Ofloxacin
Generic Name: ofloxacin
Brand Names:
Ofloxacin
DESCRIPTION Ofloxacin ophthalmic solution 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- 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 and water for injection.
Overview
DESCRIPTION Ofloxacin ophthalmic solution 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- 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 and water for injection.
Uses
INDICATIONS AND 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 : Gram - negative bacteria : Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS : Gram - positive bacteria : Gram - negative bacteria : Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens * Streptococcus pneumoniae Anaerobic species : Propionibacterium acnes * Efficacy for this organism was studied in fewer than 10 infections
Dosage
DOSAGE AND 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 throughtreatment completion Instill one to two drops, four times daily.
Side Effects
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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
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. 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).
Storage
HOW SUPPLIED Product: 50090-5425 NDC: 50090-5425-0 5 mL in a BOTTLE, PLASTIC / 1 in a CARTON
Frequently Asked Questions
What is Ofloxacin used for?▼
INDICATIONS AND 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 : Gram - negative bacteria : Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS : Gram - positive bacteria : Gram - negative bacteria : Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens * Streptococcus pneumoniae Anaerobic species : Propionibacterium acnes * Efficacy for this organism was studied in fewer than 10 infections
What are the side effects of Ofloxacin?▼
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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the important warnings for Ofloxacin?▼
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. 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).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.