Universal reference book for medicines
Product name: L-OPTIC ROMFARM (L-OPTIC ROMPHARM)

Active substance: levofloxacin

Type: Antibacterial drug of the group of fluoroquinolones for topical application in ophthalmology

Manufacturer: SC ROMPHARM Company (Romania)
Composition, form of production and packaging
Drops of the eye
in the form of a clear solution from pale yellow to light yellow with a greenish tinge.

1 ml

levofloxacin (in the form of hemihydrate) 5 mg

Excipients: sodium chloride - 8.75 mg, benzalkonium chloride - 0.05 mg, hydrochloric acid 10% solution or sodium hydroxide solution 1M - up to pH 6.5 ± 0.05, purified water - up to 1 ml.

5 ml - a bottle-droppers polymer (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Antimicrobial preparation of a wide spectrum of action, fluoroquinolone.
Has a bactericidal effect. Levofloxacin 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.
It is active against 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 morganii, 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. group of viridians.
PHARMACOKINETICS

After instillation into the eye, levofloxacin is well preserved in the lacrimal film.
In studies on healthy volunteers, it was shown that the average concentrations of levofloxacin in the lacrimal film, measured at 4 and 6 hours after topical application, were 17 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. In four out of six volunteers, this 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 h after application is from 0.86 ng / ml per day to 2.05 ng / ml.
C max levofloxacin in plasma, equal to 2.25 ng / ml, was detected on the 4th day after two days of the drug every 2 hours up to 8 times / day. C max levofloxacin, reached on the 15th day, is more than 1000 times lower than those concentrations that are noted after oral administration of standard doses of levofloxacin.
INDICATIONS

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

DOSING MODE

Apply topically to the affected eye.

Adults and children over the age of 1 year instilled 1-2 drops in the affected eye (a) every 2 hours up to 8 times / day during the waking period during the first 2 days, then 4 times / day from the 3rd to the 7th day.
The duration of the drug is 5-7 days.
SIDE EFFECT

From the side of the organ of vision: often (1-10%) - short-term burning in the eyes, red eyes, decreased visual acuity;
infrequently (0.1-1%) - the appearance of mucus in the form of strands in the lacrimal film; rarely (0.01-0.1%) - blepharitis, chemosis, papillary growths and the appearance of follicles on conjunctiva, dry eye syndrome, erythema eyelids, itching and pain in the eyes, photophobia.
Other: rarely (0.01-0.1%) - allergic reactions, headache, rhinitis.

Since the drug contains benzalkonium chloride, contact dermatitis and eye irritation are possible.

CONTRAINDICATIONS

- Children's age up to 1 year;

- hypersensitivity to the components of the drug;

- hypersensitivity to levofloxacin and other quinolones.

With caution should znachat drug in childhood and adolescence to 18 years.

PREGNANCY AND LACTATION

Studies in animals have not shown any specific risk.
But because of the lack of clinical trial data and because of the risk of exposure to fluoroquinolones for cartilage formation, the administration of the drug is only possible in cases where the expected benefit of therapy for the mother exceeds the possible risk to the fetus.
If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR CHILDREN

Contraindicated in children under 1 year.

With caution: children under 18 years.

SPECIAL INSTRUCTIONS

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

L-Optik Rompharm, eye drops 5% can not be administered subconjunctivally, direct instillation in the anterior chamber of the eye should be avoided.

In the treatment of fluoroquinolones for systemic use, there were reactions of increased sensitivity, even after a single dose.
If allergic reactions occur during treatment with levofloxacin, discontinue use immediately.
As with other antibiotics, prolonged use of levofloxacin can lead to excessive growth of resistant microorganisms and fungi.

During treatment, if there is a worsening or no improvement within 3-5 days, treatment should be discontinued and an alternative therapy should be prescribed.

Drops should not be used when wearing soft contact lenses due to the presence in the preservative drops of benzalkonium chloride, which can be absorbed by contact lenses and have an adverse effect on the eye tissue and cause discoloration of the contact lenses.

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

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

Impact on the ability to drive vehicles and manage mechanisms

In the case of transient reduction in visual acuity after instillation of drops of L-Optik Rompharm it is not recommended to drive vehicles or work with potentially dangerous mechanisms before its recovery.

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-Optik Rompharm eyes should be washed with clean (tap) water at room temperature.
Symptoms: with deliberate or accidental ingestion, nausea, erosive lesions of the gastrointestinal mucous membranes, prolongation of the QT interval, confusion, dizziness, convulsions are possible.

Treatment: symptomatic therapy, dialysis is ineffective.

DRUG INTERACTION

After topical application of C max levofloxacin in plasma is 1000 times less than with oral intake, so the effects of interaction with other drugs are unlikely.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
After opening the bottle, the drops should be used within 4 weeks.

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