The composition and form of issue
Signitzer eye drops
1 ml contains: levofloxacin the hemihydrate equivalent to levofloxacin 5, 0 mg.
Auxiliary substances: benzalkonium chloride, hypromellose, sodium chloride, sodium hydroxide, hydrochloric acid, water for injection, in plastic vial-dropper with 5 ml of solution.
Signitzer – antibiotic class of fluoroquinolones, levofloxacin does DNK-girazu and topoisomerase IV, violates supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, cell wall and membranes of bacteria. The activity of levofloxacin in vitro approximately 2-fold greater than for ofloxacin against Enterobacteriaceae, P. aeruginosa and gram-positive microorganisms.
The drug is effective against: gram-negative aerobes – Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, the gram-positive aerobes – Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and other microorganisms sensitive to levofloxacin – Chlamydia trachomatis.
The maximum concentration of levofloxacin is achieved by using eye drops 5 mg/ml, more than 100 times greater than the minimum inhibitory concentration (MIC) of levofloxacin for the sensitive microorganisms.
Signitzer assigned to adults and children aged 1 year and older for:
Treatment of infections of the eye adnexa and anterior segment of the eye caused by sensitive to levofloxacin flora.
The prevention of complications after surgical and laser eye surgery.
Hypersensitivity to any component of the drug or other hinolonam, pregnancy, lactation, children up to age 1 year. With caution: children up to age 18 years.
Application of pregnancy and breastfeeding
Contraindicated in pregnancy and breastfeeding.
Method of application and doses
Locally, in the affected eye. 1-2 drops in affected eye(s) every two hours up to 8 times day during wakefulness within the first 2 days, then four times day with 3 to 5 day. The duration of treatment is determined by a physician, usually 5 days.
Side effects may occur in about 10% of patients. Common side effects (1-10 % of patients) – reduction of visual acuity and the appearance of the mucous strands. Rare side effects (0, 1-1 % of patients) blepharitis, chemosis, papillary growths on the conjunctiva, swelling of the eyelids, discomfort in your eye, burning and itching in the eye, blurred vision, eye pain, conjunctival hyperemia, mucous discharge, conjunctival follicules syndrome, dry eye, erythema of the eyelids, contact dermatitis, photophobia and allergic reactions, headache, rhinitis.
Eye drops, Signitzer 0, 5% is impossible to enter the subconjunctival and anterior chamber of the eye. With simultaneous use of other ophthalmic means the interval between the instillations must be at least 15 minutes. Drops should not be used while wearing hydrophilic (soft) contact lenses, in connection with the presence in the droplets of the preservative benzalkonium chloride which can be absorbed by contact lenses and have adverse effects on the tissues of the eyes and also cause discoloration of contact lenses. To avoid contamination of the dropper tip and solution, when backfilling should not touch the eye.
Special studies on interaction of eye drops, Signitzer 0, 5% was carried out. Since the maximum concentration of levofloxacin in plasma after topical application in the eye at least 1000 times lower than after taking standard doses inside, interaction with other drugs, typical for systemic use, clinically insignificant.
The total number of levofloxacin contained in one bottle of eye drops, too small to cause toxic reactions even after casual intake.
Symptoms: may increase side effects.
Treatment: after local application of excessive doses of eye drops, Signitzer 0, 5%, eyes should be rinsed with clean water at room temperature.
Keep at temperature not exceeding 30 °C in a dark place, do not freeze.
Shelf life – 2 years. 30 days after opening the bottle.