Bepotastine Besilate

Bepotastine besilate ophthalmic solution, 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 )

Bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see Adverse Reactions (6.2) ] . Hypersensitivity to any component of this product. ( 4 )

• Contamination of Solution: Do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 )
• Contact Lens Wear: Bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation. ( 5.2 )

5.1Contamination of Tip and Solution

To minimize contaminating the dropper tip and solution, advise the patient not to touch the eyelids or surrounding areas with the dropper tip of the bottle and to keep the bottle tightly closed when not in use.

5.2Contact Lens Wear

Bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation. Bepotastine besilate ophthalmic solution should not be instilled while wearing contact lenses. Patient should remove contact lenses prior to instillation of bepotastine besilate ophthalmic solution, because benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of bepotastine besilate ophthalmic solution.

8.1Pregnancy Risk Summary

There are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. Oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. Maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m 2 basis) [see Data] .