BEPREVE

Instill one drop of BEPREVE into the affected eye(s) twice a day. Remove contact lenses prior to instillation of BEPREVE.

Ophthalmic solution containing bepotastine besilate 15 mg/mL (1.5%).

BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients

BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of  BEPREVE contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is:

Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. BEPREVE ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of  BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is approximately 295 mOsm/kg.

Each mL of  BEPREVE (bepotastine besilate ophthalmic solution) 1.5% contains:

Clinical efficacy was evaluated in two conjunctival allergen challenge (CAC) studies (237 patients). BEPREVE (bepotastine besilate ophthalmic solution) 1.5% was more effective than its vehicle for relieving ocular itching induced by an ocular allergen challenge, both at a CAC 15 minutes post-dosing and a CAC 8 hours post-dosing of  BEPREVE.

The safety of  BEPREVE was evaluated in a randomized clinical study of 861 subjects over a period of 6 weeks.

BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is supplied in a white low density polyethylene bottle with a sterile linear low density polyethylene controlled dropper tip and a white polypropylene cap in the following sizes:

NDC 24208-629-02 5 mL Bottle

Store at 15°C to 25°C (59°F to 77°F).

9291104 (folded)

BEPREVE

(bepotastine besilate

Sterile