For Healthcare Professional Only

Ofloxacin 0.3% - Eye Drops 5ml

Indications :
The following infections caused by ofloxacin-susceptible strains of Staphylococcus sp.,Streptococcus pneumoniae,Micrococcus sp.,Corynebacterium sp., sp.,Pseudomonas aeruginosa, Haemophilius sp., (H.influenzae, H. aegyptius [Koch-Weeks bacillus]), Moraxella sp., (morax-Axenfeld diplobacillus) Serratia sp., Klebsiella sp., Proteus sp., Acinetobacter sp.) and Anaerobic bacteria (Propionibacterium acnes): Blepharitis, dacryocystitis, conjunctivitis, tarsadenitis, keratitis and corneal ulcer.

Dosage :
• The recomended dosage regimen for the treatment of bacterial conjunctivitis; days 1 and 2 : Instill one to two drops every two hours in the affected eye. • The recommended dosage regimen for the treatment of bacterial corneal ulcer is: Days 1 and 2 : Instill one to two drops into affected eye every 30 minutes,while a wake,awaken at approximately four and six hours after refiring & instill one to two drops. Days 3 through 7 to 9: Instill one to two drops hourly,while awake. Days 7 to 9 through treatment completion: Instill one to two drops, four times daily.

Contraindications :
Patients with a history of hypersensitivity to the ingredient of this product or any quinolone antibiotics.

Special Precautions :
As a general rule, the duration of treatment with this drug should be limited to a minimum requirement for the treatment of diseases,after the susceptibility being confirmed,in order to avoid possible occurrence of resistant bacteria.

General precautions:
• Avoid long term use. • Sedimentation in ulcer may occur while corneal ulcer is treatment with topical quinolon. If it is not treat carefully,it can distruct corneal tissues. • Use during pregnancy: Since the safety of this product during pregnancy has not been established,this product should be given to pregnant woman or women suspected of being pregnant only if the expected therapeutic benefit is judged to outweigh any possible risk. • Not for injection: Tarivid solution should not be injected subconjunctivally,nor should it be introduced directly into the anterior chamber of the eye. Serious and occasionally fatal hypersensivity (anaphylactic) reactions, some following the first dose,have been reported in patient's receiving systemic quinolones,including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciouness,angioedema (including laryngeal,pharyngeal,or facial edema), airway obstruction, dyspnea, urticaria and itching. A rare occurrence of Stevens-Johnson syndrome,which pregressed to toxic epidermal necrolysis has been reported in patient who was receiving topical ophtalmic ofloxacin. If an allergic reaction to ofloxacin occurs,discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment, oxygen and airway management, including intubation should be administered as clinically indicated • As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organism,including fungi. If superinfection occurs,discontinue use and institute alternative therapy. Whenever clinical judgment dictates the patients should be examined with the did of fluorocein staining. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. The systemic administration of quinolones, including ofloxacin,has led to lesions or erosions of the cartilage in weight bearing joints and other signs of arthropathy in immature animals of various species. Ofloxacin,administered systemically at 10mg/kg/day in young dogs (equivalent to 110 times the maximum recommended daily adult ophtalmic dose) has been associated with these types of effects. information for patients: avoid contaminating the applicator tip with material from the eye,fingers, or other source. Systemic quinolones, including ofloxacin have been associated with hypersensitivity reactions,even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction • Route administration: Ophthalmic use only.

Adverse drug reactions:
The most frequently reported drug related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging,redness, itching, chemical conjunctivitis/keratitis, periocular / facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received.

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