Indication
Ophthalmology. Bacterial infections of the anterior segment of the eye caused by pathogens sensitive to ofloxacin: infectious conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis, dacryocystitis, barley, chalaziones and corneal ulcers. To prevent infectious eye damage, the drug is indicated in the preparation for surgery, after intraocular operations, after removal of foreign bodies and eye injuries. As a component of general therapy for the treatment of bacterial endophthalmitis.
Otology. Treatment of bacterial infections caused by pathogens that are sensitive to ofloxacin in adults and children 12 years of age, for the treatment of external otitis media, chronic purulent otitis media (with perforation of the tympanic membrane), and in adults – for prophylaxis in conducting anesthesia. For the treatment of children from 1 to 11 years of age, it is used with external otitis media and acute otitis media with tympanostomy.
Composition of the substance
active substance: ofloxacin; 1 ml of solution contains ofloxacin 3 mg;
excipients: sodium hydroxide phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, benzalkonium chloride, water for injection.
Medicinal form
Drops eye / ear, solution.
Pharmacological properties
Pharmacodynamics.
Uniflox contains a bactericidal synthetic chemotherapeutic substance – ofloxacin, which belongs to the group of fluoroquinolones. Ofloxacin has a wide range of antimicrobial activity. In bacterial cells, onloxacin inhibits the DNA of the glycerin, which is required for duplication and transcription of bacterial DNA. It acts on Staphylococcus aureus (including strains producing penicillinase and some methicillin-resistant strains), Streptococcus pneumoniae , St. Fecal, St. pyogenes, Corynebacterium species, Micrococcus species, Bacillus species , Enterobacteriaceae (Escherichia coli, Citrobacter, Enterobacter, Klebsiela, Proteus, Salmonella, Serratia, Shigella , etc.), Pseudomonas aeruginosa and species Pseudomonas , Haemophilus influenzae, Haemophilus ducreyi, Branhamella catarhalis , Neisseria gonnorrhoeae, Neisseria meningitis , species Acinetobacter , species Campylobacter, Gardenerella vaginalis , Heliobacter pylori, Brucella . It is also effective against Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae and some other mycoplasmas.
Resistant strains, including species Clostridium , species Bacteroides and species of Peptococcus . The resistance of Pseudomonas aeruginosa is 15 × 20%, and the resistance to Staphylococcus aureus is 5? 10%.
Pharmacokinetics.
A significant advantage of the drug compared with other antibiotics of local action is its high permeability to the cornea and the anterior chamber of the eye. Of all fluoroquinolones, ofloxacin has the best ability to penetrate the cornea and the anterior chamber of the eye; its effective concentration in the lacrimal film remains even after 4 hours (240 minutes) after application. The mean concentration of ofloxacin in tears, measured 4 hours after application, was 9.2 μg / g. Systemic reabsorption after local administration to the conjunctival sac is insignificant and has no clinical significance. After administration of two drops of the drug at intervals of 30 minutes, the concentration of ofloxacin in the cornea after 4 hours was 4.4 μg / g.
After a single administration of 0.3% drops of ofloxacin in the ear, its concentration in serum was 1000 times less than the concentration at oral administration. The concentration of onloxacin in the discharge from the tympanum was very close to its concentration in the administered drug (3 g / l). A 0.3% drop of ofloxacin successfully penetrates the middle ear when the ears are removed from the outside and in the direction of the cheek at the time of insertion.
Producer
«UNIMED PHARMA Ltd».
Location of the manufacturer and the address of the place of its operation
Orieskova 11, 821 05 Bratislava, Slovak Republic.