The safety and efficacy of BEPREVE® have not been established in pediatric patients under 3 years of age
Efficacy of BEPREVE® in pediatric patients with age < 10 was extrapolated from clinical trials conducted in pediatric patients with age >10 and in adults
Relevant warnings and precautions:
For topical ophthalmic use only
Do not touch the eyelids or surrounding areas with the dropper tip of the bottle and keep bottle tightly closed when not in use
Do not use to treat contact lens-related irritation
Do not instill while wearing contact lenses. Lenses may be reinserted after 10 minutes following administration.
Should not be used in pregnant women unless the benefit to the mother justifies the potential risk to the fetus
Demonstrated a significant reduction in ocular itch at 3 minutes post CAC at the onset of action, 8-hour and 16-hour visits
Primary mechanisms of action include:1†
Non-sedating, selective antagonism of H1-histamine receptors
Mast-cell stabilization
Inhibitory action on eosinophilic migration to inflammatory sites
Suppression of vascular permeability
Product characteristics†
Low Benzalkonium Chloride (BAK) concentration of 0.005%
pH of 6.8
Comes in low-density polyethylene plastic squeeze bottle
Available in 5 mL bottle1
† Clinical significance has not been established
References:
BEPREVE®Product Monograph. Bausch & Lomb Incorporated. July 22, 2016.
Abelson MB et al. Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: A phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children. Clin Ther 2009;31:1908–21.