Signitis - instructions for use, doses, side effects, contraindications

Composition:1 ml of the preparation contains:

The active substance: levofloxacin hemihydrate, is equivalent to levofloxacin 5.0 mg.
Excipients: benzalkonium chloride 0.1 mg, hypromellose 2.0 mg, sodium chloride 9.0 mg, sodium hydroxide q.s., hydrochloric acid q.s., water for injection up to 1.0 ml.

Description:A clear solution of light yellow color.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Levofloxacin is Lisomer of racemic drug of ofloxacin. The antibacterial activity of ofloxacin is mainly related to Lisomer. As an antibacterial preparation of the class of fluoroquinolones, levofloxacin blocks DNA gyre and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes. Activity of levofloxacin in vitro approximately 2 times more than forloxacin against representatives Enterobacteriaceae, R. aeruginosa and Gram-positive microorganisms.

The drug is effective 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 eye drops 5 mg / ml is more than 100 times greater than the minimum inhibitory concentration (MIC) of levofloxacin for sensitive microorganisms.

Pharmacokinetics:

After instillation in the eye levofloxacin 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 held 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 hour 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 a 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:

Signitecef® 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;

- 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, the period of breastfeeding, children under 1 year.

Carefully:

Child age under 18 years.

Dosing and Administration:

Locally, in the affected eye. 1 to 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.

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 sprains on the conjunctiva, edema of the eyelids, unpleasant sensations in the eye, burning and itching in the eye, vision impairment, eye pain, conjunctival hyperemia, mucous discharge, conjunctival conjunctival follicle, dry eye syndrome, erythema eyelids, 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.

After topical application of an excessive dose of eye drops Signiceft® 0.5%, the eyes should be washed with clean water at room temperature.

Interaction:Special studies on the interaction of eye drops Signticef® 0.5% were not conducted. Since the maximum concentration of levofloxacin in plasma after topical application in the eye is at least 1000 times lower than after taking standard doses orally, interaction with other drugs characteristic of systemic use is clinically insignificant.

Special instructions:

Eye drops Segnicef® 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.

Form release / dosage:Eye drops 0.5%.

Packaging:

5 ml in a plastic bottle-dropper with a screw cap. Each vial-dropper along with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C in a dark place. Do not freeze. Keep out of the reach of children.

Shelf life:3 years. Drops should be used within 42 days after opening the vial. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009882/09

Date of registration:04.12.2009

The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia

Information update date: & nbsp09.10.2015

Illustrated instructions

Instructions

Signtsef® (Signicef®)