Description
Latin name
Signicef
Packaging
In a plastic dropper bottle 5 ml of solution. In the package 1 bottle.
Pharmacological action
Antibacterial drug of the fluoroquinolone group for topical use in ophthalmology.
Levofloxacin is the L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin relates mainly to the L-isomer. As an antibacterial drug of the fluoroquinolone class, levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, and causes deep 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, Streptococ. Other microorganisms sensitive to levofloxacin are Chlamydia trachomatis.
The maximum concentration of levofloxacin achieved with 0.5% eye drops is more than 100 times the minimum inhibitory concentration of levofloxacin for sensitive microorganisms.
Pharmacokinetics
After instillation into the eye, levofloxacin is well preserved in the tear film. The concentration of levofloxacin in the tear fluid after a single dose (1 drop) quickly reaches high values and is kept at a level above the MIC for most sensitive ocular pathogens (less than or equal to 2 μg / ml) for at least 6 hours. Studies in healthy volunteers showed that the average concentrations of levofloxacin in the tear film, measured 4 and 6 hours after topical application, were 17.0 μg / ml and 6.6 μg / ml, respectively. Five out of six subjects had levofloxacin concentrations of 2 μg / ml or higher 4 hours after instillation. In four out of six subjects, this concentration persisted 6 hours after instillation.
The average concentration of levofloxacin in blood plasma 1 hour after application is from 0.86 ng / ml on the first day to 2.05 ng / ml. The maximum concentration 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 / day. The maximum concentrations of levofloxacin, achieved on the 15th day, are more than 1000 times lower than those concentrations that are observed after oral administration of standard doses of levofloxacin.
Indications
Signicef ² ¹ ² ¹is prescribed for adults and children 1 year of age and older for: Treatment of infections of the adnexa and the anterior segment of the eye caused by flora sensitive to levofloxacin.
Prevention of complications after surgical and laser operations on the eye.
Contraindications
Hypersensitivity to any of the components of the drug or to other quinolones.
Pregnancy.
Breastfeeding period.
Children’s age up to 1 year.
Caution: Children under 18 years.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Composition of
1 ml of the preparation contains:
Active ingredient: levofloxacin hemihydrate, equivalent to 5.0 mg levofloxacin.
Excipients: benzalkonium chloride, hypromellose, sodium chloride, sodium hydroxide, hydrochloric acid, water for injection.
Dosage and Administration
Locally, in the affected eye. 1-2 drops into the affected eye (a) every two hours up to 8 times a day during wakefulness for the first 2 days, then four times a day from 3 to 5 days. The duration of the course of treatment is determined by the doctor, usually 5 days.
Side effects
Side effects can occur in approximately 10% of patients.
Frequent side effects (1-10% of patients) – decreased visual acuity and the appearance of mucous membranes.
Rare side effects (0.1-1% of patients) – blepharitis, chemosis, papillary growths on the conjunctiva, eyelid swelling, discomfort in the eye, burning and itching in the eye, blurred vision, eye pain, conjunctival hyperemia, mucous discharge, conjunctival folliculosis, dry eye syndrome, erythema of the eyelids, contact dermatitis, photophobia and allergic reactions, headache, rhinitis.
Drug Interaction
Special studies on the interaction of eye drops Signicef 0.5% have not been performed.
Since the maximum concentration of levofloxacin in plasma after topical application in the eye is at least 1000 times lower than after administration of standard doses orally, interaction with other medicinal products characteristic of systemic use is clinically insignificant.
Overdose
The total amount of levofloxacin contained in one vial of eye drops is too small to cause toxic reactions, even after accidental ingestion.
Symptoms: side effects may increase.
Treatment: after topical administration of an overdose of Signiccef eye drops of 0.5%, the eyes should be rinsed with clean room temperature water.
Storage conditions
Store at a temperature not exceeding 30 ° C in a dark place, do not freeze.
Expiration
2 years. 30 days after opening the vial.
Deystvuyuschee substances
Levofloxacin
pharmacy terms and conditions
prescription
Dosage
dosage form
eye drops
