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Ofloxacin (Ophthalmic)

Pronunciation

Pronunciation

(oh FLOKS a sin)

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)

Brand Names: U.S.

  • Ocuflox

Pharmacologic Category

  • Antibiotic, Fluoroquinolone
  • Antibiotic, Ophthalmic

Pharmacology

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

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 Propionibacterium acnes.

Contraindications

Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation

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: Ophthalmic: Children ≥1 year and Adolescents: Refer to adult dosing.

Corneal ulcer: Ophthalmic: Children ≥1 year and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

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

Dermatologic: Stevens-Johnson syndrome (rare), toxic epidermal necrolysis (rare)

Gastrointestinal: Nausea

Ocular: Blurred vision, burning, chemical conjunctivitis/keratitis, discomfort, dryness, edema, eye pain, foreign body sensation, itching, photophobia, redness, stinging, tearing

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions (some fatal), including anaphylaxis, 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 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 punctual occlusion for 3 to 5 minutes after application to decrease potential exposure to the fetus (Samples 1988).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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