Floxepol drops 0.5%, 5ml

Locally. Adults: 1 drop in the affected eye 3 times / day. Usually, the condition improves after 5 days and treatment should be continued for the next 2-3 days. If the condition does not improve after 5 days, the question of the correct diagnosis and / or prescribed treatment should be raised. The duration of treatment depends on the severity of the condition and the clinical and bacteriological course of the disease.

Eye drops in the form of a clear solution of greenish-yellow color.

1 ml

moxifloxacin hydrochloride 5.45 mg,?

which corresponds to the content of moxifloxacin 5 mg

Excipients: sodium chloride, boric acid, sodium hydroxide (up to pH 6.5-7.2), highly purified water.

• Hypersensitivity to moxifloxacin or other quinolones;

• breastfeeding period;

• children's age up to 1 year.

pharmachologic effect

The IV generation antibacterial drug, fluoroquinolone, has a bactericidal effect. Shows activity against a wide range of gram-positive and gram-negative microorganisms, anaerobic, acid-fast and atypical bacteria. The mechanism of action is associated with the inhibition of topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an enzyme involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme involved in the cleavage of chromosomal DNA during bacterial cell division. There is no cross-resistance with macrolides, aminoglycosides and tetracyclines. It has been reported about the development of cross-resistance between systemically used moxifloxacin and other fluoroquinolones. Moxifloxacin is active against most strains of microorganisms (both in vitro and in vivo):Gram-positive bacteria: Corynebacterium spp., Including Corynebacterium diphtheriae; Micrococcus luteus (including strains insensitive to erythromycin, gentamicin, tetracycline and / or trimethoprim); Staphylococcus aureus (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus epidermidis (including strains that are insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus haemolyticus (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus hominis (including strains that are insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus warneri (including strains,insensitive to erythromycin); Streptococcus mitis (including strains insensitive to penicillin, erythromycin, tetracycline and / or trimethoprim); Streptococcus pneumoniae (including strains insensitive to penicillin, erythromycin, gentamicin, tetracycline and / or trimethoprim); Streptococcus of the viridans group (including strains insensitive to penicillin, erythromycin, tetracycline and / or trimethoprim). Gram negative bacteria: Acinetobacler Iwoffii; Haemophilus influenzae (including ampicillin insensitive strains); Haemophilus parainfluenzae; Klebsiella spp. Other microorganisms: Chlamydia trachomatis. Moxifloxacin acts in vitro against most of the following microorganisms, but the clinical significance of these findings is unknown: Gram-positive bacteria: Listeria monocytogenes; Staphylococcus saprophyticus;Streptococcus agalactiae; Streptococcus mitis; Streptococcus pyogenes; Streptococcus group C, G, F; Gram-negative bacteria: Acinetobacler baumannii; Acinetobacter calcoaceticus; Citrobacter freundii; Citrobacter koseri; Enterobacter aerogenes; Enterobacter cloacae; Escherichia coli; Klebsiella oxytoca; Klebsiella pneumoniae; Moraxella catarrhalis; Morganella morganii; Neisseria gonorrhoeae; Proteus mirabilis; Proteus vulgaris; Pseudomonas stutzeri; Anaerobic microorganisms: Clostridium perfringens; Fusobacterium spp .; Prevotella spp .; Propionibacterium acnes. Other organisms: Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae.Acinetobacter calcoaceticus; Citrobacter freundii; Citrobacter koseri; Enterobacter aerogenes; Enterobacter cloacae; Escherichia coli; Klebsiella oxytoca; Klebsiella pneumoniae; Moraxella catarrhalis; Morganella morganii; Neisseria gonorrhoeae; Proteus mirabilis; Proteus vulgaris; Pseudomonas stutzeri; Anaerobic microorganisms: Clostridium perfringens; Fusobacterium spp .; Prevotella spp .; Propionibacterium acnes. Other organisms: Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae.Acinetobacter calcoaceticus; Citrobacter freundii; Citrobacter koseri; Enterobacter aerogenes; Enterobacter cloacae; Escherichia coli; Klebsiella oxytoca; Klebsiella pneumoniae; Moraxella catarrhalis; Morganella morganii; Neisseria gonorrhoeae; Proteus mirabilis; Proteus vulgaris; Pseudomonas stutzeri; Anaerobic microorganisms: Clostridium perfringens; Fusobacterium spp .; Prevotella spp .; Propionibacterium acnes. Other organisms: Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae.Anaerobic microorganisms: Clostridium perfringens; Fusobacterium spp .; Prevotella spp .; Propionibacterium acnes. Other organisms: Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae.Anaerobic microorganisms: Clostridium perfringens; Fusobacterium spp .; Prevotella spp .; Propionibacterium acnes. Other organisms: Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae.

Pharmacokinetics

When applied topically, moxifloxacin is systemically absorbed: Cmax is 2.7 ng / ml, AUC is 45 ng h / ml. These values ??are approximately 1600 times and 1000 times less than Cmax and AUC after a therapeutic dose of moxifloxacin 400 mg orally. T1 / 2 of moxifloxacin from plasma is about 13 hours.

Side effect

From the hematopoietic system: rarely - a decrease in hemoglobin. From the immune system: frequency unknown - hypersensitivity. From the nervous system: infrequently - headache; rarely - paresthesia; frequency unknown - dizziness. From the side of the organ of vision: often - eye pain, eye irritation; infrequently - punctate keratitis, dry eye syndrome, subconjunctival hemorrhage, itchy eyes, conjunctival injection, eyelid edema, eye discomfort; rarely - defect of the corneal epithelium, corneal disorders, conjunctivitis, blepharitis, conjunctival edema, blurred vision, decreased visual acuity, asthenopia, erythema of the eyelids; frequency unknown - endophthalmitis, ulcerative keratitis, corneal erosion, increased intraocular pressure, corneal opacity, corneal edema, corneal infiltrates, corneal deposits,allergic phenomena from the eyes, keratitis, corneal edema, photophobia, lacrimation, discharge from the eyes, sensation of a foreign body in the eyes. From the side of the cardiovascular system: the frequency is unknown - a feeling of palpitations. From the respiratory system: rarely - discomfort in the nose, pain in the larynx and pharynx, feeling of a foreign body in the throat; frequency unknown - shortness of breath. From the digestive system: infrequently - dysgeusia; rarely - vomiting, increased activity of aminotransferases and GGT; frequency unknown - nausea. On the part of the skin and subcutaneous fat: the frequency is unknown - erythema, rash, urticaria, itching. Description of selected adverse reactions There are reports of ruptures of the tendons of the shoulder joint, the joints of the hands, the Achilles tendon, as well as other tendons,which led to a long period of disability or required surgery. These phenomena have been observed in patients receiving systemic therapy with fluoroquinolones. According to clinical studies and post-registration use, the risk of tendon ruptures during systemic therapy with fluoroquinolones may increase when corticosteroids are included in the therapy regimen; elderly patients are at particular risk. Most often, injuries affect the tendons of the supporting joints, incl. Achilles tendons.elderly patients are at particular risk. Most often, injuries affect the tendons of the supporting joints, incl. Achilles tendons.elderly patients are at particular risk. Most often, injuries affect the tendons of the supporting joints, incl. Achilles tendons.

Application in children

During clinical trials involving children, incl. neonates demonstrated a safety profile of moxifloxacin in the form of instillations similar to the adult population. In patients under the age of 18, the most common were eye pain and eye irritation, the frequency of occurrence was about 0.9%. According to the results of clinical studies in the pediatric population, there were no differences from the adult population in the profile of adverse events and their severity.

Application during pregnancy and lactation

There is no sufficient experience in using the drug during pregnancy and lactation. The use of the drug during pregnancy (FDA category C) is possible only if the expected therapeutic effect for the mother outweighs the potential risk to the fetus and child. If necessary, use during lactation, breastfeeding should be discontinued for the period of treatment.

special instructions

Long-term use of the antibiotic can lead to overgrowth of resistant microorganisms, including fungi. In case of superinfection, it is necessary to discontinue the drug and prescribe adequate therapy. There is a lack of data to draw a conclusion about the efficacy and safety of using moxifloxacin for the treatment of bacterial conjunctivitis in newborns, and therefore the use in patients of this age group is not recommended. Moxifloxacin is not recommended for prophylactic use or ex juvantibus therapy (empirical treatment) of gonococcal conjunctivitis, incl. in the treatment of gonococcal ophthalmia of newborns, due to the presence of a large number of strains of Neisseria gonorrhoeae resistant to moxifloxacin. Patients with infectious diseases of the eye,caused by Neisseria gonorrhoeae should receive appropriate systemic therapy. The use of moxifloxacin for the treatment of infectious diseases of the organ of the eye caused by Chlamydia trachomatis in patients under 2 years of age is not recommended, since there is no information about the study of the drug in this category of patients. The use of moxifloxacin in patients over 2 years of age with eye diseases caused by Chlamydia trachomatis should be combined with systemic therapy. For ophthalmia of newborns, patients should receive treatment appropriate to their condition; so, with the development of conjunctivitis of chlamydial and gonorrheal etiology, this type of treatment will be systemic therapy. Influence on the ability to drive vehicles and mechanisms After using the drug, a temporary decrease in the clarity of visual perception is possible,and until its recovery, it is not recommended to drive and engage in activities that require increased attention and reaction.

Drug interactions

The interaction of topically administered moxifloxacin with other drugs has not been studied. There are data for the oral dosage form of moxifloxacin: there were no clinically significant drug interactions (unlike other fluoroquinolone drugs) with theophylline, warfarin, digoxin, oral contraceptives, probenicide, ranitidine and glibenclamide. In in vitro studies, moxifloxacin does not inhibit isoenzymes CYP3A4, CYP2D6, CYP2C9 or CYP1A2, which may indicate that moxifloxacin does not alter the pharmacokinetic properties of drugs metabolized by cytochrome P450 isoenzymes.