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Microsoft word - gatidan.doc
Each ml contains :
Dexamethasone 0.02 mg Benzalkonium Chloride USP
Ocidan is a fluorinated 4-quinolone anti-biotic . It is bactericidal in action . It is thought to exert a bactericidal
effect on susceptible bacterial cells by inhibiting DNA gyrase , an essential bacterial enzyme which is a critical
catalyst in the duplication , transcription and repair of bacterial DNA .
Ofloxacin has been shown to be active against most strains of the following organisms both in vitro and
clinically , in conjunctival and / or corneal ulcer infections . Indications and Usage :
Ocidan is indicated for the treatment of conjunctivitis , corneal ulcers , external infections of the eye and ocular
surface caused by various gram negative and gram positive bacteria and anaerobic species .
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
Ocidan is contraindicated in patients with a history of hypersensitivity to ofloxacin , to other qunolones , or to
any of the components in this medication .
NOT FOR INJECTION. Ocidan should not be injected subconjunctivally , nor shold it be introduced directly
into the anterior chamber of the eye .
Use the solution within one month after opening the container . Do not touch the nozzle tip to any surface since
this may contaminate the solution . If irritation persists or increases , discontinue use and consult physician . Precautions :
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions , some following the first dose , have
been reported in patients receiving systemic quinolones including Ofloxacin . Some reactions were
accompanied by cardiovascular collapse , loss of consciousness , angioneurotic edema (including laryngeal ,
pharyngeal or facial edema) airway obstruction dyspnea , urticaria and itching .
If an allergic reaction to ofloxacin occurs , discontinue the drug . Serious acute hypersensitivity reactions may
require immediate emergency treatment . Oxygen andairway management , including incubation should be
administered as clinically indicated .
Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases, causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
As with other anti-infectives , prolonged use may result in overgrowth of nonsusceptible organisms
including fungi . If superinfection occurs discontinue use and institute alternative therapy .
There are no established control studies to date on safety of using ofloxacin Topical , in pregnant
women . Hence discretion on the part of the physician is called for on prescribing to pregnant women .
Nursing Mothers :
Because of the potential for adverse reactions from ofloxacin , in nursing infants , a
decision should be made whether to discontinue nursing or to discontinue the drug , taking into account the
importance of the drug to the mother .
Pediatric Use :
Safety and effectiveness in infants below the age of one year have not been established . Dosage and Administration :
One or two drops of Ocidan should be instilled in the infected eye four times a day . Alternations (increase or
decrease ) of dosage may be made based upon the clinical response as judged by the physician .Therapy may be
continued foe 24 to 48 hours after targets are achieved .
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