Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ofloxacin ophthalmic solution, USP 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with tan high density polyethylene (HDPE) caps as follows: 5 mL in 10 mL bottle – NDC 65145- 141 -01 10 mL in 10 mL bottle – NDC 65145- 142 -01 STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx only Made in India Distributed by: Caplin Steriles USA Inc, Hamilton, NJ 08619. Code: TN/Drugs/TN00003457 Revised: 08/2024 22200946 Ofloxacin-oph-caplin-logo; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label - 5 mL NDC 65145- 141 -01 Rx only Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile 5 mL Carton Label - 5 mL Rx only 5 mL NDC 65145- 141 -01 Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile Container Label - 10 mL NDC 65145- 142 -01 Rx only Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile 10 mL Carton Label - 10 mL Rx only 10 mL NDC 65145- 142 -01 Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile ofloxacin-ophthalmic-5ml-container ofloxacin-ophthalmic-5ml-carton ofloxacin-ophthalmic-10ml-container ofloxacin-ophthalmic-10ml-carton
- HOW SUPPLIED Ofloxacin ophthalmic solution, USP 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with tan high density polyethylene (HDPE) caps as follows: 5 mL in 10 mL bottle – NDC 65145- 141 -01 10 mL in 10 mL bottle – NDC 65145- 142 -01 STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx only Made in India Distributed by: Caplin Steriles USA Inc, Hamilton, NJ 08619. Code: TN/Drugs/TN00003457 Revised: 08/2024 22200946 Ofloxacin-oph-caplin-logo
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label - 5 mL NDC 65145- 141 -01 Rx only Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile 5 mL Carton Label - 5 mL Rx only 5 mL NDC 65145- 141 -01 Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile Container Label - 10 mL NDC 65145- 142 -01 Rx only Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile 10 mL Carton Label - 10 mL Rx only 10 mL NDC 65145- 142 -01 Ofloxacin Ophthalmic Solution, USP 0.3% For eye use only Sterile ofloxacin-ophthalmic-5ml-container ofloxacin-ophthalmic-5ml-carton ofloxacin-ophthalmic-10ml-container ofloxacin-ophthalmic-10ml-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. Ofloxacin-structure
Indications & 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: 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 & 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.
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 Caplin Steriles Limited at 1-866-978-6111 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.
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