Bepotastine Besilate
Bepotastine Besilate Prescribing Information
Bepotastine besilate ophthalmic solution, 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
Instill one drop of bepotastine besilate ophthalmic solution into the affected eye(s) twice a day.
Remove contact lenses prior to instillation of bepotastine besilate ophthalmic solution.
Ophthalmic solution containing bepotastine besilate 15 mg/mL (1.5%).
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/m2 basis)
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
Bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients
Hypersensitivity reactions have been reported rarely during the post-marketing use of bepotastine besilate ophthalmic solution. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat.
• Contamination of Solution: Do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. ()5.1 Contamination of Tip and SolutionTo 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.
• Contact Lens Wear: Bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation. ()5.2 Contact Lens WearBepotastine 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.