L-OPTIC ROMFARM - instructions for use, doses, side effects, contraindications

Excipients: sodium chloride, 8.75 mg chloride, benzalkonium chloride 0.05 mg, 10% hydrochloric acid solution or 1M sodium hydroxide solution to pH 6.50 ± 0.05; purified water - up to 1.0 ml.

Description:From pale yellow to light yellow with a greenish shade of color, a clear solution.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Levofloxacin is a fluoroquinolone, a broad-spectrum antimicrobial bactericide. It blocks DNA-gyrase (topoisomerase-II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes of bacterial cells.

Effective at respect Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Clostridium perfringens, Chlamydia pneumonia, Enterococcus faecalis, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Morganella rhorganii, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Staphylococcus aureus ,Staphylococcus epidermidis Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus, agalactiae, Streptococcus spp. groups viridians.

Pharmacokinetics:

After instillation in the eye levofloxacin well preserved in the lacrimal film.

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 volunteers, concentrations of levofloxacin were 2 μg / ml and higher 4 hours after instillation. Four out of six volunteersThe concentration was preserved 6 hours after instillation.

The average concentration of levofloxacin when using eye drops in aqueous humor is statistically significantly higher than the average concentration of ofloxacin (p = 0.0008). In fact, it is approximately twice as high as the average concentration of ofloxacin (1139.9 ± 717.1 ng / ml and 621.7 ± 368.7 ng / ml, respectively).

The average concentration of levofloxacin in the blood plasma after 1 hour after application is from 0.86 ng / ml on the 1st day to 2.05 ng / ml. The maximum concentration of levofloxacin in the plasma, equal to 2.25 ng / ml, was detected on the 4th 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:

Treatment of infections of the anterior part of the eye caused by microorganisms sensitive to levofloxacin.

Contraindications:

Hypersensitivity to levofloxacin or other excipients, as well as to other quinolones;

children's age until 1 of the year.

Carefully:Children under 18 years.

Pregnancy and lactation:

Pregnancy

Researchon animals did not show any specific risks. But because of this,for lack of clinical trial data and because of the risk of exposure fluoroquinolones on the formation of cartilage prescription of the drug is possible only if the benefit to the mother exceeds the possible risk to the fetus.

Lactation period

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Locally, in the astonished eye!

Adults and children over 1 of the year.

1-2 drops in the affected eye (a), every two hours up to 8 times a day during the waking period for the first 2 days, then 4 times a day from 3 to 7 days.

Duration of the drug is 5 - 7 days.

Side effects:

Often (1-10%) short-term burning in the eye, redness of the eye, reduced visual acuity.

Infrequently (0.1-1%): the appearance of mucus in the form of strands in a tear film.

Rarely (0.1-0.01%): blepharitis, chemosis, papillary overgrowth and the appearance of conjunctival follicles, dry eye syndrome, erythema eyelids, itching and pain in the eye, photophobia, allergic reactions, headache, rhinitis.

Because the drug contains benzalkonium chloride, it is possible to develop contact dermatitis and eye irritation.

Overdose:

The total amount of levofloxacin contained in one bottle of eye drops (25 mg) is too low to cause toxic reactions even after accidental ingestion. After topical application of an excessive dose of eye drops L-OPTIC-ROMFARM, the eye should be washed with clean (tap) water at room temperature.

Symptoms: with intentional or accidental ingestion may be nausea, erosive lesions of the mucous membranes of the gastrointestinal tract (GIT), lengthening the interval Q-T, confusion, consciousness, dizziness, convulsions.

Treatment: symptomatic, dialysis is ineffective.

Interaction:

Since the maximum concentration of levofloxacin in plasma after topical application is 1000 times smaller than when administered orally, effects of interaction with other drugs are unlikely.

Special instructions:

To avoid contamination of the solution, the tip of the dropper should not touch the eyelids and tissues around the eye.

L-OPTIC ROMFARM, eye drops 5.0% can not be administered subconjunctivally, direct instillation in the anterior chamber of the eye should be avoided!

Systemic fluoroquinolones were associated with hypersensitivity reactionseven after a single dose. If allergic reactions occur during treatment with levofloxacin, discontinue use immediately.

As with treatment with other antibiotics, prolonged use of levofloxacin can lead to excessive growth of resistant microorganisms to its action, including fungi. During treatment, if observed deterioration or if there is no improvement within 3-5 days, treatment should be discontinued and alternative therapy is prescribed.

Drops should not be used when wearing soft contact lenses, due to the presence in the drops of preservative benzalkonium chloride,which can be absorbed by contact lenses and have an adverse effect on the tissues eyes and cause a change in the color of the contact lens.

Do not wear any type of contact lenses in the presence of symptoms of bacterial conjunctivitis.

When simultaneous use of several ophthalmic drugs for topical application, a 15-minute interval between instillations should be observed.

Effect on the ability to drive transp. cf. and fur:

In the case of a transient reduction in visual acuity after instillation of drops L-OPTIC-ROMFARM is not recommended to drive a car or work with potentially dangerous mechanisms before its recovery.

Form release / dosage:Eye drops 0.5%.

Packaging:

5 ml of solution in a white polymer bottle dropper closed with a polymer lid with a safety ring;

One bottle-dropper, together with instructions for use in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Inaccessible to children!

Shelf life:

3 years.

After opening the bottle, drops should be used within 4 weeks.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001604

Date of registration:23.03.2012

The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania

Manufacturer: & nbsp

S.C. ROMPHARM Company, S.R.L. Romania

Representation: & nbspROMFARM COMPANY ROMFARM COMPANY Romania

Information update date: & nbsp29.09.2015

Illustrated instructions

Instructions

L-OPTIC ROMFARM (L-Optic-Rompharm)