Topical treatment of superficial ocular infections, such as bacterial conjunctivitis and keratitis, caused by microorganisms sensitive to the action Ofloxacin in adults and children. The official guidelines governing the proper use of antibacterial drugs must be followed.
Composition:
1 ml of solution contains 3 mg ofloxacin (and 0.025 mg of benzalkonium chloride).
Action:
A chemotherapeutic agent from the fluoroquinolone group for topical use. Commonly sensitive species: Gram-positive aerobic organisms: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 be a problem: Gram-positive oxygen microorganisms:Staphylococcus aureus (MRSA), coagulase-negativestaphylococci,Streptococcus pneumoniae,Enterococcus spp; Gram-negative aerobic microorganismsPseudomonas aeruginosa.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients or other quinolones.
Precautions:
The safety and efficacy of use in infants below 1 year of age has not been established. In patients taking systemic quinolons, including Ofloxacin, even serious reactions that were observed at the first dose were observed in severe and sometimes fatal hypersensitivity reactions (anaphylactic / anaphylactoid reactions). During the use of the preparation, the possibility of getting into the nasopharynx should be considered, which may contribute to the bacterial resistance and its spread. Prolonged use of ofloxacin may cause excessive multiplication of refractory microorganisms. 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. 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. 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 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 the preparation 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 due to the lack of evaluation in this group of patients. In the case of infections of the anterior segment of the eye in the newborn, appropriate treatment should be implemented, e.g. systemic treatment in the case of infections caused byChlamydia trachomatis orNeisseria gonorrhoeae. Due to the risk of corneal perforation, caution should be used when treating patients with corneal epithelial abnormalities or corneal ulceration. The preparation contains benzalkonium chloride, which may cause eye irritation and be absorbed by soft contact lenses causing their discoloration. The use of contact lenses in patients treated for ocular infections is contraindicated.
Pregnancy and lactation:
The preparation can be used in pregnant women only when it is absolutely necessary. Ofloxacin is excreted in breast milk in small amounts.The product may be used during breast-feeding, if indicated.
Side effects:
Common: eye irritation, discomfort in the eye. Very rare: hypersensitivity (including angioneurotic edema, dyspnea, anaphylactic reaction / shock, edema of the mouth and throat, and 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, eye pain, eyeball congestion, hypersensitivity (including eye itching and itching of the eyelids), nausea, periorbital edema, swelling of the face.
Dosage:
Dospojówkowo. Drop 1 drop into 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. The dose used in children is not different from the adult dose (studies on the optimal dose are not available). If other eye drops or ointments are used at the same time, keep at least 15 minutes. the interval between the administration of individual medicines and eye Ointment should always be applied at the end.