BEPREVE

Last Updated: December 22, 2009

 

Manufacturer: ISTA Pharmaceuticals Pharmacological Class: Antihistamine/mast cell stabilizer Active Ingredient(s): Bepotastine besilate 1.5%; oph soln; contains benzalkonium chloride.

Indication(s):

Treatment of itching due to allergic conjunctivitis.

Pharmacology:

Bepotastine is a topically-active histamine H₁ blocker that inhibits the release of histamine from mast cells. Its mechanism of action also includes the suppression of eosinophil migration into inflamed tissues.

Clinical Trials:

Two clinical trials involving 237 patients were conducted to evaluate the efficacy of bepotastine in the relief of ocular itching due to conjunctivitis. In these conjunctival allergen challenge studies, bepotastine besilate 1.5% ophthalmic solution was more effective than vehicle for relieving ocular itching induced by ocular allergen challenges, at both 15 minutes post-dose and at 8 hours post-dose.

Legal Classification:

Rx

Adults & Children:

<2yrs: not recommended. ≥2yrs: 1 drop in affected eye(s) twice daily.

Precaution(s):

Remove contact lenses; may reinsert 10 minutes after dosing if eye is not red. Pregnancy (Cat.C). Nursing mothers.

Adverse Reaction(s):

Mild taste, eye irritation, headache, nasopharyngitis.

How Supplied:

Soln—10mL

Last Updated:

12/22/2009