Itch relief begins within 3 minutes and persists at least 8 hours after a single drop.
OFF-LABELNot in the FDA label for this product
Vernal keratoconjunctivitis
1 drop BID, the labeled regimen, continued for 8 weeks in the cited trial
Comparative · n=50 · not sig
Single center open label comparative trial in 50 patients with vernal keratoconjunctivitis, aged 5 to 15, allocated to 1.5% solution or olopatadine 0.1% BID for 8 weeks. The authors report quicker relief of watering, ocular discomfort, and conjunctival hyperemia in the bepotastine arm but state the difference was not statistically significant; olopatadine improved papillary hypertrophy faster, and the two were equal for itching.
History of hypersensitivity reactions to bepotastine or any other ingredient in the formulation.
Available Forms
Ophthalmic solution, bepotastine besilate 15 mg/mL (1.5%), 5 mL and 10 mL LDPE dropper bottles with controlled dropper tip
Mechanism of Action
Topically active direct H1 receptor antagonist that also inhibits release of histamine from mast cells, combining immediate receptor blockade with mast cell stabilization. Animal and in vitro models add inhibition of eosinophil chemotaxis into conjunctival tissue and suppression of allergen-induced conjunctival vascular hyperpermeability.
Warnings & Precautions
Contact lens wear: Not for contact lens related irritation, and not to be instilled while lenses are worn; benzalkonium chloride 0.005% may be absorbed by soft lenses, so reinsert no sooner than 10 minutes after dosing.
Tip contamination: Keep the dropper tip off the eyelids and surrounding areas.
Common Side Effects
Ocular: Eye irritation in 2% to 5%.
Systemic: Mild taste after instillation in about 25%, the most common reaction reported; headache and nasopharyngitis in 2% to 5%.
Hypersensitivity: Rare postmarketing reports of itching, body rash, and swelling of the lips, tongue, or throat.
Pregnancy & Lactation
Pregnancy: No human data. Oral dosing of pregnant rats and rabbits through organogenesis or the pre/postnatal period produced no adverse embryofetal or offspring effects at clinically relevant systemic exposures; maternal toxicity appeared in rabbits at the lowest dose tested, 215 times the maximum recommended human ophthalmic dose on a mg/m2 basis.
Lactation: No data on presence in human milk, on the breastfed infant, or on milk production. After a single oral dose in rats, radiolabeled drug concentration in milk exceeded maternal plasma concentration at every measurement.