Quixin®

Levofloxacin 0.5% · ophthalmic solution

Antibiotic

Approved uses

Bacterial corneal ulcer

Days 1 to 3: 1 to 2 drops q30min to q2h while awake, plus doses about 4 and 6 hours after retiring. Day 4 to completion: 1 to 2 drops q1h to q4h while awake.

A single two-drop dose keeps tear levels above the MIC90 for 24 hours in healthy volunteers.

Contraindications

History of hypersensitivity to levofloxacin, to other quinolones, or to any component of this product.

Available Forms

Ophthalmic solution, 5 mL fill in a 5 cc bottle, 1.5% (15 mg/mL)

Mechanism of Action

Fluoroquinolone, the L-isomer of ofloxacin, with in vitro activity against a wide range of gram-positive and gram-negative organisms; inhibits bacterial topoisomerase IV and DNA gyrase, the type II topoisomerases required for DNA replication, transcription, repair and recombination, and is often bactericidal at concentrations equal to or slightly above inhibitory concentrations. Structure and mode of action differ from beta-lactams and aminoglycosides, so activity may persist against organisms resistant to those classes; spontaneous in vitro resistance is rare (frequency 10^-9 to 10^-10).

Warnings & Precautions

Systemic quinolone hypersensitivity: Serious and occasionally fatal anaphylactic reactions have been reported with systemically administered quinolones, some following the first dose, accompanied by cardiovascular collapse, loss of consciousness, angioedema including laryngeal, pharyngeal or facial edema, airway obstruction, dyspnea, urticaria and itching; discontinue on any allergic reaction and treat serious ones as an emergency with oxygen and airway management.
Nonsusceptible organism overgrowth: Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; on superinfection, discontinue and institute alternative therapy, examining with magnification such as slit lamp biomicroscopy and with fluorescein staining where appropriate.
Contact lens wear: Lenses are not to be worn in the presence of signs or symptoms of corneal ulcer.

Common Side Effects

Systemic, 8 to 10%: Headache and taste disturbance after instillation, the two most frequent reactions in the overall study population.
Ocular, 1 to 2%: Decreased or blurred vision, instillation site irritation or discomfort, ocular pain or discomfort, ocular infection.
Systemic, 1 to 2%: Diarrhea, dyspepsia, fever, infection, nausea, throat irritation.
Ocular, under 1%: Chemosis, corneal erosion, diplopia, floaters, hyperemia, lid edema, lid erythema.

Pregnancy & Lactation

Pregnancy: Category C. Oral dosing at 810 mg/kg/day in rats decreased fetal body weight and increased fetal mortality. No teratogenic effect in rabbits dosed orally as high as 50 mg/kg/day (systemic exposure estimated at 250 times that at the maximum recommended human ophthalmic dose) or intravenously as high as 25 mg/kg/day (120 times). No adequate and well controlled studies in pregnant women; use only if the potential benefit justifies the potential fetal risk.

Lactation: Not measured in human milk; excretion is presumed from ofloxacin data.

Pediatric Use

Safety and effectiveness below age 6 years have not been established.