Bepotastine Besilate (bepotastine besilate)

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.

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.

Bepotastine besilate is for topical ophthalmic use only.

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No dosing information is available for this tab.

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.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

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.

Rare or Very Rare

• Tongue swelling

More Frequent

• Dysgeusia

Less Frequent

• Headache disorder
• Ocular irritation
• Pharyngitis

Rare or Very Rare

• Edema
• Pruritus of skin
• Skin rash

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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.

Category C. (See Users Guide.)

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.

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