Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Ocuflox: 0.3% (5 mL) [contains benzalkonium chloride]
Generic: 0.3% (5 mL, 10 mL)
Pharmacology
Mechanism of Action
Ofloxacin is a DNA gyrase inhibitor. DNA gyrase is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; bactericidal
Pharmacokinetics/Pharmacodynamics
Absorption
Only small amounts are absorbed systemically after ophthalmic instillation.
Excretion
Urine
Use: Labeled Indications
Bacterial conjunctivitis: Treatment of bacterial conjunctivitis caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, and Pseudomonas aeruginosa.
Corneal ulcer: Treatment of corneal ulcers caused by S.aureus, S.epidermidis, S.pneumoniae, P.aeruginosa, Serratia marcescens, and Cutibacterium acnes.
Contraindications
Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation
Dosage and Administration
Dosing: Adult
Bacterial conjunctivitis: Ophthalmic: Instill 1 to 2 drops in affected eye(s) every 2 to 4 hours for the first 2 days, then instill 1 to 2 drops 4 times daily for an additional 5 days.
Corneal ulcer: Ophthalmic: Instill 1 to 2 drops in affected eye(s) every 30 minutes while awake and every 4 to 6 hours after retiring for the first 2 days; beginning on day 3, instill 1 to 2 drops every hour while awake for 4 to 6 additional days; thereafter, 1 to 2 drops 4 times daily until clinical cure.
Dosing: Pediatric
Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Initial: Instill 1 to 2 drops in affected eye(s) every 2 to 4 hours for the first 2 days (Days 1 and 2); then instill 1 to 2 drops 4 times daily for an additional 5 days (Days 3 through 7)
Corneal ulcer: Children and Adolescents: Ophthalmic: Initial: Instill 1 to 2 drops in affected eye(s) every 30 minutes while awake and every 4 to 6 hours at night for the first 2 days (Days 1 and 2); then instill 1 to 2 drops every hour while awake for 4 to 6 additional days (Days 3 through 7 to 9); thereafter, 1 to 2 drops 4 times daily until clinical cure is achieved
Administration
For ophthalmic use only; not for injection. Avoid touching tip of applicator to eye, fingers, or other surfaces.
Storage
Store 15°C to 25°C (59°F to 77°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not defined.
Central nervous system: Dizziness, foreign body sensation of eye
Gastrointestinal: Nausea
Ophthalmic: Blurred vision, burning sensation of eyes, conjunctivitis (chemical), eye discomfort, eye pain, eye pruritus, eye redness, keratitis (chemical), lacrimation, photophobia, stinging of eyes, swelling of eye, xerophthalmia
<1%, postmarketing, and/or case reports: Stevens-Johnson syndrome, toxic epidermal necrolysis
Warnings/Precautions
Concerns related to adverse effects:
- Hypersensitivity reactions: Rare severe hypersensitivity reactions (some fatal), including anaphylaxis and anaphylactic shock, have occurred with systemic quinolone therapy (some following the first dose). Some reactions were accompanied by airway obstruction, angioedema (laryngeal, pharyngeal, or facial edema), cardiovascular collapse, dyspnea, loss of consciousness, pruritus, and urticaria. Discontinue treatment if an allergic reaction occurs.
- Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection is suspected, institute appropriate alternative therapy.
- Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic quinolone antibiotics. Exposure following ophthalmic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.
Dosage form specific issues:
- Appropriate use: Not for subconjunctival injection or for introduction into the ocular anterior chamber.
Special populations:
- Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic infections.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in some animal reproduction studies. When administered orally, ofloxacin crosses the placenta (Giamarellou 1989). The amount of ofloxacin available systemically following topical application of the ophthalmic drops is significantly less in comparison to oral doses. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion for 3 to 5 minutes after application to decrease potential exposure to the fetus (Samples 1988).
Patient Education
What is this drug used for?
- It is used to treat eye infections.
Frequently reported side effects of this drug
- Burning
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Joint pain
- Joint swelling
- Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes.
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
