ofloxacin 0.3 % Ophthalmic Solution
WARNINGS
NOT FOR INJECTION.
Ofloxacin Ophthalmic Solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
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, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching.
A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic 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.
DESCRIPTION
Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution.
It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.
C 18 H 20 FN 3 O 4 Mol Wt 361.37 Chemical Name: (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid.
Contains: Active: ofloxacin 0.3% (3 mg/mL).
Preservative: benzalkonium chloride 0.005%.
Inactives: sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water.
Ofloxacin Ophthalmic Solution is unbuffered and formulated with a pH of 6.4 (range – 6.0 to 6.8).
It has an osmolality of 300 mOsm/kg.
Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
MM1
HOW SUPPLIED
Ofloxacin Ophthalmic Solution USP, 0.3% is supplied sterile in plastic DROP-TAINER* of the following sizes: 5 mL NDC 61314-015-05 10 mL NDC 61314-015-10 STORAGE: Store at 15°-25°C (59°-77°F).
Rx Only *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.
INDICATIONS AND USAGE
INDICATIONS & USAGE Ofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Pseudomonas aeruginosa Gram-negative bacteria: Enterobacter cloacae Haemophilus influenza Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION 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.