Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ofloxacin Ophthalmic Solution USP, 0.3% is supplied sterile in plastic dropper bottles with tan polypropylene cap of the following sizes: 5 mL - NDC 72485-613-10 10 mL - NDC 72485-613-11 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 Made in Switzerland 83100106 Rev. 08/23; Principal Display Panel Text for Container Label: NDC 72485-613-10 Ofloxacin Ophthalmic Solution, USP 0.3% Rx Only 5 mL Sterile NDC 72485-613-11 Ofloxacin Ophthalmic Solution, USP 0.3% Rx Only 10 mL Sterile 5 mL container 10 ml container; Principal Display Panel Text for Carton Label: NDC 72485-613-10 Ofloxacin Ophthalmic Solution, USP 0.3% Sterile Ophthalmic Solution Rx Only 5 mL Sterile NDC 72485-613-11 Ofloxacin Ophthalmic Solution, USP 0.3% Sterile Ophthalmic Solution Rx Only 10 mL Sterile 5 ml carton 10 ml carton
- HOW SUPPLIED Ofloxacin Ophthalmic Solution USP, 0.3% is supplied sterile in plastic dropper bottles with tan polypropylene cap of the following sizes: 5 mL - NDC 72485-613-10 10 mL - NDC 72485-613-11 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 Made in Switzerland 83100106 Rev. 08/23
- Principal Display Panel Text for Container Label: NDC 72485-613-10 Ofloxacin Ophthalmic Solution, USP 0.3% Rx Only 5 mL Sterile NDC 72485-613-11 Ofloxacin Ophthalmic Solution, USP 0.3% Rx Only 10 mL Sterile 5 mL container 10 ml container
- Principal Display Panel Text for Carton Label: NDC 72485-613-10 Ofloxacin Ophthalmic Solution, USP 0.3% Sterile Ophthalmic Solution Rx Only 5 mL Sterile NDC 72485-613-11 Ofloxacin Ophthalmic Solution, USP 0.3% Sterile Ophthalmic Solution Rx Only 10 mL Sterile 5 ml carton 10 ml carton
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-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -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 and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin Ophthalmic Solution USP, 0.3% 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. Figure
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:
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.
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. 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. 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 (see WARNINGS ).
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. 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.
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.
Storage & Handling
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 Made in Switzerland 83100106 Rev. 08/23
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