Index of drugs

The drug is used in adults and children in the anterior segment of the eye, caused by microorganisms sensitive to ofloxacin. The official guidelines for the proper use of antibacterial drugs should be taken into account.

1 ml of solution contains 3 mg ofloxacin. The preparation contains benzalkonium chloride.

A chemotherapeutic agent from the fluoroquinolone group for topical use. Species usually sensitive: Gram-positive aerobic microbes -Staphylococcus aureus (MSSA); Gram-negative aerobic microorganisms -Haemophilus influenzae, Enterobacteriaceae (Escherichia coli, Serratia marcescens, Enterobacter cloacae, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis), Acinetobacter baumannii, Acinetobacter lwoffi, Moraxella catarrhalis. Species for which acquired resistance may become a problem: Gram-positive aerobic microbes -Staphylococcus aureus (MRSA); Coagulase-negative staphylococci -Streptococcus pneumoniae, Enterococcus spp.; Gram-negative aerobic microorganisms -Pseudomonas aeruginosa.Mean concentrations of Ofloxacin in the tear film measured 4 h after topical administration (9.2 μg / g) were higher than the minimum concentration of 2 μg / ml ofloxacin necessary to inhibit the growth of 90% of the majority of bacterial strains causing ocular infections (MIC90)in vitro. The maximum concentration of ofloxacin in the serum after ten days of topical administration was approximately 1000-fold lower than the values ​​recorded after the standard oral doses of ofloxacin and no systemic adverse reactions were observed.

Hypersensitivity to Ofloxacin, any other quinolone or any of the excipients.

If an allergic reaction occurs, the drug should be discontinued. Caution should be exercised in patients who have been hypersensitive to other quinolone antibacterial agents. During the use of the preparation should be considered the possibility of the drug entering the nasopharynx, which can contribute to the occurrence and spread of bacterial resistance. Prolonged use may cause excessive multiplication of resistant bacteria. If the infection is worsening or if there is no clinical improvement within the anticipated period, the medicine should be discontinued and alternative therapy instituted. Patients receiving topical ophthalmic medicines containing ofloxacin have reported a Stevens-Johnson syndrome, however a causal relationship to the use of the drug has not been established. The use of the preparation in newborns with infection of the anterior segment of eyes caused byNeisseria gonorrhoeae orChlamydia trachomatis it is not recommended because it has not been evaluated in this group of patients. In the case of infections of the anterior segment of the eye, appropriate treatment should be implemented in newborns. Corneal perforation has been reported in patients with corneal epithelial defects or corneal ulcer treated with topical fluoroquinolone antibiotics. However, many of these reports describe important supportive factors such as advanced age, the occurrence of major ulcers, co-existing eye diseases (e.g., severe dry eye syndrome), systemic inflammatory diseases (e.g., rheumatoid arthritis) and concomitant use of ophthalmic steroids or NSAIDs. However, caution should be exercised when using ofloxacin for the treatment of patients with corneal epithelial defects or corneal ulceration due to the risk of corneal perforation. Corneal opacity has been reported during treatment with topical ophthalmic medicines containing ofloxacin, however a causal relationship to the use of the drug has not been established. Avoid exposure to sunlight or UV radiation when using ofloxacin due to the possibility of photosensitivity. Safety and efficacy in infants under one year have not been determined. The preparation contains benzalkonium chloride, which may cause eye irritation and discoloration of soft contact lenses. The use of contact lenses is not recommended in patients with ocular infection.

There are insufficient data on the use of the preparation in pregnant women. Serum concentration after administration of doses used in ophthalmology is at least 1000 times lower than after standard oral doses. The preparation should be used during pregnancy only when it is absolutely necessary. It is not known whether ofloxacin is excreted into breast milk after administration to the eye. Caution should be exercised when using while breastfeeding.

Common: eye irritation, discomfort in the eye. Very rare: hypersensitivity (including angioneurotic edema, dyspnoea, anaphylactic reaction, anaphylactic shock, throat edema, swelling of the tongue). Not known: dizziness, keratitis, conjunctivitis, blurred vision, photophobia, swelling of the eye, feeling of a foreign body in the eye, increased tearing, dry eye syndrome, eye pain, eye congestion, hypersensitivity (including ocular pruritus, pruritus eyelid), nausea, periorbital edema, swelling of the face.

1 drop into the conjunctival sac of the infected eye or both infected eyes every 2-4 h for the first 2 days; then the drug should be used 4 times a day. The drug should not be used for more than 14 days. It is not necessary to adjust the dose in elderly patients. The dose used in children is not different from the adult dose. However, experience in use in children is limited. There are no studies on the optimal dose. Safety and efficacy in infants under one year have not been determined. If other eye drops and / or ointments are used at the same time, a break should be maintained for at least 15 minutes between each medication and eye Ointment should always be applied at the end.