Local treatment (in children and adults) of superficial ocular infections, such as bacterial conjunctivitis and keratitis caused by microorganisms sensitive to ofloxacin. The official guidelines for the proper use of antibacterial drugs should be taken into account.
Composition:
1 ml of solution contains 3 mg ofloxacin. The preparation contains benzalkonium chloride.
Action:
A chemotherapeutic agent from the fluoroquinolone group for topical use. Species usually sensitive to Ofloxacin - Gram-positive aerobic bacteria:Staphylococcus aureus (MSSA); Gram-negative aerobic bacteria:Haemophilus influenzae, Haemophilus parainfluenzae, Enterobacteriaceae (Escherichia coli, Proteus mirabilis, Klebsiella oxytoca, Serratia marcescens, Enterobacter cloacae and Klebsiella pneumoniae), Acinetobacter baumannii, Acinetobacter lwoffii, Moraxella catarrhalis. Species in which acquired resistance may occur:Staphylococcus aureus (MRSA)Streptococcus pneumoniaecoagulase negative staphylococci,Enterococcus spp., Pseudomonas aeruginosa. The mean concentration of ofloxacin in the tear film, measured 4 h after topical administration (9.2 μg / g), was higher than the minimum concentration of ofloxacinin vitro 2 μg / ml, necessary to inhibit the growth of 90% of bacterial strains in the eye (MIC90). The maximum concentration of ofloxacin in the blood serum after ten days of topical administration was about 1000 times lower than that of the oral administration of ofloxacin and no systemic adverse reactions were observed.
Contraindications:
Hypersensitivity to ofloxacin or to any of the excipients.
Precautions:
When using the product, the possibility of getting into the nasopharynx should be considered, which may contribute to the occurrence and spread of bacterial resistance. Prolonged use ofloxacin may cause excessive multiplication of non-susceptible organisms. 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. Caution should be exercised in patients who have been hypersensitive to other quinolone antibacterial agents. Avoid excessive exposure to sunlight or UV radiation (eg, quartz lamps, tanning beds, etc.) to avoid photosensitivity. Stevens-Johnson syndrome and cases of corneal opacity have been reported in patients receiving ophthalmic ophthalmic drugs containing Ofloxacin, however a causal relationship to the use of the drug has not been established. Long-term use of high doses of other fluoroquinolones in experimental animals caused the lens to become cloudy. However, this effect has not been found in humans or in animals (including monkeys) when using topical ophthalmic medicines containing ofloxacin for up to 6 months. There are very limited data on the efficacy and safety of ofloxacin in the treatment of conjunctivitis in newborns. Use of eye drops containing ofloxacin in newborns with infection of the anterior segment of eyes caused byNeisseria gonorrhoeae orChlamydia trachomatis it is not recommended and has not been evaluated in this group of patients (it is recommended to use appropriate systemic treatment). Due to the risk of corneal perforation, caution should be used when treating patients with corneal epithelial defects or corneal ulceration. The preparation contains benzalkonium chloride, which may cause eye irritation and be absorbed by soft contact lenses causing their discoloration. It advises against the use of contact lenses during the treatment of eye infection.
Pregnancy and lactation:
The systemic exposure of ofloxacin to eye drops is predicted to be low. The drug can be used during pregnancy if necessary. It is predicted that after the use of eye drops, the concentration ofloxacin in breast milk is minimal. The drug can be used during breastfeeding, if indicated.
Side effects:
Common: eye irritation, discomfort in the eye. Not known: hypersensitivity (including allergic eye reactions), dizziness, keratitis, conjunctivitis, blurred vision, photophobia, eye swelling, foreign body sensation in the eye, increased tearing, dry eye syndrome, eye pain, itchy eye, eyelid itching , eyeball congestion, nausea, swelling around the eyes, swelling of the face.
Dosage:
1 drop into the conjunctival sac of the infected eye (eyes) every 2-4 h for the first 2 days and then 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 as well as in children and adolescents. If other eye drops 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 as the last one.