Signicef eye drops 0.5% 5ml

Signicef (Signtsef, Levofloxacin) eye drops - is an antibacterial agent of the fluoroquinolones group. It is used in ophthalmology for topical treatment of superficial bacterial infections of the eyeball and eye accessory: conjunctivitis, keratitis, blepharitis, barley, etc., after eye surgeries.

Antibacterial preparation of a group of fluoroquinolones for topical application in ophthalmology.

Levofloxacin is the L-isomer of the racemic drug of ofloxacin. The antibacterial activity of ofloxacin is mainly related to the L-isomer. As an antibacterial preparation of the fluoroquinolones class, levofloxacin blocks DNA-gyrase and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes.

The activity of levofloxacin in vitro is approximately 2 times greater than for ofloxacin against representatives of Enterobacteriaceae, Pseudomonas aeruginosa and Gram-positive microorganisms. The drug is active against gram-negative aerobes, such as Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Gram-positive aerobes such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes. Other microorganisms sensitive to levofloxacin are Chlamydia trachomatis.

The maximum concentration of levofloxacin achieved with 0.5% eye drops is more than 100 times greater than the minimum inhibitory concentration of levofloxacin for sensitive microorganisms.

Pharmacokinetics

After instillation into the eye, levofloxacin is well preserved in the lacrimal film. The concentration of levofloxacin in the lacrimal fluid after a single dose (1 drop) quickly reaches high values and is kept at a level above the MIC for the most sensitive eye pathogens (less than or equal to 2 μg / ml) for at least 6 hours. In studies on healthy volunteers, it was shown that the average concentrations of levofloxacin in the tear film, measured at 4 and 6 hours after topical application, were 17.0 μg / ml and 6.6 μg / ml, respectively. In five out of six subjects, levofloxacin concentrations were 2 μg / ml and higher 4 hours after instillation. In four out of six subjects, this concentration was preserved 6 hours after instillation.

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

Indications:

• Signyceph is prescribed for adults and children aged 1 year and older for:
• Treatment of infections of the adnexa of the eye and anterior segment of the eye caused by the flora sensitive to levofloxacin.
• Preventing complications after surgical and laser operations on the eye.

Contraindications:

• Hypersensitivity to any of the components of the drug or to other quinolones.
• Pregnancy.
• The period of breastfeeding.
• Children up to 1 year.

Carefully:

• Children under 18 years.

Special instructions:

Eye drops Signicef (Signitecef) 0.5% can not be administered subconjunctivally and into the anterior chamber of the eye.

With the simultaneous use of other ophthalmic agents, the interval between instillations should be at least 15 minutes.

Drops should not be used during the wearing of hydrophilic (soft) contact lenses, due to the presence in the drops of the preservative benzalkonium chloride, which can be absorbed by contact lenses and adversely affect the eye tissues, and cause a change in the color of the contact lenses.

To avoid contamination of the tip of the dropper and solution, do not touch the eye when digging.

Side effects:

Side effects can occur in about 10% of patients.

Frequent side effects (1-10% of patients) - decreased visual acuity and the appearance of mucosal strands.

Rare side effects (0.1-1% of patients) - blepharitis, chemosis, papillary growths on the conjunctiva, eyelid edema, unpleasant sensations in the eye, burning and itching in the eye, vision impairment, eye pain, conjunctival hyperemia, mucous discharge, follicle conjunctiva, dry eye syndrome, eyelid erythema, contact dermatitis, photophobia and allergic reactions, headache, rhinitis.

Overdose:

The total amount of levofloxacin contained in one bottle of eye drops is too low to cause toxic reactions even after accidental ingestion.

• Symptoms: may increase the side effects.
• Treatment: after topical application of an excessive dose of eye drops Signtsef 0.5%, the eyes should be washed with clean water at room temperature.

Suggested Use:

Locally, in the affected eye. 1-2 drops in the affected eye (a) every two hours up to 8 times a day during the waking period during the first 2 days, then four times a day from 3 to 5 days. The duration of treatment is determined by a doctor, usually 5 days.

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!