INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CILOXAN

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CILOXAN

CILOXAN®Eye Drops (solution)
CILOXAN®Eye Ointment (ointment)

COMPOSITION:
CILOXAN Eye Drops contains
ciprofloxacin hydrochloride equivalent to 3 mg/mL ciprofloxacin, preserved with benzalkonium chloride 0.006% (m/v).
CILOXAN Eye Ointment contains ciprofloxacin hydrochloride equivalent to 3 mg/g ciprofloxacin in an anhydrous ophthalmic ointment base. It does not contain a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.15.1 Ophthalmic preparations with antibiotics and/or sulphonamides.

PHARMACOLOGICAL ACTION:
Pharmacodynamic properties
Ciprofloxacin is a broad-spectrum water-soluble fluoroquinolone antibacterial. It has cidal and inhibitory activities against bacteria, which result from an interference with the DNA gyrase, an enzyme required by the bacterium for the synthesis of DNA. Thus, the vital information from the bacterial chromosomes cannot be transcribed any longer, which causes a breakdown in the bacterial metabolism. Ciprofloxacin has anin vitro activity against a wide range of Gram-negative microorganisms including Pseudomonas aeruginosa and Serratia marcescensand Gram-positive bacteria, such as staphylococciand streptococci includingStaphylococcus aureus (including methicillin-susceptible strains), Staphylococcus epidermidis, Streptococcus pneumoniae and Streptococcus (viridans group). Sensitivity of methicillin resistant Staphylococcus aureus is variable.
Pharmacokinetic properties
Ciprofloxacin is absorbed systemically after topical ocular administration. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL (some 450-fold less than levels observed following simple 250 mg oral administration)and the mean plasma concentration was less than 2.5 ng/mL.

INDICATIONS:
CILOXAN Eye Drops and Eye Ointment are indicated for the treatment of corneal ulceration and conjunctivitis caused by susceptible strains of bacteria.
Appropriate monitoring of bacterial response to topical antibacterial therapy should accompany the use of CILOXAN Eye Drops and Eye Ointment.

CONTRA-INDICATIONS:
Hypersensitivity to ciprofloxacin or any component of this medication. Hypersensitivity to other quinolones may also contra-indicate the use of ciprofloxacin.

WARNINGS:
CILOXAN 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.
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.
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.

DOSAGE AND DIRECTIONS FOR USE:
The recommended dosage regimens for adults and children over the age of two years are as follows:
Corneal ulcers or abscesses:
CILOXAN 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.
CILOXAN 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:
CILOXAN 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.
CILOXAN 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.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Undesirable effects
In clinical trials with CILOXAN Eye Drops and Eye Ointment, the following treatment-related signs and symptoms have been reported:
Common
Ocular: White precipitate and ocular discomfort (stinging and burning may occur upon application). In patients with corneal ulcer or frequent administration of the drug, white precipitates have been observed, which resolved spontaneously with continued application. The precipitate does not preclude continued use of CILOXAN Eye drops or CILOXAN Eye ointment, nor does it adversely affect the clinical course of the ulcer or the recovery process.
Uncommon
Ocular effects:
CILOXAN Eye Drops: Itching, foreign body sensation, lid margin crusting, crystals/scales, conjunctival hyperaemia, corneal stinging, keratopathy/keratitis, allergic reactions, lid oedema, tearing, photophobia, corneal infiltrates, and decreased vision. Hypersensitivity reactions cannot be excluded.
CILOXAN Eye Ointment: Blurred vision, hyperaemia, pruritis, decreased visual acuity, pain, tearing and photophobia.
Special senses effects: Taste perversion (metallic taste), nausea.
Skin effects: Dermatitis.
Pregnancy and lactation
Safety in pregnant women and breastfeeding mothers has not been established.
Interaction with other medicaments and other forms of interaction
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.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
A topical ocular overdose may be flushed from the eye(s) with lukewarm tap water. Treatment should be symptomatic and supportive.

IDENTIFICATION:
CILOXAN Eye Drops: Colourless, clear solution.
CILOXAN Eye Ointment: Homogenous, white to off-white ointment.

PRESENTATION:
CILOXAN Eye Drops: Low-density polyethylene bottle containing 5 mL sterile eye drops.
CILOXAN Eye Ointment: Epoxy-phenolic lined aluminium tube containing 3.5 g sterile eye ointment, with white high-density and/or low-density polyethylene nozzle (dispensing tip) and white high-density polyethylene tube closure. The text is preprinted on the tube.

STORAGE INSTRUCTIONS:
CILOXAN Eye Drops: Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
DO NOT USE MORE THAN 30 DAYS AFTER OPENING
CILOXAN Eye Ointment: Do not refrigerate. Store below 30°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
CILOXAN Eye Drops: Z/15.1/202
CILOXAN Eye Ointment: 35/15.1/0410

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA)(Pty) Ltd
261 Surrey Avenue
Randburg 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
CILOXAN Eye Drops: 13 February 1992
CILOXAN Eye Ointment: 12 March 2003

Rev: 0303

Updated on this site: October 2003
Source: Pharmaceutical Industry

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