COMPOSITION: Each mL contains ciprofloxacin HCl equivalent to 3 mg ciprofloxacin
Inactive ingredients: sodium chloride, disodium edetate, hydrochloric acid/sodium hydroxide, water for injection Preservative: Benzalkonium chloride 0,01% m/v
PHARMACOLOGICAL CLASSIFICATION: A 15.1 Ophthalmic Preparations with antibiotics and/or sulphonamides
Pharmacodynamics properties: Ciprofloxacin is a broad-spectrum, water soluble, fluoroquinolone anti-bacterial. It has bactericidal 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 an in vitro activity against a wide range of gram negative micro-organisms. Sensitivity of methicillin resistant Staphylococcus aureus is variable. In vitro sensitivity does not necessarily imply in vivo efficacy.
Micro-organisms resistant to Ciprofloxacin: Enterococcus faecium; Norcardia asteroides; Ureaplasma urealyticum; Peptostreptococcus species; Peptococcus species; Bacteroides; Treponema pallidum 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: FOXIN ophthalmic solution is indicated for the treatment of:
Conjunctivitis caused by susceptible strains of bacteria
Appropriate monitoring of bacterial response to topical anti-bacterial therapy should accompany the use of FOXIN eye drops.
CONTRA-INDICATIONS: Hypersensitivity to any of the components in the solution
Hypersensitivity to other quinolones may also contra-indicate the use of ciprofloxacin.
WARNINGS: FOXIN eye drops 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 have a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine (adrenaline) and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
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.
Tendon rupture may occur within 48 hours after starting treatment with FOXIN and may be bilateral. If tendonitis is suspected, treatment with FOXIN must be discontinued immediately and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon.
INTERACTIONS: 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 ciclosporin concomitantly.
PREGNANCY AND LACTATION: Safety in pregnancy and breast feeding mothers has not been established.
DOSAGE AND DIRECTIONS FOR USE: The recommended dosage regimen for adults and children over 2 years are as follows: Corneal ulcers or abscesses: 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 medical practitioner. Bacterial conjunctivitis: 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.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Eye disorders: Frequent White precipitate and ocular discomfort (stinging and burning may occur upon application). In patients with corneal ulcer or frequent application of FOXIN, white precipitates have been observed, which resolved spontaneously with continued application. The precipitate does not preclude continued use of FOXIN eye drops.
Less frequent 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. Gastro-intestinal disorders: Less frequent Taste perversion (metallic taste), nausea Skin and subcutaneous tissue disorders: Less frequent Dermatitis Special Precautions: FOXIN may be absorbed systemically and identical adverse reactions may be encountered as with the use of systemic administration of quinolones. The preservative, benzalkonium chloride, in FOXIN may be deposited in soft contact lenses; therefore, FOXIN should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not be reinserted earlier than 15 minutes after use.
Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, appropriate measures should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy and where appropriate, fluorescein staining. Effects on ability to drive and use machines: As FOXIN is used in the treatment of certain eye conditions, precautionary measures need to be taken to determine whether a patient can drive or operate machines whilst using FOXIN.
KNOWN SYMPTOMS OF OVER-DOSAGE 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: FOXIN (eye drops) is an almost colourless to pale yellow clear solution, practically free from particles
PRESENTATION: Transparent, colourless LDPE dropper bottle containing 5 mL sterile aqueous eye drops with white screw cap packed into printed unit carton
STORAGE INSTRUCTIONS: Store at or below 30°C. Keep in carton and protect from light. Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN.
DO NOT USE MORE THAN 30 DAYS AFTER OPENING.
REGISTRATION NUMBER: 45/15.1/0034
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION: Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300
DATE OF PUBLICATION OF THE PACKAGE INSERT: 05/12/2013
New addition to this site: June 2015
Source: Pharmaceutical Industry