L-Optic Rompharm eye drops 0.5% 5ml

L-Optic (L-Optik) Rompharm eye drops - 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.

Indications:

Treatment of infections of the anterior eye caused by sensitive to levofloxacin microorganisms.

Contraindications:

• children up to age 1 year;
• hypersensitivity to the drug;
• hypersensitivity to levofloxacin and other hinolonam.

Caution: childhood and adolescence to 18 years.

Suggested Use:

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.

Special instructions:

To avoid contamination of the solution should not touch dropper tip to eyelids and tissues around the eyes.

L-OPTIK 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-OPTIK ROMPHARM is not recommended to drive vehicles or operate potentially dangerous machinery until it is restored.

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

Packaging:

• Comes in original packaging. Item is brand new and unopened.

Storage:

• Keep away from direct sunlight.
• Keep locked and away from children.
• Store in dry place at room temperature.
• Do not exceed storage temperature higher than 25 C

Important notice- the outer box design may vary before prior notice!