Ciloxan 3 mg Solution

u2022 CILOXANu00ae Eye Drops and Eye Ointment are indicated for the treatment of corneal ulceration and conjunctivitis caused by susceptible strains of bacteria.

u2022 Appropriate monitoring of bacterial response to topical antibacterial therapy should accompany the use of CILOXANu00ae Eye Drops and Eye Ointment.

Posology

The recommended dosage regimens for adults and children over the age of two years are as follows:

• Corneal ulcers or abscesses : CILOXANu00ae Eye Drops : On the first day, instil two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the day. On the second day, instil two drops in the affected eye hourly. On the third through the fourteenth day, instil two drops into the affected eye every four hours. If the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of the physician. CILOXANu00ae Eye Ointment : Apply 1,25 cm into the conjunctival sac every 1-2 hours around the clock for two days, then every four hours for a further 12 days. The dosing may be extended at the discretion of the physician.
• Bacterial conjunctivitis: CILOXANu00ae Eye Drops : Instil one or two drops into the conjunctival sac(s) every two hours while awake for two days, then one or two drops every four hours while awake until the bacterial infection is resolved. CILOXANu00ae Eye Ointment : Apply 1,25 cm into the conjunctival sac (or on the lid margin, respectively) three times daily for two days, then twice daily for a further five days. The dosing may be extended at the discretion of the physician.

Method of administration

For ocular use.

u2022 Hypersensitivity to ciprofloxacin or any component of this medication.

u2022 Hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.

u2022 CILOXANu00ae Eye Drops and Eye Ointment should be discontinued at the first appearance of a skin rash or any other sign of a hypersensitivity reaction. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnoea, urticaria and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.

u2022 Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate measures should be initiated. Whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy and where appropriate, fluorescein staining.

u2022 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 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.

u2022 Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin, particularly in elderly patients and those treated concurrently with corticosteroids. Therefore, treatment with CILOXAN should be discontinued at the first sign of tendon inflammation ( see section 4.8 ).

u2022 In patients with corneal ulcer and frequent administration of CILOXAN, white topical ocular precipitates (medication residue) have been observed which resolved after continued application of CILOXAN. The precipitate does not preclude the continued application of CILOXAN nor does it adversely affect the clinical course of the recovery process. The onset of the precipitate was within 24 hours to 7 days after starting therapy. Resolution of the precipitate varied from immediately to 13 days after therapy commencing.

u2022 Contact lens wear is not recommended during treatment of an ocular infection. Therefore, patients should be advised not to wear contact lenses during treatment with CILOXAN.

u2022 CILOXANu00ae Eye Drops contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. In case patients are allowed to wear contact lenses they should be instructed to remove them prior to application of CILOXANu00ae Eye Drops and wait at least 15 minutes before reinsertion.

The systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effect of warfarin and its derivatives and transient increases in serum creatinine have been observed in patients receiving cyclosporin concomitantly.

Women of childbearing potential/ Contraception in males and females

No information available.

Pregnancy

Safety in pregnant women has not been established.

Breastfeeding

Safety in pregnant women and breastfeeding mothers has not been established.

Fertility

Studies have not been performed in humans to evaluate the effect of topical administration of ciprofloxacin on fertility.

CILOXANu00ae Eye Drops and Eye Ointment can cause blurred vison or other visual disturbances ( see section 4.8 Undesirable effects ) and may have no or negligible influence or effect on mental and/or physical abilities to perform or execute tasks or activities requiring mental alertness, judgment and/or sound coordination and vision.

In clinical trials with CILOXANu00ae Eye Drops and Eye Ointment, the following treatment-related signs and symptoms have been reported:

a. Summary of the safety profile

The following adverse reactions have been reported during clinical trials with CILOXANu00ae Eye drops / CILOXANu00ae Eye ointment, and are classified according to the subsequent convention: very common (u2265 1/10), common (u2265 1/100 to <1/10), uncommon (u22651/1,000 to <1/100), rare (u22651/10,000 to <1/1,000), very rare (<1/10,000). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.

Tabulated list of adverse reactions

Body System Undesirable effect Common Uncommon Rare Immune system disorders: hypersensitivity Nervous system disorders: headache dizziness Eye disorders: white precipitate and ocular discomfort (stinging and burning keratopathy/punctuate keratitis, corneal infiltrates, photophobia, ocular toxicity, keratitis, conjunctivitis, corneal epithelium defect, may occur upon application), ocular hyperaemia reduced visual acuity, lid oedema, blurred vision, eye pain, decreased tearing, eye swelling, pruritis, (itching), increased tearing, eye discharge, lid margin crusting, crystals/scales, conjunctival oedema, erythema of eyelid diplopia, hypoaesthesia eye, asthenopia, hordeolum, eye irritation, eye inflammation Ear and labyrinth disorders: ear pain Respiratory, thoracic and mediastinal disorders: paranasal sinus hypersecretion,rhinitis Gastrointestinal disorders: taste perversion (metallic taste) nausea diarrhoea, abdominal pain Skin and subcutaneous tissue disorders: dermatitis

Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data.

Body System Undesirable effect Musculoskeletal, connective tissue and bone disorders: tendon disorder

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine 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 t he u201cReport Drug Reaction Processu201d, found online under SAHPRAu2019s safety publications: https://www.sahpra.org.za/

In overdose, side effects can be precipitated and/or be of increased severity ( see section 4.8 ). A topical ocular overdose may be flushed from the eye(s) with lukewarm tap water. Treatment should be symptomatic and supportive.