Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Generic: 0.5% (5 mL)
Pharmacology
Mechanism of Action
Levofloxacin is the L-isomer of ofloxacin. Levofloxacin inhibits DNA-gyrase and topoisomerase IV in susceptible organisms and thereby inhibits relaxation of supercoiled DNA and promotes breakage of DNA strands. DNA gyrase (topoisomerase II), is an essential bacterial enzyme that maintains the superhelical structure of DNA and is required for DNA replication, transcription, repair, and recombination.
Pharmacokinetics/Pharmacodynamics
Absorption
Only small amounts are absorbed systemically after ophthalmic instillation
Use: Labeled Indications
Bacterial conjunctivitis: Treatment of bacterial conjunctivitis caused by susceptible strains of Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus groups C/F, Streptococcus group G, Viridans group streptococci, Acinetobacter lwoffii, Haemophilus influenzae, and Serratia marcescens.
Contraindications
Hypersensitivity to levofloxacin, other quinolones, or to any component of the formulation.
Dosage and Administration
Dosing: Adult
Bacterial conjunctivitis: Ophthalmic:
Treatment day 1 and day 2: Instill 1 to 2 drops into affected eye(s) every 2 hours while awake, up to 8 times daily
Treatment day 3 through day 7: Instill 1 to 2 drops into affected eye(s) every 4 hours while awake, up to 4 times daily
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: 0.5% solution:
Day 1 and 2: Instill 1 to 2 drops into affected eye(s) every 2 hours while awake, up to 8 times/day
Day 3 to 7: Instill 1 to 2 drops into affected eye(s) every 4 hours while awake, up to 4 times/day
Administration
For topical ophthalmic use only; not for injection. Avoid touching tip of applicator to eye or other surfaces.
Storage
Store at 20°C to 25°C (68°F to 77°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%:
Central nervous system: Headache (1% to 3%)
Ophthalmic: Burning sensation of eyes (transient, 1% to 3%), eye pain (1% to 3%), foreign body sensation of eye (1% to 3%), photophobia (1% to 3%), vision loss (transient, 1% to 3%)
Respiratory: Pharyngitis (1% to 3%)
Miscellaneous: Fever (1% to 3%)
<1%, postmarketing, and/or case reports: Dry eye syndrome, eyelid edema, eye pruritus, hypersensitivity reaction
Warnings/Precautions
Concerns related to adverse effects:
- Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported with systemic quinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.
- Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. Discontinue use and institute appropriate alternative therapy if superinfection is suspected.
Other warnings/precautions:
- Appropriate use: For topical use only. Do not inject subconjunctivally or introduce into anterior chamber of the eye. Contact lenses should not be worn during treatment for bacterial conjunctivitis.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in some animal reproduction studies. When administered orally or IV, levofloxacin crosses the placenta (Ozyüncü and Beksac 2010; Ozyüncü and Nemutlu 2010). The amount of levofloxacin available systemically following topical application of the ophthalmic drops is significantly less in comparison to oral or IV 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
- 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, headache, foreign body sensation in eye, sensitivity to light, or sore throat. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (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 healthcare 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.
