Signicef, eye drops 0.5%, 5 ml

Composition

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

Auxiliary substances:

benzalkonium chloride,

hypromellose,

sodium chloride,

sodium hydroxide,

hydrochloric acid,

d/i water.

Pharmacological action

The main Active ingredient of the drug levofloxacin is the L-isomer of the second-generation antibacterial agent of the group of fluoroquinolones ofloxacin.

The drug has activity against gram-negative (Branhamella catarrhalis, Neisseria gonorrhoeae, Haemophilus influenzae, Pseudomonas aeruginosa) and gram-positive (Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes) anaerobes. Another microflora sensitive to levofloxacin is Chlamydia trachomatis. The maximum concentration of levofloxacin achieved with the use of eye drops exceeds the values of the minimum inhibitory concentration of this Active ingredient for sensitive microorganisms by more than a hundred times.

After instillation directly into the eye, levofloxacin is able to remain well preserved in the tear film, causing a persistent therapeutic effect.

Pharmacokinetics

After instillation into the eye, levofloxacin is well preserved in the tear film. The concentration of levofloxacin in the lacrimal fluid after a single dose (1 drop) quickly reaches high values and is kept above the MIC for most sensitive eye pathogens (less than or equal to 2 mcg / ml) for at least 6 hours.

In studies on healthy volunteers, it was shown that 5 out of 6 subjects had levofloxacin concentrations of 2 micrograms / ml or higher 4 hours after instillation. In 4 out of 6 subjects, this concentration was preserved 6 hours after instillation.

The average concentration of levofloxacin in blood plasma 1 h after application-from 0.86 ng / ml on the first day to 2.05 ng / ml. Cmax of levofloxacin in plasma, equal to 2.25 ng / ml, was detected on the fourth day after two days of using the drug every 2 hours up to 8 times a day.

Cmax of levofloxacin, reached on day 15, is more than 1000 times lower than those concentrations observed after oral administration of standard doses of levofloxacin.

Indications

• infections of the adnexal apparatus of the eye and anterior segment of the eye caused by levofloxacin-sensitive flora (treatment);
• complications after surgical and laser ophthalmic operations (prevention).

Use during pregnancy and lactation

Contraindicated in pregnancy and lactation, children under 1 year of age.

Caution should be exercised when prescribing the drug to children and adolescents under the age of 18.

Contraindications

• pregnancy;
• breast-feeding;
• children of the first year of life;
• individual intolerance to quinolones or any of the components of the drug.

Children and adolescents under 18 years of age, the drug is prescribed with caution.

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 mucous cords.

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, visual impairment, eye pain, conjunctival hyperemia, mucous discharge, conjunctival folliculosis, dry eye syndrome, eyelid erythema, contact dermatitis, photophobia and allergic reactions, headache, rhinitis.

Interaction

Special studies on the interaction of Signicef 0.5% eye drops have not been conducted.

Since the maximum plasma concentration of levofloxacin after topical application in the eye is at least 1000 times lower than after taking standard oral doses, the interaction with other drugs characteristic of systemic use is clinically insignificant.

How to take, course of administration and dosage

Topically, in the affected eye.

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

Overdose

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

Symptoms: possible increased side effects.

Treatment: after topical application of an excessive dose of Signicef 0.5% eye drops, the eyes should be rinsed with clean water at room temperature.

Special instructions

Signicef is not installed subconjunctivally or in the anterior chamber of the eyes.

At the same time, when using other ophthalmic agents with this drug, the interval between instillations should be observed for at least 15 minutes. You should not prescribe Signicef simultaneously with antacids, the interval between the use of these drugs should be at least 2 hours.

When wearing soft hydrophilic lenses, Signicef is not recommended due to the presence of benzalkonium chloride in the preparation. This preservative can be absorbed by contact lenses, adversely affecting the eyes and causing discoloration of the lenses themselves.

To avoid contamination of the tip of the dropper or solution, avoid touching the eye during installation.

Form of production

Eye drops 0.5% in the form of a clear solution of light yellow color.

Storage conditions

In a dark place, at a temperature not exceeding 30 °C (do not freeze)

Shelf life

2 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, Children over 1 year of age

Indications

Eye Infections, Conjunctivitis

Weight

Weight: 14 gr.