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brand bepreve 1.5% eye drops

In stock Manufacturer VALEANT/BAUSCH 24208062902
$232.50 / 5 Milliliters Drop Btl

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Uses

Allergic Conjunctivitis

Bepotastine besilate is used for the symptomatic treatment of ocular itching associated with allergic conjunctivitis.

Clinical efficacy of bepotastine besilate was evaluated in 2 randomized, double-blind, placebo-controlled conjunctival allergen challenge (CAC) studies in 237 adults and pediatric patients 10 years of age or older with a history of allergic conjunctivitis. Bepotastine besilate 1.5% ophthalmic solution was more effective than vehicle for relieving ocular itching, but not conjunctival hyperemia, induced by an ocular allergen instilled into the conjunctival sac at 15 minutes and 8 hours following administration of the ophthalmic solution. Clinical trials establishing comparative efficacy of bepotastine besilate and other topical agents used in the treatment of allergic conjunctivitis are lacking.

The safety of bepotastine besilate 1.5% ophthalmic solution (administered twice daily) was evaluated in a multicenter, randomized double-blind, placebo-controlled clinical study of 861 healthy individuals (including 127 healthy children 3-9 years of age) over a period of 6 weeks. No adverse ocular effects or serious adverse events were reported.

Dosage and Administration

Administration

Bepotastine besilate is applied topically to the eye as an ophthalmic solution.

The manufacturer states that bepotastine besilate ophthalmic solution should not be used for the symptomatic management of contact lens-related irritation. Patients should be advised not to wear their contact lenses if their eye(s) are red. Patients should also be advised to remove their contact lenses prior to administration of bepotastine besilate ophthalmic solution because the solution contains benzalkonium chloride, which may be absorbed by some soft contact lenses. Patients whose eyes are not red may reinsert their lenses after 10 minutes following administration of the ophthalmic solution.

Dosage

The recommended dosage of bepotastine besilate for the symptomatic treatment of ocular itching associated with allergic conjunctivitis in adults and children 2 years of age and older is 1 drop of a 1.5% solution in the affected eye(s) twice daily.

Cautions

Contraindications

The manufacturer states that there are no known contraindications to the use of bepotastine besilate ophthalmic solution.

Warnings/Precautions

Administration

Bepotastine besilate is for topical ophthalmic use only.

Proper Handling to Avoid Contamination

To minimize the risk of contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. The container should be tightly closed when not in use.

Contact Lenses

Bepotastine besilate ophthalmic solution should not be used for the symptomatic management of contact lens-related irritation. Patients should be advised not to wear their contact lenses if their eye(s) are red. Because the preservative in the ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses, patients should be advised to remove their contact lenses prior to instillation. Patients whose eyes are not red may reinsert their lenses after 10 minutes following administration of the drug.

Specific Populations

Pregnancy

Category C.

Lactation

Bepotastine besilate is distributed into milk in rats following oral administration. It is not known whether bepotastine besilate is distributed into human milk. Caution is advised if the drug is administered in nursing women.

Pediatric Use

Safety and efficacy of bepotastine besilate ophthalmic solution have not been established in pediatric patients younger than 2 years of age. Efficacy in pediatric patients younger than 10 years of age was extrapolated from clinical trials conducted in adults and pediatric patients older than 10 years of age.

Geriatric Use

No overall differences in efficacy or safety were observed between geriatric and younger patients.

Common Adverse Effects

The most common adverse effect reported in individuals receiving bepotastine besilate ophthalmic solution is mild taste following instillation, which occurs in approximately 25% of individuals receiving the drug. Other adverse effects occurring in 2-5% of individuals receiving the drug include ocular irritation, headache, and nasopharyngitis.

Drug Interactions

Results of in vitro studies indicate that bepotastine besilate does not inhibit the metabolism of various cytochrome P-450 (CYP) substrates via inhibition of CYP isoenzymes 3A4, 2C9, and 2C19. The effect of bepotastine besilate on the metabolism of substrates of CYP isoenzymes 1A2, 2C8, and 2D6 has not been established. Bepotastine besilate has a low potential for drug interactions via inhibition of CYP isoenzymes 3A4, 2C9, and 2C19.

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