OCUFLOX

1 Dosing Considerations Prolonged use of OCUFLOX may result in overgrowth of nonsusceptible organisms, including fungi. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

If the infection is not improved within 7 days, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy. 2 Recommended Dose and Dosage Adjustment One to two drops every two to four hours for the first two days, and then four times daily in the affected eye(s) for 8 days.

Health Canada has not authorized an indication for pediatric use. 4 Administration Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of the eye drops.

The preservative in OCUFLOX, benzalkonium chloride, may be absorbed by and cause discoloration of soft contact lenses. OCUFLOX should not be administered while wearing soft contact lenses. Contact lenses should be removed prior to instillation of OCUFLOX and may be reinserted 15 minutes following its administration.

5 Missed Dose Patients should be instructed to instill the drops as soon as they remember, and then to return to their regular routine.

1 Adverse Reaction Overview Since a small amount of ofloxacin is systemically absorbed after topical administration, adverse reactions reported with systemic use could possibly occur.

Ophthalmic Use of Ofloxacin:

The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions were ocular irritation, redness, stinging, itching, photophobia, tearing and dryness. One report of dizziness, one report of headache and one spontaneous report of toxic epidermal necrolysis have also been received.

Systemic Effects of Ofloxacin:

As with all topical ophthalmic drugs, the potential exists for systemic effects. Ofloxacin used systemically has rarely been associated with serious side effects. Serious reactions reported for systemic dosing of ofloxacin include convulsions and increased intracranial pressure.

For the oral dosage form of ofloxacin, gastrointestinal symptoms, mainly nausea/vomiting, pain/discomfort, diarrhea and anorexia, were reported most frequently, followed by central nervous system events (such as dizziness and headaches) and dermatological or hypersensitivity reactions.

Additional effects OCUFLOX (ofloxacin) Page 7 of 20 seen with systemic dosing of ofloxacin and other fluoroquinolones are QT prolongation, exacerbation of myasthenia gravis symptoms, tendinitis and tendon rupture. Photophobia was reported rarely in clinical trials with systemic ofloxacin and phototoxicity has been reported with other drugs in this class.

5 Post-Market Adverse Reactions The following adverse reactions have been identified during post marketing use of OCUFLOX in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

General OCUFLOX is not for injection into the eye. Contact of the tip of the dispensing container with the eye or surrounding structures may lead to eye injury and contamination of eye drops. The use of ofloxacin with other products may lead to drug interactions.

For established or potential drug interactions. See 9 DRUG INTERACTIONS. Driving and Operating Machinery As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

Immune Hypersensitivity Use OCUFLOX with caution in patients who have exhibited sensitivities to other quinolone antibacterial agents. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions may require immediate emergency treatment with epinephrine.

Oxygen, intravenous steroids and airway management, including intubation, should be administered as clinically indicated. OCUFLOX should be discontinued if an allergic reaction occurs. Hypersensitivity reactions including angioedema, dyspnea, anaphylactic reaction/shock, oropharyngeal swelling, Stevens-Johnson syndrome, tongue swollen and toxic epidermal necrolysis have been reported with OCUFLOX.

5 Post-Market Adverse Reactions. In patients receiving systemic quinolone therapy, serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching.

Musculoskeletal Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ofloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Treatment with OCUFLOX should be discontinued at the first sign of tendon inflammation.

OCUFLOX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

A history of hypersensitivity to other quinolones also contraindicates use of ofloxacin.