Bepreve
Generic Name: bepotastine besilate ophthalmic solution
Date of Approval: September 8, 2009
Company: ISTA Pharmaceuticals, Inc.
FDA Approves Bepreve
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The U.S. Food and Drug Administration (FDA) has approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.
What is Bepreve?
Bepreve (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.
How Do I Use Bepreve?
Instill one drop of Bepreve into the affected eye(s) twice a day (BID).
Warnings and Precautions
To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.
Bepreve should not be used to treat contact lens-related irritation.
Remove contact lenses prior to instillation of Bepreve.
Bepreve Side Effects
The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
Highlights of Prescribing Information
These highlights do not include all the information needed to use Bepreve (bepotastine besilate ophthalmic solution) 1.5% safely and effectively. See full prescribing information for Bepreve.
Indications and Usage
Bepreve is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Dosage and Administration
Instill one drop into the affected eye(s) twice a day (BID).
Dosage Forms and Strengths
Solution containing bepotastine besilate, 1.5%.
Warnings and Precautions
- To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.
- Bepreve should not be used to treat contact lens-related irritation.
- Remove contact lenses prior to instillation of Bepreve.
Adverse Reactions
The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
To report SUSPECTED ADVERSE REACTIONS, contact ISTA Pharmaceuticals, Inc. at 1-877-788-2020, or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.
Patient Counseling Information
Topical Ophthalmic Use Only
For topical ophthalmic administration only.
Sterility of Dropper Tip
Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
Concomitant Use of Contact Lenses
Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that Bepreve should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Bepreve. The preservative in Bepreve, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bepreve.
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