Ofloxacin 0,3 % Solution

OFLOXACIN 0,3 % w/v Eye Drops FDC is indicated for the topical treatment of external ocular infections caused by ofloxacin susceptible bacteria.

The recommended dosage for the treatment of bacterial conjunctivitis is: One drop every two to four hours for the first two days, then four times daily in the affected eye(s). Treatment should not exceed ten days.

The recommended dosage regimen for the treatment of bacterial corneal ulcer is:

Days 1 and 2: Instil one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instil one to two drops.

Days 3 through 7 to 9: Instil one or two drops hourly, while awake.

Days 7 to 9 through treatment completion: Instil one to two drops, four times daily.

Method of administration: For ocular use

• OFLOXACIN 0,3 % w/v Eye Drops FDC is contraindicated in patients hypersensitive to ofloxacin or any of its components (see section 6.1).
• Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that OFLOXACIN 0,3 % w/v Eye Drops FDC not be used by pregnant or lactating women (see section 4.6).
• Safety and effectiveness in infants below the age of one year have not been established (see section 4.4).

OFLOXACIN 0,3 % w/v Eye Drops FDC is not for injection. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching. If an allergic reaction to OFLOXACIN 0,3 % w/v Eye Drops FDC occurs, discontinue the product and contact your medical practitioner. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

Use OFLOXACIN 0,3 % w/v Eye Drops FDC with caution in patients who have exhibited sensitivities to other quinolone antibacterial medicines. When using OFLOXACIN 0,3 % w/v Eye Drops FDC eye drops the risk of rhinopharyngeal passage, which can contribute the occurrence and the diffusion of bacterial resistance, should be considered. Prolonged use may result in overgrowth of non-susceptible organisms. If superinfection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute appropriate therapy.

Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylactic reaction/shock have been reported in patients receiving ofloxacin as in OFLOXACIN 0,3 % w/v Eye Drops FDC. Corneal precipitates, and corneal perforation in patients with pre-existing corneal epithelial defect or corneal ulcer, have been reported during treatment with ofloxacin as in OFLOXACIN 0,3 % w/v Eye Drops FDC. Long-term, high-dose use of fluoroquinolones in experimental animals has caused lenticular opacities. However, this effect has not been reported in human patients.

OFLOXACIN 0,3 % w/v Eye Drops FDC contains the preservative benzalkonium chloride, which may cause eye irritation. As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmic preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease. The use of OFLOXACIN 0,3 % w/v Eye Drops FDC while wearing soft contact lenses is not recommended. Benzalkonium chloride may be absorbed by soft contact lenses and discolour them. Contact lenses should be removed prior to installation and may be reinserted 15 minutes following administration.

Elderly use: No comparative data are available with topical dosing in the elderly versus other age groups.

Paediatric use: Safety and effectiveness in infants below the age of one year have not been established. The use of OFLOXACIN 0,3 % w/v Eye Drops FDC eye drops in neonates with ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended as it has not been evaluated in such patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomatis or Neisseria gonorrhoeae. Ofloxacin have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of OFLOXACIN 0,3 % w/v Eye Drops FDC to immature animals has not shown any arthropathy (see section 4.3).

It has been shown that the systemic administration of some quinolones inhibits the metabolic clearance of caffeine and theophylline. Interaction studies conducted with systemic ofloxacin have demonstrated that metabolic clearance of caffeine and theophylline are not significantly affected by ofloxacin. Although there have been reports of an increased prevalence of central nervous system toxicity with systemic dosing of fluoroquinolones when used concomitantly with systemic non-steroidal anti-inflammatory drugs (NSAIDs), this has not been reported with the concomitant systemic use of NSAIDs and ofloxacin. No interaction studies with OFLOXACIN 0,3 % w/v Eye Drops FDC have been performed.

Pregnancy: Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that OFLOXACIN 0,3 % w/v Eye Drops FDC not be used in pregnant women (see section 4.3).

Breastfeeding: Ofloxacin and other quinolones are excreted in breast milk, therefore there is a potential for harm to nursing infants. OFLOXACIN 0,3 % w/v Eye Drops FDC is not recommended for breastfeeding women and temporary discontinuation of breastfeeding should be considered (see section 4.3).

Transient blurring of vision may occur on instillation of eye drops. Do not drive or operate hazardous machinery unless vision is clear.

General: Since a small amount of OFLOXACIN 0,3 % w/v Eye Drops FDC is systemically absorbed after topical administration, adverse events reported with systemic use could possibly occur.

Tabulated list of adverse reactions:

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

In the event of accidental ingestion of 10 ml of OFLOXACIN 0,3 % w/v Eye Drops FDC, 30 mg of ofloxacin would be ingested. This amount does not appear to be clinically significant in terms of overdosage. However, there would be an increased potential for systemic reactions (see section 4.4). In the event of a topical overdosage, flush the eye with a topical ocular irrigant. Treatment is symptomatic and supportive.