Levofloxacin, eye drops 0.5% 5 ml

A broad-spectrum antimicrobial agent, a fluoroquinolone.

Bactericidal action. It blocks DNA-enzyme (topoisomerase II) and topoisomerase IV, disrupts superspiralization and cross-linking of DNA breaks, inhibits DNA synthesis, causes deep morphological changes in cytoplasm, cell wall and membranes.

. Active against Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providcncia stuartii, Serratia marcescens, Clostridium perfringens.

Indications

Treatment of superficial bacterial infections of the eye caused by susceptible microorganisms in adults and children over 1 year old.

Active ingredient

Levofloxacin

Composition

1 ml – levofloxacin 5 mg, which corresponds to the content of levofloxacin hemihydrate 5.12 mg

How to take, the dosage

Topically, into the affected eye.

The duration of the course of treatment is determined by the severity of the condition, its clinical and bacteriological features.

The average duration of the course of therapy is 5 days.

1 to 2 drops in the affected eye(s) every two hours up to 8 times a day during the waking period for the first 2 days, then four times a day from days 3 to 5.

If more than one medication is used, the interval between instillations should be at least 15 minutes.

Interaction

Levofloxacin increases T1/2 of cyclosporine.

The effect of levofloxacin is reduced by drugs that inhibit intestinal motility, sucralfate, magnesium- and aluminum-containing antacids and iron salts (a break of at least 2 hours between doses is necessary).

Concomitant use of NSAIDs, theophylline increases seizure activity, and GCS increases the risk of tendon rupture.

Cimetidine and drugs that block tubular secretion slow the excretion of levofloxacin.

The levofloxacin solution for intravenous administration is compatible with 0.9% sodium chloride solution, 5% dextrose solution, 2.5% Ringer’s solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Levofloxacin solution for intravenous administration should not be mixed with heparin and solutions that have an alkaline reaction.

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Special Instructions

The drug should not be injected subconjunctivally and into the anterior chamber of the eye.

The drug shall not be used while wearing hydrophilic (soft) contact lenses due to the presence of benzalkonium chloride preservative which may be absorbed by contact lenses and have an adverse effect on the eye tissue and cause discoloration of contact lenses.

To avoid contamination of the drip tip and solution, do not touch the eyelids and tissues around the eye when injecting. During long-term treatment with levofloxacin (as well as other antibiotics) overgrowth of insensitive microorganisms, including fungal flora, is possible.

If the course of disease worsens or if there is no improvement with levofloxacin it is necessary to discontinue levofloxacin therapy and switch to therapy with antibacterial agents of other groups with advanced ophthalmologic examination including biomicroscopy and fluorescein test.

There are no data on efficacy and safety of levofloxacin in therapy of corneal ulcers. No formation of corneal precipitates has been noted in clinical studies.

Impact on ability to drive vehicles, machinery: The drug does not significantly affect the ability to drive vehicles, machinery. Immediately after instillation there may be temporary blurring of vision.

It is not recommended to drive vehicles and engage in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions until the visual clarity is restored.

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Contraindications

Hypersensitivity to levofloxacin or to any of the drug components, other quinolones. If you have one of the above mentioned diseases, always consult your doctor before taking the drug.

Side effects

The incidence of adverse reactions during therapy with levofloxacin was approximately 10%. Most commonly, the severity of adverse reactions ranged from mild to moderate; adverse reactions were mostly observed in the visual organs.

The data on adverse events were obtained in the course of clinical trials and post-registration use.

Immune system disorders: rare (more than 1/10000, but less than 1/1000) – systemic allergic reactions, including skin rash; very rare (less than 1/10000) – anaphylactic shock.

Nervous system disorders: infrequent (more than 1/1000, but less than 1/100) – headache.

Visual organ disorders: Frequent (more than 1/100, but less than 1/10) – burning in the eye, decreased vision, filamentous mucous discharge in the conjunctival cavity; infrequent (more than 1/1000, but less than 1/100) – chemosis, conjunctival injection, papillary conjunctivitis, eyelid edema, eyelid erythema, discomfort in the eye, itching in the eye, pain in the eye, “dry” eye syndrome, photophobia.

Respiratory, thorax and mediastinum disorders: infrequent (more than 1/1000, but less than 1/100) – rhinitis; very rare (less than 1/10000) – laryngeal edema.

The profile of adverse events when using the drug in the pediatric population is comparable to the adult population. If any of the side effects listed in the instructions are aggravated, or if you notice any other side effects not listed in the instructions, inform your physician.

Overdose

The total amount of levofloxacin contained in one tube-drop or bottle-drop is too small to cause toxic reactions even after accidental ingestion.

Pregnancy use

Levofloxacin is contraindicated in pregnancy and during lactation (breastfeeding).

Similarities

Signicef, Tavanic, Oftavix, Flexid, Levolet R, Levofloxacin-Teva, Glevo, Haileflox, Leflobakt, L-Optik Rompharm, Levofloxacin, Korfecin