CILOXAN

Adults, newborn infants (0-27 days), infants and toddlers (28 days to 23 months), children (2-11 years) and adolescents (12 – 16 years) Corneal Ulcers: CILOXAN must be administered in the following intervals, even during night time: On the first day, instil 2 drops into the affected eye every 15 minutes for the first six hours and then 2 drops into the affected eye every 30 minutes for the remainder of the day.

On the second day, instil 2 drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every 4 hours. If the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of the attending physician.

Superficial Ocular Infection:

The usual dose is one or two drops in the affected eye(s) four times a day. In severe infections, the dosage for the first two days may be one or two drops every two hours during waking hours. For either indication a maximum duration of therapy of 21 days is recommended.

The dosage in children above the age of 1 year is the same as for adults. Use in children Safety and effectiveness of CILOXAN Eye Drops were determined in 230 children between the ages of 0 and 12 years of age. No serious adverse drug reaction was reported in this group of patients.

Use in renal and hepatic impairment No studies have been performed using CILOXAN Eye Drops in patients with kidney or liver problems.

In clinical trials, the most frequently reported adverse drug reactions were ocular discomfort, dysgeusia and corneal deposits occurring approximately in 6%, 3% and 3% of patients respectively. Tabulated summary of adverse reactions The adverse reactions listed below are classified according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience. The following undesirable effects were reported in association with the ophthalmic use of CILOXAN: System Organ Classification MedDRA Preferred Term (v.

1) Immune system disorders Rare: hypersensitivity Nervous system disorders Uncommon: headache Rare: dizziness Eye disorders Common: corneal deposits, ocular discomfort, ocular hyperaemia Uncommon: keratopathy, punctate keratitis, corneal infiltrates, photophobia, visual acuity reduced, eyelid oedema, blurred vision, eye pain, dry eye, eye swelling, eye pruritus, lacrimation increased, eye discharge, eyelid margin crusting, eyelid exfoliation, conjunctival oedema, erythema of eyelid Rare: ocular toxicity, keratitis, conjunctivitis, corneal epithelium defect, diplopia, hypoaesthesia eye, asthenopia, eye irritation, eye inflammation, hordeolum Ear and labyrinth disorders Rare: ear pain Respiratory, thoracic and mediastinal disorders Rare: paranasal sinus hypersecretion, rhinitis Gastrointestinal disorders Common: dysgeusia Uncommon: nausea Rare: diarrhoea, abdominal pain Skin and subcutaneous tissue disorders Rare: dermatitis Musculoskeletal and connective tissue disorders Not known: tendon disorder Description of selected adverse events With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative, Stevens-Johnson syndrome and urticaria occur very rarely.

After cap is removed, if tamper evident snap collar is loose, remove before using product. For ocular use only. The clinical experience in children less than one year old, particularly in neonates is very limited. The use of CILOXAN eye drops in neonates with ophthalmia neonatorum of gonococcal or chalamydial origin is not recommended as it has not been evaluated in such patients.

Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition. When using CILOXAN eye drops one should take into account the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, were observed in patients receiving treatment based on systematically administered quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnoea, urticaria and itching.

8). Serious acute hypersensitivity reactions to ciprofloxacin may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated. CILOXAN should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

As with all antibacterial preparations prolonged use may lead to overgrowth of non- susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin, particularly in elderly patients and those treated concurrently with corticosteroids.

8). In patients with corneal ulcer and frequent administration of CILOXAN Eye Drops, white topical ocular precipitates (medication residue) have been observed which resolved after continued application of CILOXAN Eye Drops. The precipitate does not preclude the continued application of CILOXAN Eye Drops nor does it adversely affect the clinical course of the recovery process.

1. • Hypersensitivity to quinolones.