Itch relief begins within 3 minutes and lasts about 8 hours.
OFF-LABELNot in the FDA label for this product
Conjunctival redness of allergic conjunctivitis
1 drop in each affected eye BID, the labeled regimen, given for 6 weeks in the trial
RCT · n=139
Randomized 22-center trial in perennial allergic conjunctivitis (N=139) against masked placebo, with an open-label levocabastine arm: itching and conjunctival redness both improved versus placebo (P<0.001), the combined score improving 1.9 (SD 1.1) versus 0.6 (SD 1.1) on placebo at day 7 from a baseline of 3.7 to 3.8 on a 0 to 6 scale, and continuing to improve through day 42. Bitter taste and application site reaction were the most frequent adverse events. The US indication covers itching only, not redness.
Known or suspected hypersensitivity to any component of the solution.
Available Forms
6 mL solution in a 10 mL bottle, 0.05% (0.5 mg/mL)
Mechanism of Action
Relatively selective histamine H1 antagonist that also inhibits release of histamine and other mediators from mast cells, so it blocks the receptor driving itch and limits further mediator release. Human cell line studies show additional inhibition of allergic mediators such as leukotrienes and PAF, plus decreased eosinophil chemotaxis and activation.
Warnings & Precautions
Route restriction: Ocular use only, not for injection or oral use.
Soft contact lens wear: The benzalkonium chloride preservative is absorbed by soft lenses; insert lenses no sooner than 10 minutes after instillation, and not at all while the eye is red.
Contact lens-related irritation: Not an indication for this solution.
Dropper tip contamination: Contact with any surface, the eyelids or surrounding areas contaminates tip and solution.
Common Side Effects
Ocular: Transient burning or stinging approximately 30%, generally mild; eye pain, conjunctivitis and temporary blurring 1% to 10%.
Systemic: Headache approximately 15%; asthma, dyspnea, fatigue, influenza-like symptoms, pharyngitis, rhinitis and pruritus 1% to 10%, several of which overlap with the underlying allergic disease.
Bitter taste: Approximately 10% with dosing up to 56 days; with application site reaction, also the most frequent adverse event in independent perennial allergic conjunctivitis trials.
Pregnancy & Lactation
Pregnancy: Category C. Embryotoxic, fetotoxic and teratogenic (external and skeletal abnormalities) in mice at an oral 68.6 mg/kg/day, roughly 57,000 times the recommended ocular human use level; delayed ossification and increased 14th rib incidence in rats at 30 mg/kg/day (25,000 times). No adequate and well-controlled studies in pregnant women; use only if the potential benefit justifies the potential fetal risk.
Lactation: Excretion in human milk is unknown; caution in a nursing woman.
Pediatric Use
Safety and effectiveness below age 3 not established.
Available Forms
Mechanism of Action
Pregnancy & Lactation
Pediatric Use