In case of excessive application of drops topically, the eye should be immediately rinsed with clean running water at room temperature.

Symptoms of overdose: when taken orally, erosive lesions of the gastrointestinal mucosa, nausea, prolongation of the QT interval, dizziness, confusion, convulsions are possible.

Treatment: symptomatic therapy, dialysis is ineffective.

Special instructions

L-Optik, eye drops 5% are not administered subconjunctivally and avoid direct contact with the anterior eye chamber.

To avoid infection of the solution, the tip of the dispenser does not need to touch any surfaces.

Hypersensitivity reactions were observed during treatment with fluoroquinolones, even after a single dose. If allergic reactions occur during treatment with levofloxacin, its use should be stopped immediately.

As with other antibiotic therapy, long-term use of L-optik can lead to the growth of fungi, as well as other resistant microorganisms.

During treatment, if improvement does not occur in the first 3 or 5 days, the drug should be discontinued by prescribing an alternative therapy.

These eye drops are not used when using soft contact lenses, because they contain the preservative benzalkonium chloride, which is absorbed by contact lenses and can have an adverse effect on the visual organ and cause discoloration in contact lenses.

Contact lenses of any type are contraindicated in the presence of symptoms of bacterial conjunctivitis.

Simultaneous use of several topical ophthalmic medications requires a 15-minute break between their installations.

Influence on the ability to drive motor vehicles and manage mechanisms

In the event of a decrease in visual acuity when instilling drops of L-optik, it is not recommended to drive vehicles, as well as work with dangerous mechanisms, until visual acuity returns to normal.

Form of production

Eye drops in the form of a clear solution from pale yellow to light yellow with a greenish tinge of color.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Eye Infections, Inflammatory eye diseases