Signitsef drops Ch. 0.5% 5ml vial-cap.

Description

Composition
Active substance:
1 ml contains: Levofloxacin hemihydrate equivalent to 5.0 mg of levofloxacin.
Excipients:
Benzalkonium chloride 0.1 mg, 2.0 mg of hypromellose, 9.0 mg sodium chloride, sodium hydroxide q.s., hydrochloric acid q.s., water for injection to 1.0 ml.
Description:
The clear light yellow solution.
Product form:
0.5% eye drops.
5 ml into a plastic dropper bottle-screw cap. Each vial-IV together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to any component of the drug or to other quinolones, pregnancy, lactation, children under 1 year.
Carefully.
Children up to age 18 years.
Dosage
5 mg / ml
Indications
Signitsef® designate adults and children aged 1 year or older for:
treat infections of the eye adnexa and anterior segment of the eye, caused by susceptible to levofloxacin flora; prevention of complications after surgical and laser eye surgery.
Interaction with other drugs
Special studies on the interaction Signitsef® 0.5% eye drops not conducted. Because the maximum concentration in plasma levofloxacin after topical application in the eye at least 1000 times lower than after ingestion of standard doses inwardly, interaction with other drugs, characteristic for systemic use, clinically insignificant.
Overdose
Total levofloxacin contained in one bottle of eye drops, is too small to cause toxic reactions even after accidental ingestion.
After topical administration of an excess dose eye drops Signitsef® 0.5%, the eyes should be rinsed with clean water at room temperature.
pharmachologic effect
Pharmacological group:
The antimicrobial agent – fluoroquinolone.
Pharmacodynamics:
Levofloxacin – a L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin relates mainly to the L-isomer. As an antibacterial drug class of fluoroquinolones, levofloxacin blocking DNA gyrase and topoisomerase IV, and crosslinking gives supercoiling of DNA breaks, inhibits DNA synthesis, causes profound morphological change in the cytoplasm, the cell wall and membranes of bacteria. In vitro activity of levofloxacin is approximately 2 times greater than for ofloxacin against members of the Enterobacteriaceae, P. 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 pathogens susceptible to levofloxacin are Chlamydia trachomatis. The maximum concentration of levofloxacin achieved by using eye drops of 5 mg / ml, more than 100 times greater than the value of the minimum inhibitory concentration (MIC) of levofloxacin sensitive microorganisms.
Pharmacokinetics:
After instillation into the eye levofloxacin is well maintained in the tear film. Levofloxacin concentrations in tear fluid after a single dose (1 drop) rapidly reaches high values ​​and is maintained at a level above the MIC for most sensitive ocular pathogens (less than or equal to 2 mcg / ml) for at least 6 hours. In studies in healthy volunteers have shown that the mean levofloxacin concentration in the tear film, as measured at 4 and 6 hours after topical application amounted to 17.0 .mu.g / ml and 6.6 ug / ml, respectively. Five of the six subjects levofloxacin concentrations were 2 mg / ml or higher after 4 hours after instillation. In four of the six subjects, this concentration has remained at 6 hours after instillation.
Average concentrations of levofloxacin in plasma 1 hour after the application – from 0.86 ng / ml on the first day to 2.05 ng / ml. Maximum concentration in plasma levofloxacin, equal to 2.25 ng / ml, detected at the fourth day after two days of the drug every 8 hours prior to 2 times per day. The maximum concentrations of levofloxacin, achieved on the 15 th day, more than 1000 times lower than the concentrations that have been observed after oral administration of standard doses of levofloxacin.
Conditions of supply of pharmacies
On prescription.
side effects
Side effects may occur in approximately 10% of patients.
Common side effects (1-10% of patients)
decreased visual acuity and the appearance of mucous strands.
Rare side effects (0.1-1% of patients)
blepharitis, chemosis, papillary growths on the conjunctiva, eyelid edema, eye discomfort, burning and itching of the eye, blurred vision, eye pain, hyperemia of conjunctiva, mucous discharge, folliculosis conjunctiva, syndrome of “dry eye”, erythema age, contact dermatitis , photophobia, and allergic reactions, headache, rhinitis.
special instructions
Eyedrops Signitsef® 0.5% can not be administered subconjunctivally in the anterior chamber of the eye.
With simultaneous use of other ophthalmic instillation means spacing should be at least 15 minutes.
Drops should not be used while wearing hydrophilic (soft) contact lenses, due to the presence of drops of the preservative benzalkonium chloride, which may be absorbed by contact lenses and have an adverse effect on the eye tissue, and may cause discoloration of contact lenses.
To avoid contamination of the dropper tip and solution, with instillation should not touch the eye.
Storage conditions
At a temperature of not higher than 30 ° C, protected from light. Do not freeze. Keep out of the reach of children.
Dosing and Administration
Locally, in the affected eye. 1-2 drops in the affected eye (s) every two hours up to 8 times per day during wakefulness during the first 2 days, then four times a day, from 3 to 5 minutes per day. Duration of treatment is determined by a physician, usually 5 days.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist