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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™.
BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5%
Initial U.S. Approval: 2009

DESCRIPTION

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.

Clinical pharmacology

CLINICAL PHARMACOLOGY
Mechanism of Action
Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.

Indications and usage 

INDICATIONS AND USAGE

BEPREVE™ is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.

Contraindications

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Precautions

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

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.

Dosage and administration 

DOSAGE AND ADMINISTRATION

Instill one drop into the affected eye(s) twice a day (BID).

How supplied

DOSAGE FORMS AND STRENGTHS

Solution containing bepotastine besilate, 1.5%.

Reference

Package Insert data: 

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5%