Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ofloxacin ophthalmic solution USP, 0.3% is supplied sterile in opaque white LDPE plastic bottles and natural dropper tips with tan polypropylene caps as follows: 5mL in 10mL bottle - NDC 59390-140-05 Note: Store at 20°-25°C (68°-77°F) Rx only Revised March 2013 Altaire P harmaceuticals Inc. Aquebogue N.Y. 11931, U.S.A.; Principal Display Panel NDC 59390-140-05 Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile NDC 59390-140-05- Carton Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile; Principal Display Panel NDC 59390-140-05 Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile NDC 59390-140-05- Label Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile
- HOW SUPPLIED Ofloxacin ophthalmic solution USP, 0.3% is supplied sterile in opaque white LDPE plastic bottles and natural dropper tips with tan polypropylene caps as follows: 5mL in 10mL bottle - NDC 59390-140-05 Note: Store at 20°-25°C (68°-77°F) Rx only Revised March 2013 Altaire P harmaceuticals Inc. Aquebogue N.Y. 11931, U.S.A.
- Principal Display Panel NDC 59390-140-05 Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile NDC 59390-140-05- Carton Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile
- Principal Display Panel NDC 59390-140-05 Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile NDC 59390-140-05- Label Rx Only Ofloaxcin ophthalmic solution 0.3% FOR USE IN THE EYES ONLY 5 mL Sterile
Overview
Ofloxacin Ophthalmic Solution USP , 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fiuoro-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%). C 18 H 20 FN 3 O 4 Mol Wt. 361.37 Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution, USP 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.
Indications & Usage
Ofloxacin ophthalmic solution, USP is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Enterobacter cloacae Haemophilus influenza Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Pseudomonas aeruginosa Serratia marcascens ' Anaerobic species: Propionibacterium acnes * Efficacy for this organism was studied in fewer than 10 infections
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 corn eal 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.
Warnings & Precautions
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.
Contraindications
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.
Adverse Reactions
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.
Drug Interactions
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.
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