Ofloxacin

Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:

• The recommended dosage regimen
• For the treatment of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s)
• Days 3 through 7 Instill one to two drops four times daily
• The recommended dosage regimen
• For the treatment of bacterial corneal ulcer is: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake
• Awaken at approximately four and six hours after retiring and 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

• Safety and effectiveness in infants below the age of one year have not been established
• Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of ofloxacin to immature animals has not shown any arthropathy
• There is no evidence that the ophthalmic dosage form of ofloxacin has any effect on weight bearing joints

No overall differences in safety or effectiveness have been observed between elderly and younger 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

Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see WARNINGS ).

Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. …

Ophthalmic use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received. Refer to WARNINGS for additional adverse reactions. To report SUSPECTED ADVERSE REACTIONS, contact Sentlss at 1--855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy: Teratogenic Effects: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight and increased fetal mortality in rats and rabbits, respectively. …

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 USA Manufactured by: Ophtapharm AG, Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Ma …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.