Overdose
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Shelf life
2 years unopened.
Discard 28 days after first opening.
Incompatibilities
None known.
List of excipients
Benzalkonium chloride (EP) 0.005% w/v
Sodium chloride (EP) 0.9% w/v
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Purified water (EP)
Undesirable effects
General
Serious reactions after use of systemic ofloxacin are rare and most symptoms are reversible. Since a small amount of ofloxacin is systemically absorbed after topical administration, side-effects reported with systemic use could possibly occur.
Frequency categories: 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) and not known (cannot be estimated from the available data):
Immune System Disorders
Not Known: Hypersensitivity reaction including signs or symptoms of Eye allergy (such as Eye pruritus and Eyelid pruritus) and Anaphylactic reactions (such as angioedema, dyspnea, anaphylactic shock, oropharyngeal swelling, facial oedema and tongue swollen)
Nervous System Disorders
Not known: Dizziness
Eye Disorders
Common: Eye irritation; Ocular discomfort
Not known: Keratitis; Conjunctivitis; Vision blurred; Photophobia; Eye oedema; Foreign body sensation in eyes; Lacrimation increased; Dry eye; Eye pain; Ocular hyperaemia; Periorbital oedema (including eyelid oedema)
Cardiac disorders
Not known: ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation); ECG QT prolonged
Gastrointestinal Disorders
Not known: Nausea
Skin and Subcutaneous Tissue Disorders
Not Known: Stevens-Johnson syndrome; Toxic epidermal necrolysis
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 medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Preclinical safety data
There are no toxicological safety issues with this product in man as the level of systemic absorption from topical ocular administration of ofloxacin is minimal.
Animal studies in the dog have found cases of arthropathy in weight bearing joints of juvenile animals after high oral doses of certain quinolones. However, these findings have not been seen in clinical studies and their relevance to man is unknown.
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals, anti-infectives, fluoroquinolones
ATC code: S01AE01.
Ofloxacin is a synthetic fluorinated 4-quinolone antibacterial agent with activity against a broad spectrum of Gram negative and to a lesser degree Gram positive organisms.
Ofloxacin has been shown to be active against most strains of the following organisms both in vitro and clinically in ophthalmic infections. Clinical trial evidence of the efficacy of EXOCIN® against S. pneumoniae was based on a limited number of isolates.
Gram-negative bacteria: Acinetobacter calcoaceticus var. anitratum, and A. calcoaceticus var. iwoffi; Enterobacter Sp. including E. cloacae; Haemophilis Sp, including H. influenza and H. aegyptius; Klebsiella Sp., including K. Pneumoniae; Moraxella Sp., Morganella morganii; Proteus Sp., including P. Mirabilis; Pseudomonas Sp.; including P. Aeruginosa, P. cepacia, and P. fluoroscens; and Serratia Sp., including S. marcescens.
Gram-positive bacteria: Bacillus Sp.; Corynebacterium Sp.; Micrococcus Sp.; Staphylococcus Sp., including S. aureus and S. epidermidis; Streptococcus Sp., including S. Pneumoniae (see above), S. viridans and Beta-haemolytic.
The primary mechanisms of action is through inhibition of bacterial DNA gyrase, the enzyme responsible for maintaining the structure of DNA.
Ofloxacin is not subject to degradation by beta-lactamase enzymes nor is it modified by enzymes such as aminoglycoside adenylases or phosphorylases, or chloramphenicol acetyltransferase.
Pharmacokinetic properties
After ophthalmic instillation, ofloxacin is well maintained in the tear-film.
In a healthy volunteer study, mean tear film concentrations of ofloxacin measured four hours after topical dosing (9.2 µg/g) were higher than the 2µg/ml minimum concentration of ofloxacin necessary to inhibit 90% of most ocular bacterial strains (MIC90) in-vitro.
Maximum serum ofloxacin concentrations after ten days of topical dosing were about 1000 times lower than those reported after standard oral doses of ofloxacin, and no systemic side-effects attributable to topical ofloxacin were observed.
Date of revision of the text
April 2016
Marketing authorisation holder
Allergan Ltd
Marlow International
The Parkway
Marlow
Bucks SL7 1YL
United Kingdom
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
A bottle and an applicator tip of low density polyethylene (LDPE) and medium or high impact polystyrene cap.
The bottle contains 5 ml or 10 ml of suspension.
Not all pack sizes may be marketed.
Marketing authorisation number(s)
PL 00426/0070
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Transient blurring of vision may occur on instillation of eye drops. Do not drive or operate hazardous machinery unless vision is clear.
Special precautions for disposal and other handling
There is no special requirement for disposal.
Any unused product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation/renewal of the authorisation
Date of first authorisation: 26th October 1992
Date of last renewal: 8th November 2004
